The European Commission has approved an extension to the indications of Bavarian Nordic’s mpox vaccine, Imvanex, to include adolescents aged from 12 to 17 years, in a move intended to help health authorities in Africa and elsewhere tackle the spread of the disease.
EU OKs Imvanex Vaccine In Younger People To Help Tackle Mpox Spread In Africa
The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.
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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 Two companies have withdrawn their marketing authorization applications.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.
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The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.
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Companies marketing pharmaceutical products in Saudi Arabia are being urged to prepare for upcoming mandatory pharmacoeconomic assessments to demonstrate the added value of their drugs over existing treatments.
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The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.