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

Shares of Endo International (ENDP) declined 2.27% to close the trading session on Sep 22 at $66.16 following Auxilium Pharmaceuticals’ (AUXL) rejection of Endo’s unsolicited takeover bid. Auxilium Pharma after reviewing Endo’s $2.2 billion or 28.10 per share offer turned it down as it felt that the proposal grossly undervalued the company. However, Auxilium Pharma did not shut the door permanently as far as a … Continue reading Biotech Stock in News: Auxilium Pharmaceuticals Not Favoring Endo Bid

Amarin Corporation (AMRN) tumbled 17.7% after the company announced that the FDA’s Office of New Drugs (OND) denied the company’s appeal regarding the rescission of the Special Protocol Assessment (SPA) covering the phase III ANCHOR study on Vascepa. Vascepa has been available in the U.S. since Jan 2013 as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) … Continue reading Biotech News: Amarin Stock Plummets after the FDA Denies Major Appeal