The draft document, which was dated April 10 and labeled “pre-decisional,” appears to come from the Office of Management and Budget. Known in budgetary parlance as a passback, it outlines the Trump administration’s priorities for the agency. The Washington Post first reported on the document’s existence.
User fees, which are collected by the FDA from drug and medical device manufacturers, are expected to continue through the 2026 fiscal year, according to Grossman’s reading of the document. User fees made up about 69% of the FDA’s $2.34 billion budget for human drugs work in fiscal 2024. The document claims the preliminary budget would provide “sufficient budget authority levels to meet statutory requirements necessary for FDA to collect medical product user fees in support of its premarket review activities.”
Politico’s Agency IQ reported earlier this month that, due to the Trump administration’s laying off of thousands of staffers, the FDA risked hitting a “trigger,” whereby the FDA could be required to refund industry fees if spending by the agency falls below a certain level. READ MORE
by Elise Reuter
Source: biopharmadive.com
Bristol Myers Squibb (BMS) and Chinese biopharma company Hengrui Pharma have inked one of the largest licensing and collaboration deals in the industry’s history, centering around several early-stage oncology, immunology and haematology assets.
The appointment marks a planned transition in leadership structure to continue to build on the company’s success. A combination of organic growth and targeted acquisitions has led Symeres to evolve into a fully integrated transatlantic partner.
Sun Pharma’s recent, nearly $12 billion acquisition reflects growing global ambitions of India’s pharma industry to evolve from its roots in the generics market. But is the country poised for a China-esque pivot toward becoming a powerhouse of innovation?
