Negotiations hit an impasse in the House yesterday on a stopgap measure to fund federal agencies beyond an upcoming deadline on Friday night. Source: Drug Industry Daily

A federal appeals court has upheld Mylan’s challenge to a Biogen patent covering the latter’s blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate). Source: Drug Industry Daily

The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF)…

The FDA has lifted the clinical hold it placed in 2019 on the research and development of Entolimod for acute radiation syndrome (ARS), allowing new owner Statera Biopharma to proceed…

Sanofi plans to advance 10 vaccine candidates into the clinic by 2025, the company announced yesterday. Source: Drug Industry Daily

Armed with strong results from a late-stage clinical trial, ImmunoGen plans to submit a new Biologics License Application (BLA) for its drug/antibody conjugate Mirvetuximab (mirvetuximab soravtansine) as a treatment for…

With government funding set to expire on Friday, the House could vote as soon as today on a stopgap measure to avert a shutdown and keep federal agencies operating. Source:…

GlaxoSmithKline (GSK), whose COVID-19 vaccine development efforts have lagged behind those of competitors, has hired away one of the top scientists behind the Pfizer COVID-19 jab, which has been the…

Amid the increasing travel bans, cancelations and worry caused by the new Omicron variant of the SARS-CoV-2 virus, Acting FDA Commissioner Janet Woodcock said yesterday that the FDA is ready…

In a 13-10 vote yesterday, an FDA advisory committee recommended that the FDA should grant Emergency Use Authorization (EUA) for molnupiravir, the antiviral pill co-developed by Merck and Ridgeback Biotherapeutics.…