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Zydus gets nod from Mexican authority for Covid-19 therapy clinical trials

Drug firm Zydus Cadila said it has received approval from Mexico's regulatory authority Cofepris to conduct clinical trials with its biological therapy "Pegylated Interferon alpha-2b"

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Coronavirus | Coronavirus Vaccine | Zydus Cadila

Press Trust of India  |  New Delhi 

Zydus

Drug firm on Friday said it has received approval from Mexico's regulatory authority Cofepris to conduct in the Latin American country with its biological therapy "Pegylated Interferon alpha-2b" for treatment of COVID-19.

Clinical and regulatory development of the therapy in COVID-19 is being executed in by Avant Sant Research Center S.A. de C.V., a contract research organisation (CRO) headquartered in Monterrey,

In a regulatory filing, said it had received approval from the Mexican regulatory authority Cofepris to conduct with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHepTM'.

It added that this will be an open-label, randomised, comparator controlled study... to evaluate safety, efficacy and tolerability in patients with COVID-19.

Zydus had earlier approached the Drug Controller General of India to investigate the role of Pegylated Interferon alpha-2b for COVID-19 and the are now underway, the company said.

It is also working with the US Food and Drug Administration to open an investigational new drug application for Pegylated Interferon alpha-2b.

Earlier this month, had also received approval from Cofepris to test one of its lead research candidate Desidustat in the management of COVID-19.

Shares of Cadila Healthcare, the listed entity of the group, were trading 1.14 per cent higher at Rs 365.05 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Fri, July 17 2020. 11:48 IST
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