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The FDA has placed a partial clinical hold on Bluebird Bio’s gene therapy for sickle cell disease (SCD), lovotibeglogene autotemcel (lovo-cel), for trial participants under the age of 18 after a volunteer contracted persistent anemia. Read More
AbbVie is pushing the International Trade Commission (ITC) to prevent Iceland-based biosimilar developer Alvotech from marketing its biosimilar candidate to AbbVie's blockbuster Humira (adalimumab). Read More
Amid an ongoing dispute with the National Institutes of Health (NIH) over who exactly invented the mRNA sequence of Moderna’s COVID-19 vaccine, the company is hitting the pause button on pursuing a patent for the sequence. Read More
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