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Moderna chooses mRNA vaccine manufacturing centre location
Following finalisation a ten-year strategic partnership with the UK government, Moderna has chosen the location for its Innovation and Technology Centre (MITC).
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EMA’s human medicines committee (CHMP) meeting highlights – February 2023
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
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New workflow for the analysis of mRNA therapeutics
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
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Simplified HIV treatment options effective in major trial
The world‘s first international trial into second-line HIV therapy has shown two simplified treatments are at least as effective as standard of care.
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Pfizer and BioNTech mRNA shingles vaccine study begins
A Phase I/II trial for the first mRNA-based shingles vaccine programme has been initiated by Pfizer Inc. and BioNTech SE.
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Three-year patent strategy for greater medicine access announced
The Medicines Patent Pool's 2023-2025 strategy plans to expand medicine access by improving the availability of innovative medicines in low- and middle-income countries.
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Pfizer offers 1.2 billion in poorer countries access to full medicine portfolio
Pfizer has expanded its not-for-profit initiative ‘An Accord for a Healthier World’ to enable 45 lower-income countries access to its full product portfolio.
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mRNA vaccine trial shows efficiency in older adults with RSV
Moderna's mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults demonstrated promising efficacy in a Phase III trial.
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EC approves influenza antiviral for children over one years old
Xofluza® offers the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost 20 years.
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FDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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World’s first approval of an allogeneic T-cell immunotherapy
Ebvallo™ is the first authorised allogeneic T-cell immunotherapy and has been approved for EU patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease.
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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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Comirnaty® authorised for patients six months to four years
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
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Vaccines Europe launches first pipeline review
In its first pipeline review, Vaccines Europe has set out four key actions to ensure adults are protected from vaccine-preventable diseases.
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Pfizer’s €1.2 billion manufacturing site expansion
Pfizer’s €1.2 billion investment in its Grange Castle site in Dublin is expected to double the plant’s capacity for manufacturing biologics.
