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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
Prominent industry figures have praised the FDA’s recent draft guidance on using electronic health records (EHRs) and medical claims data in trials, but they hope it will acknowledge issues inherent to real-world data (RWD), offer clarity in certain areas and be flexible as sponsors adjust to the new recommendations. Read More
Immunocore’s Kimmtrak (tebentafusp-tebn) has won FDA approval for treating inoperable or metastatic uveal melanoma, a rare adult eye cancer with poor prognosis. Read More