Company Expects to Complete Submission for Fast Track Designated Medicine by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Aug. 21, 2017– Alkermes plc (NASDAQ:ALKS) today announced the initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a […]
Once-Daily, Oral Product Candidate Demonstrated Antipsychotic Efficacy Statistically Superior to Placebo and Similar to Olanzapine in ENLIGHTEN-1 Study Management to Hold Conference Call Today at 4:30 p.m. ET DUBLIN–(BUSINESS WIRE)–Jun. 29, 2017– Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from ENLIGHTEN-1, the first of two key phase 3 studies in the ENLIGHTEN […]
Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation Company Reiterates Plans to Submit New Drug Application to FDA by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Jun. 12, 2017– Alkermes plc (NASDAQ: ALKS) today announced the initiation of study 217, a phase 3b trial of ALKS 5461, a […]
Designed to Assess Weight Gain Profile of Olanzapine Compared to ALKS 3831 in Patients Diagnosed With Schizophrenia, Schizophreniform or Bipolar I Disorder Who Are Early in Their Illness Supportive Study in the ENLIGHTEN Clinical Development Program for ALKS 3831, an Investigational, Novel, Once-Daily, Oral Atypical Antipsychotic for the Treatment of Schizophrenia DUBLIN–(BUSINESS WIRE)–Jun. 8, 2017– […]
First and Only Long-Acting Atypical Antipsychotic With Two-Month Dosing Option Approval Expands ARISTADA’s Product Offerings to Include Once-Monthly, Once-Every-Six-Weeks and Once-Every-Two-Months Dosing Durations DUBLIN–(BUSINESS WIRE)–Jun. 6, 2017– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. […]
Anonymous donation will help create safe, healing space for emergency patients RALEIGH, N.C. February 13, 2017 – UNC REX Healthcare plans to build a new holding area for behavioral health patients who seek treatment in the emergency department, thanks to an anonymous donor who is contributing $2.5 million. The separate behavioral health zone will include […]
Partnership of government, academics and industry will develop new ways of studying and screening drugs for major psychiatric illnesses LA JOLLA – August 31, 2016 —The Johns Hopkins University School of Medicine and the Salk Institute for Biological Studies will co-lead a $15.4 million effort to develop new systems for quickly screening libraries of drugs for […]
NUPLAZID is the First and Only FDA-Approved Drug for this Indication An Estimated 40 Percent of Parkinson’s Disease Patients Have Psychosis SAN DIEGO–(BUSINESS WIRE)–May 31, 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 […]
First Wave of Healthcare Providers Being Trained in 55 Cities over the Next Six Weeks Probuphine Will Be Available to Patients in June 2016 PRINCETON, N.J. — May 31, 2016—Braeburn Pharmaceuticals announces plans to make Probuphine available to healthcare providers and patients in June, immediately following Food and Drug Administration (FDA) approval on May 26, […]
Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid epidemic May 26, 2016 – The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in […]