Archive for June 21st, 2012

GENT expects CHMP decision 3Q 2012. STEM initiates Phase 1/2 AMD trial. DEPO acquires Zipsor

Jun 21, 2012 No Comments by

Gentium S.p.A. (Nasdaq:GENT)  announced today that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to its Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic […]

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ONXX receives positive recommendation from ODAC. POZN bio-equivalence of PA32540 not shown. CYTK offering. CTIC President resigns

Jun 21, 2012 No Comments by

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 [with 1 abstention] in favour of  Kyprolis (carfilzomib) for the treatment of relapsed and refractory multiple myeloma. The PDUFA date  for accelerated approval is July 27, 2012. Cytokinetics, Incorporated (Nasdaq: CYTK) priced two underwritten offerings for total gross proceeds of $60m. […]

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