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The plaintiffs offered no evidence that false or misleading marketing caused an increase in medically inappropriate prescriptions, the judge said. Read More
EU regulators may delay a decision on the purchase and open a months-long investigation if they have serious concerns about the proposed deal. Read More
COVID-19 vaccine makers didn’t undergo pre-approval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says. Read More
In a 14-0 vote yesterday, a Centers for Disease Control and Prevention (CDC) expert panel recommended the Pfizer/BioNTech COVID-19 vaccine for children age five to 11 years. Read More
A federal judge in California has handed four drugmakers their first win in the ongoing opioid crisis liability wars, rejecting claims by three counties that the companies created a public nuisance by recklessly promoting their medications. Read More
Congressional Democrats have struck a compromise allowing drug pricing reform to be included in the $1.75 trillion Build Back Better Act — almost a week after the White House disappointed progressives and left out drug pricing provisions from the package’s framework. Read More
The FDA held a virtual public meeting yesterday to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA), the agency’s agreement with regulated industry on reauthorizing user fees for fiscal years 2023 through 2027, and the reception was positive. Read More
The incidence of brain blood clots in one healthcare system increased by almost four times after introduction of the Johnson & Johnson (J&J) COVID-19 vaccine, according to data published in the Nov. 1 issue of the Journal of the American Medical Association. Read More
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Read More
A federal judge has ruled that HHS acted incorrectly in warning drugmakers that ending discounts via the 340B Drug Price Program would constitute a violation of the law. Read More