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Biocon Ltd (BION.NS)

BION.NS on National Stock Exchange of India

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Latest Key Developments (Source: Significant Developments)

Biocon Q4 Net Profit Up 2 Percent
Thursday, 26 Apr 2018 10:55am EDT 

April 26 (Reuters) - Biocon Ltd ::Q4 NET PROFIT UP 2 PERCENT TO 1.30 BILLION RUPEES; Q4 TOTAL REVENUE 12.37 BILLION RUPEES VERSUS 9.74 BILLION RUPEES YEAR-AGO.  Full Article

Mylan, Biocon Seek To Accelerate Introduction Of Adalimumab Biosimilar In EU
Wednesday, 11 Apr 2018 07:23am EDT 

April 11 (Reuters) - Biocon Ltd ::MYLAN, BIOCON SEEK TO ACCELERATE INTRODUCTION OF ADALIMUMAB BIOSIMILAR IN EU.  Full Article

India's Biocon ‍Says U.S. FDA Completed Pre-Approval Inspection At Malaysia Unit ​
Tuesday, 20 Feb 2018 10:20pm EST 

Feb 21 (Reuters) - Biocon Ltd ::‍U.S. FDA COMPLETED PRE-APPROVAL INSPECTION AT MALAYSIA FACILITY AND ISSUED FORM 483 WITH 6 OBSERVATIONS​.  Full Article

Cytosorbents Expands Its Partnership With Biocon To Launch Cytosorb In Malaysia
Thursday, 15 Feb 2018 06:55am EST 

Feb 15 (Reuters) - Cytosorbents ::CYTOSORBENTS EXPANDS ITS PARTNERSHIP WITH BIOCON TO LAUNCH CYTOSORB® IN MALAYSIA.CYTOSORBENTS CORP - ‍BIOCON HAS EXCLUSIVE RIGHTS TO DISTRIBUTE CYTOSORB IN MALAYSIA, WHERE CYTOSORB IS ALREADY REGISTERED​.CYTOSORBENTS CORP - ‍FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED​.  Full Article

Mylan And Biocon Receive Positive CHMP Opinion For Semglee, Biosimilar Insulin Glargine
Monday, 29 Jan 2018 06:00am EST 

Jan 29 (Reuters) - Biocon Ltd ::MYLAN AND BIOCON RECEIVE POSITIVE CHMP OPINION FOR SEMGLEE™, BIOSIMILAR INSULIN GLARGINE.MYLAN NV - CHMP POSITIVE OPINION WILL BE CONSIDERED BY EUROPEAN COMMISSION.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN - IN ADDITION TO EUROPEAN SUBMISSION, MARKETING APPLICATIONS FOR SEMGLEE BEEN SUBMITTED IN AUSTRALIA, CANADA, U.S. & PLANNED FOR KEY EMERGING MARKETS.  Full Article

Biocon And Mylan's Biosimilar Trastuzumab Gets Approval From ANVISA, Brazil
Friday, 29 Dec 2017 01:12am EST 

Dec 29 (Reuters) - Biocon Ltd ::CO AND MYLAN'S BIOSIMILAR TRASTUZUMAB RECEIVES APPROVAL FROM ANVISA, BRAZIL THROUGH THEIR PARTNER LIBBS.LIBBS FARMACEUTICA TO COMMERCIALIZE PRODUCT IN BRAZIL UNDER BRAND NAME ZEDORA.  Full Article

Biocon Says Has Paid Facility Fee For Its API Facility To U.S. FDA
Wednesday, 13 Dec 2017 01:43am EST 

Dec 13 (Reuters) - Biocon Ltd ::CLARIFIES ON NEWS ITEM REGARDING CO'S NAME ON FDA LIST FOR NOT PAYING FACILITY FEE.SAYS CO'S API UNIT HAS DIFFERENT FEI NO FOR WHICH FACILITY FEE TO U.S. FDA HAD BEEN PAID FOR IN SEPT 2017.  Full Article

EMA Accepts Marketing Authorization Applications For Mylan And Biocon's Proposed Biosimilars
Thursday, 30 Nov 2017 12:55pm EST 

Nov 30 (Reuters) - Mylan NV ::EUROPEAN MEDICINES AGENCY ACCEPTS MARKETING AUTHORIZATION APPLICATIONS FOR MYLAN AND BIOCON'S PROPOSED BIOSIMILARS TRASTUZUMAB AND PEGFILGRASTIM.EMA ACCEPTANCE OF TRASTUZUMAB, PEGFILGRASTIM FOLLOWS EARLIER WITHDRAWAL OF APPLICATIONS IN RESPONSE TO AUDIT OF BIOCON'S DRUG PRODUCT FACILITY.  Full Article

Biocon says co's facility receives EIR with VAI status​
Sunday, 19 Nov 2017 09:47pm EST 

Nov 20 (Reuters) - Biocon Ltd :Says ‍Biocon's facility receives EIR with vai status​.  Full Article

Biocon says Mylan resubmits Biosimilar Trastuzumab and Pegfilgrastim dosseirs with EMA‍​
Monday, 6 Nov 2017 09:25pm EST 

Nov 7 (Reuters) - Biocon Ltd :Says mylan resubmits Biosimilar Trastuzumab and Pegfilgrastim dosseirs with EMA‍​.  Full Article

BRIEF-India's Biocon Says USFDA, European Regulator Issue Observations On Bangalore Plant

* SAYS US-FDA COMPLETED PRE-APPROVAL INSPECTION OF STERILE DRUG PRODUCT PLANT IN BANGALORE AND ISSUED A FORM 483 WITH 7 OBSERVATIONS

No consensus analysis data available.