Specialty Pharmacy

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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Lilly Study Reveals Less than 30% of People Living with Migraine Take Recommended Prescription Medications

INDIANAPOLIS, June 16, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that less than 30 percent of people with migraine are taking a recommended prescription medication, highlighting the need for improvement in migraine care. These data are from the initial cohort of the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study, which …

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Inventiva’s Lanifibranor Meets Primary and Key Secondary Endpoints in Phase IIb Trial in Non-Alcoholic Steatohepatitis

Daix (France), June 15, 2020 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced positive topline results from the Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) …

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Pfizer Announces Positive Top-Line Results from a Phase 3 Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results from the Phase 3 JADE TEEN study of abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients 12 to <18 years of age with moderate to severe atopic dermatitis (AD) who were also on background topical …

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FDA Approves Lilly’s Tauvid for Injection for Use in Patients Being Evaluated for Alzheimer’s Disease

INDIANAPOLIS, May 28, 2020 /PRNewswire/ — TAUVID™, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).1 A neuropathological …

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Ironwood and AbbVie to Halt Development of MD-7246 After Drug Fails to Meet Endpoints in Phase 2 Trial in Patients with Abdominal Pain Associated with IBS-D

BOSTON–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary or key secondary endpoints. Based on these …

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FDA Approves Dupixent as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

PARIS and TARRYTOWN, N.Y. – May 26, 2020 – The U.S. Food and Drug Administration (FDA)  approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic …

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