Inrebic (fedratinib) is set to become the first new therapy in Europe in nearly a decade for myelofibrosis.
EU Approvals Beckon For Inrebic & Novel Adalimumab Biosimilar
TETEC Withdraws EU Filing for ATMP For Cartilage Defects
Inrebic, Celgene’s myelofibrosis treatment, and Yuflyma, Celltrion’s high-concentration adalimumab biosimilar, are among the latest new drugs that have been recommended for approval for use across the EU. Meanwhile, TETEC has withdrawn its EU marketing application for Artobend.
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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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.
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England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
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Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.