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A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with a single documentation filing. Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir). Read More
Regeneron Pharmaceuticals and Sanofi are pulling their supplemental Biologics License Application (sBLA) for the indication of cervical cancer for their human monoclonal antibody, Libtayo (cemiplimab-rwlc). Read More
The U.S. International Trade Commission (ITC) will investigate whether Alvotech and its partner Teva Pharmaceuticals misappropriated trade secrets in producing a biosimilar candidate for AbbVie’s autoimmune mega-blockbuster Humira (adalimumab). Read More
Michigan’s Attorney General is pursuing court approval to begin an investigation into Eli Lilly over the high insulin prices the company charges. Read More
Protection against Omicron-related death in people 50 and older reached as high as 95 percent after a booster dose of a messenger RNA (mRNA) vaccine, the UK Health Security Agency (UKHSA) announced Thursday. Read More
Merck’s Keytruda (pembrolizumab) has made a couple of headlines this week, drawing attention as a potential weapon against latent HIV infections, and winning approval in Europe as a kidney cancer monotherapy. Read More