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Latest From Biocon, Ltd.

Does The Pandemic Present Opportunities To Rethink Regulatory Approaches?

Biocon chair believes new perspectives on regulatory science and processes emerging from the US's "Warp Speed" efforts to accelerate COVID-19 vaccines have potential for wider application, although Regeneron's president urges caution around relying only on small studies to advance repurposed drugs.

Regulation Coronavirus COVID-19

No EUA For COVID-19 Vaccines Prior To Trials Completion, Says India

The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate

Policy & Regulation Research and Development Strategies

No EUA For COVID-19 Vaccines Prior To Trials Completion, Says India

The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate

Coronavirus COVID-19 Vaccines

Mylan And Biocon Launch Semglee Insulin Glargine In US

Mylan and Biocon have launched their Semglee version of insulin glargine in the US, revealing pricing details for the Lantus rival. At the same time, the firms have offered an update on their attempts to have Semglee classified as a biosimilar as they seek an interchangeability designation.

Launches Biosimilars
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