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Apotex’s application for a biosimilar version of Amgen’s chemotherapy Neulasta has been accepted by the FDA, one of several recent signs that regulatory movement on approving the therapies is gaining momentum. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More
Development and approval times of central nervous system drugs that treat conditions such as depression, Alzheimer’s and Parkinson’s disease lag behind those of other drugs, a recent report finds. Read More
The FDA approved seven new drugs last month, pushing its total to 41 last year, the highest number of new molecular entities cleared by the agency since 1996. Read More
Vertex Pharmaceuticals’ cystic fibrosis drug Kalydeco has won FDA approval for an additional indication to treat patients six years and older with at least one copy of the R117H gene mutation. Read More
The FDA approved Hospira’s nonsteroidal anti-inflammatory drug (NSAID) analgesic Dyloject to treat mild to moderate pain as well as moderate to severe pain either on its own or in combination with opioid analgesics. Read More
Genentech bolstered its case that Gazyva is more effective at treating front-line leukemia than the company’s older drug Rituxan, which is set to face stiff biosimilar competition in a few years. Read More