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...
01:03 , Jan 12, 2019 |  BioCentury  |  Finance

Warning: cash needed

  A near decade-long run of cheap money appears to be coming to a close, and most of the biotech sector isn’t well positioned for the new reality. BioCentury’s analysis shows that two-thirds of biotech...
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...
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...
21:19 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...
23:31 , Dec 12, 2018 |  BC Extra  |  Clinical News

Tremfya superior to Cosentyx in head-to-head Phase III trial

Janssen Biotech Inc. said Tremfya guselkumab met the primary endpoint of improving PASI 90 response rate vs. Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) in the Phase III ECLIPSE trial to treat moderate to severe...
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...