U.S. health officials said Wednesday they have agreed to purchase another 105 million doses of Pfizer’s COVID-19 vaccine in anticipation of a fall booster campaign. The $3.2 billion deal announced by the Biden administration comes as federal scientists consider how to update the vaccines to better protect Americans from the rapidly evolving virus. Federal officials said the purchase agreement includes the option to purchase a total of 300 million doses, including a mix of doses for both adults and children…
The fast-spreading BA.4 and BA.5 sub-variants of Omicron are estimated to make up a combined 52% of the coronavirus cases in the United States as of June 25, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday…
After working with biotechs and Big Pharmas to accelerate their research programs, high-tech molecule modeler Schrödinger is taking its first steps as a clinical company itself. It has secured an FDA green light to study its computer-designed therapy for non-Hodgkin lymphomas in an early-phase trial. The company’s machine-learning-powered platform sorted through 8.2 billion potential compounds over a period of 10 months, identifying 78 that were synthesized and filtered through preclinical experiments to select the most promising candidate…
At least some U.S. adults may get updated COVID-19 shots this fall, as government advisers voted Tuesday that it’s time to tweak booster doses to better match the most recent virus variants. Advisers to the Food and Drug Administration wrestled with how to modify doses now when there’s no way to know how the rapidly mutating virus will evolve by fall — especially since people who get today’s recommended boosters remain strongly protected against COVID-19′s worst outcomes…
The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations. Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting in Chicago. Michele Piepoli, a senior quality consultant with MHP Consulting also highlighted some of the challenges with virtual inspections and records requests and shared some best practices on managing these audits…
ReCode Therapeutics has stuck to a formula of $80 million funding rounds, but, thanks to investments from the venture arms of Bayer and Amgen, the genetic medicine and mRNA biotech is breaking the mold with a $120 million extended series B. The initial $80 million series B financing round was announced last October and co-led by Pfizer Ventures—an active investor in biotechs and emerging science the Big Pharma deems promising—with recent contributions fueling Dren Bio and ImCheck Therapeutics, among others. The other leader was EcoR1 Capital, a San Francisco biotech investment firm that boasts 65 portfolio companies. Other initial series B investors included Sanofi Ventures, Orbimed, Vida Ventures and more…