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- PMLiVE

Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

- PMLiVE

FDA approves Pfizer and BioNTech’s jab for COVID-19

Globally, five billion doses of the companies’ vaccine have been distributed

- PMLiVE

Moderna’s LP.8.1-adapted COVID-19 vaccine recommended by CHMP

Global health authorities have recommended that vaccines for the 2025-2026 season should target LP.8.1

- PMLiVE

AstraZeneca announces $2.5bn investment in China to boost R&D capabilities

The funds will go towards a new global research and development centre in Beijing’s BioPark

- PMLiVE

EC approves CSL/Arcturus’ self-amplifying mRNA COVID-19 vaccine Kostaive

Kostaive is designed to instruct the body to make more mRNA to boost immune response

- PMLiVE

WHO urges US to ‘reconsider’ withdrawal from global health organisation

President Donald Trump said the agency mishandled the COVID-19 pandemic and other global health crises

- PMLiVE

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

The combined vaccine approach could simplify immunisation practices and lead to higher uptake

- PMLiVE

Merck and Ridgeback initiate phase 3 study of COVID-19 oral antiviral in high-risk adults

Lagevrio is already available in the US under emergency use authorisation to treat certain cases of COVID-19

- PMLiVE

Seven strategic steps to enhance patient recruitment & retention in your influenza studies

The development of all treatments, including vaccines, is dependent on people taking part in clinical trials but this can be challenging for influenza studies, especially given the typically short patient...

Innovative Trials

- PMLiVE

Novavax announces FDA clinical hold lift on phase 3 COVID-19/flu vaccine study

The serious adverse event reported was found to be unrelated to the vaccine

- PMLiVE

Pfizer/BioNTech’s KP.2-adapted COVID-19 vaccine receives CHMP recommendation

The updated vaccine was shown to generate an improved response against currently circulating variants

- PMLiVE

Moderna’s JN.1-adapted COVID-19 vaccine approved by MHRA for adults and children

The JCVI has already advised the UK government on eligible groups for this year’s autumn vaccination programme

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