21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT) for...
18:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA panel to discuss Alkermes' depression candidate

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Nov. 1 to discuss an NDA from Alkermes plc (NASDAQ:ALKS) for ALKS 5461 as an adjunct to treat major depressive...
16:39 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Braeburn’s CAM2038 meets in Phase III for chronic low back pain

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said CAM2038 met the primary endpoint in the Phase III HS-16-555 trial to treat moderate to severe chronic low back pain in patients previously on long-term daily opioid therapy....
17:28 , Sep 14, 2018 |  BC Week In Review  |  Company News

ICER finds opioid use disorder treatments not cost-effective

In a draft evidence report, ICER found that newer extended-release formulations of medication-assisted treatments (MATs) for opioid use disorder were not cost-effective compared with generic medicines. The institute compared the clinical effectiveness and value of three...
23:10 , Sep 10, 2018 |  BC Extra  |  Company News

ICER finds opioid use disorder treatments are not cost-effective

In a draft evidence report, ICER found that newer extended-release formulations of medication-assisted treatments (MATs) for opioid use disorder were not cost-effective compared with generic medicines. The institute compared the clinical effectiveness and value of three...
16:45 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency. Opioids...
18:02 , Aug 29, 2018 |  BC Extra  |  Preclinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency. Opioids...
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...