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FDA Puts Clinical Hold on CRISPR and Vertex’s IND Application for CTX001 for the Treatment of Sickle Cell Disease

BOSTON and ZUG, Switzerland and CAMBRIDGE, Mass., May 30, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions that will be …

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FDA Expedites Review of Novartis’ Promacta for First-Line Severe Aplastic Anemia

Basel, May 30, 2018 – Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation to Promacta®(eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of severe aplastic anemia (SAA). Promacta, which is marketed as …

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WellCare to Acquire Meridian for $2.5 Billion

TAMPA, Fla., May 29, 2018 /PRNewswire/ — WellCare Health Plans, Inc. (NYSE: WCG) announced today that it has entered into a definitive agreement to acquire Meridian Health Plan of Michigan, Inc., Meridian Health Plan of Illinois, Inc., and MeridianRx, a pharmacy benefit manager (PBM), (collectively, “Meridian”) for $2.5 billion in …

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Quest Diagnostics Study Finds Physicians Lack the Time and Tools to Discover Hidden Risks in Patients with Chronic Conditions

SECAUCUS, N.J., May 23, 2018 /PRNewswire/ — The vast majority of primary care physicians don’t have the time or tools to adequately address the needs of their patients with multiple chronic conditions, leaving some patients to struggle with health-related social and behavioral issues on their own, according to new research …

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Cytox and Mayo Clinic Collaborate to Evaluate Novel Genetic Based Approaches for Assessing Alzheimer’s Risk

OXFORD, England & MANCHESTER, England–(BUSINESS WIRE)–Cytox, a precision medicine front-runner which today is commercializing polygenic risk scoring (PRS) approaches for assessing genetic risk for developing Alzheimer’s and other neurological diseases, has announced it has entered into a research collaboration with Mayo Clinic to test current and develop new proprietary algorithms …

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Biosimilars Could Facilitate Early Access to Life Changing Biological Treatments for Patients

BALTIMORE–(BUSINESS WIRE)–At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring …

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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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