Organizers of a new European initiative to speed up the search for potential treatments for COVID-19 and future coronavirus threats have framed the project as an “unprecedented” exercise in cooperation between the public and private sectors.
European COVID-19 Project An ‘Unprecedented’ Exercise In Cooperation
37 Public & Private Partners To Research Potential New Treatments
Repurposed drugs, new compounds and neutralizing antibodies are among the targets of a new collaborative venture supported by Europe’s Innovative Medicines Initiative.
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The European Medicines Agency says it will take appropriate measures to update the Ozempic’s package leaflet if new evidence arises.
Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Alhemo, Novo Nordisk's product for the prevention of bleeding in patients with hemophilia A and FVIII inhibitors or hemophilia B and FIX inhibitors.
EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.
More from Geography
Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.
The European Medicines Agency says it will take appropriate measures to update the Ozempic’s package leaflet if new evidence arises.
Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.