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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
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
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
HHS has contracted with San Diego-based Pfenex Pharmaceuticals to develop an anthrax vaccine that is effective after exposure — under an agreement valued at up to $143 million. Read More
Spectrum Pharmaceuticals is on track to file an NDA for its cancer drug apaziquone by the end of this year, following agreement with the FDA on a special protocol assessment for a Phase 3 clinical trial in patients with non-muscle invasive bladder cancer. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More