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FDA grants Fast Track designation to two COVID-19 vaccines
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
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Vaccines
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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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Further billions pledged to ensure equitable access to COVID-19 treatments
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
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First COVID-19 vaccine given green light for Phase I trial in China
CanSino Biologics' Ad5-nCoV vaccine, a potential COVID-19 prophylactic, has been approved for study in a Phase I clinical trial in China.
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First COVID-19 vaccine clinical trial approved in India
Indian authorities have given the green light to test Bharat Biotech's COVID-19 vaccine in Phase I and Phase II clinical trials.
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The extra mile: preparing a supply chain for a COVID-19 vaccine
Dr Madhav Durbha explains the importance of implementing and ensuring stable supply chains to deliver potential COVID-19 vaccines.
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Moderna and Catalent to collaborate on COVID-19 vaccine manufacture
Catalent's biologics facility will conduct large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate.
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Comparison of new vaccine approaches – COVID-19
The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
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Patents and approvals – medicines, vaccines and diagnostics for COVID-19
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
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Over 2,000 clinical trials currently underway for COVID-19 therapies, finds study
New findings have revealed that over 2,000 clinical trials are being conducted to test COVID-19 therapies while 583 companies are involved in treatment and vaccine development.
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First patient dosed with COVID-19 vaccine using self-amplifying RNA
A Phase I clinical trial to test Imperial College London's COVID-19 vaccine candidate has been initiated, with the first patient dosed.
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Consortium established to monitor COVID-19 vaccines after marketing
A new consortium has been formed for the study of COVID-19 vaccines after their approval, to monitor their safety and efficacy.
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Bioprocessing & Bioproduction In-Depth Focus 2020
This in-depth focus includes articles detailing five important considerations for European companies entering the US biosimilar market and explaining why virally vectored DNA and mRNA vaccines could prevent the spread of COVID-19.
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European Pharmaceutical Review Issue 3 2020
In this issue is a discussion on the promise of virally vectored DNA and mRNA vaccines to combat COVID-19 as well as articles on how packaging could help to ensure patient adherence, regulatory issues for medicines and diagnostics during the pandemic and the benefits of digitalising the pharmaceutical supply chain.…
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AstraZeneca commits to supply Europe with 400 million doses of COVID-19 vaccine candidate
AstraZeneca plans to produce up to 400 million doses of the University of Oxford’s COVID-19 vaccine candidate, with deliveries to begin by the end of the year.
