00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
18:53 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

FDA wants more data for Alkermes' depression therapy

Alkermes plc (NASDAQ:ALKS) said FDA issued a complete response letter for its NDA for ALKS 5461 as an adjunct treatment of major depressive disorder. The company said the agency is requesting additional clinical data showing...
21:36 , Feb 1, 2019 |  BC Extra  |  Company News

FDA wants more data for Alkermes' depression therapy

Alkermes plc (NASDAQ:ALKS) said FDA issued a complete response letter for its NDA for ALKS 5461 as an adjunct treatment of major depressive disorder. The company said the agency is requesting additional clinical data showing...
19:52 , Jan 17, 2019 |  BioCentury  |  Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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...
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...