Specialty Pharmacy

FDA Lifts Clinical Holds on CymaBay’s Seladelpar IND Applications in NASH, PBC, and PSC

NEWARK, Calif., July 23, 2020 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today that the Food and Drug Administration (FDA) lifted clinical holds on seladelpar for all three Investigational New …

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Genfit Discontinues Phase 3 Trial of Elafibranor in NASH After Failing Interim Analysis

Lille (France), Cambridge (Massachusetts, United States), July 22, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced the discontinuation of the RESOLVE-IT Phase 3 clinical trial of elafibranor in adults with non-alcoholic steatohepatitis (NASH) and …

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Rinvoq Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

NORTH CHICAGO, Ill., July 21, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis.1 The co-primary endpoints were at least a …

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FDA Grants Priority Review to Merck’s Vericiguat for Treatment of Patients with Heart Failure

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular …

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Ipsen Announces Updated Indication for Dysport® (abobotulinumtoxinA) for the Treatment of Spasticity in Children

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 approved the expanded use of Dysport® (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug …

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Biogen Submits BLA to the FDA for Approval of Aducanumab as a Treatment of Alzheimer’s Disease

CAMBRIDGE, Mass. and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for …

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Can-Fite Announces Final Data Analysis from Phase II NASH Study: Highly Significant and Sustained Reduction in Liver Fat Volume

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that the final data analysis from its Phase II study of Namodenoson in the treatment of patients with non-alcoholic fatty …

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Heron Therapeutics Receives Complete Response Letter from the FDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, June 29, 2020 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on June …

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FDA Approves Zogenix’s Fintepla for Treatment of Seizures Associated with Dravet Syndrome

EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) — Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA will be …

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FDA Approves Novartis’ Cosentyx for Treatment of Active Non-Radiographic Axial Spondyloarthritis

Basel, June 17, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum9. “The results from the PREVENT trial …

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