The U.S. Food and Drug Administration held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Avenue Therapeutics’ IV tramadol.
Shares of Flexion Therapeutics soared in trading on Oct. 11 after Pacira Biosciences announced the acquisition of the Burlington, Massachusetts-based biopharmaceutical company for $427 million in cash.
Biogen reported positive topline results from the company’s Phase II CONVEY trial of vixotrigine for the treatment of small fiber neuropathy (SFN).
Avenue Therapeutics Inc. said on June 14 the U.S. Food and Drug Administration had once again declined to approve the company’s non-opioid painkiller tramadol, sending the drugmaker’s shares lower in trading.
Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.
Acadia Pharmaceuticals is adding a novel pain portfolio to the company’s pipeline through the acquisition of Texas-based CerSci Therapeutics for $52.5 million.
Frank Reynolds, the founder and former chief executive officer of PixarBio, was sentenced to seven years in prison for defrauding investors.
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.
A lower dose of non-opioid painkiller developed by Pfizer Inc. and Eli Lilly and Co. failed to meet main goals in a late-stage study in patients with moderate-to-severe osteoarthritis of the hip or knee, the companies said.
Malvern, Penn.-based Recro Pharma will terminate 50 employees of the company’s Acute Care Segment less than two weeks after receiving a Complete Response Letter from the U.S. Food and Drug Administration for the non-opioid pain medication, IV meloxicam.