Australian Regulator On The Highs & Lows Of Project Orbis
The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard.
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Tucatinib, approved for advanced unresectable or metastatic HER2-positive breast cancer, has a list price of $18,500 per month or $111,000 for a full course. Doctors can order the drug immediately.
A group of EU member states has written to the European Commission saying that an exclusivity voucher scheme intended to stimulate R&D into new antimicrobials will stifle innovation by competitor companies and push up costs for national health systems.
As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.