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...
19:37 , Jan 16, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Pain In vitro and mouse studies identified methyloxymorphone-based dual MOR/DOR agonists that could help treat pain. Chemical synthesis and in vitro testing of methyloxymorphone analogs yielded six compounds that bound MOR and DOR with...
17:51 , Jan 11, 2019 |  BC Week In Review  |  Clinical News

BlackThorn deprioritizing MDD compound after Phase IIa miss

BlackThorn Therapeutics Inc. (San Francisco, Calif.) said it will deprioritize development of BTRX-246040 (formerly LY-2940094) to treat major depressive disorder (MDD) after the compound missed the primary and secondary endpoints in a Phase IIa trial....
20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
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...