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Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy against symptomatic disease as proof that the shot works in a world with multiple COVID-19 variants. Read More
Homology Medicines’ phenylketonuria (PKU) gene therapy study is on clinical hold while the company investigates abnormalities in liver enzymes in patients who received the treatment, which is delivered by a viral vector. Read More
Disappointing pharmacies who have had a beef with pharmacy benefit managers (PBMs) for years, the U.S. Federal Trade Commission voted against beginning an investigation into how PBM drug price negotiating practices affect independent and specialty pharmacies. Read More
Sanofi and Regeneron have stopped their investigation of Dupixent (dupilumab) as a treatment for chronic spontaneous urticaria (CSU) in patients who don’t respond to Genentech’s Xolair (omalizumab). Read More
A patient death has prompted Atara Biotherapeutics to issue a voluntary hold on patient recruitment into its potentially groundbreaking phase 1 trial of the CAR-T cell therapy ATA2271 for pleural mesothelioma, an untreatable cancer. Read More
Amgen has become the latest company to discontinue development of an obesity drug candidate from what had been an emerging class of medicines based on growth/differentiation factor-15 (GDF-15) protein. Read More
Sage Therapeutics’ investigational antidepressant, zuranolone, posted positive topline results this week in a phase 3 trial showcasing its potential as an add-on therapy co-administered with a range of standard-of-care antidepressants. Read More