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...
treatment News
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...
Baltimore, Maryland – A single dose of the typhoid conjugate vaccine, Typbar TCV®, provides lasting efficacy in preventing typhoid fever in children ages 9 months to 12 years old, according to a new study conducted by researchers at University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and...
BOSTON, Mass. — Sionna Therapeutics, a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF), today announced that the first healthy subject has been dosed in a Phase 1 clinical trial of SION-109 following clearance of its Investigational New Drug application (IND) by the...
BOSTON — Sionna Therapeutics, a clinical-stage life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF), today announced the presentation of preclinical data on highly potent Series 2 nucleotide binding domain-1 (NBD1) stabilizers, SION-719 and SION-451. These data show that SION-719 and SION-451 fully restore...
HONG KONG, GERMANTOWN, Md. and SUZHOU, China — Sirnaomics Ltd., a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, published a research article with NAR Cancer. The article reveals a novel mechanism of action of lead RNAi cancer drug candidate, STP707, a polypeptide nanoparticle (PNP) formulation...
SEOUL, Korea – SK bioscience and the International Vaccine Institute (IVI) announced today that the typhoid conjugate vaccine developed by SK bioscience with technology transfer from IVI has achieved the World Health Organization prequalification (PQ), which paves the way for public procurement of the vaccine by UN organizations and gives a...