18:52 , Feb 22, 2019 |  BC Week In Review  |  Company News

Generic Suboxone products enter U.S. market

At least three companies have launched in the U.S. generic versions of opioid dependence drug Suboxone buprenorphine/naloxone sublingual film from Indivior plc (LSE:INDV). The generic Suboxone manufacturers include Alvogen Inc. (Pinebrook, N.J.), the Sandoz unit...
19:47 , Feb 15, 2019 |  BC Week In Review  |  Company News

Indivior divests Suboxone tablets to China’s Zhejiang Pukang

Indivior plc (LSE:INDV) will sell Chinese rights to its sublingual tablet formulation of Suboxone buprenorphine/naloxone to Zhejiang Pukang Biotechnology Co. Ltd. (Hangzhou, China) so that Indivior can focus on long-term growth of its extended release...
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...
19:52 , 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...
01:44 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

‘Tentative’ FDA approval for Braeburn's opioid addiction product

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. The drug is for use in patients who have...
20:04 , Dec 26, 2018 |  BC Extra  |  Company News

‘Tentative’ FDA approval for Braeburn's opioid addiction product

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. The drug is for use in patients who have...
19:27 , Dec 21, 2018 |  BC Week In Review  |  Company News

Orexo regains ex-U.S. rights to Zubsolv from Mundipharma

Orexo AB (SSE:ORX) will regain global, ex-U.S. rights to Zubsolv buprenorphine/naloxone from Mundipharma International Ltd. (Dublin, Ireland), effective April 13. Orexo, which holds U.S. rights to the drug, said the news follows a portfolio reorganization...
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...