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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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Vaccines
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Whitepaper: Optimising omni-channel intake in pharmacovigilance
Know how a cognitive technology approach optimises PV and product quality intake operations to collect AEs and PQCs with focus on patient safety.
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New agreement makes “Africa’s own COVID-19 vaccine” a reality
Under a new agreement with J&J, Aspen SA Operations will be able to manufacture and make available Aspen-branded COVID-19 vaccines in Africa.
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Chikungunya vaccine candidate safe and immunogenic in Phase III
Valneva’s single-shot chikungunya vaccine candidate, VLA1553, offered a very high level of seroprotection in all adults, including the elderly.
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Prioritising bold innovation throughout the pandemic and beyond
Following his first full year as Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals, healthcare leader Chinmay Bhatt shares his learnings from the pandemic and reflects on what’s next.
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Plant “biofactories” produce proteins for potential COVID-19 vaccine
Transiently infecting tobacco plants, researchers were able to produce recombinant proteins that could be developed into COVID-19 vaccines.
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Could COVID-19 vaccines be swallowed?
New pre-clinical research demonstrates the potential of gastric autoinjectors to deliver mRNA in sufficient quantities for vaccination.
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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
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MCAP for top bio/pharma companies reached $3.4 trillion in 2021
Market capitalisation (MCAP) for the top bio/pharma companies grew 24.9 percent in 2021, with BioNTech and Moderna entering the top 20 for the first time.
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Playbook: Critical cold chain shipments best practices
Learn how the pharma supply chain is evolving, the role of real-time data in critical cold chain shipments and how to increase & improve visibility.
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First patients dosed in HIV vaccine immunogens trial
Moderna and IAVI take steps towards HIV vaccination, with initiation of a trial dosing patients with HIV immunogens delivered by mRNA.
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New studies look to assess immunogenicity of Omicron-based vaccines
A new clinical study by Pfizer Inc. and BioNTech SE, and Phase II study by Moderna, are seeking to evaluate the immunogenicity and safety of Omicron-based vaccines and boosters.
