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The new definition of Alzheimer’s as any abnormal level of amyloid beta or tau — even in the absence of symptoms — could vastly expand the market for treating the disease, just as the FDA approved its third antiamyloid antibody, Lilly’s Kisunla (donanemab). Read More
The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and other biologic products, including recommendations for high-level best practices for these studies. Read More
Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will comply with the US Supreme Court’s new decision on who ultimately is in charge of interpreting federal regulations — federal agencies or the courts and Congress. Read More
An Indian plant that makes a number of drugs and active pharmaceutical ingredients (API) was socked with a six-observation Form 483 noting multiple problems with validation testing for API and drug batches, as well as the validation tests themselves. Read More
This week, the FDA published a draft guidance on drug delivery outputs for devices used to deliver drugs and general principles on plan, design, and analysis of pharmacoepidemiological studies. Read More
It looks like glucagon-like peptide 1 receptor agonists (GLP-1) are pulling another trick out of their seemingly bottomless black bag. In addition to regulating blood sugar, trimming fat and cutting cardiovascular disease, they’re now associated with significant reductions in the risk of 10 obesity-related cancers. Read More
A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due to the Inflation Reduction Act’s (IRA) drug pricing provisions. Read More
The FDA on Tuesday approved Kisunla (donanemab-azbt), Eli Lilly’s once-monthly injection for adults with early symptomatic Alzheimer's disease (AD), along with earlier approvals of four other drugs for various conditions. Read More
The FDA has issued a complete response letter (CRL) to Rocket Pharmaceuticals requesting additional chemistry, manufacturing and controls (CMC) information before reviewing the company’s BLA for Kresladi (marnetegragene autotemcel). Read More