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BRIEF-Shire receives orphan drug designation for gene therapy candidate for treatment of Hemophilia A
October 25, 2017 / 11:05 AM / 25 days ago

BRIEF-Shire receives orphan drug designation for gene therapy candidate for treatment of Hemophilia A

Oct 25 (Reuters) - Shire Plc

* SHIRE RECEIVES ORPHAN DRUG DESIGNATION FOR GENE THERAPY CANDIDATE SHP654 (BAX 888) FOR THE TREATMENT OF HEMOPHILIA A

* ‍SHP654 INVESTIGATIONAL NEW DRUG (IND) APPLICATION ACCEPTED BY FDA​

* RECEIVES ORPHAN DRUG DESIGNATION FOR GENE THERAPY CANDIDATE SHP654 (BAX 888) FOR TREATMENT OF HEMOPHILIA A​

* ‍REGULATORY AGENCY ALSO GRANTED SHIRE INVESTIGATIONAL NEW DRUG (IND) STATUS FOR SHP654​

* ALSO RECEIVED FDA CLEARANCE FOR IND APPLICATION IT SUBMITTED EARLIER THIS YEAR TO INITIATE A GLOBAL MULTI-CENTER STUDY​

* ‍COMPANY ANTICIPATES THAT SHP654 PHASE 1/2 STUDY WILL BEGIN BY END OF 2017​ Source text for Eikon: Further company coverage:

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