15:02 , Mar 20, 2019 |  BC Extra  |  Politics & Policy

National Academies: Equitable access to medicines key to curbing opioid abuse disorder

A consensus report on the value of medication based treatment for opioid use addiction from the National Academies of Sciences, Engineering and Medicine found that available drugs are underutilized, and concluded that improving broad patient...
02:36 , Feb 28, 2019 |  BC Week In Review  |  Clinical News

FDA accepts NDA for multiple sclerosis prodrug from Alkermes, Biogen

Alkermes plc (NASDAQ:ALKS) said FDA accepted for review an NDA for diroximel fumarate (BIIB098) to treat relapsing forms of multiple sclerosis. The PDUFA date is in 4Q19. The company submitted the NDA submitted under under...
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...
01:08 , Feb 1, 2019 |  BC Week In Review  |  Company News

AZ, UPMC in value-based agreement for Brilinta

To reduce out-of-pocket costs for Medicare patients, AstraZeneca plc (LSE:AZN; NYSE:AZN) signed a value-based contract with UPMC Health Plan for Brilinta ticagrelor that links reimbursement of the drug to cardiovascular outcomes following a recent hospitalization...
22:22 , Jan 28, 2019 |  BC Extra  |  Company News

AZ, UPMC in value-based agreement for Brilinta

To reduce out-of-pocket costs for Medicare patients, AstraZeneca plc (LSE:AZN; NYSE:AZN) signed a value-based contract with UPMC Health Plan for Brilinta ticagrelor that links reimbursement of the drug to cardiovascular outcomes following a recent hospitalization...
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...