Specialty Pharmacy

Data from Phase 3 Study of Genfit’s NASH Candidate Elafibranor Delayed

Lille (France), Cambridge (Massachusetts, United States), February 20, 2020 – GENFIT (Nasdaq and Euronext: 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 unblinding of the Phase 3 RESOLVE-IT data will be delayed to …

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Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, Feb. 19, 2020 /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 the U.S. Food and Drug Administration (FDA) has extended the …

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Teva’s Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint

TEL AVIV, Israel–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary …

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Incyte Announces Positive Topline Results From Phase 3 Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the second randomized, vehicle-controlled, pivotal Phase 3 study from the TRuE-AD clinical trial program has met its primary endpoint. Building on the previously-reported positive topline results from TRuE-AD2, the results of TRuE-AD1 also show that significantly more patients treated with ruxolitinib cream 0.75% …

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Genentech Provides Topline Results from Phase II/III Trial With Gantenerumab in Rare Inherited Form of Alzheimer’s Disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease (AD). This form of AD, …

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FDA Grants Fast Track Designation to Alector’s AL101 for the Treatment of Patients with Frontotemporal Dementia

SOUTH SAN FRANCISCO, Calif., Feb. 05, 2020 (GLOBE NEWSWIRE) — Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AL101 for the treatment of patients with progranulin gene mutations causative of frontotemporal dementia …

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Premier to Acquire Acurity and Nexera Businesses from the Greater New York Hospital Association for $291.5 Million

CHARLOTTE, N.C.–(BUSINESS WIRE)–Premier Inc. (NASDAQ: PINC), a leading healthcare improvement company, today announced that it has entered into a definitive agreement to acquire substantially all the assets and certain liabilities of Acurity, Inc. and Nexera, Inc., two indirect wholly owned subsidiaries of the Greater New York Hospital Association (“GNYHA”), for …

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Akcea and Ionis Report Positive Topline Results from Phase 2 Study of AKCEA-APOCIII-L Rx

BOSTON and CARLSBAD, Calif., Jan. 22, 2020 /PRNewswire/ — Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), today announced positive topline results from the Phase 2 study of AKCEA-APOCIII-LRx in the treatment of patients with hypertriglyceridemia who are at risk …

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Biogen Pays $75 Million for Pfizer’s Early-Stage Alzheimer’s Disease Drug Candidate

CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced an agreement to acquire from Pfizer Inc. (NYSE: PFE) PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and …

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FDA Approves Intra-Cellular Therapies’ Novel Antipsychotic Caplyta for Treatment of Schizophrenia in Adults

NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that CAPLYTA® (lumateperone) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. The Company …

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