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...
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Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.
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While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
