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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
The Senate Finance Committee has released amended Build Back Better Act text, which would exempt generics and biosimilars at risk of supply chain shortages from rebates drugmakers would have to pay to the government if they raise prices faster than the annual rate of inflation. Read More
In a final guidance released Friday, the FDA adopted International Council for Harmonization (ICH) guidelines for three solvents used in drug manufacturing processes, based on the most up-to-date data on reproductive, genetic and carcinogenic toxicities. Read More
In a draft guidance released Friday, the FDA’s Center for Drug Evaluation and Research (CDER) offers advice for sponsors developing products for bowel cleansing prior to colonoscopy, suggesting the necessary attributes of patients for enrollment in clinical trials. Read More
In a 269-page report released Friday, the House Committee on Oversight and Reform challenges claims that high prescription drug prices are necessary to support innovation and details a slew of anticompetitive practices drugmakers have allegedly used in recent years. Read More
The individualized products should be from “a well-characterized chemical class for which there is substantial clinical and nonclinical experience,” the agency said. Read More
The settlement marks Allergan’s withdrawal from the ongoing trial in the Suffolk County State Supreme Court, leaving Teva Pharmaceuticals as the sole defendant. Read More
Minor changes to a drugmaker’s chemistry, manufacturing and controls (CMC) production processes for approved biologics must be documented in a yearly report, the FDA said in a final guidance released yesterday. Read More