Fort Lee, NJ — Nuvectis Pharma, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced a collaboration with Mayo Clinic to evaluate NXP800 in an Investigator-sponsored clinical trial in cholangiocarcinoma. Mitesh Borad,...
treatment News
Tokyo, Japan and Cambridge, UK – Nxera Pharma Co. Ltd (TSE 4565) – formerly known as Sosei Group or Sosei Heptares – announces it has joined the World Orphan Drug Alliance (WODA), a global alliance of commercial distributors dedicated to providing access to treatments for rare diseases and specialty medicines...
New York, NY – For some proteins, a single mutation, or change in its DNA instructions, is all it takes to tip the balance between functioning normally and causing cancer. But despite causing major disease, these slightly mutated proteins can resemble their normal versions so closely that treatments designed to...
TAIPEI, Taiwan — OBI Pharma, a clinical stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody – drug conjugate (ADC) cancer therapy targeting TROP2. OBI plans...
PRINCETON, N.J. – Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG). The FDA Fast Track is a process designed to facilitate the development...
REDWOOD CITY, Calif. – Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of...
LACHEN, Switzerland — New clinical data from Octapharma’s haematology portfolio will be presented during the scientific program at the 65th American Society of Hematology (ASH) Meeting and Exposition, which is being held on December 9–12, 2023, in San Diego, California. New data from the prospective clinical trial using wilate® for...
PARAMUS, N.J. — Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years...
MALVERN, Pa. — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data Safety and Monitoring Board (DSMB) for the OCU410ST clinical trial recently convened and approved to proceed dosing with the medium dose of...
BEDFORD, Mass. — Ocular Therapeutix Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal...