A Congressional committee is sifting through drug rebate data from 12 big Medicare Part D plans. According to Congress' accounting arm, making the data public will cost the government as much as $10 billion dollars. But industry better be nervous about what happens next.
By Michael McCaughan
The House Government Oversight and Government Reform Committee is sifting through some very valuable data—information about prescritpion drug prices under...
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Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
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.
Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.
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.
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.
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.
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.
