18:37 , Apr 4, 2019 |  BC Extra  |  Company News

Management tracks: Gottlieb's next move, plus Vertex, Centogene and more

FDA Commissioner Scott Gottlieb will return to the American Enterprise Institute as a resident fellow after he leaves the agency. His last day at FDA is Friday. Gottlieb expects to work part-time at AEI, where...
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...
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,...
22:35 , Jun 25, 2018 |  BC Extra  |  Company News

Management tracks: Nordic Nanovector, Molecular Partners

Cancer company Nordic Nanovector ASA (OSE:NANO) hired Eduardo Bravo as CEO, effective July 2. He was CEO at TiGenix N.V. (NASDAQ:TIG; Euronext:TIG). Protein therapeutics company Molecular Partners AG (SIX:MOLN) said CSO Michael Stumpp has become...