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Pfizer 20vPnC vaccine as safe as Prevenar 13®
The paediatric pneumococcal conjugate vaccine (20vPnC) can help protect against all 20 pneumococcal disease-causing serotypes, says Pfizer.
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European Medicines Agency (EMA)
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Pharmacovigilance deep dive: risk minimisation measures
Here IQVIA’s Dr Sophie Jouaville discusses the importance of risk minimisation measures, how their effectiveness can be assessed and why transparent reporting of these effectiveness studies is crucial.
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EMA issues guidance for global development of antimicrobial medicines
The European Medicines Agency (EMA) has published its final guideline on the evaluation of human medicines for the treatment of bacterial infections to help support the development of new antimicrobial medicines.
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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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United efforts to accelerate drug development
From the Cancer Drug Development Forum (CDDF), John Smyth (Chairman), Axel Glasmacher (Treasurer) and Jaap Verweij (Managing Director) clarify the importance of a collaborative industry approach to cancer therapy development and highlight the most pressing challenges for discussion in their meetings and workshops.
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EMA launches the Regulatory Science Research Needs initiative
The European Medicines Agency (EMA) has issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development.
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EMA recommends RoActemra in adults with severe COVID-19
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Dec 2021
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
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EMA initiates rolling review of Valneva’s COVID-19 vaccine (VLA2001)
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
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Drug repurposing pilot to support not-for-profit organisations and academia
The European Medicines Agency (EMA)'s pilot project will support not-for-profit organisations and academia in gathering evidence for the use of a drug in a new indication.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, Oct 2021
EMA's drug safety committee (PRAC) assessed risks with COVID-19 vaccines and identified no risk of death with Imbruvica and ACE inhibitors.
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CHMP recommends COVID-19 vaccine Spikevax booster dose
The European Medicines Agency (EMA)'s human medicines committee (CHMP) concludes that a booster dose of Spikevax can be administered in adults aged 18 or over.
