Biotech Finance News

Halozyme’s Clinical Hold Lifted by FDA : Biotech

Halozyme Therapeutics, Inc (HALO) announced that the FDA has lifted the clinical hold from a phase Ib/II study (Study S1313). The study is evaluating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with a modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients suffering from metastatic pancreatic adenocarcinoma. The Study S1313, which is being sponsored and conducted by SWOG…

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Halozyme Therapeutics, Inc (HALO) announced that the FDA has lifted the clinical hold from a phase Ib/II study (Study S1313). The study is evaluating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with a modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients suffering from metastatic pancreatic adenocarcinoma. The Study S1313, which is being sponsored and conducted by SWOG…

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Major Biotech Stock in News: Amgen Files Blinatumomab Marketing Application

Amgen (AMGN) announced that it has submitted a Biologics License Application (BLA) to the FDA for its oncology candidate, blinatumomab. The company is looking to get the candidate approved for the treatment of adults suffering from Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). The BLA includes positive data from a phase II study which…

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