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Psychiatry

Braeburn Pharmaceuticals Announces FDA Approves Probuphine® (buprenorphine) Implant: The First Implant for Treatment of Opioid Dependence

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Patients and Providers Have a New Option to Combat Opioid Dependence PRINCETON, N.J.—May 26, 2016—Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per […]

Braeburn Pharmaceuticals Announces Decision to Continue with North Carolina Manufacturing Facility Plans

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Company Will Stay and Fight for Civil Rights and Diversity Princeton, New Jersey— May 17, 2016—Braeburn Pharmaceuticals, developer of medications for opioid addiction and other chronic neurological diseases, will proceed with plans to develop a manufacturing and research facility in Durham County, North Carolina, despite the enactment of HB2, the controversial law that overturns local […]

Braeburn Pharmaceuticals and Camurus announce positive top line results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use disorder

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Princeton, New Jersey and Lund, Sweden — 11 May, 2016 — Braeburn Pharmaceuticals and Camurus today announce top line results of a multiple-dose, pivotal Phase 2 study assessing the blockade by CAM2038 of subjective opioid effects of multiple randomized hydromorphone challenges in adults with opioid use disorder. A key objective of medication-assisted treatment for opioid […]

FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks

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SAN DIEGO–(BUSINESS WIRE)–Mar. 29, 2016– ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits […]

ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis

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Advisory Committee Meeting Scheduled for March 29, 2016 SAN DIEGO–(BUSINESS WIRE)–Jan. 29, 2016– ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug […]

Alkermes Announces Positive Results of Phase 2 Clinical Trial of ALKS 3831 in Schizophrenia

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Once-Daily, Oral Product Candidate Showed Efficacy Equivalent to Olanzapine With Clinically Meaningful and Statistically Significant Lower Weight Gain in 300-Patient Study Company Plans to Initiate Pivotal Development Program in 2015 DUBLIN–(BUSINESS WIRE)–Jan. 7, 2015– Alkermes plc (NASDAQ: ALKS) today announced positive topline results from the 12-week, randomized, double-blind, active-controlled, dose-ranging stage of a phase 2 […]

Alkermes Announces Positive Results From Study of ALKS 5461 for Treatment of Major Depressive Disorder

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Safety and Tolerability Profile of ALKS 5461 Confirmed in FORWARD-1 Study, a Supportive Study in the FORWARD Phase 3 Pivotal Program Dosing Regimen Confirmed; Efficacy Data Showed Statistically Significant Improvements in Depression Scores Beginning at Week One and Continuing Through Eight-Week Treatment Period DUBLIN–(BUSINESS WIRE)–Jan. 6, 2015– Alkermes plc (NASDAQ: ALKS) today announced topline results […]

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