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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
Evusheld’s EUA was supported by data from a phase 3 study, which showed the combination reduced the risk of developing symptomatic COVID-19 by 77 percent vs. placebo. Read More
The FDA has published further draft guidance on real-world evidence (RWE), this time outlining regulatory considerations for noninterventional studies that use real-world data (RWD). 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
In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Read More
Aprea Therapeutics has received FDA clearance to continue its eprenetapopt development, with the lifting of a full clinical hold placed last summer on the drug’s nonHodgkin’s lymphoma clinical trial program. Read More
The FDA has revised Pfizer/BioNTech’s Emergency Use Authorization (EUA), allowing a booster of the companies’ COVID-19 vaccine in teenagers aged 16 and 17 six months following completion of a primary vaccination series. Read More