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EMA committee recommends 13 medicines for approval in January meeting
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
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Biologics
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Valneva begins manufacturing its inactivated, adjuvanted COVID-19 vaccine
The company announced that the Phase I/II trial for VLA2001 is now fully enrolled and that it has begun manufacturing the vaccine candidate on an industrial scale.
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Study finds some antibody therapies are not effective against new COVID-19 variants
In vitro neutralisation assays show REGEN-COV and AZD7442 are effective against the new SARS-CoV-2 variants, while other antibody therapies, including Eli Lilly’s bamlanivimab, were not.
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Lilly’s antibody combo reduces COVID-19 hospitalisations and risk of death by 70 percent
Data from a Phase III trial shows high-risk patients treated with bamlanivimab and etesevimab were 70 percent less likely to be hospitalised due to COVID-19.
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COVAX to purchase up to 40 million COVID-19 vaccine doses from Pfizer and BioNTech
Through COVAX, doses of the Pfizer-BioNTech vaccine will be provided at a not-for-profit price for 92 low- and lower-middle-income countries.
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Gavi to make 500,000 doses of Ebola vaccine available for outbreak response
The global stockpile will provide developing countries responding to Ebola outbreaks with doses of the approved single-dose Ebola vaccine, rVSV∆G-ZEBOV-GP, live, free of charge.
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Article: CCI test method development using headspace gas ingress
Update your blue dye ingress test and generate robust analytical CCI data in all stages of the product life cycle.
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Johnson & Johnson’s COVID-19 vaccine safely elicits an immune response
An interim analysis of Phase I/II trial data shows 90 percent of 18-55 year olds had a neutralising antibody response that lasts at least two months.
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Case study: Biochemistry company uses RMM analyser to streamline process control
See how a leading biochemistry company implemented real-time microbial monitoring to streamline process control in their water system.
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Japan has pre-ordered COVID-19 vaccine doses for more than four times its population, says report
Japan has procurement deals with half of the companies leading the COVID-19 vaccine development race, according to GlobalData.
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US could purchase over 1.5 million doses of Regeneron’s COVID-19 antibody cocktail
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
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Valneva may provide Europe with the only inactivated virus vaccine for COVID-19
The Europe Commission is currently in discussions to procure millions of doses of Valneva’s COVID-19 innactivated virus vaccine, VLA2001.
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COVID-19 antibody therapy shows promise in Phase II/III trial
CT-P59, a monoclonal antibody therapy for COVID-19, was found to be particularly effective at reducing recovery times in moderate COVID-19 patients aged 50 plus.
whitepaper
Whitepaper: Turbocharging Raman measurements
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
