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 (a cancer research cooperative group funded primarily by the National … Continue reading 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 (a cancer research cooperative group funded primarily by the National … Continue reading

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 evaluated the use of blinatumomab in adults with Ph- relapsed/refractory … Continue reading Major Biotech Stock in News: Amgen Files Blinatumomab Marketing Application

Shares of Gilead Sciences (GILD) declined approximately 0.9% to close the trading session on Sep 17 at $103.84 following a couple of setbacks — the failure of an oncology candidate to meet the primary endpoint in a phase II study and highly concerning data on the company’s blockbuster hepatitis C drug Sovaldi. Gilead’s pipeline candidate simtuzumab in combination with Eli Lilly and Company’s (LLY) Gemzar … Continue reading Biotech Stock Gilead Down Due To Weak Data Results

The HealthCare segment at Bayer (BAYRY) announced that its blockbuster eye treatment, Eylea, was approved for yet another indication in Japan. The drug was approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of myopic choroidal neovascularization (myopic CNV). Eylea’s approval in the myopic CNV indication was based on encouraging results from the phase III MYRROR study. The drug … Continue reading Active Stock in News: Bayer/Regeneron Successfully Expand Eylea Label

Regeneron Pharmaceuticals’ (REGN) shares were up 2.7% on the news that the FDA has granted Breakthrough Therapy designation to its eye drug Eylea, for the treatment of diabetic retinopathy in patients suffering from diabetic macular edema (DME). Breakthrough Therapy designation helps to accelerate the development and review process of experimental drugs that address an unmet medical need. The designation not only includes all of the … Continue reading Biotech Stocks Breaking News: Regeneron Gets Breakthrough Therapy Status