Specialty Pharmacy

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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Bone Therapeutics’ Allogeneic Cell Therapy Product Meets Primary Endpoints in Phase 2a Study in Patients Undergoing Lumbar Spinal Fusion

Gosselies, Belgium, 13 June 2019, 7 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapeutics to address high unmet medical needs in orthopaedics and bone diseases, today announces that its allogeneic cell therapy product, ALLOB, successfully completed …

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CymaBay’s Seladelpar Fails to Meet the Primary Endpoint in an Ongoing Phase 2b Trial in Patients with NASH

NEWARK, Calif., June 11, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced 12-week topline results from an ongoing 52-week Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH). Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist …

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La Jolla Pharmaceutical Announces Positive Interim Results from Phase 2 Study of LJPC-401 in Patients with Hereditary Hemochromatosis

SAN DIEGO, June 06, 2019 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq: LJPC), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced positive results from the pre-specified interim analysis of its Phase 2 study of LJPC-401 …

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