- 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.
- PR Newswire•2 months agoBiocon, Quark Announce Initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India
BENGALURU, India and FREMONT, Calif., June 23, 2016 /PRNewswire/ -- Biocon Ltd . (BSE code: 532523, NSE: BIOCON), Asia's premier biopharmaceutical company, and Quark Pharmaceuticals, Inc., a leader in ...
- PR Newswire•3 months agoMylan and Biocon to Present Phase 3 Trastuzumab Biosimilar Data at the American Society of Clinical Oncology (ASCO) Annual Meeting
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, June 3, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab.
Biocon Limited (BIOCON.NS)
NSE - NSE Delayed Price. Currency in INR
|Day's Range||877.25 - 892.40|
|52wk Range||418.00 - 897.60|
|1y Target Est||N/A|
Trade prices are not sourced from all markets
|P/E Ratio (ttm)||18.80|
|Avg Vol (3m)||1,277,112|
|Dividend & Yield||N/A (N/A)|