NEW YORK – Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has received European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for...
treatment News
NEW YORK, NY — SELLAS Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, today announced follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor...
NEW YORK – SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, announced encouraging updated clinical data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS),...
NEW YORK, NY — SELLAS Life Sciences Group, Inc., a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, the Company’s novel and...
INDIANAPOLIS — Semafore Pharmaceuticals, Inc., a privately held cancer drug discovery and development company, today presented data from a Phase I clinical trial of its vascular targeted pan-PI3K/mTORC1/2 inhibitor, SF1126, at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Orlando, Florida. Dr. E. Gabriela Chiorean,...
CAMBRIDGE, Mass. – Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announces the U.S. Food and Drug Administration (FDA) has indicated studies for SER-155 may proceed under an Investigational New Drug (IND) application. SER-155 is an investigational oral, rationally-designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal...
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...
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...
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...