Archive for July 15th, 2011

TSGEN favourable Adcom vote. PPHM VICL EXEL pipeline updates. PCYC shelf

Jul 15, 2011 No Comments by

Futher to the update yesterday, Seattle Genetics (SGEN) announced unanimous recommendations from the FDA Advisory Committee in favour of Accelerated Approval of ADCETRIS(TM) for Post-Transplant Relapsed Hodgkin Lymphoma and Relapsed or Refractory Systemic ALCL. Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) provided an update on its clinical pipeline – - Phase 2 front-line NSCLC trial evaluating bavituximab […]

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TSPT receives CRL for Intermezzo. Safety concerns noted

Jul 15, 2011 No Comments by

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced Thursday that it had received a CRL from the FDA regarding the resubmitted NDA for Intermezzo. The FDA stated that it cannot conclude that Intermezzo can be used safely based on the information in the Intermezzo NDA. The proposed label indicates that Intermezzo should only be taken when patients […]

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