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The UK’s National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Mayzent (siponimod) for treating secondary progressive multiple sclerosis (MS) after previously declining to support the drug. Read More
A highly anticipated meeting of the FDA’s COVID-19 vaccine advisory committee will take place Oct. 22 to discuss the emergency authorization and approval of vaccine candidates, including what is necessary for post-market studies. Read More
A group of Democrats led by Sen. Maggie Hassan (D-N.H.) have asked FDA Commissioner Stephen Hahn to detail what the agency is doing to ensure COVID-19 drugs and vaccines will be safe and effective in older patients. Read More
President Trump’s touting of Regeneron Pharmaceuticals’ COVID-19 antibody treatment as a cure for the disease that would imminently become available to all Americans for free has come under congressional scrutiny. Read More
HHS on Wednesday shot down a story claiming that department officials had asked the FDA to consider COVID-19 Emergency Use Authorizations (EUAs) as “pre-licensures” even as the FDA issued a statement detailing why pre-licensure approvals would not be appropriate for COVID-19 vaccines. Read More
Cytiva has finalized a $31 million deal with HHS’ Biomedical Advanced Research and Development Authority to develop and manufacture COVID-19 vaccine component parts. Read More
San Diego-based Allele Biotechnology has filed lawsuits against Regeneron Pharmaceuticals, Pfizer and BioNTech, alleging infringement of its patent for mNeonGreen, a reagent used to develop COVID-19 therapies. Read More