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The FDA is requiring additional warnings on the labeling of Leo Pharma’s Picato topical gel for actinic keratosis after receiving reports of severe allergic reactions and shingles associated with its use. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
The FDA has granted rare pediatric disease designation to two investigational Duchenne Muscular Dystrophy therapies — Sarepta Therapeutics’ eteplirsen and BioMarin Pharmaceutical’s drisapersen — the first DMD candidates to win the designation. Read More
A first-of-its-kind “basket study” of responses to Daiichi Sankyo and Genentech’s Zelboraf on a host of cancer mutations is showing positive results, Memorial Sloan Kettering Cancer Center researchers report. Read More
Sandoz and Amgen are separately asking the full Federal Circuit Court of Appeals to review a July decision by a three-judge panel on the biosimilar approval pathway, saying the ruling is contrary to Congress’ intent in the Biologics Price Competition and Innovation Act. Read More
Pfizer has released positive topline results of two Phase 3 studies of its meningitis vaccine Trumenba, saying its ability to provoke an immune response and safety data are consistent with the findings that formed the basis for its FDA accelerated approval. Read More
Novartis has agreed to pay up to $1 billion for the rights to autoimmune indications for GlaxoSmithKline’s Arzerra, including multiple sclerosis, following an earlier deal for the drug’s oncology indications. Read More
Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance reduced the risk of cardiovascular events in adults with Type 2 diabetes who are at high risk of such events, making it the only glucose-lowering agent to demonstrate this benefit in a dedicated trial. Read More
Valeant Pharmaceuticals wasted no time in signing a deal to acquire Sprout Pharmaceuticals for $1 billion, following Tuesday’s FDA approval of Sprout’s female libido drug, Addyi. Read More
Merck is recalling thousands of bottles of Temodar and temozolomide capsules, because cracks in the caps have rendered the child-resistant closure ineffective. Read More