17:33 , Feb 8, 2018 |  BC Extra  |  Politics & Policy

FDA facilitating generic versions of complex drugs

FDA released new guidance documents Thursday that are intended to facilitate generic competition for “complex,” hard-to-copy drugs. It issued product-specific guidance on 19 complex medicines, including six that have no generic competition. The drugs are...
21:10 , Dec 30, 2016 |  BC Week In Review  |  Company News

BioDelivery Sciences, Endo deal

Endo will terminate a 2012 deal granting it exclusive, worldwide rights to develop and commercialize Belbuca buprenorphine to treat chronic pain, effective Jan. 6. BioDelivery will regain all rights to the product. The companies said...
08:00 , Feb 29, 2016 |  BC Week In Review  |  Company News

Endo sales and marketing update

Endo launched Belbuca buprenorphine in the U.S. to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The wholesale acquisition cost (WAC) of a 75...
08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

Buprenorphine buccal film regulatory update

FDA approved an NDA from Endo for Belbuca buprenorphine buccal film to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The approval triggered a $50...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Belbuca buprenorphine buccal film: Phase II data

A double-blind, 2-way crossover Phase II trial in 35 confirmed opioid-dependent patients receiving once-daily around-the clock therapy with 80-220 mg doses of a full opioid agonist showed that switching to 300 and 400 ug doses...
07:00 , Jul 13, 2015 |  BioCentury  |  Finance

Big news

The performance of big cap biotechs has lagged that of companies one tier down, but the second half includes a host of milestones that could put the bellwethers on a steeper upward trajectory. Buysiders...
07:00 , Mar 16, 2015 |  BC Week In Review  |  Clinical News

Belbuca buprenorphine buccal film regulatory update

BioDelivery and Endo said FDA accepted for review an NDA for Belbuca buprenorphine buccal film to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The...
08:00 , Feb 2, 2015 |  BC Week In Review  |  Clinical News

Buprenorphine Buccal Film BEMA buprenorphine regulatory update

Endo and BioDelivery submitted an NDA to FDA for Buprenorphine Buccal Film to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The partners are...
08:00 , Dec 22, 2014 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changesCompanyBankAnalystCoverageOpinionWk chg12/19 clsBioDelivery Sciences International Inc. (NASDAQ:BDSI)Roth Capital PartnersScott HenryUpgradeBuy (from neutral)0%$13.82 Henry upgraded after a recent decline in BioDelivery's share price of about 25% since the November launch...
07:00 , Sep 15, 2014 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 9/12cls BioDelivery Sciences International Inc. (NASDAQ:BDSI) Summer Street Jim Molloy...