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Specialty Pharmacy

Alzheon Presents New Findings in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease and Planned Confirmatory Clinical Trial with ALZ-801

FRAMINGHAM, Mass.–(BUSINESS WIRE)–Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer’s disease (AD) and other neurological and psychiatric disorders, today announced the upcoming presentation of data at the Alzheimer’s Association International Conference (AAIC) in Chicago on Wednesday, July 25th, 2018. The presentation at the …

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FDA Grants Fast Track Designation to Tonix Pharmaceuticals’ Investigational Treatment for Agitation in Alzheimer’s Disease

NEW YORK, July 16, 2018 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer’s disease. The same drug, TNX-102 SL, or …

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FDA Grants Orphan Drug Designation to Acceleron’s Facioscapulohumeral Muscular Dystrophy Drug

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation for ACE-083, the Company’s locally acting “Myostatin+” muscle agent, for …

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Avella’s Use of AdhereTech Improves Adherence of Multiple Specialty Medications and Diseases

PHOENIX, July 10, 2018 /PRNewswire/ — Avella Specialty Pharmacy and AdhereTech are proud to share the results that their successful partnership continues to have for patients. Avella currently uses the AdhereTech program for five specialty medications, in programs with four different pharmaceutical manufacturers. Averaged across all patients and programs from …

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Luspatercept Demonstrates Positive Results in Late-Stage Study in Adults with Transfusion-Dependent Beta-Thalassemia

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a phase III, randomized, double-blind, multi-center clinical study (BELIEVE). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 …

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Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 in Alzheimer’s Disease

TOKYO and CAMBRIDGE, Mass., July 05, 2018 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ:BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 …

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Alnylam Announces Publication of Phase 3 Results for Investigational RNAi Therapeutic Patisiran in Hereditary ATTR Amyloidosis

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the pivotal study results from the APOLLO Phase 3 trial of patisiran were published online today in The New England Journal of Medicine (NEJM). The study showed that patisiran improved measures of polyneuropathy, quality of life, activities of daily living, …

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Luspatercept Demonstrates Positive Results in Phase 3 Trial in Patients with Low-to-Intermediate Risk Myelodysplastic Syndromes

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a phase III, randomized, double-blind, multi-center clinical study (MEDALIST). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least 8 …

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Lilly’s Taltz Met Primary and Major Secondary Endpoints in Late-Stage Ankylosing Spondylitis Trial

INDIANAPOLIS, June 28, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first …

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FDA Approves GW’s Cannabis-Based Drug Epidiolex for the Treatment of Rare, Severe Forms of Epilepsy

London, UK, Carlsbad, CA, June 25, 2018: GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that the U.S. Food and Drug Administration …

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