FDA Finds Gaps In Cesca's Stem Cell Trial Plan For Critical Limb Ischemia
This article was originally published in The Gray Sheet
Executive Summary
The agency noted deficiencies in Cesca Therapeutcs' investigational device exemption submission for the CLIRST III pivotal study of its SurgWerks stem cell therapy system in critical limb ischemia. But the company says the overall message for the 224-patient study is positive.
You may also be interested in...
Regenerative Medicine Firm Cesca Therapeutics Eyeing Major Device Players
The new company, forming from the merger of ThermoGenesis and TotipotentRx, aims to use its cell processing systems and cell formulations to recast the way physicians treat various cardiovascular and orthopedic problems. It is in discussions with device firms about potential partnerships.
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.