News

PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 ...

Trial shows Vascazen (Pivotal Therapeutics) effective in altering cholesterol levels in patients with CV Risk

A trial has demonstrated that Vascazen (omega-3 oil), from Pivotal Therapeutics, is highly effective in correcting an omega-3 deficiency. The company suggests this could have benefits for people at risk of developing CardioVascular Disease. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA ...

FDA approves Ilesto 7 ICD/CRT-D (Biotronik) for patients with Heart Failure

The FDA has granted approval for the Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, for patients who need resynchronisation therapy. The device is one of the world's smallest ICDs and uses ProMRI technology, which enables access to MR scans. Patients also benefit from secure remote monitoring via Biotronik's Home Monitoring system to improve diagnosis. The Ilesto ...

FDA approves Viva and Evera defibrillators for Heart Failure

Medtronic, Inc. announced FDA approval and U.S. launch on 6 May 2013 of its newest cardiac devices: the Viva portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera portfolio of implantable cardioverter-defibrillators (ICD).

The Viva CRT-D significantly improves response rate to the therapy for many indicated Heart Failure patients, with a demonstrated 21 percent reduction in overall ...

Four year follow up on EVEREST II study of Mitra Clip (Abbott)

Four-year follow-up of the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) show no differences in the primary end point between the Mitra Clip (Abbott) procedure and surgery and significantly more follow-up surgeries for residual mitral regurgitation (MR) in the clip group.At four years, surgery for mitral-valve dysfunction was needed for one out of every four patients treated with the ...

Phase III trial shows benefits of Resolute ZES (Medtronic) in CAD patients with Diabetes

New data shows that treatment with the Resolute (zotarolimus-eluting stent), from Medtronic, led to positive outcomes for CAD patients with Diabetes who were not taking insulin and for CAD patients without Diabetes. It presents the results of two analyses from the Phase III RESOLUTE program, which enrolled a total of 5,130 patients. This set a 12-month target vessel failure (TVF) ...

REMEDEE study of COMBO Dual Therapy Stent (Orbus Neich) meets primary endpoint

Data from the REMEDEE study of the COMBO Dual Therapy Stent, from Orbus Neich, demonstrated that the stent met the study's primary endpoint in CAD patients and was found to be effective in controlling neointimal proliferation. Specifically, the COMBO Stent was shown to be non-inferior to a drug eluting stent (DES) with respect to angiographic in-stent late lumen loss at ...

EMA Pharmacovigilance Risk Assessment Committee recommends restrictions on Protelos (Servier) as a treatment for Osteoporosis

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended restrictions in the use of Protelos/Osseor (strontium ranelate) from Servier, following the evaluation of data showing an increased risk of heart problems, including heart attacks. It will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.

Phase II study of CQR 1 (Cardio3Biosciences) published in Journal of the American College of Cardiology

Results from a Phase II prospective, multicenter, randomized study to evaluate the feasibility, safety, and efficacy of CQR 1 (formerly C-CURE), from Cardio3Biosciences in the treatment of patients with chronic Heart Failure secondary to ischemic cardiomyopathy have been published in the Journal of the American College of Cardiology. The paper shows a statistically significant improvement in cardiac function for the ...

IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The Institute for Quality and Efficiency in Healthcare (IQWiG)in Germany said that Eliquis (apixaban) from BMS and partner Pfizer Inc.has "significant" additional benefit to prevent Stroke and Systemic Embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors -- an indication approved by the European Commission in November.

IQWiG said Eliquis provides "significant" additional ...

CHMP recommends Xarelto (Bayer) for prevention of atherosclerotic events after ACS

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events (myocardial infarction, cardiovascular death or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ...

FDA approves AdreView (GE HealthCare) for gamma scintigraphic assessment of Heart Failure

The FDA has on 22 March 2013, approved an extension to the indication of AdreView (Iobenguane I 123 Injection) from GE HealthCare for the scintigraphic assessment of Myocardial Sympathetic Innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III Heart Failure and Left Ventricular Ejection Fraction (LVEF) ...

FDA Advisory Committee recommends MitraClip (Abbott Vascular)to treat Mitral Regurgitation

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has on 20 March 2013, voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device from Abbott Vascular, outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high ...

Orbit Artherectomy System (Cardiovascular Systems) filed at FDA to treat Calcified Arteries

Cardiovascular Systems (CSI) has announced it has submitted its Premarket Approval (PMA) application to the FDA for its Orbital Atherectomy System, used to treat calcified coronary arteries.

The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI's technology ...

Inspra(Pfizer) success in REMINDER trial for acute STEMI patients

Pfizer Inc. announced results from the REMINDER trial of Inspra (eplerenone) showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of Heart Failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) 40% ...

EU approves Carotid Embolic Protection Stent (InspireMD) for Stroke prevention

InspireMD's Carotid Embolic Protection Stent has received CE mark approval in the EU. It is based on MicroNet mesh technology, designed to provide procedural and post-procedural distal embolic protection in carotid artery stenting procedures to reduce the risk of Stroke. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris ...

Phase III trial of Aranesp (Amgen) in anemic Heart Failure patients shows drug offers no real benefit

Results from the RED-HF trial involved 2,278 anemic Heart Failure patients given either Aranesp (darbepoetin alfa), from Amgen, or placebo shows the drug does not improve patients' health, nor does it reduce their risk of death from Heart Failure. In the darbepoetin alfa group, 50.7 percent of the patients experienced death from any cause or hospitalization for worsening Heart Failure. ...

STREAM Trial shows that Metalyse/TNKase (Boehringer) offers some benefits in STEMI patients

Results from the STREAM trial of 1,915 patients with ST-elevation myocardial infarction (STEMI), given Metalyse/TNKase (tenecteplase), from Boehringer, indicates that the drug offers some benefits compared to alternative PCI treatment. Patients were seen in community hospitals or by emergency medical personnel where angioplasty was not possible. Before transfer, subjects were randomized to either percutaneous coronary intervention immediately after arrival or ...

Study shows Metalyse/TNKase (Boehringer) benefits patients with Pulmonary Embolism

A new study shows that in patients with Acute Pulmonary Embolism, Metalyse/TNKase (tenecteplase), from Boehringer, prevents death or circulatory collapse and is particularly effective for patients aged below 75 years. The prospective, randomized, double blind PEITHO study enrolled 1,006 patients with confirmed APE. Patients were assigned heparin plus tenecteplase or heparin plus placebo. The primary endpoint was death from any ...

CHAMPION PHOENIX Phase III trial of cangrelor (Medicines Company) success in PCI

The Medicines Company has reported results of CHAMPION PHOENIX, a 11,145 patient Phase III randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing Percutaneous Coronary Intervention (PCI).

Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ...

Positive results in three-year trial of Absorb Vascular Scaffold (Abbott)

Three-year results from 101 patients treated with the Absorb Vascular Scaffold (bioresorbable everolimus eluting stent system), from Abbott, in the second stage of the ABSORB trial show that improvements are seen in blood vessel movement and area inside the vessel where the scaffold was placed. Results showed the rate of major adverse cardiovascular events (MACE) in 101 patients was 10 ...

Ranexa(Gilead Sciences) success in Phase IV TERISA trial to treat Chronic Stable Angina in diabetic patients.

Gilead Sciences, has announced data from the Phase IV TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of Ranexa (ranolazine) to background antianginal therapy in chronic angina patients with Type 2 Diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Results ...

Xarelto(Bayer/Janssen) initiates trial for non valvular Atrial Fibrillation

Bayer HealthCare announced the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto (rivaroxaban) to investigate how best to treat patients with non-valvular Atrial Fibrillation who undergo Percutaneous Coronary Intervention with stent placement.

The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two ...

Promus Element stent (Boston Scientific) continues to outperform the Xience V stent at 3 years

At three years, the Promus Element everolimus eluting stent, from Boston Scientific, continued to demonstrate advantages for CAD patients over the Xience V Stent. The trial reported a three-year target lesion revascularization (TLR) rate of 3.5 percent for the Promus Element Stent, the lowest TLR rate in any pivotal FDA approval trial, compared to 4.9 percent for the Xience V ...

Trial of Stentys self-apposing stent (Stentys) demonstrates low mortality rates in CAD patients

One-year results of the APPOSITION III clinical trial in 1000 CAD patients post treatment of a severe heart attack show that the Stentys Self-Apposing Stent, from Stentys, demonstrates low mortality rates in patients. The APPOSITION III trial is a prospective single-arm multi-center study designed to assess the long term performance of Stentys Self-Apposing Stents in routine clinical practice in Europe ...

PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients

New results on the PREVAIL trial, which randomized 407 patients with nonvalvular Atrial Fibrillation to either LAA closure with the Watchman device, from Boston Scientific or warfarin, indicates the study has met 2 of its 3 primary end points. Data shows that the device was implanted more successfully in the trial (95.1%) than in 2 prior Watchman studies: PROTECT AF ...

Tredaptive (Merck Inc) fails to meet primary end point in HPS2-THRIVE Dyslipidaemia trial

Detailed results of HPS2-THRIVE, a study of Tredaptive (nicotinic acid plus laropiprant), from Merck Inc, in 25673 patients with Dyslipidaemia suggests adding Tredaptive to statin therapy did not significantly further reduce the risk of major vascular events. In the trial the composite primary endpoint of major vascular events (coronary death non-fatal heart attack stroke or any arterial revascularization) occurred in ...

MitraClip System (Abbott Vascular) success in EVEREST II trial for reatment of Mitral Regurgitation

Abbott announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip System for the treatment of Mitral Regurgitation (MR). Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco

Results showed: A 30-day mortality rate significantly lower than ...

Xarelto enters Phase III trial for Heart Failure and CAD

Bayer HealthCare and Janssen Research & Development, LLC announced the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with Chronic Heart Failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for ...

Study reveals mechanism providing benefit of omega-3 fatty acids on Cardiovascular health

A new study has uncovered a mechanism by which omega-3 fatty acids can benefit Cardiovascular health. Prof. Heinemann (Jena University), Prof. Dr. Michael Bauer (Jena University Hospital) and Prof. Dr. Toshinori Hoshi (University of Pennsylvania) have shown that the 'SLO1' potassium channel is an important component in the effectiveness of omega-3 fatty acids. These ionic channels act like very specific ...

FDA rejects again Xarelto ( Janssen/Bayer) for treatment of Acute Coronary Syndrome

The FDA has rejected for the second time, the supplemental new drug application for Xarelto (rivaroxaban) from Janssen Pharma/Bayer as a therapy to reduce the risk of cardiovascular events in patients with Acute Coronary Syndrome (ACS). The drug was rejected last June after the Cardiovascular and Renal Drugs Advisory Committee a month earlier voted 6-4, with one abstention, against approval ...

FDA awards "Generally Recognized as Safe" status to Cardioviva (Micropharma) to help reduce bad cholesterol

The FDA have awarded heart health probiotic, Cardioviva (Lactobacillus reuteri NCIMB 30242), from Micropharma Ttd, with "Generally Recognized as Safe" (GRAS) status. This designation signifies that Cardioviva is considered safe by experts to use as an ingredient in food. Of the top 10 probiotic supplements in the US, Cardioviva is one of two to achieve FDA's GRAS approval.

The specific ...

EU approves Promus Premier Stent (Boston Scientific) for treating CAD

Boston Scientific has received CE Mark approval for the Promus Premier everolimus-eluting platinum chromium Coronary Stent System, the company's next-generation polymer drug-eluting stent (DES) technology for treating Coronary Artery Disease, and is starting its European market launch. The Promus Premier features a customized Platinum Chromium (PtCr) stent architecture, the everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery ...

Chelsea to re-file Northera at FDA for Symptomatic Neurogenic Orthostatic Hypotension

Chelsea Therapeutics International, Ltd. has received written guidance from the Director of the Office of New Drugs at the FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera (droxidopa) New Drug Application (NDA) for the treatment of Symptomatic Neurogenic Orthostatic Hypotension (NOH). The guidance suggests that "data strongly demonstrating ...

Two trials demonstrate benefits of Pradaxa/Rendix (Boehringer) for patients with VTE

New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE, show that Pradaxa/Rendix (dabigatran etexilate), from Boehringer, reduces the risk of recurrent Venous ThromboEmbolism (VTE). RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent ...

St.Jude Medical initiates trial of EnligHTN system for CV Risk reduction

St. Jude Medical, Inc. has announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood pressure. The EnligHTNment trial is the first large-scale study that will examine the long-term effects of the EnligHtN System of renal denervation in patients who have uncontrolled hypertension to see ...

FDA approves Aorfix (Lombard Medical) for treatment of Abdominal Aortic Aneurysms

Lombard Medical Technologies PLC, the specialist medical technology company focused on innovative vascular products, announced on 15 February 2013 that Aorfix has been approved for commercial sale in the U.S. by the FDA.

Aorfix is a flexible stent graft for the endovascular repair of Abdominal Aortic Aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix, has demonstrated that ...

EU approves Ilesto 7 (Biotronik) for patients with Heart Failure

The Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, has received CE approval in the EU for patients with Heart Failure who require resynchronisation therapy. The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI technology, which enables access to potentially life-saving MR scans. The Ilesto offers patients and physicians the greatest longevity ...

Treprostinil diolamine extended release tablets (United Therapeutics) re-filed at FDA for treatment of PAH

United Therapeutics Corporation has announced that the FDA has acknowledged the re-submission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension. The FDA classified the re-submission as a complete, class 1 response to the FDA Complete Response Letter and set a user fee goal date of March 31, ...

Bayer files riociguat for CTEPH and Pulmonary Arterial Hypertension at FDA and EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) for regulatory approval in the United States and in the European Union. Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase. Riociguat ...

Success for Solitaire FR (Covidien) in STAR revasculization study

Covidien reports results from the two year Solitaire FR Thrombectomy for Acute Revasculization study(STAR study). The prospective, multi-center, single arm clinical study started with an enrollment of 202 patients at 14 centers across Europe, Australia and Canada in May 2010. In the study, patients diagnosed with Acute Ischaemic Stroke (AIS) (as confirmed by radiographic assessment) were treated with the ...

StJude Medical expands scope of EnligHtN RDS system in uncontrolled Hypertension with EnligHTN II trial

St. Jude Medical, Inc. has announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN Renal Denervation System in patients with uncontrolled hypertension.The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all ...

FDA approves Kynamro (Genzyme/Sanofi) to treat Homozygous Familial Hypercholesterolemia

The FDA 0n 29 January 2013 approved Kynamro (mipomersen sodium) injection, from Genzyme/Sanofi, as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).

HoFH, an ...

Novartis withdraws application at EMA for Ruvise treatment for PAH

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100- and 400-mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of Pulmonary Arterial Hypertension.

The company stated that it is ...

NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention

NICE (The National Institute of Health and Clinical Excellence) has recommended the oral anticoagulant Eliquis (apixaban) from BMS and Pfizer, as an option for Prevention of Sroke and Systemic Embolism in people with non-valvular Atrial Fibrillation with one or more risk factors.

The NICE appraisal committee considered that Eliquis was cost effective and more clinically effective for reducing stroke and ...

EU approves Tresiba and Ryzodeg (Novo Nordisk) for Diabetes

Novo Nordisk has announced that the European Commission on 21 January 2013, has granted marketing authorisations for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of Diabetes in adults. The authorisations cover all 27 European Union member states.

Tresiba, the brand name for insulin degludec, is a once-daily new-generation basal insulin analogue with an ultra-long duration ...

CE Mark granted to st Jude Medical for Amplatzer LAA Occluder

European CE Mark approval is granted to St. Jude Medical for its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot ...

Aranesp (Amgen) fails Heart Failure trial

Amgen announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target ...

Merck Inc,. withdraws Tredaptive treatment for Dyslipidaemia

Merck Inc.,announced that it is taking steps to suspend the availability of Tredaptive (extended-release niacin/laropiprant) tablets worldwide. Tredaptive is not approved for use in the United States.

Merck is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, ...

Cangrelor(The Medicines Company) success in Phase III trial for PCI

The Medicines Company has announced results for its pivotal Phase III clinical trial of cangrelor, which is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Following the recommendation of the trial's Data Safety Monitoring Board (DSMB) in July 2012 to continue the protocol ...

Study finds CholestOff (Nature Made) reduces Cholesterol levels in patients with CV risk

A new study suggests CholestOff, a sterol/stanol ester-based softgel capsule, from Nature Made, offers benefits for decreasing LDL cholesterol in individuals with high Cholesterol levels. The randomized, placebo-controlled, crossover trial lasted 17 weeks during which all subjects followed a heart healthy diet (National Cholesterol Education Program TLC Diet). One group received a sterol/stanol softgel for 6 weeks while the other ...

Phase II success for AT 2220 in Pompe Disease

Amicus Therapeutics has announced positive preliminary results from all 4 dose cohorts in a Phase II study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT 2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme and Lumizyme). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are ...

FDA approves Xience Xpedition everolimus eluting cardiac stent (Abbott Vascular)

Abbott Vascular has announced that the Xience Xpedition Everolimus Eluting Coronary Stent System has received FDA approval and is launching immediately in the United States , providing physicians with a next-generation technology with the largest size matrix in the U.S. market.

Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies. ...

FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism

The FDA on 28 December 2012 approved the anti-clotting drug Eliquis (apixaban) from BMS/Pfizer, an oral tablet used to reduce the risk of Stroke and dangerous blood clots (Systemic Embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by ...

FDA approves Juxtapid (Aegerion Pharma) for patients with Homozygous Familial Hypercholesterolemia

The FDA has approved Juxtapid (lomitapide), from Aegerion Pharma, as an adjunct to diet and other lipid-lowering treatments to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with Homozygous Familial Hypercholesterolemia (HoFH). The FDA based its approval on a pivotal Phase III study, which evaluated the safety and effectiveness of ...

Tredaptive (Merck Inc) fails in HPS2-THRIVE trial

The HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck Inc., and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to ...

Migalastat (Amicus/GSK) disappoints in Phase III trial for Fabry Disease

Amicus Therapeutics and GSK announced the 6-month primary treatment period results from the first Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy in males and females with Fabry Disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay.

GL-3 clearance from the kidney interstitial capillaries is used as a ...

Further positive results for Symplicity (Medtronic) Renal Dernervation System

Medtronic, Inc. has announced one-year results from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation for Resistant Hypertension, that were published online before print in Circulation, the Journal of the American Heart Association.

These data showed patients who initially received treatment with the Symplicity renal denervation system (n=47) sustained a significant drop in blood pressure (-28/-10 ...

FDA approves Iclusig(Ariad Pharma) for CML and Ph+ ALL

Ariad Pharmaceuticals Inc. announced that following a priority review, the FDA on 14 December 2012, has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase Chronic Myeloid Leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that ...

New assessment of evidence for the effectiveness of TAVI rates the technique's benefits as 'moderate'

The ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, has evaluated the evidence behind the use of the only transcatheter heart valve approved for marketing in the US and Europe in transcatheter aortic valve implantation (TAVI). Based on the results of its systematic search of the literature for clinical studies that compared the device ...

CHMP rejects Kynamro (Sanofi) for treatment of Homozygous Familial Hypercholesterolemia

Genzyme, a Sanofi company and Isis Pharmaceuticals Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH). Genzyme plans to request a re-examination of the CHMP Opinion....

The Medicines Company and BMS collaborate in marketing Recothrom for Haemostasis.

The Medicines Company and Bristol-Myers Squibb Company announced that the companies have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures.Recothrom was approved by the FDA in January 2008 and is marketed in Canada by Bayer HealthCare....

Positive data from Phase III study of Eliquis (BMS/Pfizer) for VTE prevention

Results of the Phase III AMPLIFY-EXT trial evaluating Eliquis (apixaban), from BMS/Pfizer, vs placebo for preventing VTE, shows it demonstrated superiority in reducing recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis groups. Eliquis also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and ...

FDA approves Evarrest (Ethicon Biosurgery) for problematic bleeding during Surgery

The FDA has approved Evarrest fibrin sealant patch, from Ethicon Biosurgery, a product that rapidly aids in stopping problematic bleeding during Surgery. Evarrest consists of a coating of biologics and a flexible patch that work together to encourage the hemostasis process. Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard ...

EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of ...

FDA give 510(k) approval for NeuViz 64 CT Imaging System (Neusoft Medical)

The NeuViz 64 multi-slice CT scanner (Neusoft Medical) has received FDA 510(k) clearance. The NeuViz 64 design delivers low-dose scanning, high patient throughput, and performs advanced Cardiac Imaging along with a wide variety of clinically-relevant post processing and diagnostic techniques. Neusoft Medical is based in Shenyang, China. In 2004, Neusoft Medical Systems signed a joint venture with Philips (Netherlands) to ...

New analysis explains competing findings in studies of omega-3 fatty acids and impact on CV Risk

A new analysis has sorted through many of the competing findings from studies of omega-3 fatty acids, and helps to explain why so many of the studies seem to arrive at differing conclusions.

The study, by scientists in the Linus Pauling Institute at Oregon State University and published in the Journal of Lipid Research, concludes that both fish consumption and ...

Actelion submits Opsumit to EMA for treatment of PAH

Actelion has announced that the submission of the Marketing Authorisation Application for macitentan (Opsumit) for the treatment of patients with Pulmonary Arterial Hypertension to the EMA has been accepted. The FDA had already received the registration dossier on October 22nd 2012.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome ...

Phase III trial succes for perindopril/amlodipine combination (Xoma) for Hypertension

Xoma Corporation has announced the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC, containing a patent-protected proprietary form ...

Study shows benefits of high dose treatment with HeartLight (CardioFocus) for patients with AF

New data demonstrates the benefits of high-dose laser ablation using the HeartLight endoscopic ablation system, from CardioFocus, compared to low-dose treatment in patients with Atrial Fibrillation. Using the HeartLight System, investigators in Frankfurt, Germany were able to achieve an acute pulmonary vein isolation (PVI) rate of 89% after an initial visually guided ablation circle and reported a long-term clinical success ...

European Commission approves Xarelto (Bayer) for PE and treatment of recurrent Deep Vein Thrombosis

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission (EC) for the treatment of Pulmonary Embolism (PE) and the prevention of Recurrent Deep Vein Thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the EU. The approval of rivaroxaban for the treatment of PE and ...

Study suggests probiotic Cardioviva (Micropharma) can help reduce bad cholesterol in blood

A new study suggests that a probiotic Cardioviva (lactobacillus reuteri), from Micropharma, can lower key cholesterol-bearing molecules in the blood as well as "bad" and total cholesterol in patients with high cholesterol. The study involved 127 adult patients with high cholesterol. About half the participants took L. reuteri NCIMB 30242 twice a day, while the rest were given placebo capsules. ...

Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the ...

FDA Advisory Committee recommends Tresiba and Ryzodeg for Types 1 and 2 Diabetes

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has unanimously recommended that a cardiovascular outcomes trial should be conducted regarding the New Drug Applications (NDA) for Tresiba (insulin degludec )and Ryzodeg (insulin degludec/insulin aspart), and voted 8-4 in favor of approving the products with a post-approval outcomes trial commitment...

Boston Scientific acquires Vessix Vascular and its renal denervation system for Hypertension

Boston Scientific has acquired Vessix Vascular and with it the Vessix V2 Renal Denervation System for the treatment of Hypertension.Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The Vassix system now has CE Mark approval and is approved in Australia...

FREEDOM study finds that CABG has better outcomes than PCI in diabetic patients with Coronary Disease

The FREEDOM study of 1900 patients over 5 years was funded by the National Heart,Lung and Blood Institute and found that for patients with diabetes and advanced coronary disease, coronary bypass surgery grafting (CABG) has a better outcome than percutaneous coronary intervention (with stents) (PCI).After five years, the CABG group had a lower combined rate of strokes, heart attacks, and ...

RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure

RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 ...

Positive results comparing programming of S-ICD and CRT-D defibrillators (Boston Scientific) in patients at risk of Cardiac Arrest

New results from the MADIT-RIT clinical trial demonstrated improved programming of Boston Scientific dual-chamber implantable cardioverter defibrillator (S-ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death. MADIT-RIT is a prospective randomized three-arm trial comparing conventional programming with two alternative settings: a high-rate therapy arm and a duration-delay arm. It evaluated 1,500 primary ...

Positive results in Phase III study of lomitapide (Aegerion Pharmaceuticals) for Homozygous Familial Hypercholesterolemia

New results from a Phase III clinical trial of lomitapide, from Aegerion Pharmaceuticals, show it substantially and stably reduced LDL cholesterol in patients with the orphan disease Homozygous Familial Hypercholesterolemia (HoFH). Twenty-nine adult HoFH patients from across the world were enrolled, with 23 patients completing both the efficacy and the safety phases. All of the patients received lomitapide along with ...

AMG 145 (Amgen) success in RUTHERFORD study for HeFH

Amgen has announced that treatment with AMG 145 in combination with statin therapy, with or without ezetimibe, resulted in a reduction in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, by up to 56 percent in patients with heterozygous familial hypercholesterolemia (HeFH) in the Phase II RUTHERFORD study.

AMG 145 is an investigational fully human monoclonal antibody directed against PCSK9, ...

AMG 134 success in GAUSS study in patients intolerant of statins

Amgen has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins. Reductions of up to 51 percent were observed in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, with AMG 145 and 63 percent with the combination of AMG 145 and ezetimibe, compared to 15 percent with ezetimibe alone. ...

Epanova (Omthera Pharma) successes in EVOLVE and ESPIRIT trials for Dyslipidaemia

Omthera Pharmaceuticals, announced that Phase III results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertrRglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints. Highlights: • Epanova significantly lowers triglycerides (TG) and reduces Non-HDL-C, widely believed to be the most accurate predictor ...

FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure

Maquet Cardiovascular has received 510(k) clearance from the FDA and CE mark approval in the EU for its new Sensation Plus 40cc intra-aortic balloon (IAB) catheter. IAB therapy is used in patients with left ventricular failure and other cardiac conditions to augment coronary blood flow and to increase myocardial oxygen supply and decrease myocardial oxygen demand. This new larger-volume, fiber-optic ...

Study shows second generation drug-eluting stents are safe and effective

A study found that second-generation drug-eluting stents are safe and effective in the treatment of left main coronary artery lesions. The ISAR-LEFT MAIN 2 trial is the first and largest multicenter comparison trial between second-generation zotarolimus-eluting (ZES) and everolimus-eluting stents (EES) in invasive treatment of unprotected left main coronary artery (uLMCA) lesions.

The incidence of major adverse cardiac events (MACE) ...

Clear benefits of transcatheter aortic valve replacement for patients with Aortic Valve Disease

A study found that transcatheter aortic valve replacement (TAVR) yielded lower mortality rates after three years compared with medical therapy in patients deemed to be ineligible for conventional Aortic Valve surgery. A total of 358 patients underwent randomization at 21 centers. According to results of the PARTNER Cohort B trial, the Kaplan Meier estimated rates of death at three years ...

FDA approves Affinity Pixie Oxygenation System (Medtronic Inc) for use in Heart Surgery on children

The FDA have given 510(k) clearance for the Affinity Pixie Oxygenation System, from Medtronic Inc, for use during lifesaving open-heart (cardiopulmonary bypass) surgeries in neonates, infants and small children, including those with congenital heart defects. The Affinity Pixie Oxygenation System serves as a child’s lungs during open-heart surgery by removing carbon dioxide and adding oxygen to the child’s blood before ...

Sideguard coronary stent success in Coronary Bifurcation Disease

Cappella Medical Devices Ltd a company developing solutions for the treatment of Coronary Bifurcation Disease, has announced the multicenter long term follow up results for its innovative Sideguard coronary sidebranch stent . Long term follow up data on the Sideguard stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 ...

Positive results for Phase III trial of BAY 63-2521 (Bayer HealthCare) in patients with CTEPH

Data from the Phase III CHEST-1 trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery showed the study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance. In the CHEST-1 study, 261 patients with inoperable CTEPH ...

Oral Treprostinal (United Therapeutics) attracts Complete Response Letter from FDA

A Complete Response Letter was received by United Therapeutics from the FDA declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension (PAH).

The FDA letter questioned the clinical importance of the 6 Minute Walk Distance (6MWD) effect size shown in the FREEDOM-M study, the ...

Actelion files Opsumit at FDA for treatment of PAH

Actelion has announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for macitentan Opsumit (macitentan)for the treatment of patients with Pulmonary Arterial Hypertension.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN, in which 742 patients suffering from pulmonary arterial hypertension ...

NICE positive for Procoralan (Servier) for Heart Failure

The National Institute for Health and Clinical Excellence (NICE) has now published final draft guidance recommending Procoralan (ivabradine) from Servier Labs, as an option for treating Chronic Heart Failure, specified as NYHA class II to IVi. It has, however, stipulated that the drug should only be used in patients with systolic dysfunction, those who are in sinus rhythm, when ...

Phase III trial of BAY 63-2521 (Bayer HealthCare) for PAH meets primary endpoint

The Phase III PATENT-1 Pulmonary Arterial Hypertension (PAH) trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid has met its primary endpoint. PATENT is an international program with active centers in 32 countries. It includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1) ...

CHMP recommends Tresiba (Novo Nordisk) for treatment of Diabetes

The CHMP has made recommendation for Tresiba (insulin degludec), a new basal analogue insulin from Novo Nordisk, for the treatment of Diabetes mellitus in adults. It is introduced in a pre-filled pen in two formulations – 100 units/ml and 200 units/ml.

This is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, ...

CHMP recommends Xarelto (Bayer) for the treatment of Pulmonary Embolism and the prevention of recurrent Deep Vein Thrombosis and Pulmonary Embolism in adults.

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The decision of the European Commission on the approval is expected before the year-end. The CHMP recommendation to ...

CHMP recommends Ryzodeg(Novo Nordisk) for treatment of Diabetes Mellitus

On 18 October 2012 the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ryzodeg (insulin degludec) from Novo Nordisk, 100 units/ml and 200 units/ml, solution for injection, intended for the treatment of Diabetes Mellitus. The benefits with Ryzodeg are its ability to lower blood glucose levels and a lower risk of nocturnal ...

CHMP recommends Ryzodeg combination (Novo Nordisk) for treatment of Diabetes

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ryzodeg, 100 units/mL, solution for injection from Novo Bordisk, intended for the treatment of diabetes mellitus. The active substances of Ryzodeg are insulin degludec and insulin aspart, a soluble insulin product consisting of the basal insulin degludec and ...

FDA Advisory Committee recommends Kynamro for treatment of Homozygous Familial Hypercholesterolemia

Genzyme, a Sanofi company and Isis Pharmaceuticals have announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 9 to 6 that Genzyme had provided sufficient efficacy and safety data to support the marketing of Kynamro (mipomersen sodium) for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH). Many people with HoFH have aggressive cardiovascular disease beginning ...

FDA Advisory Committee recommends lomitapide (Aegerion Pharma) for HoFH

In a 13-2 vote, the FDA Endocrinologic and Metabolic Drugs Advisory considered that Aegerion Pharma provided sufficient efficacy and safety data to support marketing of lomitapide for Homozygous Familial Hypercholesterolemia (HoFH), despite its association with liver toxicity. The application was based on a single 18-month open-label, single-arm pivotal Phase III trial, which only enrolled 29 patients with HoFH, with supportive ...

Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk

The reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) from BMS/Pfizer ,compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation. These results of a subanalysis from the ARISTOTLE trial were published today in The Lancet.The subanalysis demonstrated ...

Absorb, the bioresorbable vascular scaffold (Abbott Vascular) available in EU, Latin America and Asia

Abbott has announced that Absorb, the world's first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatment of Coronary Artery Disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the ...

FDA approve S-ICD (Boston Scientific) for sudden Cardiac Arrest

The FDA had given approval for the S-ICD System (Boston Scientific), making it the first commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden Cardiac Arrest. FDA approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients ...

Generic Diovan HCT launched in USA

The US patent on Diovan (valsartan) and the combination product Diovan HCT (valsartan plus the diuretic hydrochlorothiazide) from Novartis has expired. Mylan has launched its generic version of Diovan HCT and Sandoz (the genetics division of Novartis) has launched an authorised generic version of Diovan HCT. No generic version of Diovan monotherapy is yet available in the US....

Merck returns all rights to vernakalant to Cardiome Pharma for Atrial Fibrillation

Merck & Co has returned the global marketing and development rights to Cardiome Pharma Corporation for both the intravenous and oral formulations for the anti-arrhythmic , Brinavess (vernakalant). Merck has been marketing the intravenous form of the drug, as Brinavess, in the European Union and Latin America for the rapid conversion of recent onset Atrial Fibrillation and planned to launch ...

Phase III study results for serelaxin (Novartis) for Acute Heart Failure

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with Acute Heart Failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. The study had two primary endpoints using different scales to measure reduction in ...

CHMP recommends Eliquis (BMS/Pfizer) for Prevention of Stroke and Systemic Embolism in NVAF patients

BMS and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the Prevention of Stroke and Systemic Embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke The positive ...

Positive results from study of pTeroPure (Glanbia) in patients with high cholesterol

New findings from a Phase II/III trial of pTeroPure (pterostilbene), from Glanbia, show this nutritional ingredient significantly reduced blood pressure in adults. The double-blind, placebo-controlled trial included 80 adults averaging 54 years of age with high cholesterol (total cholesterol of 200 or greater and/or LDL cholesterol of 100 or greater). Most participants were women (71%) and some had been diagnosed ...

Assessment finds some benefit of Eliquis (BMS/Pfizer) in patients with hip replacements

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment of Eliquis (apixaban), from BMS/Pfizer, to detect any added benefits after operations to replace a hip or knee joint. Its studies showed that apixaban was more effective in preventing symptomatic Deep Vein Thrombosis than the comparator therapy: about one in 1000 patients ...

FDA Advisory committee rejects lixivaptan

The Cardiovascular and Renal Drugs Advisory Committee of the FDA has recommended againstthe approval of lixivaptan from CardioKine/Cornerstone for the treatment of symptomatic hypervolemic and euvolemic Hyponatraemia associated with Heart Failure. The panel also voted 5-3 against the drug's use in Syndrome of Inappropriate Antidiuretic Hormone (SIADH).The risks of the drug outweighed its modest benefit in raising sodium levels and ...

No evidence for effect of omega-3 fatty acids on Cardiovascular Risk

In a study that included nearly 70,000 patients, supplementation with omega-3 polyunsaturated fatty acids was not associated with a lower risk of all-cause death, cardiac death, sudden death, heart attack, or stroke. Evangelos C. Rizos of the University Hospital of Ioannina, Ioannina, Greece, and colleagues performed a large-scale synthesis of the available randomized evidence by conducting a systematic review and ...

Impella CP heart pump (Abiomed Inc,) receives 510(k) clearance in USA

Abiomed, Inc., announced it has received 510(k) clearance from the FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac ...

CPL 1001 (Sorbent Therapeutics) success in Phase II Heart Failure trial

There has been positive data from a randomized, double-blind Phase IIa clinical study of CLP 1001 from Sorbent Therapeutics. In the study of 111 Heart Failure patients with chronic kidney disease, CLP 1001 demonstrated improvement in Heart Failure symptoms as compared to placebo. CLP1001-treated patients achieved significantly greater weight loss – an accepted measurement of fluid retention – as compared ...

Janssen responds to FDA Complete Response Letter for Xarelto for Acute Coronary Syndrome

Janssen Research & Development, LLC has submitted its reply to the Complete Response Letter from the FDA for the use of Xarelto (rivaroxaban) 2.5 mg twice daily in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). The submission includes the information requested by the FDA in its letter ...

Positive results for Edarbyclor (Takeda) in Phase III study of Hypertension

Results of a 10-week, Phase III study of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, for patients with Hypertension found the clinic systolic blood pressure (SBP) reductions for Edarbyclor were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide. Data also showed that more patients achieved their target blood pressure levels when taking the ...

Aspirin-clopidogrel no better than aspirin alone for patients with Lacunar Stroke

Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination carries a greater risk of gastrointestinal bleeding, according to results of a trial funded by the National Institutes of Health. Lacunar strokes occur due to chronic high blood pressure and typically produce small ...

Study finds link between chocolate consumption and Stroke risk

In a study based on a prospective investigation of a large group of male patients over 10 years, researchers have seen a link between chocolate consumption and stroke risk. The team looked at questionnaire responses from 37,103 Swedish men aged 49 to 75 and using data from the Swedish Hospital Discharge Registry, researchers identified 1,995 cases of first stroke among ...

Aquilion CT scanner (Toshiba) accurately assess coronary blockages

The Toshiba Aquilion 320-detector computed tomography (CT) scanner can accurately sort out which people with chest pain need or don't need an invasive procedure such as cardiac angioplasty or bypass surgery to restore blood flow to the heart, according to an international study. The CORE 320 study is the first prospective, multicenter study to examine the diagnostic accuracy of high ...

Xarelto(Bayer/Janssen) sub group analysis of TIMI trial shows reduction in mortality for ACS patients

A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with ACS and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily, from Bayer/Janssen, when added to standard antiplatelet therapy, provides a significant mortality benefit. The analysis showed that adding rivaroxaban to standard antiplatelet therapy significantly reduced the ...

Positive results from study of PressureWire (St Jude Medical) in PCI patients

Results of the FAME II Trial demonstrate patients with FFR-guided stenting that use PressureWire (technology used to measure blood flow restriction in the coronary arteries), from St Jude Medical, plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results revealed this yielded an 86 percent relative risk reduction for unplanned re-admission to the ...

Positive results in trial of Solitaire (Covidien) for blood flow restoration

The Solitaire Flow Restoration Device for opening blocked arteries, from Covidien, performs better than a conventional device, according to new results from the SWIFT trial which have been published in The Lancet.

In the double-blind, randomised trial of 113 patients, the researchers compared the performance of the Solitaire device to the Merci retriever. Patient outcomes were significantly improved in the ...

TRILOGY ACS study results for Efient/Effient (Daiichi Sankyo/Eli Lilly)

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced data from the TRILOGY ACS study, a phase III trial comparing Effient/Efient (prasugrel) plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI), who were managed medically without an artery-opening procedure. At 30 months, 13.9 percent of prasugrel patients versus 16.0 ...

Two new Phase III studies of Xarelto (Bayer HealthCare) initiated for AF patients scheduled for surgery

Bayer HealthCare has initiated two new studies investigating Xarelto (rivaroxaban) in patients with Atrial Fibrillation who are scheduled for cardioversion or first catheter ablation. X-VeRT is the largest randomised study dedicated to evaluating patients with AF scheduled for cardioversion. It will include approximately 1,500 patients across 17 countries worldwide, including the UK. The study will further examine the efficacy and ...

Watchman LAAC device (Boston Scientific) receives expanded CE indication

European regulators have approved an expanded indication for the Boston Scientific Watchman Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants, a new treatment option for Stroke Reduction.

Patients in AF have an increased risk of stroke due to the migration of clots ...

LCZ 696 success in study for Heart Failure with preserved ejection fraction

The Phase II PARAMOUNT study showed that the investigational compound LCZ 696 (Novartis) is the first therapy to significantly reduce a key predictor of morbidity and mortality in patients with a condition called heart failure with preserved ejection fraction (HF-PEF). This difficult-to-treat disease affects up to half of the 20 million people with heart failure in Europe and the US ...

Medtonic receives CE mark for Viva and Brava CRT-D devices for Heart Failure patients

Medtronic Inc has received CE Mark in Europe for its Viva and Brava Cardiac Resynchronization Therapy with Defibrillation (CRT-D) devices for treating patients with Heart Failure. The family of CRT-Ds features a new algorithm, called AdaptivCRT(R), which significantly improves heart failure patients' response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients' normal heart rhythms ...

Xience Xpedition everolimus stent (Abbott Vascular) receives CE Mark

The Xience Xpedition Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of Coronary Artery Disease. Abbott Vascular is launching the product immediately in CE Mark countries. Xience Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. Xience Xpedition is supported by the robust clinical evidence of the ...

Delay in review of QT 1571(Novartis) for PAH

The FDA postponed a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review QT 1571 which is imatinib (Gleevec/Glivec in its cancer indication) from Novartis for Pulmonary Arterial Hypertension. Novartis has decided to withdraw the NDA to allow time to produce more information for the FDA...

FDA approve Trevo Pro Retriever (Stryker) for clot removal

The Trevo Pro Retriever, from Stryker, has been granted 510(k) market clearance by the FDA for clot removal. Approval is based on clinical results from the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularization in a randomized embolectomy stroke device trial, and achieved significantly better post-procedure revascularization ...

FDA approves GeNOsyl MV-1000 (GeNo LLC) for neonates

GeNo LLC has received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system GeNOsyl MV-1000. The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings. The GeNOsyl MV-1000 injects a constant ...

NICE recommends Procoralan (Servier) for treatment of Chronic Heart Failure

Procoralan (ivabradine) from Servier Labs has been recommended by NICE in draft guidance as a treatment option for people with Chronic Heart Failure. The treatment has been recommended in combination with standard therapy or when beta-blocker therapy is contraindicated or not tolerated, after impressing in clinical trials....

FDA approves CorPath 200 (Corindus Inc) robotic-assisted system for PCI

The FDA has given 510(k) clearance for the CorPath 200 System, from Corindus Inc, to be used in Percutaneous Coronary Interventions (PCI). The technology is now approved in the US to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with Coronary Artery Disease (CAD).

The CorPath PRECISE Trial—a prospective, single-arm, ...

ODYSSEY Phase III trials enroll for SAR 236553 treatment of LDL Cholesterol

Sanofi and Regeneron Pharmaceuticals, Inc. announced that several trials within ODYSSEY, the Phase III clinical program of SAR236553/REGN727, have initiated patient enrollment. SAR236553/REGN727 is a potential first-in-class, subcutaneously administered, fully-human antibody that lowers low-density lipoprotein (LDL) cholesterol by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), an enzyme which binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) ...

AutoRIC (CellAegis) receives CE mark for AMI patients

CellAegis has received a CE Mark for its autoRIC device, which allows simple automation of remote ischemic conditioning (RIC) at the point of care for patients with Acute Myocardial Infarction. CellAegis' autoRIC Device has been developed for acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home. Remote ischemic conditioning uses ...

Update recommends Brilinta (AstraZeneca) for Heart Attack patients

Brilinta/Brilique (ticagrelor), from AstraZeneca, should be considered along with older blood thinners clopidogrel and prasugrel for treating patients who are experiencing chest pain or some Heart Attacks, according to joint updated guidelines issued by the American Heart Association (AHA) Task Force on Practice Guidelines and the American College of Cardiology (ACCF) Foundation.

The “focused update” on unstable angina ...

Trial finds that Brilinta / Brilique (AstraZeneca) is cost effective for Acute Coronary Syndrome patients

Full data results of the PLATO health economics substudy, which have been published online in the European Heart Journal, demonstrate that even at a higher drug cost and incremental cost per Acute Coronary Syndrome (ACS) patient, Brilinta / Brilique (ticagrelor), from AstraZeneca, numerically lowered non-drug healthcare costs versus generic clopidogrel and is cost-effective. The analysis used in the health economics ...

FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention

The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps ...

FDA refuses to recommend semuloparin (Sanofi) for prevention of VTE

The FDA's Oncologic Drugs Advisory Committee voted 14 to 1 not to recommend approval of semuloparin, from Sanofi, for the prevention of Venous Thromboembolism (VTE) in patients receiving chemotherapy for metastatic Lung or Pancreatic Cancer. The committee also rejected its use in patients with advanced solid tumours with a VTE risk score greater than or equal to three. The submission ...

FDA issues Complete Response Letter relating to Xarelto (Bayer/Janssen Pharma) for Acute Coronary Syndrome

Bayer HealthCare announced that the FDA has issued a Complete Response Letter regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with Acute Coronary Syndrome (ACS). Bayer is evaluating the Complete Response ...

NOP 47 significant impact on Vascular Endothelial function

Whey protein intake reduces CVD risk, but little is known whether whey-derived bioactive peptides regulate vascular endothelial function (VEF). Researchers determined the impact of a whey-derived extract (NOP-47) from Glanbia Nutrition on VEF in individuals with an increased cardiovascular risk profile. Men and women with impaired brachial artery flow-mediated dilation (FMD) (n 21, age 55 (sem 1·3) years, BMI 27·8 ...

Sub-analysis of RE-LY trial shows Pradaxa (Boehringer) similar to warfarin in Atrial Fibrillation patients undergoing surgery

A new retrospective sub-analysis of the RE-LY trial for Pradaxa (dabigatran etexilate), from Boehringer, vs warfarin suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a Stroke or systemic embolism, in non-valvular Atrial Fibrillation (NVAF) patients undergoing a surgical or invasive procedure. A total of 4,591 out of 18,113 patients in the trial had anti-coagulant therapy interrupted at ...

Phase III study of Edarbyclor (Takeda) shows positive results for Hypertension

Results of a 12-week, head-to-head, Phase III study found systolic blood pressure (SBP) reductions of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide in patients with Hypertension. Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by ...

Intergard Synergy vascular graft (Maquet Cardiovascular) receives CE mark

Maquet Cardiovascular has received the CE mark for its Intergard Synergy vascular graft. This graft combines the antimicrobial properties of silver acetate and triclosan. Vascular graft infection, although rare, is one of the most serious complications of vascular reconstructive surgery and in vitro testing of the Intergard Synergy vascular graft demonstrates antimicrobial efficacy against a broad spectrum of micro-organisms including ...

Semuloparin (Sanofi) may need more data for FDA approval for prophylaxis of VTE

Semuloparin, a low molecular weight heparin from Sanofi ,is filed at the FDA for the prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors. FDA regulators have commented that the application does not have enough data to support its approval for that use. The ...

New results for Livazo(Kyowa Hakko Kirin) in Dyslipidaemia

New results show Lival/Livazo (pitavastatin)from Kyowa Hakko Kirin is as effective as other commonly used statins at lowering low density lipoprotein cholesterol (LDL-C), with excellent tolerability. It is also effective at elevating high density lipoprotein (HDL-C) levels, reducing triglyceride levels, and appears to have less effect on glycaemic control, than some other statins. Comparisons to simvastatin in patients with dyslipidemia ...

Study shows positive results with HeartLight EAS (CardioFocus) for Atrial Fibrillation

A new study demonstrates high acute success (98%) and durable pulmonary vein (PV) isolation rates in the treatment of Atrial Fibrillation, using the HeartLight EAS ablation system, from CardioFocus. HeartLight Endoscopic Ablation System incorporates an illuminating endoscope to provide physicians with direct visualization within a beating heart, in real time and without radiation. To determine durability, the study involved a ...

ORIGIN trial of Lantus(Sanofi)shows no CV effect or cancer risk

The landmark ORIGIN trial (Outcome Reduction with Initial Glargine Intervention)showed that Lantus (insulin glargine [rDNA] injection) from Sanofi had no statistically significant positive or negative impact on cardiovascular outcomes versus standard care during the study period. Results also showed that insulin glargine delayed progression from pre-diabetes to Type 2 Diabetes and there was no association between insulin glargine use and ...

Insulin Degludec(Novo Nordisk) success in Nocturnal Hypoglycaemia

Ultra-long-acting insulin degludec, an investigational insulin being developed by Novo Nordisk, significantly reduced the rate of hypoglycaemia at night in adults with Type 2 Diabetes while obtaining equivalent improvement in glucose control compared with insulin glargine over a 52-week period. This phase IIIa study was presented today at the 72nd Scientific Sessions of the American Diabetes Association (ADA).The study also ...

Positive data from EASIE trial for Lantus (Sanofi) in patients with early Type 2 Diabetes

Patients with early Type 2 Diabetes uncontrolled on metformin demonstrated superior HbA1c (glycated hemoglobin) reduction with Lantus (insulin glargine [rDNA origin] injection), from Sanofi, versus sitagliptin, according to data from the EASIE trial. Notably 50% more patients on Lantus achieved HbA1c less than 7% (68 vs. 42%) and less than 6.5% (40 vs. 17%) compared to sitagliptin, indicating improved glycemic ...

Medtronic files PMA for MiniMed 530G System for Diabetes monitoring and treatment

Medtronic has filed the final module of its Pre-Market Approval (PMA) application with the FDA for the MiniMed 530G system, an integrated insulin pump and continuous glucose monitor that automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value. Medtronic’s PMA submission includes data from the in-clinic ASPIRE study, which met its ...

Prescribing update to Pradaxa (Boehringer) for Stroke Prevention (AF) patients

Prescribing information for Pradaxa (dabigatran etexilate) capsules, from Boehringer, has been updated to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the Clinical Studies section is based on the results of the pivotal RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). In the RE-LY trial, ...

NICE recommends Xarelto for DVT and PE

In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) recommends the use of Xarelto (rivaroxaban) from Bayer HealthCare as an option for treating deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism in adults diagnosed with acute DVT....

FDA approves two new lengths of the Promus Element stent system (Boston Scientific)

The FDA has approved the 32 mm and 38 mm lengths for the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, from Boston Scientific. The Promus Element Plus Stent System is now available in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm on both Monorail ...

PREVAIL trial shows positive effects of Livalo(Kowa Hakko Kirin) over pravastatin in LDL-C

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company have announced results of the PREVAIL U.S. study which evaluated the efficacy of Livalo (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed Dyslipidemia. ...

FDA approves revised labelling for Boston Scientific Defibrillators

The FDA has approved revised product labeling for the Boston Scientific Corporation Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings. Projected ...

SAR 236553 success in Phase II study for heFH

Sanofi and Regeneron have announced results from study 1003 of SAR 236553/REGN 727, a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) intended to treat Heterozygous Familial Hypercholesterolemia (heFH). The trial randomized 77 patients with heFH whose LDL-cholesterol (LDL-C) levels remained uncontrolled on statin therapy with or without ezetimibe. Across the four different dosing regimens tested, patients ...

Positive data from VOYAGER trial of Crestor (AstraZeneca) for Dyslipidemia patients

Data presented from the VOYAGER study demonstrate the benefits of aggressive statin therapy with Crestor (rosuvastatin), from AstraZeneca, in comparison to atorvastatin and simvastatin in high risk Dyslipidemia patients. VOYAGER is an individual patient data meta-analysis of 32 258 patients from 37 randomised studies, comparing the effects of statin therapy with Crestor (rosuvastatin) to that of atorvastatin and simvastatin. The ...

Positive data from ADVANCE trial of Ventricular Assist Device (HeartWare) for Heart Failure patients

Updated results from the ADVANCE trial evaluating the use of the Ventricular Assist Device, from HeartWare, as a bridge to heart transplantation demonstrate the potential utility of the pump to improve treatment outcomes for end-stage Heart Failure patients. Success for the primary endpoint was judged by establishing non-inferiority between the HeartWare device and data derived from contemporaneous patients from the ...

FDA Advisory Committee rejects Xarelto for Acute Coronary Syndrome

The Cardiovascular and Renal Drugs Advisory Committee voted 6-4 (with one abstention) against the approval of Xarelto (rivaroxaban) 2.5 mg BID from Johnson & Johnson/Bayer HealthCare, in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome). The FDA is not bound to follow the panel's advice, although it usually does, ...

Positive results for Carillon Mitral Contour System (Cardiac Dimensions) for Heart Surgery

New results of the TITAN trial of the Carillon Mitral Contour System, from Cardiac Dimensions, show that implanted patients demonstrated significant reductions in functional mitral regurgitation (FMR) as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.5 to 17.4 ml through 12 months (p<0.001). Additionally, patients experienced significant reverse remodeling with left ventricular diastolic and systolic volumes ...

FDA expands use of Levemir (Novo Nordisk) for Type 1 Diabetic children

The FDA has approved Levemir (insulin detemir [rDNA origin] injection), from Novo Nordisk, for expanded use in children ages two to five years with Type 1 Diabetes. With the expansion of its pediatric indication, Levemir is now available for Type 1 Diabetes patients from age two through adulthood and adult patients with Type 2 Diabetes. The decision was based on ...

Lancet study shows raising HDL may not affect Heart Disease risk

A new study published in The Lancet has found that raising HDL levels may not make a difference to heart disease risk. People with genes that result in higher HDL levels have no less heart disease (myocardial infarction) than those who inherit genes that give slightly lower levels. If HDL were protective those with genes causing higher levels should have ...

Positive two-year results in study of Promus Element Cardiac Stent (Boston Scientific)

Two-year results from the PLATINUM Small Vessel study demonstrate that the 2.25 mm Promus Element (Everolimus-Eluting) Platinum Chromium Cardiac Stent System, from Boston Scientific, shows positive safety and effectiveness outcomes in treating de novo coronary lesions in small coronary vessels. The PLATINUM study met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 ...

FDA approves generic Plavix

The FDA has approved on 17 My 2012 generic versions of Plavix (clopidogrel) for Dr Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals for 300 milligram (mg) clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel....

Positive data from EVOLVE trial of Synergy Cardiac Stent system (Boston Scientific)

Data from the EVOLVE trial shows the Synergy everolimus-eluting Coronary Stent system, from Boston Scientific, demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the Promus Element everolimus-eluting stent system. The trial reported one-year clinical and six-month intravascular ultrasound (IVUS) outcomes data, evaluating the safety and effectiveness of the Synergy stent. Data demonstrated that ...

REPRISE 1 trial reports for Lotus Aortic Valve System (Boston Scientific)

The REPRISE I feasibility trial, evaluated the acute safety of the Lotus Aortic Valve System from Boston Scientific, in patients with severe Aortic Valve Disease. Data presented at the annual EuroPCR Scientific Program in Paris demonstrated successful deployment of the valve in all patients with virtually no paravalvular regurgitation after valve placement or at discharge. REPRISE I is a prospective, ...

Lumax 740 defibrillator (Biotronik) is FDA approved

Biotronik has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients' arrhythmias and heart failure under ever-changing medical conditions. Lumax 740 is more informative to help manage a patient's heart failure progression; more specific to help reduce the chances of patients receiving ...

Study shows CorPath 200 robotic PCI surgery system (Corindus Inc) is safe and practical

The CorPath 200 robotic system, from Corindus Inc, can safely assist surgeons in performing Percutaneous Coronary Interventions (PCI) while significantly reducing the physician's exposure to radiation and improving precision and control, according to results of the PRECISE study. The CorPath 200 System consists of a robotic drive and single-use cassette mounted on an articulating arm attached to the cath lab ...

Success For Watchman LAAC device ( Boston Scientific) in Stroke Prevention

Results were announced by Boston Scientic from the ASA Plavix (ASAP) Study, which studied the Watchman Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.The prospective multi-center ASAP Study evaluated 150 patients with contraindications ...

FDA approves Paradym defibrillators (Sorin) for patients at risk of Cardiac Arrest

The FDA has approved the Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices, from Sorin, for patients at risk of sudden Cardiac Arrest, including some whose heart failure can be managed by cardiac resynchronization therapy. These new heart devices, including the single-chamber Paradym RF VR, the dual-chamber Paradym RF DR and the Paradym RF ...

Roche halts development of RG 1658 for Dyslipidaemia

Roche has halted development of RG 1658 (dalcetrapib) due to its lack of efficacy in treating Dyslipidaemia. This decision is based on results from OUTCOMES, a trial that has been halted after RG 1658 failed to show any benefit for patients already experienced symptoms of coronary artery obstruction taking the drug plus existing standard of care, though there were no ...

US Court rules against Mylan that Zetia (Merck Inc.) patent is valid

A US Federal judge has ruled in two jointly related patent infringement suits against Mylan that a patent on hypolipaemic Zetia (ezetimibe) and related product Vytorin (ezetimibe plus simvastatin) from Merck Inc. is valid and has issued an injunction blocking the approval of generic versions by Mylan until the patent at issue expires 25 April 2017. Merck Inc.has agreed with ...

Janssen files Xarelto at FDA for Venous Thromboembolism and ACS

Janssen Research & Development, a Johnson & Johnson subsidiary, has filed at the FDA for approval of Xarelto (rivaroxaban) as a treatment for Deep Vein Thrombosis and Pulmonary Embolism, and as a preventative treatment for recurring Venous Thromboembolism. Deep Vein Thrombosis is a blood clot in large veins, usually in the legs. Those blood clots sometimes dislodge and travel to ...

Macitentan(Actelion) success in Phase III for PAH

Initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist from Actelion, in 742 patients suffering from Pulmonary Arterial Hypertension (PAH) and treated for up to three and a half years, has met its primary endpoint. SERAPHIN is the largest randomized, controlled study in PAH patients with a long-term treatment to include ...

Study shows Stroke risk high when Xarelto (Bayer HealthCare) stopped

Patients with irregular heartbeats who are taken off anti-clotting medication Xarelto (rivaroxaban), from Bayer HealthCare, face a high risk of Stroke within a month. Researchers analyzed data from the Phase III ROCKET AF trial following concerns about possible increased rates of Stroke and blood clots after discontinuing Xarelto. They found strokes and blood clots occurred at similar rates with either ...

REPRISE I and II trials to commence for Lotus Aortic Valve System (Boston Scientific)

Boston Scientific has completed enrollment in the REPRISE I clinical trial, which is designed to evaluate the acute safety of the Lotus Aortic Valve System, the first transcatheter aortic valve replacement device of its kind for patients with severe Aortic Valve Stenosis that is both fully repositionable and retrievable prior to release. This prospective, single-arm feasibility study enrolled 11 patients ...

AstraZeneva and The Medicines Company to co-promote Brilinta in USA

AstraZeneca and The Medicines Company have announced a global collaboration for their acute ischaemic heart disease compounds. The first part of this collaboration is a US co-promotion for AstraZeneca’s oral antiplatelet medicine Brilinta (ticagrelor).Under the terms of the co-promotion agreement, The Medicines Company sales force will begin supporting Brilinta in May 2012. This will complement the AstraZeneca sales team’s promotion ...

Lower rates of hypoglycaemia with Insulin Degludec compared to Insulin Glargine

Two phase III studies included in total 1,635 participants investigated insulin degludec from Novo Nordisk compared to insulin glargine in a basal-bolus regimen in people with Type 1 and Type 2 Diabetes. Both studies were ‘treat-to-target’ studies, meaning patient insulin doses were adjusted systematically to allow them to achieve a targeted fasting glucose level. As a result, patients, successfully achieved ...

Aliskiren (Novartis)availability terms agreed with FDA

Novartis announced that the Tekturna labels have been updated in the USA, following the FDA review of the preliminary findings from the ALTITUDE study.The label change includes a contraindication against combined use of aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning ...

FDA approve Contour Next EZ (Bayer HealthCare) for blood glucose monitoring

The FDA has cleared the Contour Next EZ blood glucose monitoring system, from Bayer HealthCare, for use by diabetic patients in the US. The Contour Next EZ includes an easy-to-use meter and test strip sensors with innovative technology for advanced accuracy. Bayer's new BGM system is being introduced on a market-by-market basis and is currently available in other countries as ...

Endurant AAA Stent Graft System(Medtronic) two year results

Medtronic Inc.has announced the two-year results from its U.S. clinical study of the Endurant AAA Stent Graft System for Abdominal Aortic Anuerysm. Presented at this year's Charing Cross International Symposium in London, the prospective Endurant U.S. investigational device exemption (IDE) study's complete results at two years continue to demonstrate durable clinical performance with strong safety and efficacy in long-term follow-up. ...

Ellipse Cardioverter Defibrillator ( St Jude) receives CE Mark

CE Mark approval has been granted for the Ellipse implantable cardioverter defibrillator (ICD)from st Jude Medical. Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry's smallest high-energy Implantable Cardioverter Defribillator.Designed with feedback from more than 200 physicians from around the world, the Ellipse ...

FDA extends approval of Total Artificial Heart (Syncardia)to be used in destination therapy

SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has announced that the FDA has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.The FDA approval ...

CE Mark approval for Advantio/Ingenio pacemakers from Boston Scientific for Bradycardia

CE Mark approval has been given and European market launch is taking place for Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P) from Boston Scientific. Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen. The Ingenio ...

Arrow VPS System(Teleflex) received CE Mark approval for catheter positioning

Teleflex Inc., announced that its VasoNova Inc. subsidiary has been issued CE certification from the British Standards Institution to market the company's Arrow VPS system to the European Union. The Arrow VPS system is the first to use a unique micro-Doppler ultrasound technology in combination with intravascular ECG and advanced algorithms to provide precise guidance to clinicians and enable correct ...

RenalGuard (PLC Medical Systems) trial in Contrast Induced Nephropathy

Results from a new clinical trial of RenalGuard from PLC Medical Systems conducted in Italy -- the first to follow longer-term outcomes -- were presented at the annual conference of the American College of Cardiology (ACC.12), March 24 - 27, 2012, Chicago, Illinois. These results showed that RenalGuard is superior to two alternative methods at reducing rates of mortality, in-hospital ...

Generx(Cardium Therapeutics) enters Phase III for Myocardial Ischaemia

The ASPIRE Phase III registration study has been initiated to evaluate the therapeutic effects of Generx (Ad5FGF-4) from Cardium Therapeutics in patients with myocardial ischemia (insufficient blood flow in the heart due to coronary artery disease).The ASPIRE study is a 100-patient, randomized and controlled multi-center study being conducted at up to six leading cardiology centers in the Russian Federation. The ...

ETC 1002 (Esperion Therapeutics) positive in Phase II trial for Dyslipidaemia

Esperion Therapeutics, has announced positive results from a Phase II clinical trial for ETC-1002. This novel small molecule activator of AMP Kinase has demonstrated preclinical and clinical activity as a metabolic regulator of imbalances in lipid and carbohydrate metabolism. Results were presented in an oral presentation at the 2012 American College of Cardiology meeting in Chicago....

NICE recommends Xarelto (Bayer) for Stroke Prevention

NICE (The National Institute for Health and Clinical Excellence) has recommended Xarelto (rivaroxaban) from Bayer Healthcare in a final draft guidance as an option for the Prevention of Stroke and Systemic Embolism in people with atrial fibrillation. NICE revised its original decision not to recommend Xarelto after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the ...

Complete Response Letter for Northera (Chelsea Therapeutics) for Neurogenic Orthostatic Hypotension

The FDA has issued a Complete Response Letter regarding the new drug application for Northera (droxidopa) from Chelsea Therapeutics for the treatment of Symptomatic Neurogenic Orthostatic Hypotension in patients with primary autonomic failure. The FDA requests an additional study for efficacy and durability of effect over 2-3 months. Chelsea believes an ongoing Study 306 may meet this criteria....

Kynamro (Genzyme/Sanofi)is filed at FDA for Homozygous Familial Hypercholesterolaemia

Kynamro(mipomersen) from Genzyme/Sanofi and Isis Pharma has been filed at the FDA as a New Drug Application for the rare genetic condition of Homozygous Familial Hypercholesterolaemia. The first-in-class apo-B synthesis inhibitor was filed in Europe in July last year....

Positive results for Xarelto (Bayer/Janssen) in PE and VTE

The results of the Phase III EINSTEIN-PE 4,833-patient study have been presented at the American College of Cardiology meeting in Chicago which show that Xarelto (rivaroxaban) from Bayer/Janssen was as effective and safe as the current dual drug approach of subcutaneous Lovenox (enoxaparin), followed by warfarin, in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing ...

S-equol supplement (PharmaVite) success in lipids trial

A 12-week treatment of the fermented soy germ-based nutritional supplement containing S-equol from PharmaVite significantly lowered hemoglobin A1c (HbA1c), LDL cholesterol and improved vascular stiffness, all factors that occur as part of Metabolic Syndrome, according to a first-of-its-kind peer-reviewed study reported in a poster at the Women's Health 2012 annual meeting....

AMG 145 success in Phase 1b trial for High Cholesterol

Amgen has announced positive results from a Phase 1b clinical study of AMG 145, an investigational PCSK9 inhibitor, in patients with high cholesterol who were taking statins. The study demonstrated that multiple doses of AMG 145 significantly reduced serum low density lipoprotein cholesterol (LDL-C), also known as "bad" cholesterol, by up to 81 percent versus placebo (maximum reduction) in subjects ...

Phase II success of SAR236553/REGN727 for Cholesterol Lowering

Regeneron/Sanofi announced data from two Phase II trials with SAR236553/REGN727, an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), were presented at the American College of Cardiology’s (ACC) 61st Annual Scientific Meeting in Chicago. The data showed that treatment with SAR236553/REGN727 over 8 to 12 weeks significantly reduced mean low-density lipoprotein-cholesterol (LDL-C, or “bad” cholesterol) ...

Positive results for the ClearWay RX Infusion Catheter (Atrium) for PCI

Results of the INFUSE-AMI study demonstrated that in patients with large anterior STEMI presenting early after symptom onset and undergoing Percutaneous Coronary Intervention (PCI), intracoronary administration of the platelet inhibitor abciximab delivered directly to the Heart Attack lesion site via Atrium's ClearWay RX Local Therapeutic Infusion Catheter significantly reduced the size of the MI at 30 days (primary endpoint). The ...

Resolute DES (Medtronic) delivers clinical benefits out to two years

The Resolute drug-eluting stent (DES), from Medtronic, maintains a powerful and persistent treatment effect for a wide variety of patients with Coronary Artery Disease, including those with Diabetes. A new study that includes 2 years of follow-up, the RESOLUTE US clinical study and two pooled analyses of the entire Resolute clinical program –– one on safety measures for all patients ...

Vorapaxar (Merck) plus standard of care significantly reduces risk of Cardiovascular Events

Top-line results of the TRA-2P study of vorapaxar, from Merck, showed that the addition of vorapaxar to standard of care (e.g. aspirin, or thienopyridine or both) resulted in a significant reduction in the risk of the composite of cardiovascular (CV) death, heart attack, stroke or urgent coronary revascularization by 12 percent compared to placebo. This is the first time that ...

Merck inc withdraws from oral vernakalant collaboration

Merck Inc., ceases development of the oral formulation of anti arrhythmic vernakalant which it has licensed from Cardiome Pharma of Canada. The oral drug was being developed for long term prevention of atrial fibrillation recurrence. Merck Inc.,was influenced by its view of the regulatory environment and projected development timelines. Meck Inc., already markets the i.v. formulation as Brinavess in the ...

Signifor(Novartis) success in Phase III Cushings Disease trial

Signifor (pasireotide)from Novartis, significantly reduced urinary cortisol levels and improved symptoms of Cushing's disease in the largest clinical study of this endocrine disorder ever conducted. Results of the clinical trial conducted at centers on four continents appear in the March 8 New England Journal of Medicine and show that treatment with pasireotide cut cortisol secretion an average of 50 percent ...

Surfaxin (Discovery Labs) is FDA approved for Respiratory Distress Syndrome

The FDA has approved Surfaxin (lucinactant) from Discovery Laboratories for the prevention of Respiratory Distress Syndrome (RDS), a breathing disorder that affects premature infants.The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has ...

GSK files at FDA for H5N1 subtype Influenza vaccine

GSK has submitted a regulatory application to the FDA seeking approval for an H5N1 influenza vaccine. The Biologics License Application seeks approval for the “active immunisation for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine” for use as directed by ...

Positive results for NA-1 (NoNo) in Phase II Trial of Stroke patients

Final results of the ENACT Phase II clinical trial of the drug, NA-1 (TAT-NR2B9c) for reducing Stroke damage, from NoNo Inc, have been presented. The ENACT trial was a 185-patient, randomized, double-blind placebo-controlled study performed to assess the safety and efficacy of NA-1 in reducing small embolic strokes in patients that underwent an endovascular repair of intracranial Aneurysms. Patients enrolled ...

DCCR (Essentialis) shows promise in Phase IIb trial for Hypertriglyceridemia

New results have been announced for a Phase IIb trial of DCCR, from Essentialis, demonstrating a reduction in triglyceride (TG) levels by 30 to 40 percent in Hypertriglyceridemia patients whose TG levels exceeded 500 mg/dL (Very High Triglycerides [VHTG]). VHTG are a well-characterized risk factor for acute Pancreatitis. About half of the patients were in the atorvastatin combination sub-group, randomized ...

Baxter initiates Phase III stem cell therapy trial for Chronic Myocardial Ischaemiad

Baxter has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individuals own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).The trial will enroll approximately 450 patients across 50 clinical sites in the United States , who will be randomized to one of three arms: treatment ...

FDA approves ION and TAXUS Liberte Drug-Eluting Coronary Stents (Boston Scientific) in Heart Attack patients

The ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS Liberte Paclitaxel-Eluting Coronary Stent System, from Boston Scientific, have received FDA approval for use in patients experiencing an Acute Myocardial Infarction or heart attack. They are the only US drug-eluting stent systems with an approved indication to treat patients with AMI. The new indication, which accounts for approximately 10 percent ...

FDA Advisory Committee recommends Northera(Chelsea Therapeutics) for Symptomatic Neurogenic Orthostatic Hypotension

The FDA Cardiovascular and Renal Drugs Advisory Committee voted 7-4 with 1 abstention and 1 non-vote to recommend approval of Northera (droxidopa) for the treatment of Symptomatic Neurogenic Orthostatic Hypotension (also known as Neurogenic OH or NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.The ...

Trial of Vessix V2 Denervation System (Vessix Vascular) underway for Hypertension patients

Patient treatments have begun in the multi-centre REDUCE-HTN renal denervation clinical study of the Vessix V2 Renal Denervation System, from Vessix Vascular, for patients with uncontrolled Hypertension. REDUCE-HTN is a non-randomized, prospective, single cohort, 64-patient study designed to validate the clinical performance of the Vessix V2 System for medication-resistant Hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that ...

FDA accepts NDA for oral Remodulin (United Therapeutics) for PAH

The FDA has accepted for review the new drug application (NDA) for oral Remodulin (treprostinil diethanolamine sustained release), from United Therapeutics, for the treatment of Pulmonary Arterial Hypertension. The NDA will be subjected to a standard 10-month review period, with a targeted user fee deadline of October 27, 2012....

FDA approve Resolute Integrity (Medtronic Inc) Drug-Eluting Stent

The FDA has approved the Resolute Integrity Drug-Eluting Stent (DES), from Medtronic Inc, for the treatment of Coronary Artery Disease (CAD). The device’s approval stems from the results of a series of studies of the Resolute DES, which showed consistent clinical performance across a broad spectrum of patients –– including those with Diabetes, a common contributor to Coronary Artery Disease ...

CHMP defines limits of aliskiren (Novartis) in Hypertension

Novartis announced that the CHMP has concluded the risk-benefit review of Rasilez (aliskiren) and combination products containing aliskiren and confirmed it remains positive in the European Union for the treatment of essential Hypertension. In addition, the CHMP has requested an update to the product information of Rasilez® (aliskiren) and combination products containing aliskiren available in the EU. The CHMP has ...

Epanova (Omthera) has better bioavailability than Lovaza

Omthera Pharmaceuticals has reported positive data showing that its prescription-grade omega-3 fatty acid candidate, Epanova, has better bioavailability than Lovaza (omega-3 ethyl esters) – the only FDA-approved omega-3 acid drug on the US market from GSK. The latest reported data from a 52-patient pharmacokinetic study showed that after 14 days of dosing and with a low fat diet, plasma EPA ...

FDA approves trial of Celution System (Cytori Therapeutics) for CMI

Cytori Therapeutics has received an Investigational Device Exemption (IDE) approval from the FDA to begin the ATHENA trial using its Celution System. ATHENA will investigate the use of the Celution System to treat a form of Coronary Heart Disease, Chronic Myocardial Ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011. The trial will enroll up ...

FDA approves wider indication for fibrin sealant Tisseel (Baxter)

The FDA has approved Tisseel [Fibrin Sealant] from Baxter to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.TISSEEL mimics the final stages of the body’s own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis....

NICE final guidance positive for Eliquis(BMS/Pfizer)in VTE

NICE, the health technology appraisal body for England and Wales, has published final guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for preventing venous thromboembolism after knee and hip surgery. Eliquis will compete against Pradaxa from Boehringer abd Xarelto from Bayer HealthCare in this indication. No decision was made as to cost benefit comparisons....

Cangrelor (AstraZeneca/ The Medicines Company) maintains platelet inhibition and anti-clotting levels prior to Cardiac Surgery

A study shows that cangrelor, from AstraZeneca/The Medicines Company, has the unique properties of achieving very fast blood thinning effects when needed to protect from heart attacks, but also dissipates rapidly so patients can undergo surgery without the excessive bleeding often associated with blood thinning medications. The BRIDGE trial tested the efficacy of this intravenous antiplatelet therapy that allows patients ...

Combination treatment with Tekturna/Rasilez (Novartis) raises risk for patients with Hypertension

Following the closure of the Phase III ALTITUDE trial, researchers have published the first detailed figures showing the risk of using Tekturna/Rasilez, from Novartis, in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) drugs. After reviewing 10 large trials, researchers found that patients taking Tekturna/Rasilez as well as an ACE inhibitor or ARB had about a ...

Pradaxa(Boehringer) risk of Myocardial Infarction and Acute Coronary Syndrome

Pradaxa/Rendix (dabigatran etexilate), from Boehringer, is associated with an increased risk of Myocardial Infarction (MI) or Acute Coronary Syndrome (ACS) in a broad spectrum of patients when tested against some other medicines, according to a study published by the Archives of Internal Medicine. The meta-analysis of 7 studies, with 30,514 participants, Ken Uchino and Adrian V. Hernandez of the Cleveland ...

Xarelto (Bayer/Janssen) is FDA filed for Acute Coronary Syndrome

Bayer HealtCare and Janssen Pharmaceuticals have submitted a supplemental New Drug Application to the FDA seeking approval for the use of Xarelto (rivaroxaban) to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome.The application is based on the ATLAS ACS 2-TIMI 51 study,...

Xareto (J&J/Bayer) is FDA filed for Acute Coronary Syndrome

Johnson & Johnson and Bayer HealthCare submitted a supplemental new drug application to the FDA on 29 December seeking approval to market the oral anticoagulant Xarelto (rivaroxaban) as a therapy to reduce the risk of thrombotic events in patients with Acute Coronary Syndrome. The submission includes data from the pivotal Phase III ATLAS ACS 2 TIMI 51 trial, which showed ...

EU approval is given for intravenous formulation of Remodulin (United Therapeutics)

European approval has been given to United Therapeutics Corp for the intravenous formulation of its prostacyclin vasodilator, Remodulin (treprostinil), to treat Pulmonary Arterial Hypertension (PAH). Twenty two European Union member states have approved the formulation through the French regulatory agency AFSSAPS under the mutual recognition process. United Therapeutics has separately filed in the US for the oral version of Remodulin. ...

Tekturna (Novartis) fails ALTITUDE study in Diabetic Hypertensive patients with Renal Impairment

Tekturna/Rasilez (aliskiren) from Novartis has failed to show a benefit in target organ protection which has resulted in the early closure of the Phase III ALTITUDE study by reason of safety concerns. The 8,606-patient trial was assessing the effects of adding aliskiren to standard antihypertensive treatment in patients with Type 2 Diabetes and RenalImpairment. Researchers found a higher rate of ...

CHMP recommends Procoralan (Servier Labs) for Chronic Heart Failure

The CHMP has recommended Procoralan (ivabradine) from Servier Laboratories for Chronic Heart Failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is = 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated....

FDA updates label safety warning for Multaq (Sanofi-Aventis)

The FDA adds new safety warnings to the label of Multaq (dronedarone), from Sanofi-Aventis, after studies revealed the drug doubles the rate of cardiovascular death, stroke, and heart failure in patients with permanent Atrial Fibrillation. The revised labelling stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. The ...

FDA approves EXCOR Pediatric System (Berlin Heart) to support Heart Failure patients until a donor is found

The FDA has approved the EXCOR Ventricular Assist Device from Berlin Heart, a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. This is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children. The device consists of one or ...

Onduarp (Boehringer) is EMA approved for Essential Hypertension

Onduarp(telmisartan plus amlodipine) from Boehringer has been approved by the EMA for patients whose blood pressure is not adequately controlled by amlodipine alone. Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets. The drug is FDA approved as Twynsta....

EU approves Edarbi (Takeda) for Hypertension

The European Commission has approved the once-daily angiotensin receptor blocker (ARB) Edarbi (azilsartan medoxomil) from Takeda for Essential Hypertension. The approval is based on seven Phase III trials involving nearly 6,000 patients where the drug showed its superiority to placebo and the highest approved doses of two commonly-prescribed ARBs, Benicar (olmesartan) from Daiichi Sankyo and Diovan (valsartan)from Novartis. The drug ...

Meta Analysis supports no increased risk of cancer by use of Lantus (Sanofi-Aventis)

A new meta-analysis in relation to Lantus( insulin glargine) was presented at the World Diabetes Congress in Dubai, which added to "the wealth of evidence resulting from more than 80,000 patients enrolled in clinical trials and 38 million patient years of treatment exposure to Lantus (insulin glargine)". The figures are derived from databases as well as from clinical trials and ...

Insulin Degludec plus Insulin Aspart (Novo Nordisk) in Phase III Diabetes trials

Insulin degludec plus insulin aspart from Novo Nordisk, reduced rates of hypoglycaemia by 58% in people with Type 2 Diabetes compared to biphasic insulin aspart when dosed twice-daily. The study was released by Novo Nordisk at the International Diabetes Federation (IDF) 21st World Diabetes Congress. In the study, insulin degludec/insulin aspart reduced the overall occurrence of hypoglycaemia during the day ...

Generic Caduet (Pfizer) launched in USA by Ranbaxy

Ranbaxy has launched in the USA, an authorised generic version of Caduet, the fixed-dose combination of atorvastatin-amlodipine besylate for Hypertension , as part of an agreement between Pfizer and Ranbaxy...

Generic Lipitor is launched in USA by Ranbaxy

The FDA on 30 November 2011 approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets) marketed by Pfizer. Ranbaxy Laboratories Inc., has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths.The drug is to launch today and is known as Atorvastatin....

NICE recommends Eliquis (BMS/Pfizer) for Venous Thromboembolism Prevention

The National Institute for Clinical Excellence (NICE) has published final draft guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery/...

FDA accepts for review Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The FDA has accepted for review a New Drug Application for Eliquis (apixaban) from BMS/Pfizer,an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 28, 2012. An application ...

Rasitrio (Novartis) combination is EU approved for Hypertension

Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide in a single pill from Novartis has received approval from the European Commission for the treatment of high blood pressure. The pivotal study supporting the application showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, ...

AMR 101 (Amarin Corpn)is filed at the FDA for High Triglycerides

A New Drug Application for AMR101 (ethyl EPA) from Amarin Corporation has been accepted for filing by the FDA. Amarin seeks approval to market and sell AMR 101 in the United States for the indication studied in the MARINE trial—the treatment of patients with very high triglycerides (=500mg/dL). The NDA for AMR 101 is supported by data from both Phase ...

FDA approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts

The FDA has given 510(K) approval for the HeliFX Aortic Securement System, from Aptus Endosystems, the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large Aortic Aneurysm. The HeliFX Aortic Securement System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. ...

Sevikar HCT (Daiichi Sankyo) now available in the UK

Sevikar HCT (olmesartan medoxomil, amlodipine besylate plus hydrochlorothiazide) from Daiichi Sankyo Europe, the first three-in-one pill to treat Hypertension, has been launched in the UK. Currently around 2 million people in the UK need to take three or more pills daily to treat their hypertension. The drug is approved in the USA and available as Tribenzor....

CHMP continues to monitor safety profile of Pradaxa (Boehringer) for VTE

The EMA has issued a safety update on VTE treatment Pradaxa/Rendix, from Boehringer. It reports that the Agency is aware of recent media interest regarding fatal cases of bleeding in patients treated with the drug, but the CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding. A worldwide total ...

FDA investigates longitudinal failure of ION Coronary Stent (Boston Scientific)

According to a case report in the Journal of Interventional Cardiology, a patient experienced a heart attack after the recently marketed ION Coronary Stent (called the Taxus platinum in Europe), from Boston Scientific, in his artery shortened and accordioned. The ION Coronary Stent was approved by the FDA earlier this year. According to Cindy Grines, of the Detroit Medical Center ...

Trial comparing Xience V (Abbott) with Endeavor Resolute (Metronic) shows non-inferiority for PCI patients

The TWENTE clinical trial, which compared two second generation drug-eluting stents – the Endeavor Resolute zotarolimus stent from Medtronic and the Xience V everolimus-eluting stent from Abbott – established non-inferiority between the two stents as measured by the primary endpoint: target vessel failure (TVF) at one year. Both stents also demonstrated low rates of stent thrombosis. TVF at one year ...

PolarCath PD System (Boston Scientific) decreases risk of In-stent Restenosis in Diabetic patients

A clinical trial of patients with Diabetes has demonstrated that cryoplasty post-dilitation using the PolarCath Peripheral Dilatation System, from Boston Scientific, compared to conventional balloon angioplasty in the superficial femoral artery (SFA) decreased the risk of In-Stent Restenosis (ISR). Diabetes is associated with increased risk of in-stent restenosis after SFA stenting with nitinol self-expanding stents (nSES). The objective of the ...

Trial of Cre8 polymer-free stent (CID) shows promising results for patients with Coronary Artery Lesions

Researchers have found that the Cre8 polymer-free amphilimus-eluting stents, from Carbostent and Implantable Devices(CID), in de novo coronary artery lesions showed a significantly lower in-stent late loss at six months compared to paclitaxel-eluting stents with permanent polymers. NEXT is a prospective, randomized trial comparing Cre8 polymer-free amphilimus-eluting stent to a paclitaxel-eluting stent. A total of 323 patients were enrolled, with ...

Merck terminates early the TRACER study of vorapaxar in Acute Coronary Syndrome

Merck Inc. has announced that the Phase III TRACER study of vorapaxar,a selective PAR-1 Thrombin Receptor Antagonist, was terminated early as the drug did not reduce the primary composite endpoints (CV Death, Myocardial Infarction, Stroke or Recurrent Ischaemia)and increased the risk of major bleeding, including intracranial haemorrhage. The secondary prevention trial called TRA-2P with vorapaxar in patients who had already ...

Combo Dual Therapy Stent (Orbus Neich) safe and effective in Heart Disease trial

A randomized comparison of the Combo Dual Therapy Stent, from Orbus Neich, which combines low-dose sirolimus delivery from an abluminal biodegradable polymer matrix with a covalently bound anti-CD34 antibody layer, with a paclitaxel-eluting stent, showed that the dual therapy stent effectively controls neointimal proliferation and was shown to be safe and effective. The REMEDEE trial was designed to demonstrate the ...

Xarelto(Bayer/Johnson &Johnson) success in ATLAS ACS 2 TIMI 51 study in Acute Coronary Syndrome

Xarelto (rivaroxaban) from Bayer/Johnson & Johnson twice daily with standard anti- platelet therapy significantly reduced both the rate of cardiovascular death, myocardial infarction and stroke in Acute Coronary Syndrome patients compared to those receiving standard anti-platelet therapy alone. In addition Xarelto 2.5 mg in combination with standard therapy significantly reduced mortality. Results from the ATLAS ACS 2-TIMI 51 study were ...

ABSORB trial Five year and Two year results for the Bioresorbable Vascular Scaffold(Abbott Vascular)

Positive long-term data are reported from the two-stage ABSORB trial, which is evaluating the ABSORB drug eluting bioresorbable vascular scaffold (BVS) from Abbott Vascular for the treatment of coronary artery disease. Five-year results from the first stage and two-year and 18-month data from the second stage of the ABSORB trial were recently presented at the 2011 American Heart Association's Scientific ...

Eliquis versus enoxaparin in ADOPT study for VTE acutely ill patients

Phase 111 ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial evaluated Eliquis (apixaban) versus enoxaparin in acutely ill medical patients and showed that Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of venous thromboembolism (VTE) and VTE-related death at day 30. The apixaban arm had a 13 percent lower rate of events ...

Cangrelor (AstraZeneca) maintains platelet inhibition without major bleeding in Acute Coronary Syndrome patients

New data demonstrates that intravenous use of cangrelor, from AstraZeneca, was effective at maintaining platelet inhibition in patients on thienopyridines who required bypass surgery. The data is from BRIDGE, a multicenter trial in 210 patients with Acute Coronary Syndrome (ACS) or treated with a coronary stent on a thienopyridine awaiting coronary artery bypass grafting (CABG) to receive either cangrelor or ...

Thrombosis risk in early drug eluting stents

The risk of late stent thrombosis (ST) in the first generation of drug-eluting stents continues for up to seven years after implantation, and certain types of patients, including smokers and those who are younger, are at higher risk, according to results of the DESERT registry. There is an existing need to understand the factors predicting ST and define those patients ...

ADAPT-DES registry data for ACS patients shows risk of Stent Thrombosis

Data on the ADAPT-DES registry presented at the 23rd annual Transcatheter Cardiovascular Therapeutics scientific symposium shows patients with Acute Coronary Syndrome and/or Diabetes who show poor response to dual antiplatelet therapy as measured by platelet function testing are at greater risk of stent thrombosis after PCI with drug-eluting stents. The researchers found that absolute and relative levels of platelet inhibition ...

EU approvbes Plenadren (DuoCort Pharma) for Adrenal Insufficiency

The European Commission has granted marketing authorisation for dual-release hydrocortisone replacement therapy Plenadren (hydrocortisone, modified-release) from DuoCort Pharma as a once-daily oral treatment for adults with adrenal insufficiency – the first new therapy for the condition in 50 years. DuoCort Pharma is being acquired by Viro Pharma....

FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients

The FDA has approved the Ovation Abdominal Stent Graft System, from Trivascular, which provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening Abdominal Aortic Aneurysms. Such aneurysms can be repaired through open surgery or less invasively using a stent graft. However this treatment depends on the patient’s anatomy. A small number of people ...

FDA approves Sapien Transcatheter Heart Valve(Edwards Lifesciences) for patients with inoperable Aortic Valve Disease

The FDA has approved the transfemoral delivery of the Edwards Sapien Transcatheter Aortic Heart Valve for the treatment of inoperable patients with severe symptomatic Aortic Valve Disease or Stenosis. This is the first US commercial approval for a transcatheter device enabling aortic valve replacement (TAVR) without the need for open-heart surgery. The safety and effectiveness of the Sapien Transcatheter Valve ...

Vytorin recommended for reduction of CV risk in CKD patients

A panel of outside experts at the FDA has recommended the expanded use of Vytorin (ezetimibe and simvastatin) from Merck inc. at the 10/20mg dose as a treatment for patients with chronic kidney disease (CKD not on dialysis. This would be the first drug for this indication, if approved. The recommendation is based on a review of data from the ...

Xarelto(Bayer/Johnson & Johnson) is FDA approved for Stroke prevention in patients with non valvular atrial fibrillation

The FDA has approved Xarelto (rivaroxaban) from Bayer HealthCare/Johnson & Johnson for prevention of stroke in patients with nonvalvular atrial fibrillation, making it the first oral direct factor Xa inhibitor to secure an indication for stroke prevention.The drug had already been approved for prevention of deep vein thrombosis in patients undergoing joint replacement surgery...

NICE recommends Pradaxa for Stroke Prevention in non vavular atrial fibrillation patients

NICE has made a final appraisal determination that recommends the direct thrombin inhibitor Pradaxa (dabigatran etexilate) from Boehringer as an option for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more of the following risk factors •previous stroke, transient ischaemic attack or systemic embolism; •left ventricular ejection fraction below 40%; •symptomatic heart failure of ...

Lixiana development in VTE for USA and EU is discontinued

The US and EU development of Lixiana (edoxaban) from Daichi Sankyo is discontinued for the prevention of venous thromboembolic events after orthopaedic surgery although the drug is approved in Japan for that indication. Daiichi Sankyo will concentrate on the indication of stroke prevention in atrial fibrillation, for which results from the ongoing ENGAGE AF-TIMI 48 Phase III trial which compares ...

FDA approves Xience Prime Everolimus Coronary Stent

The FDA has given approval for the next-generation Xience Prime Everolimus Eluting Coronary Stent System (Xience Prime),from Abbott Vascular, for the treatment of coronary artery disease. The decision was supported by the clinical results from the SPIRIT group of trials. Xience Prime uses the same drug and biocompatible polymer as the Xience V Everolimus Eluting Coronary Stent System and features ...

Lipitor ineffective for Atherosclerosis in pediatric Lupus

A trial to determine the efficacy and safety of Lipitor (atorvastatin), from Pfizer, in preventing subclinical Atherosclerosis progression in pediatric-onset Systemic Lupus Erythematosus (SLE) found that the therapy was ineffective in reducing Atherosclerosis progression in children and adolescents. However results from the trial showed that the treatment could benefit patients with more severe SLE who were not included in the ...

NICE final guidance recommends Briique in Acute Coronary Syndrome

Brilique (ticagelor) from AstraZeneca has a positive recommendation from NICE, the health technology appraisal body for England and Wales in its final guidance. NICE recommends Brilique in combination with aspirin, for up to 12 months in patients with ST-segment-elevation myocardial infarction (STEMI) that is to be treated with primary percutaneous coronary intervention or non-ST-segment-elevation myocardial infarction (NSTEMI). It is also ...

Genetics and Plavix/Iscover play role in risk of post-stent thrombosis

A new study published in JAMA shows that it is possible to identify genetic or other factors in patients who have received a coronary stent which give this sub-population a higher potential risk of experiencing a blood clot within the stent. Despite the use of dual antiplatelet therapy - DAPT; aspirin and Plavix/Iscover (clopidogrel), from BMS and Sanofi-Aventis - which ...

AstraZeneca to present positive health economics data on Brilique/Brilinta at ISPOR meeting in November

AstraZeneca will present key results from health economics sub-studies from the PLATO trial at the upcoming International Society for Pharmacoeconomics and Outcomes Research (ISPOR) EU meeting, 5-8 November in Madrid. Data from eight countries will show that using Brilique/Brilinta plus aspirin to treat acute coronary syndrome patients for one year is associated with cost-savings, gain in quality-adjusted life years, and ...

Brilinta/Brilique is reviewed for ACS by IQWiG the German Health Quality Institute

Brilique/Brilinta (ticagrelor) from AstraZeneca has been reviewed by the German Institute for Quality and Efficiency in Health Care (IQWiG) ) for its use in Acute Coronary Syndrome (ACS) in comparison with conventional therapies. The Institute has come to the conclusion that ticagrelor provides considerable added benefit to patients with "mild" myocardial infarction without the typical changes in the ECG (NSTEMI), ...

Crestor patent challenged by generic companies

Generic manufacturers have challenged the AstraZeneca "314" patent for Crestor (rosuvastatin) and are appealing a decision that upheld the patent in the lower courts. The appeal is based on inequitable conduct. AstraZeneca and its partner Shionogi are seeking to maintain the patent until 2016. Commentators believe the appeal will be unsuccessful. Crestor was worth $5.7 billion to AstraZeneca in 2010....

Higher HDL Cholesterol levels reduces Heart Attack and Stroke risk in Diabetes patients

A new study of more than 30,000 patients with Diabetes shows that increasing levels of high-density lipoproteins (HDL cholesterol) reduced the risk for heart attack and stroke. While there is considerable evidence that reducing the amount of low-density lipoprotein, (LDL cholesterol) can reduce the risk of heart disease, the relationship between HDL cholesterol and heart disease is less clear. The ...

Trial of Omega Platinum Chromium Coronary Stent System now enrolling patients

Boston Scientific has started enrollment in the OMEGA clinical trial to evaluate the safety and effectiveness of its Omega Platinum Chromium Bare-Metal Coronary Stent System in treating patients with a single coronary artery lesion. The trial will enroll 328 patients at 40 sites in the U.S. and Europe. Rates of target lesion failure (TLF), a composite measure that includes target ...

Xience Prime/Xience V stents as alternative to CAGB in EXCEL trial

Abbott Vascular announces the enrollment of the first patients in the EXCEL study which will assess the safety and effectiveness of the Xience Prime/Xience V everolimus eluting coronary stent as an alterantie to coronary artery by pass grafting (CABG) in patients with Left Main Disease, a high risk sub set of Coronary Artery Disease.Joseph Sabik, M.D., chairman, Department of Thoracic ...

Astellas cancels its oral Factor Xa inhibitor ,darexaban

Astellas Pharma has decided to cancel its oral Factor Xa inhibitor, darexaban, after considering the competitive market for anticoagulants and the difficulty in finding a partner for the drug....

RESPeRATE device study shows benefits for Heart Failure patients

Results of a 72-patient controlled study of RESPeRATE, from InterCure, demonstrate that device–guided respiratory modulation with RESPeRATE applied at home can significantly relieve symptoms of Heart Failure in elderly patients. RESPeRATE is an FDA-cleared, CE-marked device indicated for the adjunctive treatment of hypertension for use as a relaxation aid by leading the user through interactively guided and monitored breathing exercises. ...

Xarelto shows benefit for ACS patients

Xarelto (rivaroxaban) from Bayer HealthCare, cuts the rate of heart attacks, strokes, myocardial infarction, and cardiovascular death compared to placebo, according to data from a Phase III study involving patients with Acute Coronary Syndrome (ACS). However, according to this study, patients who took Xarelto also face a higher risk of major bleeding not linked to coronary artery bypass graft surgery. ...

Carillon Mitral Contour System receives CE mark for Cardiac Surgery

The EU has awarded the CE mark for the newly enhanced version of the Carillon Mitral Contour System, a novel therapy fom Cardiac Dimensions, for treating heart failure patients suffering from functional mitral regurgitation (FMR). The Carillon Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and ...

CHMP recommends Edarbi/Ipreziv for Hypertension

The CHMP recommends Edarbi/Ipreziv (azilsartan medoxomil)from Takeda for essential hypertension.Azilsartan medoxomil blocks the angiotensin II type 1 receptors and inhibits the renin angiotensin aldosterone system, reducing blood pressure. The drug was approved by the FDA in February 2011.Takeda sees the drug as the successor to candesartan whose patent will expire in 2012....

Xarelto reccommended in Europe for DVT, Stroke and AF

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of Stroke and systemic embolism in adults with non-valvular Atrial Fibrillation (AF), as well as for the treatment of Deep Vein Thrombosis (DVT) and prevention of recurrent DVT and Pulmonary Embolism (PE) following an ...

CHMP recommends Onduarp for Hypertension

The CHMP recommends Onduarp (telmisartan plus amlodipine) from Boehringer for Essential Hypertension. The combination is FDA approved as Twynsta. The combination will be directed at difficult to treat BP patients and those having Type 2 Diabetes or who are obese or elderly....

Imatinib effective in Pulmonary Arterial Hypertension

The pivatol Phase III IMPRES clinical trial showed that the investigational therapy QTI571 (imatinib), known as Gleevec and Glivec in oncology indications from Novartis, significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo. Evidence indicates that QTI571 targets an underlying cause of PAH by counteracting uncontrolled growth of arterial smooth muscle cells. ...

Eliquis launched in UK for VTE

BMS and Pfizer have launched their oral direct Factor Xa inhibitor, Eliquis (apixaban), in the UK for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery....

CHMP recommends triple combination Rasitrio for Hypertension

The CHMP has adopted a positive opinion for Rasitrio (aliskiren/amlodipine/HCTZ )from Novartis for the treatment of high blood pressure.Rasitrio has been recommended as replacement therapy in patients whose blood pressure is adequately controlled on a combination of its components given concurrently at the same dose level as in the combination.Adherence to treatment is often very challenging for patients requiring three ...

EMA confirms risk benefit of Multaq

EMA has confirmed a positive benefit-risk balance for Multaq (dronedarone) from Sanofi- Aventis for the treatment of a newly defined population of paroxysmal and persistent Atrial Fibrillation patients, following its review under the Article 20 procedure. A new indication for Multaq is: indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or ...

New Drug Eluting Stents safer for PCI patients

Results from the SCAAR Study, presented at the European Society of Cardiology Congress 2011, showed that Percutaneous Coronary Intervention with "new generation" Drug Eluting Stents (DES), was associated with a 38% lower risk of clinically meaningful restenosis and a 50% lower risk of stent thrombosis compared to old generation DES. The SCAAR study evaluated the long-term outcome in all patients ...

EMA confirms risk benefit of Multaq

EMA has confirmed a positive benefit-risk balance for Multaq (dronedarone) from Sanofi- Aventis for the treatment of a newly defined population of paroxysmal and persistent Atrial Fibrillation patients, following its review under the Article 20 procedure. A new indication for Multaq is: indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or ...

New review of Cryoballoon Ablation treatment for Atrial Fibrillation

A new research review comparing the efficacy and safety of cryoballoon ablation for Atrial Fibrillation finds that a single cryoballoon ablation procedure for paroxysmal AF results in high acute and medium-term efficacy rates, with lower success rates when used as stand-alone therapy for persistent AF. The rate of complications is relatively low and includes a 6.38% incidence of PNP, most ...

FDA warns Multaq increases risk of death, stroke and heart failure in patients with Permanent Atrial Fibrillation

According to the FDA, analysis of preliminary clinical trial data reveals that patients with permanent Atrial Fibrillation who take antiarrhythmic medication Multaq (dronedarone), from Sanofi-Aventis, have double the risk of death and double the risk of being hospitalised for heart failure or developing stroke compared to those on a placebo. This study of the drug's benefits for patients aged 65+ ...

Insulin Degludec success in Types 1 and 2 Diabetes

Ultra-long acting insulin degludec, under development by Novo Nordisk, lowers blood glucose levels with significantly reduced rates of hypoglycaemia (low blood sugar) compared to insulin glargine, according to data presented at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego. The advantage of Insulin Degludec is that it has a duration of action that lasts up ...

Merck Inc. returns rights to betrixaban to Portola Pharma

Merck will return to Portola Pharma all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio....

MiStent (Micell Technologies) enters Phase III trial for CAD

Micell Technologies,Inc. announced it has enrolled the first patient in the DESSOLVE II (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lesions in the native coronary arteries) clinical trial. This clinical investigation is being conducted to support CE Mark approval of the company's MiStent Drug-Eluting Coronary Stent System and compares the MiCell MiStent ...