- PR Newswire•2 days agoMylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Trastuzumab Accepted for Review by European Medicines Agency
BENGALURU, India and HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe.
- Capital Cube•last month
Click here to see latest analysisETF’s with exposure to Biocon Ltd.Here are 5 ETF’s with the largest exposure to 532523-IN. Comparing the performance and risk of Biocon Ltd. with the ETF’s that have exposure to it gives us some ETF choices that could give us similar returns with lower volatility.TickerFund Name532523-IN Exposure (%)1 Year Price […] (Read more...) The post ETF’s with exposure to Biocon Ltd. : July 25, 2016 appeared first on CapitalCube.
- PR Newswire•last monthMylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Pegfilgrastim Accepted for Review by European Medicines Agency
BENGALURU, India, HERTFORDSHIRE, England and PITTSBURGH, July 21, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines Agency (EMA) has accepted for review, Mylan's Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Mylan and Biocon, who have co-developed the proposed biosimilar, received EMA's acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016.
Biocon Limited (BIOCON.BO)
BSE - BSE Delayed Price. Currency in INR
|Day's Range||883.30 - 909.90|
|52wk Range||420.10 - 909.90|
|1y Target Est||N/A|
|P/E Ratio (ttm)||19.92|
|Avg Vol (3m)||147,788|
|Dividend & Yield||N/A (N/A)|