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BNT162b2 vaccine is 95 percent effective against COVID-19, finds final efficacy analysis
The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.
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Biologics
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Microbial contract biomanufacturing market to be worth $9.3 billion by 2030
A new analysis suggests that Europe and North America will capture more than 80 percent of the $9.3 billion market by 2030.
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Stem cell therapy trial for COVID-19 patients with ARDS advised to continue
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
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Pfizer and BioNTech to supply the EU with 200 million doses of BNT162b2 vaccine
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
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FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
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Using Th17 cells researchers make adoptive T-cell transfer therapy viable
Adoptive T-cell transfer therapy has had limited use due to the time involved in CD8+ T cell expansion, using a different type of T cell researchers were able to shorten this timeline, making the therapy more accessible.
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
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COVID-19 therapeutics to rely on large-scale biomanufacturing reactors, report says
A new report has found that if COVID-19 biologics are approved, it could apply pressure to the global biomanufacturing capacity.
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CVnCoV COVID-19 vaccine safely elicits immune response in Phase I testing
The interim Phase I data suggests CVnCoV can safely induce a neutralising antibody response similar to that of convalescent COVID-19 patients with two 12μg vaccine doses.
whitepaper
Fact sheet: TOC monitoring efficiency quiz
Take our 10-question quiz to find out how efficient your Total Organic Carbon (TOC) monitoring programme is for your applications.
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Takeda to supply Japan with Moderna’s COVID-19 vaccine
Takeda will import and distribute 50 million doses of the mRNA-1273 vaccine candidate under an agreement with Moderna and Government of Japan.
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FDA approves first-in-human trial of COVID-19 vaccine candidate
The safety and immunogenicity of CORVax12, a novel DNA-encodable COVID-19 vaccine, will be evaluated in 36 healthy volunteers.
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US to receive 300,000 vials of experimental COVID-19 antibody therapy
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.
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Alternative routes of administration – a focus on oral biologics
A major challenge in achieving clinically relevant oral delivery of biologics is overcoming the multiple physiological barriers in the gastrointestinal tract. In this article Nikki Withers discusses these challenges with Shawn Davis, Head of Drug Delivery, BioPharmaceuticals Development, R&D at AstraZeneca, who shares some of the latest advances in drug…
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Expert view: The OXYCAPT™ multilayer plastic vial and syringe provides solutions for problems with current primary containers
There are several problems with existing primary containers; for example, glass suffers from breakage, delamination, etc., and plastic is an insufficient oxygen and ultraviolet (UV) barrier.
