BioSpace News Archive

The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.

The FDA approved Sage and Biogen’s zuranolone Friday as the first oral medication for postpartum depression but declined to approve the application in major depressive disorder.

Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.

In a lawsuit filed Monday, Nektar Therapeutics accused Eli Lilly of scheming to ensure rezpegaldesleukin would not succeed after acquiring a competing medicine.

The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.

BioCity Biopharma announced that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for a Phase 1 study of BC3448.

XNK Therapeutics AB announced that the abstracts Harnessing the potential of autologous NK cells for immunotherapy of patients with advanced bladder cancer and Feeder-Free Expansion of Autologous Cytotoxic NK Cells for Acute Myeloid Leukemia Treatment will be presented at the 38th Meeting of the Society for Immunotherapy of Cancer in San Diego in November.

Duality Biologics Co. Ltd. announced that the company has expanded its collaboration with BioNTech SE to develop, manufacture and commercialize a third ADC candidate DB-1305 globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region.

Annexon, Inc., a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

Medivir AB, a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced the formation of a Scientific Advisory Council as the company intensifies its plans for next phase of development.