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.
A global coalition of regulators has recommended permanent use of the remote inspections of drug manufacturing plants that regulatory bodies began to use during the COVID-19 pandemic. 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
Australian biotech firm CSL will purchase Swiss pharmaceutical company Vifor Pharma for $11.7 billion in a deal set to close in mid-2022, the companies announced. 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 new team will support Joaquin Duato, the company’s current vice chairman, who is set to take the reins as CEO from Alex Gorsky after the new year. Read More
The findings are in line with newly published data from the UK Health Security Agency, which showed reduced vaccine effectiveness against Omicron vs. the Delta variant. Read More
Gilead and Bristol-Myers Squibb (BMS) are touting positive data from studies of their bespoke CAR-T cell treatments, each company hailing the results as a new treatment era for patients with relapsed or treatment-resistant large B-cell lymphoma. 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