Category: Clinical trials

Three-year Follow-up Phase 3 Data Provide Additional Information on Efficacy, Durability and Safety of Investigational Luxturna (voretigene neparvovec) in Patients with Biallelic RPE65-mediated Inherited Retinal Disease

PHILADELPHIA, Nov. 10, 2017 (GLOBE NEWSWIRE) -- Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, today announced new three-year follow-up data from the...

Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)--Nov. 8, 2017-- Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”), today announced dosing of the first patient in EV-103, a...

New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer’s Disease

TOKYO, Nov 6, 2017 - (ACN Newswire) - Eisai Co., Ltd. announced today that Biogen Inc. (Nasdaq: BIIB) presented new data from the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, an investigational treatment for Alzheimer's...

AbbVie Announces Positive Phase 3 Extension Study Data for Investigational Oral Treatment Elagolix for Management of Endometriosis with Associated Pain

NORTH CHICAGO, Ill., Nov. 1, 2017 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced detailed results from two replicate...

Kura Oncology Lead Candidate Tipifarnib Shows Durable Anti-Tumor Activity in HRAS Mutant Head and Neck Cancer in AACR-NCI-EORTC Update

SAN DIEGO, Oct. 27, 2017 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, today presented updated preliminary results from its Phase 2...

Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies

NORTH CHICAGO, Ill., Oct. 26, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab,...

FDA Grants Breakthrough Therapy Designation for BioMarin’s Valoctocogene Roxaparvovec (formerly BMN 270), an Investigational Gene Therapy for Hemophilia A

SAN RAFAEL, Calif., Oct. 26, 2017 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) granted valoctocogene roxaparvovec (formerly BMN 270) Breakthrough Therapy Designation....

Atara Biotherapeutics Receives Rare Pediatric Disease Designation from FDA for ATA230 for Treatment of Congenital Cytomegalovirus (CMV) Infection

SOUTH SAN FRANCISCO, Calif., Oct. 26, 2017 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune diseases and serious...