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…
The FDA offered guidance for sponsors of individualized drugs developed for use against life-threatening genetic diseases in two draft guidances released yesterday. Source: Drug Industry Daily
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…
The world’s first plant-based COVID-19 vaccine just returned positive results in a late-stage study. Source: Drug Industry Daily
Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates. Source: Drug Industry Daily
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. Source: Drug Industry Daily
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…
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…
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…
Democrats are reportedly set to meet with the Senate parliamentarian today to start discussing healthcare components in the Build Back Better Act — and to gauge whether the chamber’s gatekeeper…