FDA orphan drugs staff
Executive Summary
Former Center for Biologics Evaluation & Research Office of Cellular, Tissue & Gene Therapies Acting Director Phil Noguchi, MD, joins Office of Orphan Products Development as medical reviewer. Joyce Frey-Vasconcells assumes acting director post at CBER's cell therapies office...
You may also be interested in...
FDA orphan products development
Former Center for Biologics Evaluation & Research Office of Cellular, Tissue & Gene Therapies Acting Director Phil Noguchi, MD, will leave FDA at the end of August. Noguchi has held the position of medical officer within the Office of Orphan Products Development since May (1"The Pink Sheet" May 17, 2004, In Brief)...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.