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...
19:21 , May 18, 2018 |  BC Extra  |  Company News

FDA reviewers cast doubt on Insys analgesic's utility, safety

FDA reviewers said data from an NDA of Buvaya buprenorphine sublingual spray from Insys Therapeutics Inc. (NASDAQ:INSY) do not support its usage to treat acute pain. The remarks came in briefing documents issued ahead of...
22:57 , May 14, 2018 |  BC Extra  |  Politics & Policy

FDA to hold public meeting on chronic pain therapy

FDA will hold a public meeting July 9 to discuss drug development for chronic pain. Topics include the symptoms and daily affect of chronic pain on patients and patients' perspectives on current treatment. FDA Commissioner Scott...
00:25 , May 12, 2018 |  BioCentury  |  Politics, Policy & Law

Getting reorganized

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review oversight more consistent while encouraging senior staff to become thought leaders. The changes at OND...
21:33 , May 11, 2018 |  BioCentury  |  Finance

Seroquel stepping stone

The $538 million acquisition by Luye Pharma Group Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new emerging markets for the Chinese pharma’s internal CNS pipeline. On...
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...