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Cutting prices for costly therapies approved under an accelerated pathway may not significantly reduce total prescription drug spending by Medicare, says a new study by researchers at Brigham and Women’s Hospital in Boston, Mass. Read More
Merck’s islatravir-based HIV antiretroviral program has hit another bump in the road, with the company pausing enrollment in two phase 3 studies that are key to advancing the once-a-month oral regimen. Read More
Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates. Read More
Janus kinase (JAK) inhibitor anti-inflammatories made by Pfizer, AbbVie and Eli Lilly for inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis, have all received the strictest warnings added to their labels by the FDA, which cited risk of serious health issues and the possibility of death in patients age 50 and over. Read More
President Biden delivered a speech yesterday highlighting the drug pricing reform measures in the Build Back Better Act — especially for insulin products — shortly after Sen. Majority Leader Chuck Schumer (D-N.Y.) released a letter outlining Democratic attempts to pass the $2 trillion bill by Christmas. Read More
Aeglea BioTheraputics hopes to snag a first-in-class approval for its recombinant human enzyme pegzilarginase after finding that the molecule normalized plasma arginine levels in more than 90 percent of patients with ARG1-D, an inability to process the protein. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) has issued two manuals for agency staff on user fees — one updated and one brand new. Read More