The going rate to buy a voucher that speeds up a regulatory review in the US is about $100m but the France-headquartered firm has managed to get considerably more from an unnamed big pharma.
Ipsen SA has shown itself to be a canny dealmaker over the past few years and its negotiating skills have been shown again with the sale of a priority review voucher (PRV) at well above market rate.
The French drugmaker has revealed that it has agreed to sell its rare pediatric disease PRV to "a large global...
Pharma companies like Sarepta, Replimune and Capricor made gains on Wall Street after news broke that the FDA Center for Biologics Evaluation and Research director Vinay Prasad is leaving.
PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.
The US FDA approved the complement C3 inhibitor for new indications in C3G and primary IC-MPGN, providing a new growth opportunity for Apellis.
Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Japan has emerged as a global leader in the development of new drugs for the rare cancer angiosarcoma, reflecting its rapidly ageing population and the limitations of current therapies.
Second quarter revenue and EPS beat consensus and BMS raised its 2025 revenue guidance, but after multiple recent Phase III failures, executives said the company is reviewing studies with near-term readouts.
