Priority Review Voucher Value Still Confounds, But Remains An Incentive For Sponsors
• By The Pink Sheet Daily
As FDA increases the asking price, a survey by non-profit finds companies would expect to invest an average of $100 million to obtain a voucher, but responders gave a wide range of potential amounts.
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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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Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."