BioSpace News Archive

Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy.

Compass Therapeutics, Inc. announced that it will be added to the Russell 2000® and Russell 3000® Indexes as part of the Russell indexes annual reconstitution, effective after the US market opens on June 26, 2023.

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain, announces a ratio change on its American Depositary Receipts from one ADR representing five ordinary shares, to the new ratio of one ADR representing four hundred ordinary shares.

The Cigna Group announced Chris DeRosa, President, U.S. Government, will assume leadership of Cigna Healthcare’s Medicare and Individual & Family Plan businesses, as Chuck Berg, Senior Advisor, announces his departure.

Intercept Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has issued a Complete Response Letter in response to the Company’s New Drug Application for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis.

Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), announced that effective today, Edward J. Borkowski, former Chief Financial Officer of Mylan N.V, has been appointed to the Company’s Board of Directors.

CEL-SCI Corporation announced it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck, at the American Head and Neck Cancer Society’s 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada.

BIO International Convention is the world’s largest international biotech industry exhibition and forum organized by the Biotechnology Industry Organization in the U.S. every year.

Medigene AG presents an overview on elevated activity of T cell receptor engineered T cell therapies when combining Medigene´s PD1-41BB switch receptor with T cell receptors targeting different antigens at the Immuno-Oncology Summit Europe June 20-22, 2023 in London, UK.

Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), heralded today’s decision by the Food and Drug Administration (FDA) to approve the first-ever U.S. application for a gene therapy treatment for Duchenne patients ages 4-5 years old.