Daily round-up of news and notes from the 2019 J.P. Morgan Healthcare Conference in San Francisco: US generics see gains, researcher calls for more tech transfer, and biotech investor sentiment rises as big deals bring optimism – among other items from the last day of this year's JPM.
Generic drug manufacturers presenting at the J.P. Morgan Healthcare Conference were cautiously optimistic that US drug pricing pressure is resolving. US generic drug prices have been under pressure for several years, driven by buyer consolidation and increased generic drug approvals from the FDA.
Teva Pharmaceutical Industries Ltd. CEO Kare Schultz referred to the trend as a "death spiral," while Mylan NV...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
