Merck Halts Enrollment in Islatravir HIV Study
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…
Medicago Gets Positive Results on Plant-Based COVID-19 Vaccine Using GSK Booster
The world’s first plant-based COVID-19 vaccine just returned positive results in a late-stage study. Source: Drug Industry Daily
Gilead Sciences Recalls Remdesivir Lots Over Glass Particulates
Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates. Source: Drug Industry Daily
CDER Publishes Manuals on Failure to Pay PDUFA and BsUFA Fees
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
JAK Inhibitors Take a Hit as FDA Requires Serious Box Label Warnings
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’s Enzyme Pegzilarginase Normalizes Plasma Arginine in 90 Percent of Patients in Late-Stage Study
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…
Biden, Schumer Offer Update on Drug Pricing Provisions in Build Back Better Act
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 to Meet With Senate Parliamentarian Over Build Back Better
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…
FDA Revises Its Fiscal 2022 GDUFA Science and Research Priorities
The FDA has revised its fiscal 2022 Generic Drug User Fee Act (GDUFA) II research priorities based on feedback gleaned from a June public workshop in which generic drugmakers critiqued…
Many Vaccines Offer Protection as Boosters but Pfizer’s, Moderna’s May Work Best
Several different COVID-19 booster shot combinations appear to improve protection against infection but the messenger RNA (mRNA)-based jabs from Pfizer and Moderna might be the most effective. Source: Drug Industry…