Specialty Pharmacy

Acacia Pharma Announces FDA Approval of Barhemsys for Treatment and Prevention of Postoperative Nausea and Vomiting

Cambridge, UK and Indianapolis, US – 27 February 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer …

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Takeda to Acquire PvP Biologics and its Investigational Celiac Disease Drug in Deal Worth $330 Million

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that it has acquired PvP Biologics, Inc. following the conclusion of a Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. TAK-062 is a potential best-in-class, highly potent super glutenase – a protein that …

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NGM Bio Announces Positive Preliminary Topline Liver Histology and Biomarker Data from 24-Week Phase 2 Study of Aldafermin in NASH Patients

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2020 (GLOBE NEWSWIRE) — NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a biotechnology company focused on developing transformative therapeutics for patients, today announced positive preliminary topline results from the 24-week double-blind, randomized, placebo-controlled cohort (Cohort 4) of an adaptive Phase 2 study evaluating the efficacy, safety …

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FDA Approves Lundbeck’s Vyepti, the First and Only Intravenous Preventive Treatment for Migraine

DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck today announced that VYEPTI™ (eptinezumab-jjmr) has been approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults and will be available in April 2020. The recommended dose is 100 mg every 3 months; some patients may benefit from a dose …

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Data from Phase 3 Study of Genfit’s NASH Candidate Elafibranor Delayed

Lille (France), Cambridge (Massachusetts, United States), February 20, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that unblinding of the Phase 3 RESOLVE-IT data will be delayed to …

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Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, Feb. 19, 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 the U.S. Food and Drug Administration (FDA) has extended the …

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Teva’s Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint

TEL AVIV, Israel–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary …

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Incyte Announces Positive Topline Results From Phase 3 Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the second randomized, vehicle-controlled, pivotal Phase 3 study from the TRuE-AD clinical trial program has met its primary endpoint. Building on the previously-reported positive topline results from TRuE-AD2, the results of TRuE-AD1 also show that significantly more patients treated with ruxolitinib cream 0.75% …

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Genentech Provides Topline Results from Phase II/III Trial With Gantenerumab in Rare Inherited Form of Alzheimer’s Disease

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease (AD). This form of AD, …

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FDA Grants Fast Track Designation to Alector’s AL101 for the Treatment of Patients with Frontotemporal Dementia

SOUTH SAN FRANCISCO, Calif., Feb. 05, 2020 (GLOBE NEWSWIRE) — Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AL101 for the treatment of patients with progranulin gene mutations causative of frontotemporal dementia …

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