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AstraZeneca’s Farxiga Meets Primary Endpoint in Phase 3 Trial for the Treatment of Patients with Heart Failure

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that FARXIGA (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalization or an urgent heart failure visit), compared to …

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Lilly Announces Positive Results from its Phase 3 Study of Emgality in Patients who Failed Previous Migraine Preventive Treatments

INDIANAPOLIS, Aug. 5, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that Emgality® (galcanezumab-gnlm) met the primary and all key secondary outcomes in CONQUER, a Phase 3 study evaluating the efficacy and safety of Emgality in the preventive treatment of chronic and episodic migraine in patients with …

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Pfizer’s Rivipansel Fails to Meet its Primary or Key Secondary Endpoints in Phase 3 Trial in Sickle Cell Patients with a Vasco-Occlusive Crisis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the Phase 3 Rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with sickle …

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Acadia’s Pimavanserin Fails to Meet the Primary Endpoint in its Phase 3 Trial in Patients with Schizophrenia

SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced top-line results from its Phase 3 ENHANCE study, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with persistent inadequate response to their current antipsychotic therapy. A total of 396 patients with moderate-to-severe psychotic symptoms were randomized to receive …

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FDA Approves Merck’s Recarbrio for Treatment of Complicated UTI’s and Intra-Abdominal Infections Where Limited or No Alternative Treatments are Available

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. RECARBRIO is indicated in patients 18 years of age and older who …

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FDA Grants Priority Review to Novartis’ BLA for its Investigational Sickle Cell Medicine Crizanlizumab

Basel, July 16, 2019 – Novartis today announced the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine crizanlizumab (SEG101). If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular …

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FDA Grants Fast Track Designation to Prevail’s PR001 for the Treatment of Parkinson’s Disease with a GBA1 Mutation

NEW YORK, July 08, 2019 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL) (Prevail), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the Company’s lead gene therapy program, …

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FDA Approves Allergan’s Botox for Treatment of Pediatric Patients with Upper Limb Spasticity

DUBLIN, June 21, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted …

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Sanofi and Regeneron Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma

PARIS and TARRYTOWN, NY – June 21, 2019 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. The trial also …

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Eiger’s Avexitide Granted Breakthrough Therapy Designation by FDA for the Treatment of Post-Bariatric Hypoglycemia

PALO ALTO, Calif., June 17, 2019 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avexitide for the treatment of post-bariatric hypoglycemia (PBH).  …

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