Regulatory Update
The UK’s MHRA granted marketing authorization for baricitinib for the treatment of severe alopecia areata. In October 2022, Sanofi signed an agreement with Provention to promote teplizumab in the U.S. Teplizumab has a PDUFA date of 11/17/2022. Published Research Updates A meta-analysis of 26 randomized trials of 1,736 patients with type 1 hepatorenal syndrome (HRS) found that treatment with terlipressin increased HRS reversal compared with placebo (142 reversals per 1,000 patients) and may decrease mortality.
The FDA has updated to the EUA for the COVID-19 monoclonal antibody combination of tixagevimab plus cilgavimab (Evusheld) to indicate that Omicron subvariant BA.4.6 is not susceptible to the antibody combination. Comments are closed.
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