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FDA grants Fast Track designation to COVID-19 ARDS treatment
The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
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MHRA approves Pfizer and BioNTech COVID-19 vaccine
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
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FDA grants COVID-19 treatment Fast Track designation
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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Survey finds 64 percent of UK adults would receive COVID-19 vaccine
A survey of 1,500 adults in the UK showed that most would be happy to receive a COVID-19 vaccine, while nine percent said they would be unlikely to get the vaccine.
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Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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Pharma cold chain: is our industry ready, willing and scalable?
The pharmaceutical cold chain includes numerous participants – David Lewandowski discusses why this must be scalable to ensure efficient delivery of a COVID-19 vaccine.
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EMA highlights link between hydroxychloroquine and psychiatric disorders
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
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UK secures total of 357 million doses of various COVID-19 vaccines
After purchasing an additional two million doses of Moderna's COVID-19 vaccine, the UK will now receive a total of 357 million doses of vaccines from seven developers.
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WHO report suggests African countries are not ready for COVID-19 vaccines
The WHO Regional Director for Africa urges governments to “ramp up readiness” as report suggests the region is not prepared for a COVID-19 vaccine roll-out.
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EU secures 80 million doses of Moderna COVID-19 vaccine
The European Commission and Moderna have agreed that the company will supply at least 80 million doses of mRNA-1273, the company's COVID-19 vaccine candidate.
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COVAXX commits to deliver 140 million COVID-19 vaccine doses to emerging markets
The company suggests their experimental COVID-19 vaccine, UB-612, has the features and potential to disrupt the traditional vaccine distribution and supply status quo.
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EDQM releases updated pharmacopoeial quality standards for vaccines
To aid COVID-19 vaccine developers, the EDQM has released an updated European Pharmacopoeia that can be accessed for free.
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Trial to compare dexamethasone and baricitinib in hospitalised COVID-19 patients
The fourth iteration of the COVID-19 treatment trial will determine whether remdesivir plus baricitinib or dexamethasone is more effective at promoting recovery from COVID-19.
