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GSK to collaborate on development of antibodies for neurodegeneration
GSK will support the development of Alector’s immuno-neurology monoclonal antibodies for Parkinson’s disease, frontotemporal dementia and Alzheimer’s.
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Biologics
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
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First patients vaccinated with AstraZeneca’s COVID-19 variant vaccine
The Phase II/III trial will assess the safety and immunogenicity of AstraZeneca’s novel COVID-19 variant vaccine candidate, AZD2816.
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Novel COVID-19 vaccine shows promise in Canadian trial
Phase I data shows VBI-2902a induced neutralisation and antibody titres up to five times that of people who had recovered from COVID-19 infection.
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Novavax’ COVID-19 vaccine almost 90 percent effective in Phase III trials
In UK trials where 60 percent of COVID-19 cases were caused by the Alpha SARS-CoV-2 variant, the NVX-CoV2373 COVID-19 vaccine was 89.7 percent effective.
whitepaper
Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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Extended dosing intervals may increase efficacy of Vaxzevria COVID-19 vaccine
An analysis shows a single dose of Vaxzevria induced immunity lasting at least a year and an interval of up to 45 weeks significantly increases neutralising antibody titres.
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Partnership to revolutionise RNA production
Under a strategic collaboration eTheRNA immunotherapies and Quantoom Biosciences will develop a novel, scalable RNA production system.
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Bioprocessing & Bioproduction In-Depth Focus 2021
Download this in-depth focus to discover why new licensing guidance could prompt a biosimilar boom in the UK and learn about recent developments in O-glycan analytical approaches for therapeutic proteins.
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What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
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New regulatory guidance could lead to UK biosimilar boom
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
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Article: Survey of the status of rFC and LAL equivalence determination
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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FDA approves Actemra for emergency use in hospitalised COVID-19 patients
The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
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VIRTUAL ROUNDTABLE HIGHLIGHTS: Emerging tools for the analysis of biologics and biosimilars
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
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Solid- and Liquid-State NMR for monitoring of polysaccharide antigen in the manufacturing process
Francesco Berti, Scientific Director at GSK Vaccines - Siena, Italy, reveals how NMR spectroscopy tools are invaluable in vaccine production.
