Celgene (CELG) Unit to Request Re-Examination of Negative Opinion on ISTODAX from EMA CHMP
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EMA CHMP Affirms Negative Opinion on Celgene's (CELG) Istodax
November 16, 2012 7:58 AM ESTOn 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorization for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma. The company that applied for authorization is Celgene Europe Ltd (Nasdaq: CELG).
The applicant requested a re-examination of the opinion. After considering the grounds for this request, the... More
