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Biocon and Mylan receive US FDA approval for Semglee, an insulin glargine injection expresspharma
June 12, 2020
FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes-1.
Biocon’s partner Mylan receives favourable ruling from US PTAB on Sanofi’s four device patents for L expresspharma
June 02, 2020
Reportedly, the PTAB also found Sanofi’s proposed amended claims for the ‘486 and ‘844 patents unpatentable.
EU GMP Certification for Biocon Biologics Drug Substance Facilities in Bengaluru expresspharma
May 14, 2020
These facilities were inspected by the regulatory agency between January 20 and 23, 2020.
Biocon and Mylan launch fulphila — biosimilar to pegfilgrastim, in Canada expresspharma
April 29, 2020
The approval of fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
Biocon and Mylan Launch Fulphila, Biosimilar Pegfilgrastim, in Australia expresspharma
April 15, 2020
The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from US FDA expresspharma
April 01, 2020
The Inspection has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020.
India needs to get into vaccine production in a big way: Kiran Mazumdar-Shaw expresspharma
March 13, 2020
India should step up research on communicable diseases and get into vaccine production in a big way, says biotechnology industry veteran Kiran Mazumdar-Shaw in the backdrop of the coronavirus outbreak globally.
Biocon, Mylan win patent litigation for Insulin Glargine device patent in the US expresspharma
March 12, 2020
Brings Biocon closer to commercialising Semglee in the US in 2020.
FDA Accepts BLA for Proposed Biosimilar Bevacizumab for Review americanpharmaceuticalreview
March 10, 2020
Mylan and Biocon announced the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway.
True North acquires 3% stake in Biologics India for $100m pharmaceutical-technology
January 07, 2020
Private equity fund True North has acquired 3% stake in Biologics India (BBIL) for nearly $100m, reported The Economic Times.

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