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Emergency Medicine
FDA approves Ellipse and SJM Assura ICDs and CRT-Ds (St Jude Medical) for Heart Failure
15-Jun-2013The FDA has approved the next-generation Ellipse and SJM Assura portfolio of implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), from St Jude Medical, for use in patients with Heart Failure. The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. Additionally the devices feature the DynamicTx Over-Current Detection Algorithm, ...
FDA approves Nymalize (Arbor Pharmaceuticals) for Sub Arachnoid Haemorrhage
15-May-2013The FDA has approved the New Drug Application (NDA) for Nymalize (nimodipine) oral solution, from Arbor Pharmaceuticals, for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with Sub Arachnoid Haemorrhage. It is the only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with SAH. The company ...
FDA approves Kcentra (CSL Behring)to reverse vitamin K antagonist anticoagulation with major bleeding
01-May-2013The FDA on 29 April 2013 has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions ...
Phase III results using E 5564 (Eisai) show no significant benefit for Sepsis
21-Mar-2013A Phase III trial to evaluate the safety and efficacy of E 5564 (eritoran), from Eisai, in reducing mortality in patients with severe Sepsis shows the drug failed to demonstrate a significant effect on reducing all-cause 28-day mortality or 1-year mortality, compared with placebo. The randomized, multinational trial was conducted in 197 intensive care units. Patients were enrolled from June ...
Inspra(Pfizer) success in REMINDER trial for acute STEMI patients
18-Mar-2013Pfizer 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% ...
STREAM Trial shows that Metalyse/TNKase (Boehringer) offers some benefits in STEMI patients
16-Mar-2013Results 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
16-Mar-2013A 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 ...
EU approves Ilesto 7 (Biotronik) for patients with Heart Failure
17-Feb-2013The 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 ...
Aranesp (Amgen) fails Heart Failure trial
18-Jan-2013Amgen 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 ...
EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients
06-Dec-2012BioVentrix 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 ...
European Commission approves Xarelto (Bayer) for PE and treatment of recurrent Deep Vein Thrombosis
21-Nov-2012Bayer 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 ...
RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure
08-Nov-2012RELAX-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
08-Nov-2012New 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 ...
FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure
30-Oct-2012Maquet 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 ...
NICE positive for Procoralan (Servier) for Heart Failure
24-Oct-2012The 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 ...
CHMP recommends Xarelto (Bayer) for the treatment of Pulmonary Embolism and the prevention of recurrent Deep Vein Thrombosis and Pulmonary Embolism in adults.
22-Oct-2012Bayer 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 approve S-ICD (Boston Scientific) for sudden Cardiac Arrest
30-Sep-2012The 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 ...
Phase III study results for serelaxin (Novartis) for Acute Heart Failure
25-Sep-2012Phase 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 NexoBrid for treatment of Burns
24-Sep-2012The European Medicines Agency has recommended approval of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) from Teva, an orphan-designated medicine, for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn. Eschar is the dried-out, thick, leathery, black necrotic tissue that covers severe burn wounds. Its removal is essential to initiate the wound healing process and ...
CPL 1001 (Sorbent Therapeutics) success in Phase II Heart Failure trial
12-Sep-2012There 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 ...
Medtonic receives CE mark for Viva and Brava CRT-D devices for Heart Failure patients
24-Aug-2012Medtronic 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 ...
CytoFab (BTG/AstraZeneca) fails Sepsis trial
09-Aug-2012BTG disclosed top-line results from a Phase IIb study conducted by AstraZeneca which had compared two doses of CytoFab (polyclonal ovine anti-TNF antibody fragments) with a placebo in patients with severeSepsis and/or Septic Shock. Treatment with CytoFab failed to show any significant improvements versus placebo with regard to either the primary endpoint of ventilator-free days or secondary endpoints such as ...
NICE recommends Procoralan (Servier) for treatment of Chronic Heart Failure
08-Aug-2012Procoralan (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....
AutoRIC (CellAegis) receives CE mark for AMI patients
21-Jul-2012CellAegis 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 ...
NICE recommends Xarelto for DVT and PE
07-Jun-2012In 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 revised labelling for Boston Scientific Defibrillators
01-Jun-2012The 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 ...
Positive data from ADVANCE trial of Ventricular Assist Device (HeartWare) for Heart Failure patients
25-May-2012Updated 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 approves generic Plavix
18-May-2012The 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....
Lumax 740 defibrillator (Biotronik) is FDA approved
11-May-2012Biotronik 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 ...
FDA approves Paradym defibrillators (Sorin) for patients at risk of Cardiac Arrest
09-May-2012The 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 ...
Ellipse Cardioverter Defibrillator ( St Jude) receives CE Mark
17-Apr-2012CE 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 ...
OncoGenex/Teva initiate Phase III trial for custirsen for Prostate Cancer
10-Mar-2012OncoGeneX and Teva plan to initiate a new Phase III study to evaluate the ability of custirsen (OGX-011) to improve survival for patients with Prostate Cancer when combined with recently approved, second-line chemotherapy, Jevtana (cabazitaxel). The new study will be conducted in lieu of the Prostate Cancer Saturn Study, which aimed to assess durable pain palliation as a primary endpoint. ...
Patient enrollment complete for Phase III Dry Eye Study of SAR 1118 (SARcode)
07-Mar-2012Patient enrollment has been completed for the first pivotal Phase III clinical study (OPUS-1) of SAR 1118, from SARcode, for Dry Eye Disease. OPUS-1 is a randomized, double-masked study evaluating the safety and efficacy of SAR 1118 5.0% ophthalmic solution compared to placebo over a 12 week period. A total of 588 patients with Dry Eye Disease have been enrolled ...
FDA approves trial of Celution System (Cytori Therapeutics) for CMI
01-Feb-2012Cytori 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 ...
CHMP recommends Procoralan (Servier Labs) for Chronic Heart Failure
20-Dec-2011The 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....
BTG licence of rights to Voraxaze for Methotrexate Toxicity
12-Dec-2011BTG has agreed to licence Ohara Pharmaceutical the rights in Japan to develop and market Voraxaze (glucarpidase) its treatment for Methotrexate Toxicity due to impaired renal function. The drug is filed in the USA and EU and its PDUFA action date is 17 January 2012....
Xigris is withdrawn from all markets for Septic Shock
25-Oct-2011Xigris(drotrecogin alfa (activated)) from Eli Lilly ,which was first approved in the USA in 2001 and in the EU in 2002, is now withdrawn in all markets following results of the PROWESS-SHOCK study, which showed the drug did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. While there were ...
RESPeRATE device study shows benefits for Heart Failure patients
03-Oct-2011Results 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 reccommended in Europe for DVT, Stroke and AF
26-Sep-2011Bayer 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 ...
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