00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

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

EMA's CHMP on Sept. 21 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...
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)...
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...
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...
16:21 , Jul 20, 2018 |  BC Week In Review  |  Clinical 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,...
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...
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...