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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 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 ...

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) ...

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 ...

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 ...

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 ...

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 ...

FDA approves Eylea (Regeneron) for Macular Oedema following Central Retinal Vein Occlusion

The FDA has approved Eylea (aflibercept) Injection, from Regeneron, for the treatment of Macular Oedema following Central Retinal Vein Occlusion (CRVO). The recommended dose for Eylea is 2 milligrams (mg) every 4 weeks (monthly). The approval of Eylea for Macular Oedema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies.

In both studies, the ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

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 ...

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 ...

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....

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Regeneron files Eylea(VEGF TRAP-EYE) at FDA for CRVO

Based on the results of the GALILEO study and one otherstudy Regeneron Pharmaceuticals, has submitted a supplemental Biologics License Application (sBLA) in the US for the CRVO indication and has been granted an FDA action date of 23 September 2012....

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....

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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....

FDA approves Soliris for Hemolytic Uremic Syndrome

The FDA has approved Soliris (eculizumab) from Alexion Pharma for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare, chronic blood disease that can lead to kidney failure, stroke, heart attack and death. This is the first treatment for aHUS that has been FDA-approved and the first approval for use of Soliris in children. The decision is ...

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 ...

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....

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 ...

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+ ...

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....