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Advances in Personalized Medicine and Immuno-Oncology Fueled Major Shift in Cancer Treatment

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–During the past decade, advances in personalized medicine and immuno-oncology have fueled a major shift in treatment of cancer. Since 2011, 68 novel therapies have been approved across 22 cancer indications globally. These developments have led to more options as well as greater …

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Albertsons Expands Specialty Services through Acquisition of MedCart Specialty Pharmacy

BOISE, Idaho, May 31, 2017 /PRNewswire/ — Albertsons Companies announced today that it recently acquired MedCart Specialty Pharmacy in order to strengthen and extend its pharmacy specialty services. MedCart Specialty Pharmacy is an industry-leading, URAC accredited, pharmaceutical and healthcare provider of customized specialty care services and medication management for patients …

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FDA Approves Genentech’s Actemra for Treatment of Giant Cell Arteritis

South San Francisco, CA — May 22, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition. Actemra is the …

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Nearly 1 in 3 Drugs Found to Have Safety Concerns After FDA Approval

How often are safety concerns raised about a drug after it’s been approved by the FDA? Nicholas Downing, MD, of the Department of Medicine at Brigham and Women’s Hospital, and colleagues have found that for drugs approved between 2001 and 2010, nearly 1 in 3 had a postmarket safety event. …

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US Drug Spending Growth of 4.8 Percent in 2016 According to QuintilesIMS Institute Study

DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Growth in U.S. spending on prescription medicines fell in 2016 as competition intensified among manufacturers, and payers ramped up efforts to limit price increases, according to research released today by the QuintilesIMS Institute. New medicines introduced in the past two years continue to …

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Neurotrope’s Alzheimer’s Disease Candidate Fails Mid-Stage Trial

NEW YORK, May 1, 2017 /PRNewswire/ — Neurotrope, Inc. (NASDAQ: NTRP) today announced positive top-line results from its Phase 2 study (-202 Study) of Bryostatin-1 in patients with moderate to severe Alzheimer’s disease (AD), a population not commonly targeted in AD clinical trials. Bryostatin-1, a Protein Kinase C epsilon activator …

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The Medicines Company and Alnylam Announce Agreement with FDA on Phase 3 Program for Inclisiran

PARSIPPANY, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New …

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Bristol-Myers Squibb’s Investigational NASH Drug Demonstrates Positive Results in Phase 2 Trial

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced data from a Phase 2 study of BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) (F1-F3). The study achieved its primary endpoint of significant reduction in …

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Gilead Announces Positive Proof-of-Concept Data for its NASH Candidate

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH). The data, from ten patients treated with GS-0976 20 mg taken orally once daily for 12 weeks, indicated that treatment …

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FDA Approves Neurocrine’s Ingrezza as the First Approved Drug for Tardive Dyskinesia

SAN DIEGO, April 11, 2017 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved INGREZZATM (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and …

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