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FDA Approves Lilly’s Reyvow, the First and Only Medicine in a New Class of Acute Treatment for Migraine

INDIANAPOLIS, Oct. 11, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in …

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GSK Submits sNDA to the FDA for Trelegy Ellipta for Use in Patients With Asthma

LONDON–(BUSINESS WIRE)–GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment of asthma …

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Novartis Positive 52-week PREVENT Data Confirm Cosentyx Efficacy in Addressing Entire axSpA Spectrum

Basel, October 02, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, today announced additional positive data from the PREVENT trial, evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant …

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Pfizer’s Abrocitinib Achieves All Co-Primary and Key Secondary Endpoints in its Phase 3 Trial in Patients 12 and Older with Moderate to Severe Atopic Dermatitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second …

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FDA Grants Fast Track Designation to Inventiva’s Lanifibranor for the Treatment of NASH

Daix (France), September 26, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s …

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FDA Approves Ipsen’s Dysport for Treatment of Upper Limb Spasticity in Children, Excluding Cerebral Palsy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has expanded the use of Dysport® (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused …

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Enanta Announces Positive Results from its Phase 2a Study of its lead FXR Agonist, EDP-305, for the Treatment of NASH

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced topline results from its ARGON-1 Phase 2a study of EDP-305 for the treatment of non-alcoholic steatohepatitis (NASH). The ARGON-1 study was a 12-week, randomized, …

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The Medicines Company’s Inclisiran Meets Primary and Secondary Endpoints in Phase 3 Study in ASCVD Patients

PARSIPPANY, N.J.–(BUSINESS WIRE)–The Medicines Company (NASDAQ: MDCO) today announced positive topline results for the ORION-10 Phase 3 clinical study in patients with atherosclerotic cardiovascular disease (ASCVD), successfully completing the pivotal Phase 3 LDL-cholesterol (LDL-C) lowering clinical trials for inclisiran. ORION-10 met all primary and secondary endpoints, and inclisiran demonstrated efficacy, …

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SanBio’s SB623 Granted Regenerative Medicine Advanced Therapy Designation from the FDA for Chronic Neurological Motor Deficits Secondary to TBI

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation for SB623 cell therapy for the treatment of chronic neurological motor …

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Acceleron’s Investigational Muscular Dystrophy Therapy Fails to Achieve Functional Secondary Endpoints in Phase 2 Trial

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that treatment with ACE-083 in patients with facioscapulohumeral muscular dystrophy (FSHD) did not achieve functional secondary endpoints in the Phase 2 trial. Although …

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