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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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.
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.
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
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.
The EC has approved an extension of marketing authorisation for Regeneron and Sanofi's Dupixent (dupilumab) for children aged six to 11 with severe atopic dermatitis.
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
UK Prime Minister Boris Johnson has announced a £20 million investment fund for medicine manufacturing and supply chains in the UK.
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
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.
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.
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.
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.
The European Commission has fined Teva and Cephalon €60.5 million for a pay-for-delay deal over Cephalon's modafinil and Teva's generic.
To aid COVID-19 vaccine developers, the EDQM has released an updated European Pharmacopoeia that can be accessed for free.
The strategy outlines actions to strengthen EU supply chains, encourage innovation and ensure medicines are affordable and sustainable.