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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)

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

Biocon Ltd says co and Mylan's proposed biosimilar accepted for review by EMA
Thursday, 21 Jul 2016 

Biocon Ltd : Mylan & Biocon announce regulatory submission for proposed biosimilar Pegfilgrastim accepted for review by European Medicines Agency . Co has exclusive commercialization rights with Mylan for proposed biosimilar in US, Canada, Japan, Australia, New Zealand, European Union countries . Biocon has co-exclusive commercialization rights with Mylan for the product in rest of the world .  Full Article

India's Biocon Ltd June-qtr consol profit up about 35 pct
Thursday, 21 Jul 2016 

Biocon Ltd : India's Biocon Ltd says June-quarter consol net profit 1.67 billion rupees . Says June-quarter consol net sales 9.72 billion rupees . Consensus forecast for June-quarter net profit was 1.18 billion rupees . Says consol net profit in June-quarter last year was 1.24 billion rupees as per Ind-AS; consol net sales was 7.58 billion rupees .  Full Article

BRIEF-India's Biocon To Transfer Biosimilar Business Via Slump Sale As 'Going Concern' To Biocon Biologics India

* INDIA'S BIOCON SAYS TO TRANSFER BIOSIMILAR BUSINESS THROUGH SLUMP SALE AS 'GOING CONCERN' TO BIOCON BIOLOGICS INDIA - EXCHANGES

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