M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Pink Sheet reporters and editor discuss the potential changes at the FDA under President-elect Biden and the take-aways from the negative advisory committee recommendation for Biogen’s proposed Alzheimer’s drug aducanumab.
Rollout of a coronavirus vaccine offers chance to demonstrate distribution system’s value to policymakers, and Davis knows that could impact the trajectory of issues such as track and trace that will return to prominence after the pandemic eases.
It’s not quite the rebate rule, but final reg aims for ‘a reduction in the use of rebates and other price concessions’ driven by the transparency requirement and broad definitions. PCMA warns that ‘mandating an increased level of disclosure for this information could result in higher prescription drug prices for consumers.’
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.