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Tezepelumab significantly reduces exacerbations of severe asthma
In a Phase III trial, tezepelumab was shown to meaningfully reduce annualised asthma exacerbation rates in a range of patients with severe, uncontrolled asthma.
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Antibodies
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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FDA approves Libtayo® monotherapy for non-small cell lung cancer patients
The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
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FDA approves emergency use of Lilly’s COVID-19 antibody combination
The Emergency Use Authorization (EUA) for bamlanivimab and etesevimab was based on a trial where the antibodies lowered risk of hospitalisation and death in COVID-19 patients.
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Trial to assess AstraZeneca’s long-acting COVID-19 antibody therapy
The ACTIV-3 sub-study will evaluate the safety and efficacy of the AZD7442 synthetic antibody combination in at least 150 participants with mild-to-moderate COVID-19.
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
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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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REGEN-COV prevents symptomatic COVID-19 infections, finds analysis
Interim data from the Phase III trial evaluating REGEN-COV™ as a passive vaccine to prevent COVID-19 finds it reduces overall infection rate, viral load and length of infection.
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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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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.
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-300x278.jpg)
![Vials labelled 'COVID-19 Vaccine Pfizer' [Giovanni Cancemi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-covid-19-vaccine-scaled-e1607955047519.jpg)
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Pfizer-BioNTech COVID-19 vaccine is effective against new, highly transmissible COVID-19 strains, finds study
Research shows that the antibodies induced by the Pfizer-BioNTech COVID-19 vaccine can neutralise SARS-CoV-2 viruses with the N501Y mutation.
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Risankizumab trials show higher clinical remission in patients with Crohn’s disease
Two Phase III trials have shown that two doses of risankizumab met the primary endpoints in patients with Crohn's disease.
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Tocilizumab and sarilumab reduce COVID-19 patient mortality by 8.5 percent, data shows
IL-6 receptor antagonists tocilizumab and sarilumab have a significant impact on COVID-19 patient mortality, a study has shown.
