Coronavirus vaccine shortages are very much in the news on a global level, exacerbated by supply restrictions in India. New safety scares associated with vaccines from AstraZeneca PLC and Janssen Pharmaceutical Cos. will have done nothing to inspire confidence in the global rollout.
Coronavirus Notebook: Vaccine Shortage Fears Heightened By Safety Scares, Italian Jab Enters Phase II/III
Russia’s Sputnik V vaccine gets the all-clear in India as the COVAX initiative hits the shortages speed bump. Also, two more antibody treatments are OKd for use in COVID-19 in the UK.
More from Europe
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
More from Geography
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.