22:10 , Aug 3, 2018 |  BC Extra  |  Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
17:43 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRL for Insys' analgesic

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA issued a complete response letter for buprenorphine sublingual spray to treat acute pain. Insys was seeking the candidate's approval for the management of acute pain severe enough to require...
22:21 , Jul 27, 2018 |  BC Extra  |  Company News

FDA issues CRL for Insys' analgesic

Insys Therapeutics Inc. (NASDAQ:INSY) said FDA issued a complete response letter for buprenorphine sublingual spray to treat acute pain. Insys was seeking the candidate's approval for the management of acute pain severe enough to require...
16:21 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

FDA again reviewing Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA accepted and granted Priority Review to a resubmitted NDA for CAM2038 to treat opioid use disorder. The candidate, a ready-to-use prefilled syringe containing a lipid solution of buprenorphine,...
17:23 , Jul 16, 2018 |  BC Extra  |  Company News

FDA again reviewing Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA accepted and granted Priority Review to a resubmitted NDA for CAM2038 to treat opioid use disorder. The candidate, a ready-to-use prefilled syringe containing a lipid solution of buprenorphine,...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
20:44 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

FDA approves Suboxone generics from Mylan, Dr. Reddy

FDA approved two generic buprenorphine/naloxone sublingual film products from Mylan N.V. (NASDAQ:MYL) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY), respectively, to treat opioid dependence. FDA said they are the first approved generic versions of Suboxone sublingual...
21:20 , Jun 7, 2018 |  BC Extra  |  Politics & Policy

NIH prompts formal review of medication-assisted treatment for opioid addiction

In response to a congressional request, NIH has asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to review evidence on medication-assisted treatments (MATs) for opioid use disorder to identify knowledge gaps where additional...
17:01 , May 25, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes no for Insys' analgesic

An FDA panel voted 18-1 that the benefits of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not outweigh its risks, and thus recommended against the analgesic’s approval. The vote came at a...
22:45 , May 22, 2018 |  BC Extra  |  Company News

FDA panel rebuffs Insys' analgesic

An FDA panel voted 18-1 that the benefits of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not outweigh its risks, and thus recommended against the analgesic’s approval. The vote came at a...