FDA

Progenics receives FDA Breakthrough Therapy for Azedra

Wednesday, July 29, 2015

The FDA has designated Progenics Pharmaceuticals’ Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra currently is being evaluated in a pivotal phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.

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FDA approves Sanofi, Regeneron’s Praluent (alirocumab) Injection

Monday, July 27, 2015

The FDA has approved Sanofi and Regeneron Pharmaceuticals’ Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

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St. Jude Medical receives FDA approval for spinal cord stimulation trial system

Thursday, July 23, 2015

St. Jude Medical, a global medical device company, has received FDA approval of the St. Jude Medical Invisible Trial System. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.

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Baxalta’s shows positive data for BAX 855 in hemophilia A

Friday, July 17, 2015

Baxalta, a global biopharmaceutical provider dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has published complete data from the phase II/III pivotal study and phase I trial of BAX 855 in Blood, the journal of the American Society of Hematology. BAX 855 is Baxalta’s investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], a treatment for hemophilia A with more than 11 years of real-world patient experience.

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U.S. House passes 21st Century Cures Act

Wednesday, July 15, 2015

The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA.  On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0. 

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