Does The Pandemic Present Opportunities To Rethink Regulatory Approaches?
Top Global Execs Share Views
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.
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Scrip takes a look at the key trends that could play out in 2021 to shape the trajectory of Indian drug makers, including evolving dynamics in the US under a new president. Thorny India-China relations will add a layer of complexity, while firms may also want to look beyond the chief information officers as they ramp up digital engagement.
The president of Takeda’s global vaccines business emphasizes the need to build trust and ensure that pharma is transparent about “what we will and will not know” at the time that COVID-19 vaccines are licensed.
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