We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The ICMRA set up the working group to review the adaptation of both good clinical practice (GCP) and good manufacturing practice (GMP) inspections during the COVID-19 pandemic to remote approaches. Read More
Stanton, Calif.-based Sanitor Corporation has drawn an FDA warning letter over current good manufacturing practice (cGMP) violations for finished drugs. Read More
Did Gilead Sciences collude with other drug companies to delay its blockbuster HIV pills from reaching the end of their patents? Did the company offer sweet deals to a generic drugmaker to keep it from coming to market with much more affordable versions of Gilead’s HIV drugs? Read More
The FDA said it doesn't intend to take enforcement action against sponsors or healthcare providers with respect to the risk evaluation and mitigation strategy (REMS) that requires them to have two doses of tocilizumab on hand for CAR-T cell infusion patients. Read More
President Biden’s pick to become FDA commissioner, Robert Califf, received bipartisan support yesterday during a Senate confirmation hearing in which he fielded questions from lawmakers. Read More
In a bid to reduce healthcare costs, Oregon wants to create a closed formulary limiting the number of drugs in each class and potentially excluding drugs approved under the FDA’s accelerated approval pathway. Read More
Final data from the phase 2/3 study of Pfizer’s novel oral “at home” COVID-19 treatment, Paxlovid, was so strong, the candidate could be well-positioned to knock molnupiravir — which is authorized in the UK although not yet in the U.S. — off its perch. Read More
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a temporary policy guidance addressing the COVID-19-related shortage of Roche’s blockbuster immunosuppressive tocilizumab, which the FDA requires to be on hand during infusions of chimeric antigen receptor (CAR-T) cell immunotherapies as cancer treatments. Read More
A federal judge has issued an injunction temporarily halting a California law outlawing “pay-for-delay” agreements between branded drug manufacturers and makers of generics. Read More