WALTHAM, Mass. — Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that AstraZeneca Seroquel’s first-line patient share grew two percent since last year’s patient-level claims data analysis of prescribing trends in bipolar disorder. During this same time period other atypicals...
treatment News
BOSTON, MASS. — Servier today announced longer-term data from the Phase 3 INDIGO trial evaluating VORANIGO® (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma following surgical intervention and for whom chemoradiotherapy can be delayed were published in The Lancet Oncology. The analysis reports an additional six months of...
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)...
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...
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...
— 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...