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California drugmaker Medivation is acquiring the worldwide rights to BioMarin’s breast cancer drug talazoparib, in a move aimed at diversifying and expanding its global oncology footprint. Read More
AstraZeneca and Peregrine Pharmaceuticals are collaborating on an early-phase clinical trial to evaluate the safety and efficacy of two novel investigational drugs in patients with a range of solid tumor types. 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
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