M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.
US regulators have granted emergency authorization to the antiviral molnupiravir but only for use when "alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
After lengthy review, Merck’s antiviral gets very restricted indication as part of its EUA, apparently reflecting concerns over safety and efficacy. But molnupiravir does appear to have some advantages over Pfizer’s Paxlovid – including that more of it will be available in the short term.
Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.
Operation Warp Speed’s seal was a combination of ’70s design, au courant clip art, and 18th Century militarism, but just like the oddly assembled organization that it represented, the thing worked.
US FDA seems poised to authorize the oral COVID treatment, but panel discussion will likely highlight the limitations of the antiviral.