UK NICE recommends Vifor’s Tavneos for AAV treatment
The recommendation is based on the complete development programme data, including findings from the Phase III ADVOCATE trial.
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Celltrion’s Vegzelma receives EC approval for cancer treatments
Vegzelma was found to be similar in terms of safety, efficacy and pharmacokinetics to the reference product.
WHO recommends use of Valneva’s vaccine for Covid-19
The vaccine is not advised for usage in people aged 50 years and older.
FDA grants approval for bluebird’s Zynteglo to treat beta-thalassemia
The approval is based on findings from two Phase III clinical trials and a long-term follow-up study of Zynteglo.
Atomwise and Sanofi partner for drug discovery using AI
Atomwise is entitled to receive research, development and sales-based milestone payments totalling over $1bn.
New Zealand grants provisional approval for Novavax’s Covid-19 booster
The approval is based on findings from two Phase II trials and the UK-sponsored COV-BOOST trial.
FDA accepts Roche’s sBLA for combination therapy to treat DLBCL
Polivy plus R-CHP offered a 27% decline in disease progression, relapse or morality risk in a Phase III clinical trial.
AGC and RoosterBio partner for cell and exosome therapy manufacturing
RoosterBio will use its cell and media product portfolio to create scalable processes for hMSC and exosome therapies.