Agency appears to have a fair bit of flexibility in how to spend the additional $80m slated for coronavirus activities.
US Food and Drug Administration coronavirus activities would see another substantial jump in support as part of legislation proposed in the House of Representatives.
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France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.
Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.
Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.
Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
