President’s Council of Advisors on Science and Technology calls for establishment of infrastructure to support clinical trials and initiation of special medical use pathway; government to award $20 million prize for diagnostic to detect highly-resistant bacteria.
The federal government could provide higher reimbursement for new antibiotics as a way to incentivize companies to develop new therapies, the President’s Council of Advisors on Science and Technology (PCAST) recommends in its report on combatting antibiotic resistance.
PCAST offers several other suggestions for boosting commercial development, including that the government subsidize R&D programs for antibiotics; provide companies...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
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.
