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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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respiratory syncytial virus (RSV)
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Pfizer’s RSV vaccine effective in older patients
Pfizer’s bivalent Respiratory Syncytial Virus (RSV) vaccine candidate was 85.7 percent effective when administered to adults 60 years of age or older, according to top-line data from a Phase III trial.
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Moderna announces UK mRNA Innovation and Technology Centre
Moderna to establish a UK mRNA Innovation and Technology Centre to produce mRNA vaccines for COVID-19, influenza, respiratory syncytial virus (RSV) and more.
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Pfizer grows investigational RSV vaccine programmes with acquisition of ReViral
Pzifer's acquisition of ReViral will include its portfolio of promising therapeutic candidates, such as sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell.
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Moderna launches two new mRNA vaccine programmes
The new mRNA vaccine programmes are aimed at the major causative agents of respiratory tract infections, respiratory syncytial virus (RSV), influenza and coronaviruses.
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First participants dosed with pan-antiviral nasal spray in Phase IIa trial
The Phase IIa influenza-challenge study will enrol 123 healthy adults and support the development of INNA-051 as a pan-antiviral nasal spray.
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Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Phase III clinical trial for respiratory syncytial virus (RSV) vaccine begins
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
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Moderna to bring mRNA vaccine manufacturing facility to Canada
Moderna and the Canadian government are collaborating to build an mRNA vaccine manufacturing facility in Canada.
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FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
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NT-300 tablets show promise in Phase III COVID-19 trial
Initial results suggest NT-300 (nitazoxanide extended-release tablets, 300mg) reduces progression to severe illness in mild to moderate COVID-19 patients.
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FDA grants Emergency Use Authorisation to Abott’s SARS-CoV-2, influenza and RSV test
The PCR based Alinity™ m Resp-4-Plex molecular assay can detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV).
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Current innovations in the vaccine pipeline
As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…
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Developing a preventive vaccine regimen to tackle Ebola
Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…
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Antigen study provides a new approach to vaccine development for RSV
Medical researchers point to a promising route for designing an effective vaccine for the respiratory syncytial virus...
