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AstraZeneca’s (AZ) COVID-19 vaccine clocked in at 79 percent efficacy in preventing symptomatic infection and fully shielded against severe disease and hospitalization in the company’s phase 3 U.S. trial, opening the door for an Emergency Use Authorization (EUA) filing with the FDA in a matter of weeks. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a five-year strategic plan for 2021-2025 that outlines in broad terms how the center will use advances in science and technology — including increased use of real-world data (RWD) in clinical trials — to help achieve four main goals. Read More
The FDA sent a warning letter to Dibar Nutricional, an over-the-counter drug manufacturer in Morelia, Mexico, after a records-based inspection revealed significant lapses at the facility. Read More
HHS is postponing implementation of a final rule issued late in the Trump administration that would have required the FDA to review practically every regulation it has and redirect resources away from pandemic relief efforts. Read More
Merck’s blockbuster oncology drug Keytruda (pembrolizumab) significantly improved survival for women suffering from endometrial cancer when combined with Eisai’s Lenvima (lenvatinib) in a late-stage clinical trial, the companies announced Friday. Read More
The Russian Direct Investment Fund (RDIF) and Indian contract manufacturer Stelis Biopharma have partnered to produce 200 million doses of the Sputnik V COVID-19 vaccine. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has decided it will not fund Keytruda (pembrolizumab), Merck’s second-line advanced bladder cancer drug. Read More
The Senate confirmed Xavier Becerra as HHS secretary yesterday in a narrow 50-49 vote, with just one Republican siding with Democrats to support his confirmation and the closest vote so far for any of President Biden’s Cabinet nominations. Read More