colleen, Author at Braeburn

24 Sep Braeburn Appoints Joshua M. Cohen, MD, MPH, FAHS as Chief Medical Officer

Posted at 09:27h in Press Release

Plymouth Meeting, Pa.—September 24, 2021—Braeburn announces that Joshua M. Cohen, MD, MPH, FAHS has joined the company as Chief Medical...

26 Jun FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

Posted at 09:59h in Press Release

Prescription Drug User Fee Act (PDUFA) action date set for December 15, 2021. Plymouth Meeting, Pa. – June 26, 2021 –...

15 Jun Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

Posted at 17:00h in Press Release

Plymouth Meeting, Pa. – June 15, 2021 – Braeburn announces that today the New Drug Application (NDA) for BRIXADI (buprenorphine)...

10 Dec Braeburn Announces Arbitration Determination that It Did Not Materially Breach Its License Agreement with Camurus AB

Posted at 13:38h in Press Release

Plymouth Meeting, Pa. – December 10, 2020 – Braeburn announces that a tribunal appointed by the ICC International Court of...

02 Dec Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

Posted at 08:30h in Press Release

Plymouth Meeting, Pa. — December 2, 2020 — Braeburn announces that the U.S. Food and Drug Administration (FDA) issued a...

15 Sep Braeburn Appoints Brian Hirsch as General Counsel

Posted at 09:45h in Press Release

Plymouth Meeting, Pa. —September 15, 2020—Braeburn announces that it has appointed Brian Hirsch as General Counsel and Corporate Secretary. Mr. Hirsch...

01 Jun Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

Posted at 17:29h in Press Release

Plymouth Meeting, Pa. —June 1, 2020 — Braeburn announces that it has requested final approval from the U.S. Food and...

07 Nov FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020

Posted at 21:08h in Press Release

FDA revokes Indivior PLC’s orphan designation for opioid use disorder (OUD)* and prevents an additional five-year block of other monthly...

02 Oct Braeburn Employees Pledge to Reduce Substance Use Disorder Stigma

Posted at 11:02h in Press Release

Plymouth Meeting, Pa. – October 30, 2019 – As part of an ongoing commitment to reduce the stigma associated with...

09 Sep Opioid Overdose Prevention and Reversal

Posted at 14:10h in Culture

For Overdose Awareness Day, we shared awareness that overdose death is preventable in hopes of continuing the downward trend in...

Author: colleen