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Sage Therapeutics’ Investigational SAGE-217 Fails to Meet its Primary Endpoint in Pivotal Phase 3 Trial

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet …

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Caribou Biosciences Announces New Methods to Harness Type I CRISPR-Cas Systems for Genome Engineering in Human Cells

BERKELEY, Calif.–(BUSINESS WIRE)–Caribou Biosciences, Inc., a leading CRISPR genome editing company, announced the publication of a new study demonstrating human genome engineering with Type I CRISPR-Cas systems. The study, entitled “Harnessing Type I CRISPR-Cas Systems for Genome Engineering in Human Cells,” was published today in the peer-reviewed scientific journal Nature Biotechnology. …

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Merck and Bayer’s Vericiguat Meets Primary Endpoint in Phase 3 Study in Patients with Worsening Chronic Heart Failure

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase (sGC) stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy …

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FDA Approves Novartis’ Adakveo to Reduce Frequency of Pain Crises in Patients with Sickle Cell Disease

Basel, November 15, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab), previously known as SEG101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients aged 16 years and older with sickle cell disease.4 Adakveo represents the first FDA-approved medicine …

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Long-Term Data of Neurocrine’s Ingrezza Demonstrates Once-Daily Capsules Reduced Involuntary Movements in Tardive Dyskinesia Patients

SAN DIEGO, Nov. 12, 2019 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the Journal of Clinical Psychopharmacology1 published long-term data from the KINECT 4 Phase III, open-label study of INGREZZA® (valbenazine) capsules, demonstrating that treatment with once-daily 40 mg or 80 mg of INGREZZA reduced involuntary movements in adults who had moderate or severe …

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Galectin Therapeutics Reaches Agreement with Siemens Healthineers to Collaborate on NASH and Liver Fibrosis

NORCROSS, Ga., Nov. 11, 2019 (GLOBE NEWSWIRE) — Today, Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, announced a collaboration agreement with Siemens Healthineers, a global leader in medical technology, in nonalcoholic steatohepatitis (NASH) and liver fibrosis. This collaboration allows Siemens Healthineers to use …

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Novartis Pays $80 Million for Pliant Therapeutics’ Preclinical NASH Candidate

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2019 /PRNewswire/ — Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced it has entered into a strategic collaboration and license agreement with Novartis covering the development and commercialization of Pliant’s …

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Biogen Plans FDA Filing for its Investigational Alzheimer’s Disease Drug Aducanumab Despite Futility Failure

CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that, after consulting with the U.S. Food and Drug Administration (FDA), Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD). The Phase …

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FDA Approves AstraZeneca’s Farxiga to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. The approval is based on …

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FDA Approves Genentech’s Xofluza for People at High Risk of Developing Influenza-Related Complications

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 …

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