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Pfizer has pushed the pause button on its worldwide distribution of Chantix (varenicline) after elevated levels of the suspected carcinogen, nitrosamine, were found in some batches of the pills. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new drugs for approval at its June 21-24 meeting, including two cancer drugs, two generics and a biosimilar. Read More
A Centers for Disease Control and Prevention (CDC) vaccines expert panel voted 14-0 vote last week to recommend Sanofi’s controversial dengue fever vaccine, Dengvaxia, despite concerns over risks associated with its use. Read More
Two U.S. House committees are broadening their investigation into Emergent BioSolutions’ troubled Bayview, Md., facility, calling on Johnson & Johnson (J&J) and AstraZeneca (AZ) to provide details of their COVID-19 vaccine contracts with the firm. Read More
Incyte needs to complete another clinical trial of its proposed anal cancer treatment retifanlimab before the FDA should consider approving it, an agency advisory committee said Thursday. Read More
Remarks by Acting FDA Commissioner Janet Woodcock about the future of medical research and drug approval resulted in a backlash this week, adding to calls for her resignation from Sen. Joseph Manchin (D-W.V.) and increasing pressure from advocacy groups and federal legislators that she not be made permanent FDA commissioner. Read More
The department withdrew the opinion after the federal Delaware court denied its motion to toss out a lawsuit filed by AstraZeneca over the 340B mandate. Read More
The Supreme Court left intact a ruling that AbbVie’s complaint against Perrigo was filed only to delay a proposed generic version of AbbVie’s testosterone drug AndroGel. Read More