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EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
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Antibodies
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Benlysta approved for adult patients with active lupus nephritis in Europe
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
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Which is the best in vitro diagnostic test method?
In this article, Liz Thorn, Senior Consultant, Diagnostics at Team Consulting, explores the various in vitro diagnostics (IVDs) techniques available and where they are best applied in the context of influenza and COVID-19.
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First patient dosed with dalbavancin in S. aureus bacteremia trial
The trial will assess the efficacy of a two week regimen of the FDA-approved antibiotic dalbavancin in treating 100 patients with Staphylococcus aureus bacteremia.
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NICE recommends ravulizumab for treatment of a rare blood disorder
On the NICE’s recommendation, ravulizumab will be made available to hundreds of patients with paroxysmal nocturnal haemoglobinuria on the UK’s NHS.
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First patients dosed with Fasenra in three dermatology trials
With the addition of the new dermatology trials, Fasenra is now being evaluated in nine different indications associated with eosinophilic immune dysfunction.
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Antibody-drug conjugates: challenges, solutions and future potential
The ability to precisely direct powerful therapeutics not only makes treatments more effective, but also prevents debilitating side effects. Here, Dave Elder and Stacey Treichler highlight the great potential of antibody-drug conjugates (ADCs) for improved treatment of oncology indications and beyond.
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Formulation, Development & Delivery In-Depth Focus 2021
In this in-depth focus, experts discuss why nanoparticles are a promising alternative for delivering inflammatory bowel disease therapies and highlight the potential of antibody-drug conjugates to advance oncology treatment.
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FDA revokes bamlanivimab Emergency Use Authorization
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.
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INO-4800 COVID-19 vaccine provides cross-reactive immune responses against variants
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.
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Could precipitation reduce the cost of antibody production?
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.
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Trial to assess anti-CD14 antibody as treatment for hospitalised COVID-19 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.
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Lenzilumab™ significantly improves survival in hospitalised COVID-19 patients
In a Phase III trial, adding Lenzilumab™ to steroid and remdesivir regimens improved the likelihood of survival without need for mechanical ventilation by 54 percent.
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-300x278.jpg)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-e1617017465349.jpg)
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European Medicines Agency’s CHMP meeting highlights March 2021
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
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REGEN-COV™ antibody cocktail reduces hospitalisation or death by 70 percent
Phase III data shows treatment with REGEN-COV™ (casirivimab and imdevimab) significantly reduces the risk of high-risk COVID-19 infected outpatients being hospitalised or dying.
