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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 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

India's Biocon Sept-qtr consol profit more than halves
Thursday, 26 Oct 2017 09:10am EDT 

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​
Monday, 9 Oct 2017 11:26pm EDT 

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 says US FDA completes inspection with no observations for Vishakhapatnam facility
Monday, 18 Sep 2017 06:15am EDT 

Sept 18 (Reuters) - Biocon Ltd :Says Biocon's facility in Vishakhapatnam completes USFDA inspection with no observations.  Full Article

Biocon says insulins facility in Malaysia gets EU GMP compliance certificate
Thursday, 7 Sep 2017 07:17am EDT 

Sept 7 (Reuters) - Biocon Ltd :Says Biocon's insulins facility in Malaysia receives EU GMP compliance certificate.  Full Article

Biocon announces partnership with JDRF to support study of oral insulin drug candidate
Wednesday, 6 Sep 2017 01:31am EDT 

Sept 6 (Reuters) - Biocon Ltd :Says JDRF supports biocon study of novel, fast-acting oral insulin tregopil for type 1 diabetes treatment.  Full Article

Biocon says USFDA target action date for trastuzumab reset to Dec 3, 2017
Wednesday, 30 Aug 2017 06:39am EDT 

Aug 30 (Reuters) - Biocon Ltd :Says USFDA target action date for trastuzumab reset to December 3, 2017.Says extension will have no impact on anticipated timetable for commercialization of product in US.  Full Article

Biocon says on track to complete corrective actions related to Trastuzumab, Pegfilgrastim facilties by qtr-end
Wednesday, 16 Aug 2017 02:15am EDT 

Aug 16 (Reuters) - Biocon Ltd ::European regulatory authorities had informed co the need for a re-inspection of drug product facilty for Trastuzumab and Pegfilgrastim.On track to complete corrective, preventive actions by end of this quarter; co to seek re-inspection, re-submission thereafter.Request for withdrawal of dossiers and re-submission is part of EMA procedural requirements linked to re-inspection, & to be considered by EMA's Committee for Medicinal Products for Human Use.  Full Article

India's Biocon June qtr net profit 813 mln rs vs. 1.67 bln rs year-ago
Thursday, 27 Jul 2017 10:09am EDT 

July 27 (Reuters) - India's Biocon Ltd ::June quarter net income 813 million rupees versus 1.67 billion rupees year-ago.June quarter total revenue 9.88 billion rupees versus. 10.33 billion rupees year-ago.India's Biocon says outlook for FY18 cautious, depends on regulatory approvals and tender outcomes for biosimilars.Biocon says anticipate gst impact to roll‐over into Q2FY18, but situation would normalize by end of H1 2018.  Full Article

BRIEF-Biocon says co's facility receives EIR with VAI status​

* Says ‍Biocon's facility receives EIR with vai status​ Source text for Eikon: Further company coverage:

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