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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 Says European Medicines Agency's CMPH Recommends Approval Of Fulphila
Friday, 21 Sep 2018 

Sept 21 (Reuters) - Biocon Ltd ::BIOCON SAYS EUROPEAN MEDICINES AGENCY'S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE HAS ISSUED POSITIVE OPINION RECOMMENDING APPROVAL OF FULPHILA.SAYS CHMP POSITIVE OPINION WILL NOW BE CONSIDERED BY THE EUROPEAN COMMISSION.SAYS DECISION ON APPROVAL IS EXPECTED BY NOVEMBER 2018.  Full Article

Biocon Q4 Net Profit Up 2 Percent
Thursday, 26 Apr 2018 

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 

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 ​
Wednesday, 21 Feb 2018 

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 

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 

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 

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 

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 

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​
Monday, 20 Nov 2017 

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

CORRECTED-India's Biocon Q2 profit surges on one-off gain

Oct 25 Indian biotechnology company Biocon Ltd posted an over five-fold rise in second-quarter profit on Thursday, as the company recorded a one-off gain of 1.89 billion rupees ($25.79 million).

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