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EMA issues its requirements for adapting COVID-19 vaccines for viral variants
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
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Leukine® significantly improves lung function in hospitalised COVID-19 patients
In the trial Leukine® (sargramostim, rhuGM-CSF) improved oxygenation in COVID-19 patients with acute respiratory failure by at least a third in over half of those treated.
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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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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
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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.
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Patient dosed with first Lassa fever vaccine to reach human trials
The first trial participant has been given INO-4500 in Ghana - INO-4500 is a DNA vaccine candidate being developed to protect against Lassa fever.
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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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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.
