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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

AuroBlog - Aurous Healthcare Clinical Trials blog

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 The vaccine variant […]

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SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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Pharma Mirror Q&A with Jane Myles, Vice President of Clinical Trial Innovation at Curebase

Pharma Mirror

This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.

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Velocity Wins the 2024 Vaccine Industry Excellence Award for Best Clinical Trial Company

Velocity Clinical Research

Velocity has won the 2024 Vaccine Industry Excellence (ViE) award for Best Clinical Trial Company at The World Vaccine Congress in Washington, DC. The recognition is based on performance metrics, diversity of vaccine trial capabilities, and key initiatives to support vaccine research.

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Partnership to execute next generation Covid-19 vaccines clinical trial

Drug Discovery World

Next generation Covid-19 vaccines could have the potential to expand the breadth of coverage against existing and future variants of the virus, extend the duration of protection, and offer better protection in the prevention of illness and transmission over the current state of vaccine technologies.

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Study shines a light on representation in clinical research

Drug Discovery World

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. For example, US Census Bureau data indicates 13.4%

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Examining COVID’s impact on clinical research participant diversity

pharmaphorum

The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S.