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Specialty Pharmacy

Genfit Announces Positive 36-Month DSMB Recommendation for Continuation of Phase 3 Study of Elafibranor in NASH

Lille (France), Cambridge (Massachusetts, United States), May 14, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT) a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for …

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Premier Selling its Specialty Pharmacy Business to CVS Health Unit

CHARLOTTE, N.C. — Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company, is exiting its specialty pharmacy business to enhance the company’s focus on the continuing evolution of its core supply chain, enterprise analytics and performance improvement capabilities. On May 6, 2019, certain of Premier’s consolidated subsidiaries entered into a definitive …

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Merck’s Belsomra C-IV Meets Primary Efficacy Endpoint in Phase 3 Trial for Treatment of Insomnia in Patients with Alzheimer’s Disease Dementia

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of results of a Phase 3 trial evaluating the efficacy and safety of BELSOMRA® (suvorexant) C-IV for the treatment of insomnia in people with mild-to-moderate Alzheimer’s disease dementia. This is the first dedicated …

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Acacia Pharma Receives Complete Response Letter from the FDA for its Post-Operative Nausea & Vomiting Candidate Barhemsys

Cambridge, UK and Indianapolis, US – 3 May 2019: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a second Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug …

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Heron Therapeutics Receives Complete Response Letter From the FDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, May 1, 2019 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. …

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Data Show that Treatment with Spinraza Improved Motor Function and Provided Long-Term Benefit for Patients with Later-Onset Spinal Muscular Atrophy

CAMBRIDGE, Mass., April 30, 2019 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) today announced that data from CS2/CS12, an open-label study of the safety and tolerability of SPINRAZA in individuals with later-onset spinal muscular atrophy (SMA), were published in the peer-reviewed journal Neurology, the medical journal of the American Academy of Neurology. The data …

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FDA Approves PCSK9 Inhibitor Praluent to Reduce Risk of Heart Attack, Stroke, and Unstable Angina Requiring Hospitalization

Regeneron Pharmaceuticals, Inc. (NASDAQ:  REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. “Heart disease accounts for one quarter of all American …

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Gilead’s Investigational Selonsertib Fails to Meet Primary Endpoint in Phase 3 NAS Study

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), for patients with bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH), did …

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Gilead Presents New Data for Investigational Combination Therapy Treatment for Nonalcoholic Steatohepatitis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 11, 2019– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical research program in nonalcoholic steatohepatitis (NASH) being presented at The International Liver Congress™ 2019 in Vienna. The data support Gilead’s efforts to develop combination therapies to target different aspects of NASH, evaluate the utility …

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Alkermes Announces Positive Topline Results from Study of Aristada and Invega Sustenna for the Treatment of Schizophrenia

DUBLIN, April 9, 2019 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA® (aripiprazole lauroxil) and INVEGA SUSTENNA® (paliperidone palmitate) when used to initiate patients experiencing an …

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