XBiotech Inc. (NASDAQ: XBIT) announced today that it had completed enrollment in the U.S. for its Phase 2, open label clinical study evaluating subcutaneous administration of bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS).
Amicus Therapeutics (Nasdaq: FOLD) today announced the signing of a definitive agreement in which Amicus Therapeutics will receive worldwide development and commercial rights for ten gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State University. The ten programs are licensed to Amicus from Nationwide Children’s Hospital through the acquisition of Celenex, a private, clinical stage gene therapy company.
A recent survey of U.S. neurologists (n=99) finds that the multiple sclerosis (MS) market remains focused on Genentech’s Ocrevus 18 months postlaunch with strong uptake displacing Biogen’s Tysabri as the monoclonal antibody (mAb) class leader for the first time.
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ADVM-022. ADVM-022 is a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD).
Zealand Pharma A/S ("Zealand"), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the successful results in the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes.
Veeva Systems recently announced a next-generation cloud application to streamline clinical data management and accelerate study execution.
PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, and Datavant, Inc., a healthcare technology company focused on enabling the secure de-identification and linking of healthcare datasets, recently announced they are partnering to enhance clinical study design and operations, as well as the generation of real-world evidence.
ArQule, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to miransertib (ARQ 092) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a group of related, ultra-rare genetic disorders characterized by excessive tissue growth in various parts of the body.
Abeona Therapeutics Inc., a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, recently announced authorization to move forward with a Phase 1/2 clinical trial in Spain for the Company’s gene therapy product ABO-101 (AAV-NAGLU) for patients with MPS IIIB (Sanfilippo syndrome type B).
Gilead Sciences, Inc. and Galapagos NV recently announced that FINCH 2, a global, randomized, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12.
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