By Scott Steinke
Bayer Healthcare is asking the federal Medicare agency to extend protected class status to immunomodulators used to treat multiple sclerosis...
Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Protected Class Lobbying Begin
Bayer is CMS to add multiple sclerosis to the list of drug classes protected from formulary restrictions under the Medicare Part D prescription drug program. The first request to broaden the list of protected classes won't be the last.
More from Market Access
• By
Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
• By
A senior AstraZeneca executive says the UK MHRA must develop specialist expertise and create incentives for companies to file marketing authorizations nationally if it wants to stand out to strategic decision-makers.
• By
Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.
• By
The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.
More from Pink Sheet
‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
• By
The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
Sponsored by
In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.