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Gene Therapies Dominate New Crop Of EU PRIME Recipients

Among the six new investigational products to make it onto the European Medicines Agency’s priority medicines scheme, five were gene therapies.

Europe Regulation

Going Virtual: GSK’s Multiple Myeloma Drug Belantamab Tapped For US FDA Online AdComm In July

Announcement of the 14 July Oncologic Drugs Advisory Committee meeting follows a successful, two-day trial run of the virtual format by the oncology pediatric subcommittee that featured a mix of prerecorded and live sponsor presentations and strict adherence to a call/response approach to ensure orderly conduct.

Advisory Committees Coronavirus COVID-19

US FDA Oncology AdComm's Pediatric Study Reviews Go Virtual

ODAC's 17-18 June discussion of pediatric development plans for four investigational oncology agents will serve as a trial run of the technology platform and logistics for any future application-specific virtual advisory committee meeting, but without the stress associated with a pending application and a user fee deadline.

Advisory Committees Coronavirus COVID-19

Asia Deal Watch: Everest Licenses Asia Rights To Calliditas’ IgA Nephropathy Candidate

While an orphan indication in the US and EU, IgAN accounts for 40% of glomerular disease in China; deal also confers rights in Hong Kong, Macau, Taiwan, Singapore. Also, Y-Biologics teams with Dualogics on bispecific antibodies for cancer.

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