BOSTON, Mass. — Servier today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO® (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1)...
treatment News
VALENCIA, Calif. — SetPoint Medical, a medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that it has initiated enrollment in the pilot clinical study evaluating Setpoint System® as a potential pro-remyelination therapy for adults living with relapsing-remitting multiple sclerosis (RRMS). The study received Investigational...
VALENCIA, Calif. — SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). Breakthrough...
SEATTLE, Washington — Shape Therapeutics, a leader in RNA editing-based gene therapy, today announced a partnership with the Rett Syndrome Research Trust (RSRT) to advance SHP-401, an investigational one-time gene therapy for Rett syndrome. Under the agreement, RSRT will fund translational studies to evaluate Shape’s RNAfix® guide RNA, designed to leverage...
Pittsburgh, Pennsylvania and Toronto, Ontario – Sharp Therapeutics Corp. (TSXV: SHRX) (“Sharp” or the “Company”), a preclinical-stage biotechnology company developing small molecule therapies to treat genetic diseases, today announced that it has engaged Rho, Inc. (“Rho”), a global contract research organization (CRO), to support Sharp’s preparation and planned submission of...
OSAKA, Japan — Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the first patients were enrolled in Esprit, a global Phase 2 clinical trial evaluating S-606001, an investigational drug for the treatment of late-onset Pompe disease (LOPD). Esprit is a multicenter, randomized,...
CLONMEL, Ireland – Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced today that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the...
PRINCETON, N.J. & TOKYO & WALTHAM, Mass. — Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of...
Grand Cayman, Cayman Islands — Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the successful initiation of its Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, at Tel...
— Successfully demonstrates strong tolerability, sustained drug release and safety SARASOTA, Florida — Silo Pharma, Inc. (Nasdaq: SILO) (“Silo,” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced positive results for its preclinical study evaluating SP-26, a novel extended-release ketamine...