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Specialty Pharmacy

Janssen Halts Development of its BACE Inhibitor for Alzheimer’s Disease Due to Liver Safety Concerns

Titusville, United States, May 17, 2018 – At Janssen, the safety and well-being of people who participate in our clinical trials are of utmost importance to us. For the past several years, we have been studying an investigational drug called a BACE inhibitor. The goal of this research is to slow …

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FDA Approves Aimovig as First Calcitonin Gene-Related Peptide (CGRP) Blocker for Migraine Prevention

THOUSAND OAKS, Calif., May 17, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) …

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Pfizer’s Lyrica Oral Solution CV Meets Primary Endpoint in Late-Stage Trial in Pediatric Epilepsy

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with …

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FDA Grants Priority Review to Insmed’s ALIS in NTM Lung Disease Caused by MAC

BRIDGEWATER, N.J., May 16, 2018 (GLOBE NEWSWIRE) — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for adult …

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Diplomat Launches CastiaRx, Industry-Leading Specialty Benefit Manager

FLINT, Mich., April 30, 2018 /PRNewswire/ — Diplomat Pharmacy, Inc. (NYSE: DPLO), has unveiled CastiaRx to respond to industry demand for a leader in specialty benefit management. CastiaRx unites the full-service pharmacy benefit manager (PBM) capabilities of recently acquired LDI Integrated Pharmacy Services and National Pharmaceutical Services with Diplomat’s specialty …

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Endo to Acquire Specialty Pharmaceutical Company Somerset Therapeutics for $190 Million

DUBLIN, April 26, 2018 /PRNewswire/ — Endo International plc (NASDAQ: ENDP) today announced that it has reached definitive agreements to acquire Somerset Therapeutics, LLC, a New Jersey based specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. marketplace, and the business of its India based affiliate Wintac Limited, which operates as Somerset Therapeutics’ contract …

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Eisai and Boston University Partner to Study the Effects of Alzheimer’s Disease-Associated Genetic Variants on Brain

ANDOVER, Mass. and BOSTON, Jan. 30, 2018 /PRNewswire/ — Eisai Inc. and Boston University School of Medicine have formed a research collaboration to study the effects of Alzheimer’s disease-associated genetic variants on the behavior of brain cells, called microglia. Recent discoveries regarding the genetic underpinnings of Alzheimer’s disease (AD), suggest …

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Biogen Acquires Karyopharm’s Neurological Drug in $217 Million Deal

NEWTON, Mass., Jan. 25, 2018 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (NASDAQ:KPTI) today announced its entry into an agreement for Biogen to acquire Karyopharm’s investigational oral SINE compound KPT-350 and other assets for the treatment of certain neurological and neurodegenerative conditions.  KPT-350 is a novel therapeutic candidate that works by …

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Biohaven Announces Positive Results from Bioequivalence Study with its Amyotrophic Lateral Sclerosis Drug

NEW HAVEN, Conn., Jan. 9, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced positive results today from its bioequivalence study with BHV-0223, an innovative sublingual formulation of riluzole. The study was designed to demonstrate pharmacokinetic equivalence of sublingual BHV-0223 compared to the reference …

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Sangamo and Pfizer Collaborate for Development of Potential Gene Therapy for Treatment of ALS

RICHMOND, Calif. and NEW YORK, Jan. 3, 2018 /PRNewswire/ — Sangamo Therapeutics, Inc. (Nasdaq: SGMO) and Pfizer Inc. (NYSE: PFE) today announced a collaboration for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) to treat amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) …

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