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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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Novartis’ Fevipiprant Fails in Phase 3 Trials for Treatment of Patients with Uncontrolled Asthma

Basel, Switzerland, December 16, 2019 – Novartis today announced topline results from its pivotal global Phase III LUSTER-11 and LUSTER-22 studies exploring the efficacy and safety of the investigational oral, once-daily, DP2 receptor antagonist fevipiprant (QAW039). The pooled analyses of the LUSTER trials did not meet3 the clinically relevant threshold for reduction in rate of moderate …

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Diplomat and OptumRx Combine to Advance Access to Specialty Pharmacy Care and Infusion Services, Improve Health Outcomes

EDEN PRAIRIE, Minn. and FLINT, Mich.–(BUSINESS WIRE)–OptumRx, the pharmacy care services business of Optum, and Diplomat, a provider of specialty pharmacy and infusion services, are combining. The agreement calls for the acquisition of Diplomat’s outstanding common stock for $4.00 per share through a cash tender offer and assumption of outstanding …

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Sage Therapeutics’ Investigational SAGE-217 Fails to Meet its Primary Endpoint in Pivotal Phase 3 Trial

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet …

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Caribou Biosciences Announces New Methods to Harness Type I CRISPR-Cas Systems for Genome Engineering in Human Cells

BERKELEY, Calif.–(BUSINESS WIRE)–Caribou Biosciences, Inc., a leading CRISPR genome editing company, announced the publication of a new study demonstrating human genome engineering with Type I CRISPR-Cas systems. The study, entitled “Harnessing Type I CRISPR-Cas Systems for Genome Engineering in Human Cells,” was published today in the peer-reviewed scientific journal Nature Biotechnology. …

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Merck and Bayer’s Vericiguat Meets Primary Endpoint in Phase 3 Study in Patients with Worsening Chronic Heart Failure

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy …

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