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The FDA has issued two new guidances on the development of oncology drugs and biologics, posting a final guidance on optimizing cancer drug doses and a draft guidance on developing drugs specifically for Bacillus Calmette-Guérin-unresponsive nonmuscle invasive bladder cancer. Read More
The FDA has provided a case study of how CDER used machine learning to identify a suitable patient population for a COVID-19 treatment that was approved under the emergency use authorization (EUA). Read More
In this edition of Quick Notes, we provide a look at the first dissolvable oral contraceptive, good news for Pfizer’s hemophilia A gene therapy, approval of a new treatment for multiple myeloma and a clinical hold on a Type 1 diabetes therapy. Read More
The FDA has long erred on the side of extreme caution when it comes to sharing confidential commercial information and trade secrets out of fear it might violate federal law by disclosing them. Read More
Merck announced that its investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints. Read More
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
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
Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he milked the NIH for $16 million in grant money based on falsified data. Read More