M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.
Pink Sheet reporters and editor discuss the future of coronavirus products with an emergency use authorization, potential pandemic-inspired regulatory changes at the FDA, and preview the agency’s upcoming advisory committee meeting on coronavirus vaccines.
‘Senator, please stop undermining confidence in a vaccine,’ Pence says when confronted with the accusation that the administration is politicizing the COVID vaccine development effort.
Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.
Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.
Obamacare repeal has been replaced by rebrand as Trump administration plans to use ACA’s Medicare demonstration powers to send discount cards to seniors, one of a slew of health care announcements that include Rx importation, pre-existing conditions, insulin and EpiPens.