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...
01:51 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
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...
22:04 , Dec 31, 2018 |  BC Extra  |  Company News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
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...
18:27 , Nov 30, 2018 |  BC Week In Review  |  Company News

Dr. Reddy's gets green light to market opioid dependence generic

Dr. Reddy's Laboratories Ltd. (NYSE:RDY) said on Nov. 20 that a U.S. federal court vacated a district court's preliminary decision that prohibited the company from selling its generic version of film Suboxone buprenorphine/naloxone sublingual from...
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...