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U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab

Business Wire India
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug A.....»»

Category: press-releasesSource: businesswireindiaJan 11th, 2017

EMA accepts Biocon, Mylan biosimilar for review

Biocon and Mylan NV said Mylan’s application to market biosimilar Trastuzumab has been accepted by the European Medicines Agency (EMA) for review. The biosimilar Trastuzumab is used to treat certain ........»»

Category: topSource: the-hinduAug 25th, 2016

Journal of the American Medical Association (JAMA) Publishes Mylan and Biocon's Proposed Biosimilar Trastuzumab Phase 3 Data

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the results of.....»»

Category: press-releasesSource: businesswireindiaDec 27th, 2016

Journal of the American Medical Association (JAMA) Publishes Mylan and Biocon's Proposed Biosimilar Trastuzumab Phase 3 Data

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the results of.....»»

Category: press-releasesSource: businesswireindiaDec 27th, 2016

Journal of the American Medical Association (JAMA) Publishes Mylan and Biocon's Proposed Biosimilar Trastuzumab Phase 3 Data

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the results of.....»»

Category: press-releasesSource: businesswireindiaDec 27th, 2016

Journal of the American Medical Association (JAMA) Publishes Mylan and Biocon's Proposed Biosimilar Trastuzumab Phase 3 Data

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the results of.....»»

Category: press-releasesSource: businesswireindiaDec 27th, 2016

Mylan-Biocon seek USFDA nod for biosimilar version of cancer drug

The proposed biosimilar version of trastuzumab is indicated for treatment of certain breast and gastric cancers.....»»

Category: featuresSource: livemintNov 9th, 2016

Mylan and Biocon Announce U.S. FDA Submission for Proposed Biosimilar Trastuzumab

Business Wire India

  • Potential to be First Submission of a Proposed Biosimilar Trastuzumab in the U.S.
Category: press-releasesSource: businesswireindiaNov 8th, 2016

Mylan and Biocon Announce U.S. FDA Submission for Proposed Biosimilar Trastuzumab

Business Wire India

  • Potential to be First Submission of a Proposed Biosimilar Trastuzumab in the U.S.
Category: press-releasesSource: businesswireindiaNov 8th, 2016

Trastuzumab marketing approval may come in 12-18 months: Biocon

The European Medicines Agency (EMA) has accepted to review Mylan and Biocon’s application for a biosimilar called Trastuzumab, used for certain breast and gastric cancers......»»

Category: topSource: moneycontrolAug 26th, 2016

EMA accepts Mylan, Biocon Trastuzumab biosimilar for review

This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe, global pharma major Mylan and Biocon said in a statement today......»»

Category: topSource: moneycontrolAug 25th, 2016

Mylan and Biocon Announce Regulatory Submission for Proposed Biosimilar Trastuzumab Accepted for Review by European Medicines Agency

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) announced today that the European Medicines .....»»

Category: press-releasesSource: businesswireindiaAug 25th, 2016

Mylan, Biocon report efficacy of cancer drug

Global pharma major Mylan Inc., and Biocon have confirmed the efficacy and safety of MYL-1401O, a proposed biosimilar trastuzumab co-developed by the firms, in comparison to Roche’s branded Herceptin........»»

Category: topSource: the-hinduJun 5th, 2016

Mylan, Biocon confirm efficacy of trastuzumab biosimilar

Global pharma major Mylan Inc, and Biocon have confirmed the efficacy and safety of MYL-1401O, a proposed biosimilar trastuzumab co-developed by the firms, in comparison to Roche's branded Herceptin used for treatment of cancer.....»»

Category: topSource: moneycontrolJun 4th, 2016

EMA accepts Biocon, Mylan insulin for review

Biopharma major Biocon and Mylan NV said the European regulator has accepted their review application to market insulin glargine in Europe. The insulin glargine is used to treat adults with Type 2 ........»»

Category: topSource: the-hinduNov 3rd, 2016

European regulator EMA to review Biocon-Mylan cancer drug - Livemint

LivemintEuropean regulator EMA to review Biocon-Mylan cancer drugLivemintThe two firms anticipate that this may be the first Trastuzumab biosimilar to be reviewed by the European Medicines Agency (EMA). Photo: Hemant Mishra/Mint. Hyderabad: Drug makers My.....»»

Category: topSource: googlenewsAug 25th, 2016

Mylan & Biocon Announce Regulatory Submission for Proposed Biosimilar Pegfilgrastim Accepted for Review by European Medicines Agency

Category: press-releasesSource: businesswireindiaJul 21st, 2016

Mylan, Biocon confirm efficacy of trastuzumab biosimilar

Trastuzumab is indicated for treatment of a type of breast cancer, Biocon said.....»»

Category: featuresSource: business-standardJun 4th, 2016

Mylan, Biocon confirm efficacy of trastuzumab biosimilar

Study shows MYL-1401O has equivalent efficacy and safety to trastuzumab, and that it does not trigger an immune response.....»»

Category: featuresSource: livemintJun 4th, 2016

Mylan and Biocon to Present Phase 3 Trastuzumab Biosimilar Data at the American Society of Clinical Oncology (ASCO) Annual Meeting

Business Wire India
Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the presentation of data fr.....»»

Category: press-releasesSource: businesswireindiaJun 3rd, 2016

Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by U.S. Food and Drug Administration

Business Wire India

Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Applicati.....»»

Category: press-releasesSource: businesswireindiaMay 24th, 2016