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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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Vaccine Technology
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BioNTech to develop and supply mRNA malaria vaccine
Collaborating with global partners BioNTech will work to develop a safe and effective malaria vaccine and set up its sustainable supply for the African continent.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
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EPR Podcast Episode 3 – Inhaled and intranasal drug formulations and delivery – Dr Bill Williams, University of Texas
Join Dr Bill Williams as he discusses formulation for inhaled and intranasal drug delivery and goes into detail about thin film freezing, a novel powder formulation technique he developed.
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First people dosed with a quadrivalent seasonal flu mRNA vaccine
The Phase I/II trial will assess the safety, reactogenicity and immunogenicity of Moderna’s mRNA-1010 seasonal flu vaccine.
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Novel COVID-19 vaccine shows promise in Canadian trial
Phase I data shows VBI-2902a induced neutralisation and antibody titres up to five times that of people who had recovered from COVID-19 infection.
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What are the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines?
In response to the COVID-19 pandemic caused by the SARS-CoV-2 virus, the emergence of RNA vaccine technology has enabled rapid development of critical vaccines. Traditional vaccine production methods makerapid development challenging, requiring cell line production of viral proteins and laborious purification development, which requires extensive effort and long timelines. RNA…
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Formulation, Development & Delivery In-Depth Focus 2021
Articles in this in-depth focus discuss the development and delivery challenges associated with mRNA vaccine technology and explore how investing in the off-patent drug sector can benefit both pharma innovation and patient care.
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Additional $12mn to fund further development of Marburg virus vaccine
BARDA has awarded more funding to Public Health Vaccines to support the development of a virally vectored vaccine against Marburg virus infections.
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European Pharmaceutical Review Issue 3 2021
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
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mRNA-based therapeutic cancer vaccine enters Phase II trial
BioNTech is evaluating its investigational therapeutic mRNA-based cancer vaccine, BNT111, in combination with Libtayo® (cemiplimab) for the treatment of melanoma.
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Phase I trial of mRNA-based influenza vaccine begins
The trial will assess a monovalent mRNA-based vaccine candidate against seasonal influenza caused by the A/H3N2 strain.
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COVID-19 mRNA vaccine technology transfer hub to be set up in South Africa
A South African consortium will be the first to establish a COVID-19 mRNA vaccine technology transfer hub to scale up vaccine production and access.
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NVX-CoV2373 vaccine 90 percent effective in preventing symptomatic COVID-19
US trial results show NVX-CoV2373 was safe and effective in preventing symptomatic COVID-19, including in high-risk populations.
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Alzheimer’s vaccine shows promise in Phase II trial
Study results show AADvac1, a first-in-man Alzheimer's disease tau vaccine, is safe and potentially of benefit for patients with mild disease.