Drug Manufacturers May Catch A Break On Medicaid Rebates For Opioid Treatment
CMS believes a new law set to take effect this fall will prohibit Medicaid from collecting rebates on opioid use disorder treatments, Congressional offices and Medicaid stakeholders tell the Pink Sheet. Experts worry this interpretation could open the door for CMS to rule other drugs don’t qualify for rebates.
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Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.
As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.
Pink Sheet reporters and editor discuss the ramifications of the AstraZeneca vaccine trial hold and vaccine sponsors pledging to wait until the completion of Phase III before submitting applications, as well as efforts to extend the rare pediatric disease priority review voucher program.