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Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
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Biologics
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
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Temperature stable microneedle patch successfully delivers DNA COVID-19 vaccine
A microneedle patch, which can be stored for >30 days at room temperature, safely delivered a DNA-based COVID-19 vaccine in mice.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
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Video: tec5USA Anti-Counterfeit Solutions by Spectral Engines
All-in-one Drug Anti-Counterfeit Solution for improved pharma product security and brand protection, brought to big pharma companies via tec5USA.
![Moderna COVID-19 vaccine vials [Credit: Giovanni Cancemi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/shutterstock_1893225814-300x278.jpg)
![Moderna COVID-19 vaccine vials [Credit: Giovanni Cancemi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/shutterstock_1893225814-e1631790550214.jpg)
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COVID-19 Vaccine Moderna effective against variants of concern
New data shows that Moderna’s COVID-19 vaccine protects against variants of concern and reduces breakthrough infection risk.
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Immuno-bridging studies are sufficient for authorising new COVID-19 vaccines, say regulators
The Access Consortium, comprising regulators from the UK, Australia, Canada, Singapore and Switzerland, announce that immuno-bridging studies can be used to support COVID-19 vaccine authorisation.
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Novartis submit BLA for tislelizumab for oesophageal cancer treatment
US FDA have accepted Biologics License Application (BLA) for tislelizumab for the treatment of oesophageal squamous cell carcinoma cancer.
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US government purchases additional 1.4 million doses of REGEN-COV™
Regeneron announced a new US government agreement to purchase additional doses of REGEN-COV (casirivimab and imdevimab) antibody cocktail.
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J&J’s Ebola vaccine regimen demonstrates immune response
Johnson & Johnson’s Ebola vaccine regimen, Zabdeno® and Mvabea®, generated robust humoral immune responses in adults and children.
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Moderna and ILCM to develop Crigler-Najjar syndrome therapeutic
Moderna and the Institute for Life Changing Medicines (ILCM) are collaborating to develop an mRNA therapeutic for Crigler-Najjar syndrome.
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NICE recommends bimekizumab for severe plaque psoriasis treatment
Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
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Membrane technologies to be critical in intensifying downstream bioprocessing
Experts suggest membrane-based technologies could become a vital component in end-to-end intensified bioprocesses for monoclonal antibodies.
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EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
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BioNTech evaluates mRNA vaccine manufacturing capabilities in Africa
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.
