19:06 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Alkermes planning NDA for schizophrenia combo after passing weight gain test

Alkermes plc (NASDAQ:ALKS) said it plans to submit an NDA to FDA mid-2019 for ALKS 3831 after reporting that the samidorphan/olanzapine combination tablet led to less weight gain in schizophrenics than olanzapine alone in the...
21:15 , Nov 29, 2018 |  BC Extra  |  Clinical News

Alkermes planning NDA for schizophrenia combo after passing weight gain test

Alkermes plc (NASDAQ:ALKS) said it plans to submit an NDA to FDA mid-2019 for ALKS 3831 after reporting that the samidorphan/olanzapine combination tablet led to less weight gain in schizophrenics than olanzapine alone in the...
02:43 , Nov 10, 2018 |  BioCentury  |  Regulation

Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg problem for...
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...
23:32 , Nov 2, 2018 |  BC Extra  |  Company News

More data could be key for Alkermes after FDA panel vote

After an FDA panel did not recommend approval of ALKS 5461 as an adjunct treatment for major depressive disorder (MDD), Alkermes plc (NASDAQ:ALKS) remained tight-lipped on next steps. Members of a joint advisory panel voted...
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...
23:44 , Nov 1, 2018 |  BC Extra  |  Company News

FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder. Panelists also voted 20-3 that...
19:08 , Oct 30, 2018 |  BC Extra  |  Company News

FDA reviewers question efficacy, abuse liability of Alkermes antidepressant

In briefing documents issued ahead of an advisory committee meeting, FDA reviewers expressed multiple concerns about efficacy analyses performed in studies of ALKS 5461 from Alkermes plc (NASDAQ:ALKS) to treat major depressive disorder (MDD), as...
18:25 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of AcelRx's pain candidate

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04) from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supports its approval to manage moderate to severe acute pain...
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...