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...
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...
17:58 , Mar 30, 2018 |  BC Week In Review  |  Company News

Indivior licenses preclinical addiction candidate from C4X Discovery

C4X Discovery Holdings plc (LSE:C4XD) licensed to Indivior plc (LSE:INDV) exclusive, worldwide rights to C4X3256, a preclinical compound to treat addiction. C4X will receive $10 million up front and is eligible for up to $284...
19:07 , Mar 29, 2018 |  BC Extra  |  Company News

C4X gains after addiction deal with Indivior

C4X Discovery Holdings plc (LSE:C4XD) jumped 56p (99%) to 112.5p after licensing to Indivior plc (LSE:INDV) exclusive, worldwide rights to C4X3256, a preclinical compound to treat addiction. C4X will receive $10 million up front and...
22:13 , Dec 1, 2017 |  BC Extra  |  Company News

Indivior's Sublocade MAT to compete with Alkermes’ Vivitrol

FDA approved once-monthly subcutaneous Sublocade buprenorphine (RBP-6000) from Indivior plc (LSE:INDV) to treat opioid use disorder. The company said it expects to launch the drug next quarter at a wholesale acquisition cost (WAC) of $1,580...
01:56 , Nov 18, 2017 |  BioCentury  |  Regulation

Turning the tide

FDA’s plans to blunt the epidemic of opioid abuse, addiction and overdoses will stretch the boundaries of FDA oversight, creating precedents that could be applied in the future to other drug classes and health problems....