16:14 , Feb 20, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Pain Rat studies suggest nanoparticles loaded with Leu-enkephalin-lipid conjugate could help treat pain. In a rat model of chemical-induced pain, nanoparticles loaded with a conjugates consisting of the neuropeptide Leu-enkephalin linked to the lipid...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
13:09 , Dec 4, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Addiction Mouse studies suggest inhibitors of the heroin metabolite 6-monoacetylmorphine could help treat prenatal heroin addiction. In pregnant mouse dams exposed to heroin, an anti-6-monoacetylmorphine antibody decreased blood levels of morphine -- a heroin...
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...