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In what could turn out to be a fatal blow for the nearly $2 trillion Build Back Better spending package that included drug pricing reform provisions, Sen. Joe Manchin (D-W.Va.) said Sunday that he definitely will not vote for the landmark legislation. Read More
The FDA has called out Endo International, maker of Vasostrict, saying the agency plans to ask the Federal Trade Commission (FTC) to investigate Endo for “anticompetitive business practices” after the company pressed FDA to block generics of its best-selling drug. Read More
In another huge blow to Biogen’s controversial Alzheimer’s blockbuster, the European Medicines Agency (EMA) has declined to approve Aduhelm (aducanumab), saying the data don’t support a strong clinical benefit and studies did not show that the medicine was sufficiently safe. Read More
A federal judge has overturned a $4.5 billion settlement that protected members of the Sackler family, owners of Purdue Pharma, the maker of OxyContin. Read More
The FDA announced that it will loosen longstanding restrictions on mifepristone, known as the abortion pill, making it easier to get just as the Supreme Court seems poised to curtail abortion access nationwide and many states are tightening restrictions on abortions. Read More
The FDA offered advice on designing a visual inspection program to ensure injectable drugs are free of visible particulates in a new draft guidance released yesterday, noting that automated inspections may be more reliable than visual inspections by humans. Read More
The ICMRA set up the working group to review the adaptation of both good clinical practice (GCP) and good manufacturing practice (GMP) inspections during the COVID-19 pandemic to remote approaches. Read More
Stanton, Calif.-based Sanitor Corporation has drawn an FDA warning letter over current good manufacturing practice (cGMP) violations for finished drugs. Read More
Did Gilead Sciences collude with other drug companies to delay its blockbuster HIV pills from reaching the end of their patents? Did the company offer sweet deals to a generic drugmaker to keep it from coming to market with much more affordable versions of Gilead’s HIV drugs? Read More
The FDA said it doesn't intend to take enforcement action against sponsors or healthcare providers with respect to the risk evaluation and mitigation strategy (REMS) that requires them to have two doses of tocilizumab on hand for CAR-T cell infusion patients. Read More