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News Breaks
April 4, 2014
08:03 EDTHALOHalozyme announces temporary halt of Phase 2 trial enrollment for PEGPH20
Halozyme announced that as a result of a recommendation received yesterday from an independent Data Monitoring Committee, it is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer. The DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. The company is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing.
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September 18, 2014
09:05 EDTHALOHalozyme's pancreatic cancer candidate clinical trial approved by FDA to resume
Halozyme announced that the FDA has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1b/2 clinical trial. The trial is designed to evaluate Halozyme's investigational drug PEGPH20 in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol.
September 15, 2014
09:16 EDTHALOOn The Fly: Pre-market Movers
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September 12, 2014
20:32 EDTHALOFDA approves Baxter's HYQVIA for treatment of primary immunodeficiency
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