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...
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...
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...
18:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA panel to discuss Alkermes' depression candidate

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Nov. 1 to discuss an NDA from Alkermes plc (NASDAQ:ALKS) for ALKS 5461 as an adjunct to treat major depressive...
22:10 , Aug 3, 2018 |  BC Extra  |  Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
16:32 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Alkermes' depression candidate, reversing refusal

FDA accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will not...
13:53 , Apr 16, 2018 |  BC Extra  |  Company News

FDA reverses Alkermes refuse-to-file decision

FDA has accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will...
20:52 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA refuses to file Alkermes' NDA for depression candidate

Alkermes plc (NASDAQ:ALKS) sank $12.73 (22%) to $45.23 on April 2 after it said FDA issued a refusal-to-file letter for its NDA for ALKS 5461 as an adjunctive treatment for major depressive disorder (MDD) in...