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'Project Orbis' Oncology Pilot Eventually Will Target 'Major Impact' Applications

 
• By Kate Rawson

But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.

The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program, with a focus on those that are expected to have a major impact on the standard of care – including “Breakthrough”-designated projects and novel treatments.

OCE announced the Orbis pilot at the same time it approved the first application in conjunction with Australian and Canadian regulatory agencies: Eisai Inc.’s Lenvima (lenvatinib) in combination with...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.