With the Supreme Court upholding the Patient Protection and Affordable Care Act, the pharma sector can look forward to a projected 8.8% increase in prescription drug spending in 2014.
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Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
