EU regulators will decide this week decide whether several new treatments – including Roche’s hemophilia drug, Hemlibra (emicizumab), which is being fast-tracked through the system – should be recommended for marketing authorization.
Roche’s Hemlibra Looking For CHMP Green Light, Crunch Time for Santhera DMD Hopeful
The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
More from Europe
• By
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.
• By
In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
• By
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.
• By
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.
More from Geography
• By
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.
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.