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Monkeypox update – August 2022
In this article, EPR’s Hannah Balfour discusses the recent multi-country monkeypox outbreak, highlighting key developments in the international response.
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Covid-19
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Pharmacopoeias to further support vaccine development and supply
US and European Pharmacopoeias announce new activities to help promote vaccine development, manufacturing, quality and supply.
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Developing broad-spectrum vaccines that target the heart of mutating viruses
Alexandre Le Vert, CEO and Co-Founder of Osivax, explores some evolving approaches to vaccine development that aim to counter the effects of virus mutation.
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CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
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Nipah virus vaccine enters Phase I trial
The investigational mRNA-1215 vaccine developed to prevent Nipah virus – a bat-borne disease of pandemic potential, will be evaluated for safety, tolerability and immunogenicity.
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CEPI provides $30m to advance novel coronavirus vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with a consortium of research and technological institutions to fund the development of a novel vaccine to provide protection against COVID-19, as well other SARS-like Betacoronaviruses.
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ESG considerations in Europe and Asia: social inclusion – the new diversity frontier in life sciences
With the focus on environmental, social and governance (ESG) issues rising worldwide, in this article, Morgan, Lewis & Bockius LLP Partners, Lesli Ligorner and Louise Skinner discuss the evolving landscape, presenting the emerging regulations for reporting social factors across Asia and Europe.
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Anatomy of a ‘correlate of protection’ for T-cell vaccines
The use of proprietary vaccine constructs to prime naive CD8+ T-cells via skin dendritic cells and thus enable induction of targeted cellular immunity, establishing tissue-resident CD8+ T-memory cells, is a new vaccination strategy being explored at Emergex Vaccines. Here, Professor Thomas Rademacher, Emeritus Professor of Molecular Medicine – UCL and…
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2022 spells change for EU pharmaceutical legislation
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
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BioNTech launches African vaccine production in Rwanda
Marking the initiation of its African vaccine manufacturing network, BioNTech begins construction of its hub site in Rwanda.
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Moderna announces UK mRNA Innovation and Technology Centre
Moderna to establish a UK mRNA Innovation and Technology Centre to produce mRNA vaccines for COVID-19, influenza, respiratory syncytial virus (RSV) and more.
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Pharmaceutical C-suite update
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
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Onshoring and global health – has the pandemic sent globalisation into reverse?
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.
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EMA’s first critical medicines list for COVID-19
The approved COVID-19 vaccines and treatments on the list will be monitored to prevent and mitigate the impact of shortages.
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AstraZeneca’s Evusheld significantly reduces risk of developing severe COVID-19
AstraZeneca's Evusheld (tixagevimab and cilgavimab) provided clinically and statistically significant protection against progression to severe COVID-19 over placebo.
