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...
18:33 , Nov 30, 2018 |  BC Week In Review  |  Company News

I-Mab gains Chinese rights to MorphoSys' MOR210

MorphoSys AG (Xetra:MOR; NASDAQ:MOR) granted I-Mab Biopharma (Shanghai, China) exclusive rights to develop and commercialize preclinical compound MOR210 in China, including Hong Kong and Macau, Taiwan and South Korea. I-Mab will be responsible for all...
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...
01:20 , Nov 28, 2018 |  BC Extra  |  Company News

Management tracks: Abeona, INKEF, Incyte

Abeona Therapeutics Inc. (NASDAQ:ABEO) terminated Carsten Thiel for personal misconduct towards colleagues, less than eight months after hiring him as CEO. The rare genetic disease company named Head of R&D and CMO João Siffert interim...
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...
18:00 , Nov 9, 2018 |  BC Week In Review  |  Company News

MorphoSys shares jump amid Tremfya guidance, MOR208 data

MorphoSys AG (Xetra:MOR; NASDAQ:MOR) shares rose Nov. 6 after the company said in its 3Q18 earnings that plaque psoriasis drug Tremfya guselkumab could generate 2018 royalties at the upper end of the biotech's previous guidance....
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...
23:40 , Nov 6, 2018 |  BC Extra  |  Company News

MorphoSys shares jump amid Tremfya guidance, MOR208 data

MorphoSys AG (Xetra:MOR; NASDAQ:MOR) shares rose Tuesday after the company said in its 3Q18 earnings that plaque psoriasis drug Tremfya guselkumab could generate 2018 royalties at the upper end of the biotech's previous guidance. MorphoSys...
00:05 , Nov 6, 2018 |  BC Extra  |  Company News

Management tracks: Audentes, Veloxis

Gene therapy company Audentes Therapeutics Inc. (NASDAQ:BOLD) appointed CEO and co-founder Matthew Patterson as chairman. Patterson has been a board member since 2012. Audentes also appointed board member Louis Lange as lead independent director. Lange...
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...