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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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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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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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New regulation strengthens role of EMA in EU crisis response
The regulation sees tools, structures and processes set up by EMA during the pandemic to accelerate clinical trial approval and regulatory assessments in the EU being formally recognised.
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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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Clinical trial trends – what will 2022 bring?
Here, EPR’s Hannah Balfour examines the trends that look set to shape clinical research in 2022, with comment from Aman Khera, VP and Global Head of Regulatory Strategy at Worldwide Clinical Trials.
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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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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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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.
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Scientists behind mRNA vaccine technologies win Frontiers of Knowledge Award
Katalin Karikó, Robert Langer and Drew Weissman win BBVA Foundation Frontiers of Knowledge Award in Biology and Biomedicine for driving the advance of messenger RNA (mRNA) therapeutics.
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Omicron prompts FDA to restrict use of specific antibodies
Based on the latest data, and Omicron's current dominance in the US, the FDA has announced two monoclonal antibody treatments are not authorised for use in any US states, territories and jurisdictions at this time.
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International regulators call for multivalent COVID-19 vaccines
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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Could COVID-19 vaccines be freeze dried?
US researchers have been granted $930,000 to develop a freeze drying technique for mRNA-based COVID-19 vaccines.
