Feb. 26 COVID Quick Takes: FDA wants more data from Merck; plus ‘clear efficacy’ for Regeneron and updates from GSK, Lilly, Novavax

Merck & Co. Inc. (NYSE:MRK) no longer expects to supply the U.S. with COVID-19 therapy MK-7110 by June 30 after FDA told the company additional data would be needed to support emergency use authorization. MK-7110, which Merck gained through its $425 million acquisition of OncoImmune Inc. in November, has already reported interim Phase III data in severe and critical COVID-19 patients that showed statistically significant improvements in clinical recovery vs. standard of care. The company, which has a deal with the U.S. to supply about 60,000-100,000 doses in exchange for up to $356 million, is working to address the agency’s comments, according to the company’s annual report. Last month, Merck discontinued two COVID-19 vaccines.

‘Clear efficacy’ for Regeneron mAb
An independent data monitoring committee found REGEN-COV casirivimab/imdevimab from  Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed “clear efficacy” in reducing the rate of hospitalization and death in a Phase III trial in outpatients with COVID-19. The company will stop enrolling patients in the placebo group, per the IDMC’s recommendation. Data are expected next month...