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...
01:19 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Alkermes submits NDA to FDA for Biogen-partnered MS candidate

Alkermes plc (NASDAQ:ALKS) submitted an NDA to FDA under under section 505(b)(2) of the Food, Drug and Cosmetic Act seeking approval of diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis. Alkermes' partner Biogen...
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...
17:10 , Nov 16, 2018 |  BC Week In Review  |  Company News

Michigan to begin talks with drug manufacturers for value-based deals

With a stamp of approval from CMS on Nov. 14, Michigan joins Oklahoma as one of the only two states with the agency's OK to negotiate Medicaid outcomes-based pricing agreements with drug manufacturers. "Michigan’s waiver...
23:55 , Nov 14, 2018 |  BC Extra  |  Politics & Policy

Michigan to begin talks with drug manufacturers for value-based deals

With a stamp of approval from CMS on Wednesday, Michigan joins Oklahoma as one of the only two states with the agency's OK to negotiate Medicaid outcomes-based pricing agreements with drug manufacturers. "Michigan’s waiver will...
23:26 , Nov 13, 2018 |  BC Extra  |  Company News

Management tracks: Anchiano, ContraFect

Cancer company Anchiano Therapeutics Inc. (Tel Aviv:ANCN) appointed Stephen Hoffman chairman. He is CEO of Aerpio Pharmaceuticals Inc. (OTCQB:ARPO). Anchiano also named Robert Connelly a director. He was a venture partner at Flagship Pioneering and...
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...