Specialty Pharmacy

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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FDA Approves Allergan’s Ubrelvy for the Acute Treatment of Migraine with or Without Aura in Adults

DUBLIN, Dec. 23, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVY™ (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY™ is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for …

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Gilead’s Phase 2 Study Fails to Meet Primary Endpoint in Patients with Bridging Fibrosis and Compensated Cirrhosis due to NASH

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary …

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BioMarin Announces Positive Results from Phase 3 Data in Children with Achondroplasia Treated with Vosoritide

SAN RAFAEL, Calif., Dec. 16, 2019 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today reported positive final results from its randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of vosoritide.  The placebo-adjusted change from baseline in growth velocity after one year of treatment with vosoritide, the primary …

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