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Axon Neuroscience’s investigational anti-tau antibody treatment for Alzheimer’s disease, AADvac1, has posted positive phase 2b results, reducing cognitive slowing by up to 30 percent and neurodegeneration by 62 percent compared to placebo in patients with biomarker-confirmed disease. Read More
Despite calls to hurry the process, FDA reviews of COVID-19 vaccine Biologics License Applications (BLAs) are proceeding ahead of schedule, with full approvals expected this fall, says regulatory expert Melissa Tice from George Washington University (GWU). Read More
Humana has filed a racketeering and fraud suit against Regeneron Pharmaceuticals, alleging that the company engaged in a kickback scheme so it could inflate the price of its macular degeneration drug Eylea. Read More
The FDA has issued a rare warning about the multiple myeloma drug Pepaxto (melphalan flufenamide), saying a recent confirmatory trial showed an increased risk of death. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new quality guideline for sponsors of drug-device combination products that will go into effect on Jan. 1. Read More
A bipartisan group of U.S. senators has called on HHS Secretary Xavier Becerra to support policies that will allow Americans to “personally import” prescription drugs from Canada. Read More
Merck’s cancer immunotherapy Keytruda (pembrolizumab) has become the first drug of its kind to be approved for early triple-negative breast cancer after a previous rejection from the FDA for the indication in March due to lack of data. Read More