News

FDA approves Procysbi (Raptor Pharmaceutical) for Nephropathic Cystinosis

The FDA has approved Procysbi (cysteamine bitartrate) delayed release capsules, from Raptor Pharmaceutical, for the treatment of Nephropathic Cystinosis in adults and children 6 years and older. The approval was based on a New Drug Application (NDA) comprising data from six clinical trials, including a multi-center randomized, active-controlled Phase III trial of 43 patients with Nephropathic Cystinosis and extension data ...

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 will review Procysbi (Raptor Pharma) in April 2013

Raptor Pharmaceutical Corp. announced that the FDA will require additional time to complete its review of the New Drug Application (NDA) for RP103 (Procysbi), for the potential treatment of Nephropathic Cystinosis. In a notice received from the FDA, the initial Prescription Drug User Fee Act (PDUFA) goal date has been extended from January 30, 2013 to April 30, 2013. The ...

EPI 743 (Edison Pharmaceuticals) granted orphan status for Leigh Syndrome in EU

Edison Pharmaceuticals announced today that the Committee for Orphan Medicinal Products at the European Medicines Agency, has granted orphan designation to EPI 743 for the treatment of Leigh syndrome. Leigh Syndrome is a very rare and severe disease caused by mutations in mitochondrial respiratory enzymes, leading mainly to neurological deficits and a poor survival for these patients. In June 2012 ...

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 ...

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 ...

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 ...

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, ...

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 ...

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 ...

FDA approves Inomax (Ikaria Inc) for compatibility with 3 additional devices

The Center for Devices and Radiological Health (CDRH) branch of the FDA has granted 510(k) clearance for compatibility of the Inomax drug-delivery systems, from Ikaria Inc., with three additional respiratory care devices. The Inomax DS and the Inomax DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems and other respiratory care devices. The Inomax DS and ...

NICE endorses Victrelis (Merck Inc.)for Hepatitis C genotype 1 infection

In its final draft guidance, NICE recommends Victrelis (boceprevir) from Merck Inc., in combination with Roche’s Pegasus (peginterferon alfa) and Copegus (ribavirin) injections,as an option for the treatment of genotype 1 Chronic Hepatitis C in adults with compensated liver disease.A final endorsement is expected next month. Hepatitis C has a poor diagnosis and low treatment compliance rate, with a high ...

FDA rejects Prochieve(Watson Pharma) for risk reduction in PreTerm Birth

Watson Pharma has received a complete response letter from the FDA for its New Drug Application for Prochieve ( progesterone vaginal gel 8%) for use in the reduction of risk of Preterm Birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy....

FDA does not accept NDA for Crinone gel (Watson) for use in reducing risk of Preterm Birth

The FDA has issued a complete response to an NDA for Crinone (progesterone vaginal gel 8%), from Watson, for use in the reduction of risk of Preterm Birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy. The letter stated that the effect of treatment with Crinone in reducing the risk of ...

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 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 ...

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 ...

Surfaxin is re-filed at FDA for Respiratory Distress Syndrome

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature ...

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....