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Third COVID-19 vaccine dose could improve protection in transplant recipients
The results from the first COVID-19 vaccine booster trial in transplant recipients show a third dose is safe and highly immunogenic.
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Moderna
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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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Moderna named Best Workplace for Innovators 2021 by Fast Company
Moderna tops the 2021 Best Workplaces for Innovators list following its "epic" COVID-19 vaccine development journey and impressive growth in 2020.
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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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EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
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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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Biopharma and the life sciences ecosystem: putting the foundations in place for a productive partnership
Even now 65 percent of drugs being approved come from biopharma companies and within a decade that is expected to rise to 85 percent. This is great news for a world hungry for new breakthrough treatments. As growth in pre-clinical and clinical work intensifies globally, Ahmed Bouzidi, Vice President of…
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How could waiving COVID-19-related intellectual property rights affect biopharma?
In this article, EPR’s Hannah Balfour discusses the potential impact of waiving intellectual property rights for COVID-19-related medicine and technology on pharma, biopharma and biotech companies.
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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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Navigating pharmacovigilance complexity in the US and EU: notes for biotechs
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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EMA to assess whether COVID-19 Vaccine Moderna can be used in adolescents
The European Medicines Agency (EMA) has begun evaluating whether to extend the use of the COVID-19 Vaccine Moderna to include adolescents aged 12 to 17.
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COVID-19 Vaccine Moderna update
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
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Moderna’s COVID-19 vaccine 93 percent effective in adolescents
New Phase II/III study data shows Moderna’s COVID-19 vaccine is safe and immunogenic in patients aged 12 to less than 18 years old.
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Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
A new report suggests pharma is working hard to combat worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.
