Medison Pharma Ltd.
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Latest From Medison Pharma Ltd.
Argenx Eyes Hat-Trick Of Successful Launches For Vyvgart After CHMP Thumbs-Up
Anant Murthy, general manager of Argenx Europe, tells Scrip that the commercial infrastructure is in place for Vyvgart to enjoy a strong launch for the rare neuromuscular disorder which will mirror those seen in the US and Japan.
Deal Watch: Organon Obtains Rights To Perjeta, Prolia/Xgeva Biosimilars From Shanghai Henlius
Biosimilar licensing agreement also includes option on Yervoy-based product. Oxford BioTherapeutics, ImmunoGen pair their technologies for development of novel cancer ADCs.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.
Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says
In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.
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