The developers of Coacillium, vilobelimab, avacincaptad pegol and temozolomide were this week due to provide the European Medicines Agency with oral explanations as to why their respective drugs, which are in the late stage of the regulatory review cycle, should be approved for marketing across the EU.
EMA Schedules High-Stakes Meetings With Drug Makers
The sponsors of medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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 Two companies have withdrawn their marketing authorization applications.
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Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.