17:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up...
21:15 , Nov 2, 2018 |  BC Extra  |  Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
04:17 , Oct 13, 2018 |  BioCentury  |  Product Development

Trevena goes for MOR than morphine

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meeting on pain candidate oliceridine from Trevena Inc. gave the agency little reason to reverse its skepticism about the molecule’s benefits and risks. But it did leave...
19:30 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Advisory panel narrowly rejects olicerideine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) to manage moderate to severe pain in adults for whom IV opioids are warranted. Panelists...
22:05 , Oct 11, 2018 |  BC Extra  |  Company News

Advisory panel narrowly rejects oliceridine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) to manage moderate to severe pain in adults for whom IV opioids are warranted. Panelists...
15:44 , Oct 9, 2018 |  BC Extra  |  Company News

FDA reviewers doubt benefits of Trevena's analgesic over morphine

Trevena Inc. (NASDAQ:TRVN) was off $1.91 (64%) to $1.07 on Tuesday after FDA reviewers expressed doubts that the company’s Olinvo oliceridine (TRV130) offered a benefit over morphine, according to briefing documents released ahead of a...
01:38 , Oct 6, 2018 |  BioCentury  |  Politics, Policy & Law

SUPPORTing FDA’s fight against opioids abuse

Legislation President Donald Trump is expected to sign soon gives FDA powers that are intended to blunt the opioid abuse epidemic and incentivize development of non-addictive pain treatments. The new authorities will give FDA tools...
16:39 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Braeburn’s CAM2038 meets in Phase III for chronic low back pain

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said CAM2038 met the primary endpoint in the Phase III HS-16-555 trial to treat moderate to severe chronic low back pain in patients previously on long-term daily opioid therapy....
16:45 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency....
18:02 , Aug 29, 2018 |  BC Extra  |  Preclinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency....