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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)

Syngene International Says Promoter Biocon Proposes To Divest Part Of Its Shareholding In Co
Tuesday, 15 May 2018 

May 15 (Reuters) - Syngene International Ltd ::SAYS PROMOTER BIOCON PROPOSES TO DIVEST PART OF ITS SHAREHOLDING IN CO.  Full Article

India's Biocon Dec-Qtr Consol Profit Down About 46 pct
Wednesday, 24 Jan 2018 

Jan 24 (Reuters) - Biocon Ltd ::DEC QUARTER CONSOL PROFIT 919 MILLION RUPEES VERSUS 1.71 BILLION RUPEES LAST YEAR.DEC QUARTER CONSOL REVENUE FROM OPERATIONS 10.58 BILLION RUPEES VERSUS 10.44 BILLION RUPEES LAST YEAR.  Full Article

Biocon Announces Exclusive Global Collaboration With Sandoz On Next-Generation Biosimilars
Thursday, 18 Jan 2018 

Jan 18 (Reuters) - Biocon Ltd ::ANNOUNCES EXCLUSIVE GLOBAL COLLABORATION WITH SANDOZ ON NEXT-GENERATION BIOSIMILARS'.SAYS WORLDWIDE COMMERCIALIZATION REPONSIBILITIES TO BE DIVIDED.  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

Biocon says Mylan resubmits Biosimilar Trastuzumab and Pegfilgrastim dosseirs with EMA‍​
Tuesday, 7 Nov 2017 

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

India's Biocon Sept-qtr consol profit more than halves
Thursday, 26 Oct 2017 

Oct 26 (Reuters) - Biocon Ltd :Sept quarter consol profit 688 million rupees versus 1.47 billion rupees last year.Consensus forecast for Sept quarter consol profit was 1.14 billion rupees.Sept quarter consol revenue from operations 9.69 billion rupees versus 9.54 billion rupees last year.Approved transfer of biosimilars business by way of slump sale as a going concern to Biocon Biologics India Ltd, a step down unit of co‍​.Says "expect headwinds to ease by the end of this fiscal"‍​."Malaysia facility costs and pricing pressures in our APIs business continue to weigh on our P&L".  Full Article

Biocon says ‍U.S. FDA issued complete response letter for proposed biosimilar Pegfilgrastim​
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - Biocon Ltd ::Says ‍US FDA issues complete response letter (CRL) for proposed biosimilar Pegfilgrastim​.Says ‍CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity​.Says ‍do not expect CRL to impact commercial launch timing of biosimilar Pegfilgrastim in US​.‍CRL relates to pending update of BLA with certain data from facility requalification activities post recent plant modifications​.  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.