The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
Agios Pharmaceuticals Inc.’s potential $665 million deal for Oscotec Inc.’s cevidoplenib, a phase III-ready oral SYK inhibitor to treat immune thrombocytopenia, marks a new chapter of development focused on cancer therapy resistance for Oscotec, CEO Yoon Tae-young said.
The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement.
