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EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
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European Medicines Agency (EMA)
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EMA initiates ‘rolling review’ of remdesivir, potential COVID-19 treatment
The EMA's human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.
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EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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International regulators pledge support to combat COVID-19
The EMA has announced its support for the International Coalition of Medicines Regulatory Authorities' call for global collaboration in the fight against COVID-19.
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EMA warns about side effects of chloroquine and hydroxychloroquine for COVID-19 treatment
The COVID-19 European Medicines Agency (EMA) pandemic Task Force (COVID-ETF) warned that chloroquine and hydroxychloroquine are yet to be proved effective at treating COVID-19 and that their side effects could be fatal.
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Stem cells in the clinic: how are they regulated?
Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.
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Siltuximab – testing a potential COVID-19 therapy
Interim results from the SISCO study at the Papa Giovanni XXIII Hospital in Italy have demonstrated the promise of siltuximab as a treatment for the symptoms of COVID-19. Lee Morley explains how the drug works and the next steps for its development.
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EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
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COVID-19: regulatory implications for the UK and European life sciences industry
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
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EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
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EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
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FDA and EMA offer updates on COVID-19 treatments and vaccines in development
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
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EMA advises continued use of hypertension drugs during COVID-19 pandemic
The EMA has said that patients should continue to use angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), despite reports that these worsen COVID-19 infections.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
