EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic
EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.
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Decision Time At CHMP: Portola and Aegerion In Spotlight
Nine marketing authorization applications, 15 variation of therapeutic indication requests, two requests for accelerated assessment and a re-examination procedure. These are some of items on the agenda at the latest meeting of the EMA’s key advisory panel, the CHMP, which is under way in London.
Bumper Number Of 'Oral Explanations' Due At CHMP Meeting
An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.
New EU Submissions For Pfizer’s Lorlatinib, Teva’s Fremanezumab - And A CV Filing For Canakinumab
New products submitted for evaluation by the European Medicines Agency include Pfizer’s lorlatinib for lung cancer, Teva’s fremanezumab for migraine, and Shionogi’s lusutrombopag for thrombocytopenia. An already authorized drug, Novartis’s canakinumab, has been filed for a new use: reduction of cardiovascular risk.