![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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Biologics
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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.
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NMR spectroscopy to enhance biologic drug delivery and stability
Review shows nuclear magnetic resonance (NMR) spectroscopy has the potential to enhance biologic drug formulation, optimising delivery and bioavailability.
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Falsified Covishield vaccine identified in Africa and Asia
WHO urges supply chain stakeholders to be vigilant, after falsified Covishield COVID-19 vaccines were identified in Uganda, India and Myanmar.
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Pill may replace injections for monoclonal antibody treatments
An innovative new pill can deliver large quantities of monoclonal antibodies and other drugs into the stomach lining after swallowing.
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Continuous bioprocessing market to achieve 23 percent CAGR
Market research suggests the continuous bioprocessing market will value $348.9 million by 2027, driven by the rising demand for biopharmaceuticals.
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‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery
Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new…
