The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
The 50,000 square foot expansion will house a high-speed filling line and lyophilizers, which will increase the facility’s sterile injectable capacity by 50%
The interim data combines three mRNAs into one therapy injected directly into the tumour
The US $ 192.5 mn US government contract will help fund the centre of excellence to boost the domestic supply of critically needed laboratory plastics
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
It was recognized for its holistic initiatives designed to improve the quality of life and standards of care for patients
A Sanofi R&D executive will join the Gyroscope Clinical Advisory Board to advise on matters related to the development of GT005 for geographic atrophy (GA).
In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO
Sputnik Light has been authorised in more than 15 countries with the registration process ongoing in a further 30 countries
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