The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Shares of Pennsylvania-based Baudax Bio were up more than 40 percent after the company announced that the pain medication Anjeso was greenlit by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration’s busy schedule for drug reviews includes six supplemental BLAs for Merck’s blockbuster oncology brand Keytruda.
Switzerland-based Myovant announced an 88 percent one-year response rate in the positive Phase III LIBERTY extension study of once-daily, oral relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids.
Merck is spinning off products from the company’s Women’s Health, Legacy Brands and Biosimilars businesses.
San Diego-based Sorrento Therapeutics rejected a non-binding acquisition proposal from a private equity firm, saying that the offer “significantly undervalues Sorrento and is not in the best interest of the company’s stockholders.”
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) generated an evenly split vote on whether to recommend approval of Durect Corporation’s Posimir.
Nektar Therapeutics withdrew the application for the company’s opioid painkiller for adults with chronic low back pain, after a U.S. Food and Drug Administration panel unanimously voted against the drug’s approval.
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Alnylam Pharmaceuticals Inc. priced the company’s gene silencing drug to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval.
