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TXT Court Considering Amgen, Sandoz Cert Petitions [2861 Words] [ Price : $8.95]
Big Molecule Watch says that the Supreme Court is likely to announce in June whether it will hear any appeal of the Federal Circuit decision in Amgen v Sandoz interpreting notification provisions of the Biologics Price Competition and Innovation Act.
05/25/2016
 
 
TXT FDA Lawyer Moves to Oversee Drug Compounding [194 Words] [ Price : $8.95]
FDA Office of Chief Counsel drugs counselor Julie Dohm has been named CDER senior science advisor for compounding.
05/25/2016
 
 
TXT Roche PMA Approved for Cytomegalovirus Test [119 Words] [ Price : $8.95]
FDA approves a Roche PMA for its cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients for monitoring CMV treatment.
05/25/2016
 
 
TXT FDA Extends Review of Controversial Sarepta NDA on Eteplirsen [241 Words] [ Price : $8.95]
FDA extends its review of a Sarepta Therapeutics NDA for eteplirsen and its use in treating Duchenne muscular dystrophy.
05/25/2016
 
 
TXT Relypsa sNDA for Drug-Drug Interactions [163 Words] [ Price : $8.95]
Relypsa files a supplemental NDA requesting label changes for Veltassa (patiromer) for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers.
05/25/2016
 
 
TXT Viamet Pharma Gains Orphan Status for Valley Fever Drug [154 Words] [ Price : $8.95]
FDA grants Viamet Pharmaceuticals an orphan drug designation for VT-1598 for treating coccidioidomycosis (also known as Valley Fever).
05/25/2016
 
 
TXT Professor Sues FDA Over Sleeping Pills [2847 Words] [ Price : $8.95]
University of California emeritus professor Daniel Kripke sues to compel FDA to take specific actions regarding regulation of sleeping pills to protect the public health.
05/24/2016
 
 
TXT CGMP Violations Found at Tai Heng Industry [2812 Words] [ Price : $8.95]
FDA warns China’s Tai Heng Industry about CGMP violations in its manufacturing of active pharmaceutical ingredients.
05/24/2016
 
 
TXT CRS Wants Guidance Against ‘Draize’ Tests [2845 Words] [ Price : $8.95]
The Center for Responsible Science asks FDA to issue guidance to assure drug developers that Draize testing for skin and eye irritation is not required.
05/24/2016
 
 
TXT CGMP Violations at BBT Biotech [2758 Words] [ Price : $8.95]
FDA warns BBT Biotech about CGMP violations in its manufacturing of active pharmaceutical ingredients at a facility in Baesweiler, Germany.
05/24/2016
 
 
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