17:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

China approves Solasia's oral mucositis product

Solasia Pharma K.K. (Tokyo:4597) said China's National Medical Products Administration approved Episil (SP-03) to relieve pain associated with oral mucositis. The company added ¥50 (31%) to ¥210 on Feb. 21. Episil is a lipid-based liquid...
00:09 , Feb 22, 2019 |  BC Extra  |  Company News

China approves Solasia's oral mucositis product

Solasia Pharma K.K. (Tokyo:4597) said China's National Medical Products Administration approved Episil (SP-03) to relieve pain associated with oral mucositis. The company added ¥50 (31%) to ¥210 on Thursday. Episil is a lipid-based liquid that...
01:44 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

‘Tentative’ FDA approval for Braeburn's opioid addiction product

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. The drug is for use in patients who have...
20:04 , Dec 26, 2018 |  BC Extra  |  Company News

‘Tentative’ FDA approval for Braeburn's opioid addiction product

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. The drug is for use in patients who have...
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....
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,...