Becton Dickinson and Co. reached a $60 million settlement with the attorneys general of 48 U.S. states and Washington D.C., resolving allegations the company concealed the risks of now-discontinued pelvic mesh devices.
The U.S. Food and Drug Administration is expected to issue a new and more stringent guidance regarding a potential Emergency Use Authorization (EUA) for a Covid–19 vaccine.
A physician who heads the influential U.S. Food and Drug Administration vaccine advisory committee recused herself from the panel’s review of Covid-19 vaccines because of her role overseeing a clinical trial for Moderna Inc.’s candidate, her spokeswoman told Reuters.
A top U.S. health official told a U.S. Senate committee that he expects Covid-19 vaccinations to take place over many months and that most Americans could be vaccinated by July 2021 at the latest.
Novartis’ bid to expand the company’s $2.1 million-per-patient gene therapy Zolgensma to more spinal muscular atrophy patients faces a possible delay after U.S. regulators requested another study in older children getting the drug via a spinal infusion.
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.
ALX Oncology is partnering with pharma giant Merck to evaluate a combination of the CD47 inhibitor ALX148 with the blockbuster Keytruda as a potential treatment for patients with head and neck squamous cell carcinoma (HNSCC).
ADC Therapeutics SA announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
Swiss pharma giant Roche acquired Ireland’s Inflazome and the company’s NLRP3 inflammasome inhibitors aimed at multiple inflammatory diseases.
The United States set a one-day record with over 1 million coronavirus diagnostic tests being performed, but the country needs 6 million to 10 million a day to bring outbreaks under control, according to various experts.
