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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 more flexible transportation conditions for Pfizer-BioNTech COVID-19 vaccine
Based on new stability data, the US regulator will allow COMIRNATY® to be transported and stored at standard pharmaceutical freezer temperatures for up to two weeks.
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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.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-300x278.jpg)
![Lines of vials labelled 'COVID-19 Vaccines' [Credit: Dimitris Barletis/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Covid-19-vaccines-2-1-e1614176959561.jpg)
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FDA receives new stability data on Pfizer’s COVID-19 vaccine
New stability data could allow Pfizer and BioNTech’s COMIRNATY® COVID-19 vaccine to be stored at normal refrigerated temperatures for up to two weeks.
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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
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EU doubles its COVAX contribution, promising €1bn for safe and effective COVID-19 vaccines
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
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IMU-838 shows some clinical benefit in moderate COVID-19 patients
The oral treatment slightly shortened time to clinical improvement and recovery in a Phase II trial, with greatest benefits in high-risk and elderly COVID-19 patients.
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COVID’s impact on cancer therapeutics: clinical trial and treatment disruptions
In this article, European Pharmaceutical Review’s Hannah Balfour discusses how COVID-19 has impacted the pharma industry with regard to cancer clinical trial and treatment disruptions.
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BCG vaccine protects newborns against a variety of infectious diseases, finds study
According to researchers, ensuring that newborns in areas with high rates of infectious disease receive the BCG vaccine at birth, could have a major impact on infections and deaths.
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Pfizer-BioNTech COVID-19 vaccinee sera less able to neutralise South African variant
While the sera were able to neutralise SARS-CoV-2 viruses expressing the B.1.351-spike mutations in vitro, the neutralisation was almost two thirds weaker than for an early strain.
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The current and future landscape of HIV treatments and vaccines
Dr Caroline Forkin from ICON discusses the current status of HIV treatments and potential for researchers to develop a vaccine.
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EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
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AstraZeneca’s COVID-19 vaccines listed for emergency use by WHO
The Emergency Use Listing will allow doses of the COVID-19 vaccines to be distributed through COVAX, the WHO’s vaccine allocation facility.
