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Latest From Janssen-Cilag International

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Approvals Drug Review

Coronavirus Notebook: EMA Explains How To Get A Modified Vaccine Approved, UK Starts Oxford/AZ Variant Vaccine Trial

Draft legislation on strengthening the European Medicines Agency’s role in health crises has cleared another hurdle, and the European Commission is inviting companies to a matchmaking event aimed at scaling up the development and production of COVID-19 therapeutics.

Europe United Kingdom

Diurnal Renames Orphan Drug As Efmody, Expecting EU-Wide Approval

New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.

Europe Drug Review

EU Decision Time On Expanded Use Of BMS/Ipsen Pharma Cancer Drug Combo

The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.

Drug Review Approvals
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