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.
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There are eight new entries to the list of marketing applications filed with the European Medicines Agency, including submissions for more versions of Amgen’s Neulasta (pegfilgrastim), and a second biosimilar of Roche’s Avastin (bevacizumab).
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.