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,...
15:44 , May 4, 2018 |  BC Week In Review  |  Company News

ICER to consider broad outcomes for buprenorphines

In a draft scoping document published April 26, ICER said it will consider a broad set of outcomes in its review of three buprenorphine products as medication-assisted treatments for opioid use disorder. ICER is poised to...
21:37 , Apr 27, 2018 |  BC Extra  |  Politics & Policy

ICER to consider broad outcomes for buprenorphines

In a draft scoping document published Thursday, ICER said it will consider a broad set of outcomes in its review of three buprenorphine products as medication-assisted treatments for opioid use disorder. ICER is poised to review...
17:10 , Apr 6, 2018 |  BC Week In Review  |  Company News

ICER to evaluate buprenorphines for opioid disorder

The Institute for Clinical and Economic Review said it will develop a report that will compare the clinical effectiveness of three buprenorphine products to commonly used drugs for medication-assisted treatment of opioid use disorder. In its...
23:17 , Apr 5, 2018 |  BC Extra  |  Politics & Policy

ICER to evaluate buprenorphines for opioid disorder

The Institute for Clinical and Economic Review said it will develop a report that will compare the clinical effectiveness of three buprenorphine products to commonly used drugs for medication-assisted treatment of opioid use disorder. In its...
16:28 , Jan 26, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRL for Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA issued a complete response letter for an NDA for its monthly buprenorphine injection depot CAM2038 to treat opioid use disorder. The company said that FDA requested additional data,...
21:05 , Jan 22, 2018 |  BC Extra  |  Company News

FDA issues CRL for Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said Sunday that FDA issued a complete response letter for an NDA for its monthly buprenorphine injection depot CAM2038 to treat opioid use disorder. The company said that FDA requested...
16:35 , Jan 12, 2018 |  BC Week In Review  |  Financial News

Braeburn raises $110M mezzanine round

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) closed on Jan. 10 a $110 million mezzanine financing led by new investor Wellington Capital Management. New investors Avista Capital Partners, RA Capital Management, New Leaf Venture Partners, Deerfield Management...
22:50 , Jan 10, 2018 |  BC Extra  |  Financial News

Braeburn raises $110M in mezzanine round

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said it closed a $110 million mezzanine financing led by new investor Wellington Capital Management. New investors Avista Capital Partners, RA Capital Management, New Leaf Venture Partners, Deerfield Management and...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to a...