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The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Read More
Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
The SEC also charged the company’s subsidiaries in Brazil and Colombia for inaccurate financial records of payments to patient advocacy organizations. Read More
A federal appeals court has ruled that two Amgen patents for its blockbuster anti-inflammatory drug Enbrel are valid, blocking the launch of a biosimilar by Novartis. Read More
PhRMA has filed a lawsuit challenging a new Minnesota law that took effect on Wednesday that provides emergency access to long-term insulin for diabetics who cannot afford it. Read More
At least five drug developers working on COVID-19 therapeutics and vaccines with U.S. government funding have contracts that bypass laws that ensure taxpayer-funded drugs and vaccines are affordable, a new report says. Read More
FDA Commissioner Stephen Hahn said yesterday that he was “optimistic” that more than one COVID-19 treatment could be available by the fall in addition to Gilead Sciences’ remdesivir, which has already received Emergency Use Authorization from the agency. Read More
Any COVID-19 vaccine the FDA approves would have to be at least 50 percent more effective than a placebo, according to a new guidance it released yesterday. Read More
The FDA will allow sponsors to extrapolate efficacy results from adult studies to use in pediatric studies of anti-infective drugs, as long as the disease process and the effects of the drug are similar in both populations. Read More