Brief: Vericel Corp Says Development Partner Mediwound Received CRL From U.S. FDA

Vericel

29/06/2021 13:57

June 29 (Reuters) - Vericel Corp  VCEL.O :
    * VERICEL CORP - CO'S DEVELOPMENT PARTNER MEDIWOUND RECEIVED
A
COMPLETE RESPONSE LETTER (CRL) FROM U.S. FOOD AND DRUG
ADMINISTRATION (FDA)
    * VERICEL PROVIDES REGULATORY UPDATE FOR NEXOBRID
    * VERICEL CORP - CRL IS REGARDING BIOLOGICS LICENSE
APPLICATION
(BLA) FOR NEXOBRID
    * VERICEL CORP - FDA COMMUNICATED TO MEDIWOUND THAT IT HAD
COMPLETED REVIEW OF BLA AND HAS DETERMINED THAT IT CANNOT
APPROVE BLA IN ITS PRESENT FORM
    * VERICEL CORP - FDA IDENTIFIED ISSUES RELATED TO CHEMISTRY,
MANUFACTURING AND CONTROLS (CMC) SECTION OF BLA
    * VERICEL CORP - FDA REQUESTED THAT MEDIWOUND PROVIDE
ADDITIONAL
CMC INFORMATION.
    * VERICEL CORP - FDA ALSO STATED THAT INSPECTIONS OF
MANUFACTURING
FACILITIES IN ISRAEL AND TAIWAN ARE REQUIRED BEFORE BLA CAN BE
APPROVED
    * VERICEL CORP - CRL REFERENCED OBSERVATIONS THAT WERE MADE
DURING
GOOD CLINICAL PRACTICE (GCP) INSPECTIONS RELATED TO DETECT STUDY
    * VERICEL CORP - FDA ALSO REQUESTED THAT MEDIWOUND PROVIDE A
SAFETY UPDATE AS PART OF ITS BLA RESUBMISSION

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