Outside advisers to the U.S. Food and Drug Administration on Oct. 15 unanimously recommended the regulatory agency authorize a second shot of Johnson & Johnson’s Covid-19 vaccine for all recipients of the one-dose inoculation.
AstraZeneca requested emergency use authorization from U.S. regulators for the company’s new treatment to prevent Covid-19 for people who respond poorly to vaccines because of a weakened immune system.
As Merck & Co. and Pfizer Inc. prepare to report clinical trial results for experimental Covid-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own.
Shares of Humanigen plunged in trading after the company announced the U.S. Food and Drug Administration rejected the company’s Emergency Use Authorization request for lenzilumab, a potential treatment for Covid-19.
Merck is discontinuing development of MK-7710 (formerly known as CD24Fc), a Phase III Covid-19 therapeutic asset acquired from OncoImmune during November 2020.
Merck will have to wait to see if a Covid-19 therapeutic gained in November through the $425 million acquisition of OncoImmune can receive Emergency Use Authorization (EUA) after the U.S. Food and Drug Administration requested additional data beyond the Phase III study announced during 2020
Merck is stopping development of the company’s two Covid-19 vaccine candidates, dubbed V590 and V591, after poor responses in Phase I trials.
Merck acquired Maryland-based OncoImmune and the Covid-19 therapeutic candidate CD24Fc for $425 million in upfront cash two months after the Phase III asset demonstrated efficacy during an interim analysis.