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The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
Antibodies induced by the investigational DNA vaccine candidate, INO-4800, were found to be able to neutralise three SARS-CoV-2 emerging variants of concern.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.
Using a new precipitation method eliminates the need for the costly chromatography process and could make antibody therapies more affordable to produce, according to Andrew Zydney.
The ChAd63-KH vaccine, used to treat leishmaniasis rather than prevent in this trial, significantly improved symptoms in patients with persistent post-kala-azar dermal leishmaniasis.
Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
![Thermo Fisher Scientific company office with large company logo in Silicon Valley, US [Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Thermo-Fisher-Scientific-300x278.jpg)
![Thermo Fisher Scientific company office with large company logo in Silicon Valley, US [Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Thermo-Fisher-Scientific-e1618570463300.jpg)
The acquisition, anticipated to complete in 2021, allows Thermo to expand its ‘one-stop-shop’ of services into running clinical trials.
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
Interim Phase I/II trial results show Rocket’s ex vivo lentiviral gene therapy candidate, RP-L201, is safe and of benefit to paediatric patients with severe Leukocyte Adhesion Deficiency-I.
Research suggests the increasing R&D investment in and adoption of biologics will drive growth in the global biologics contract development and manufacturing organisation (CDMO) market.
GTB-3550 TriKE™ monotherapy was found to restore natural killer cell function and immune surveillance in relapsed or refractory AML and MDS cancer patients.
The trial will evaluate whether the novel IC14 anti-CD14 antibody can reduce recovery time and severity of COVID-19 symptoms in hospitalised patients.
BioVersys will receive €20 million in funding to support its development of new treatments for antimicrobial resistant infections.
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
A new report suggests the global biotechnology and pharmaceutical services outsourcing market will grow because of the pandemic and rising drug development costs and R&D investments.
