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First-in-human universal flu vaccine trial begins
The US National Institutes of Health have begun a first-in-human trial to assess the safety and immunogenicity of a potential universal influenza vaccine candidate, FluMos-v1.
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US National Institutes of Health (NIH)
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Gene therapy successfully treats rare immunodeficiency in paediatric patients
In three Phase I/II trials an experimental gene therapy caused all but two patients with severe combined immunodeficiency to acquire and retain robust immune function for more than two years.
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ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
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Acceleron receives FDA Notice of Noncompliance
The Notice of Noncompliance gives Acceleron 30 days to submit the required clinical trial results information to ClinicalTrials.Gov or face financial penalties.
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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The Emergency Use Authorization (EUA) was revoked after data suggested that, in the US, the prevalence of variants likely to be resistant to the monoclonal antibody bamlanivimab alone is increasing.
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NIH halts COVID-19 convalescent plasma trial
The trial evaluating COVID-19 convalescent plasma as a treatment for COVID-19 patients with mild to moderate symptoms was stopped due to ineffectiveness.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
![Vial labelled heparin. [Credit: SamaraHeisz5 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin-300x278.jpg)
![Vial labelled heparin. [Credit: SamaraHeisz5 / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Heparin-scaled.jpg)
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Increased heparin dose reduces need for life support in hospitalised COVID-19 patients
Interim data from 1,000 hospitalised patients with moderate COVID-19 symptoms shows that full doses of heparin can improve patient outcomes and could reduce ICU burden.
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Baricitinib and remdesivir reduce time to recovery in COVID-19 patients
A clinical trial in hospitalised COVID-19 patients has demonstrated that baricitinib and remdesivir reduce time to recovery.
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Trial to evaluate monoclonal antibody therapy for mild-to-moderate COVID-19
The study will determine if the combination of BRII-196 and BRII-198, two investigational antibodies for SARS-CoV-2, can prevent disease progression.
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EU secures 80 million doses of Moderna COVID-19 vaccine
The European Commission and Moderna have agreed that the company will supply at least 80 million doses of mRNA-1273, the company's COVID-19 vaccine candidate.
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NIAID trial to identify potential COVID-19 treatments for further development
The adaptive ACTIV-5/BET study will test two monoclonal antibody therapies in hospitalised COVID-19 patients to establish if they warrant larger clinical trials.
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US expands COVID-19 convalescent plasma treatment trials
Operation Warp Speed and the NIH are funding the expansion of two trials evaluating the efficacy of convalescent plasma therapy in hospitalised COVID-19 patients.
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Baricitinib and remdesivir reduce time to recovery in COVID-19 patient trial
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
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NIH launches antithrombotics trials in COVID-19 patients
The adaptive Phase III trials will assess whether various types and doses of blood thinners can prevent COVID-19 patients forming potentially fatal blood clots.
