Tag: BIOCON

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» 2018-09-25

Syngene International Ltd, the contract research unit of Biocon, announced the resignation of its chief operating officer Manoj Nerurkar. It said Nerurkar, who has been with the COO of the […]

» 2018-09-22

Biocon, one of India’s foremost research-oriented pharmaceutical companies, said the US drug regulator has completed an inspection at its Bangalore facility without remarks. “The US FDA conducted a periodic cGMP […]

» 2018-03-28

Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in […]

» 2018-02-21

The United States’ Food & Drug Administration has issued a Form 483 after inspecting Biocon’s Malaysia manufacturing plant, indicating that it found discrepancies during the inspection. Issue of Form 483 […]

» 2017-12-02

Biocon and its partner Mylan scored a key victory on Friday as the US Food & Drug Administration approved its cancer-treating biosimilar trastuzumab. “Mylan anticipates potentially being the first company […]

» 2017-12-01

Indian pharma company Biocon and its partner Mylan said EU authorities have accepted for review their applications for approving cancer treating biosimilars trastuzumab and pegfilgrastim submitted after completing corrective actions. […]

» 2017-11-23

Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India. The biosimilar — or a drug that mimics a natural […]

» 2017-11-07

Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their […]

» 2017-10-10

The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. […]

» 2017-09-18

Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident. “US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility […]

» 2016-11-09

Mylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration. Biosimilar trastuzumab is a proposed biosimilar […]

» 2016-08-25

Mylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat […]

» 2016-02-15

Biocon Ltd said it has received European approvals for generic versions of AstraZeneca’s cholesterol drug Crestor, opening up a billion dollar market. The approval has been obtained for Rosuvastatin Calcium […]

» 2015-06-22

Syngene International, an India-based Contract Research Organisation and a subsidiary of Biocon Ltd, announced that it has received the Foreign Investment Promotion Board (“FIPB”) approval for raising the foreign investment […]