Gilead spent less than $338m for the coupon entitling it to a speedier FDA review, down at least $12m from AbbVie's high-water purchase price almost a year ago.
Gilead Sciences Inc.'s understated disclosure that it has purchased a second FDA priority review voucher suggests the price of the prized regulatory review coupons is falling.
Gilead appears to have paid less than $338m for the voucher, which is below the peak publicly disclosed voucher price...
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
