Braeburn Company Updates | Glassdoor

Company Updates

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  • At Braeburn, everything we think, say and do is with patients in mind. Filing this Petition was necessary to bring vital treatment options to patients suffering with opioid addiction as soon as possible.

    Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade | Braeburn

    Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine OUD Treatment Will Enter the Market until Late 2024 Plymouth Meeting, Pa. - April 9, 2019 - Braeburn Inc.

  • CAM2038 received a positive opinion from CHMP – great news for patients in Europe with opioid dependence.

    Positive CHMP Opinion | Braeburn

    Braeburn announces that Camurus has received a positive opinion from the EMA's CHMP for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age 16 and older with opioid dependence.

  • We are pleased to announce the positive top-line results for a Phase 3 efficacy and safety study.

    Positive Top-line Phase 3 Results | Braeburn

    Plymouth Meeting, PA-September 18, 2018 - Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional (HCP) administration.

  • We’re pleased FDA has assigned a December 26 PDUFA date for our Fast Track and Priority Review NDA for CAM2038 for the treatment of moderate-to-severe #OpioidUseDisorder and are eager to work closely as we move forward.

    Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder - Braeburn

    Braeburn announces that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018, for its New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults with opioid use disorder (OUD).

  • Opioid overdoses are an increasing public health burden in the United States. Today, Braeburn hosts a congressional briefing to explore how “warm hand-off” protocols can help reduce post-emergency department visits and increase treatment adherence.

    Braeburn on Twitter

    Braeburn is honored to join Steve Fera of @IBX, @Dr_DownBlock1, @pkunzhoward and representatives from @PADrugAlcohol and @NOPETaskForce today on Capitol Hill to discuss emergency department protocols for opioid overdoses. Follow us this morning for live tweets of the event!

  • We are excited to welcome Dr. Richard Malamut to Team Braeburn! Dr. Malamut will lead our team of clinical and medical professionals that are committed to Braeburn’s mission to help address the opioid addiction epidemic.

    Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer | Braeburn

    Plymouth Meeting, PA-June 25, 2018-Braeburn announces that Richard Malamut, M.D. has joined the company as Chief Medical Officer. Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies. Dr. Malamut will lead a team of clinical and medical professionals that are committed to Braeburn's ...

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