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Zydus' COVID-19 drug shows promise in Phase 3 trials; seeks DCGI nod

Zydus COVID-19 drug shows promise in Phase 3 trials; seeks DCGI nod
Over 91.15% of patients treated with PegIFN were found to be RT PCR negative by day 7 as compared to 78.90 per cent on the standard of care arm; PegIFN reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients
BusinessToday.In | April 5, 2021 | Updated 12:51 IST
Interim results show PegIFN could help patients recover faster, avoiding complications seen in the advanced stages
Zydus Cadila announced on Monday, April 5 that it has sought approval from drug regulator DCGI (Drugs Controller General of India) for its drug Pegylated Interferon Alpha 2b (PegIFN) to be used in the treatment of COVID-19 patients. The domestic pharma company has applied for an approval for additional indication with DCGI for the use of PegIFN, announcing that its phase-III clinical trials with the drug have manifested promising results in treating coronavirus patients. ....

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Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for Covid-19 vaccine | India News

Representative photo
NEW DELHI: Drug firm Zydus Cadila on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its Covid-19 vaccine ZyCoV-D.
The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.
ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase I and II clinical trials, it added.
The phase II study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind placebo-controlled study, the drug firm said.
The trial has reviewed by an independent data safety monitoring board (DSMB) and reports were submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. ....

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