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Crinetics reports second PhIII win for acromegaly drug, eyes 2025 launch (Endpoints)
With positive PhIII data in hot flashes, Bayer is a step closer to challenging Astellas’ Veozah (Endpoints)
Bayer to seek approval for menopausal relief drug after third trial win (Reuters)
Medtech
‘An AI foundry’: Nvidia’s Jensen Huang pitches biotech on easy AI, with focus on software going beyond chips (Endpoints)
Titan Medical to merge with imaging firm Conavi, ending strategic review (MedTech Dive)
J&J Medtech, Nvidia partner to bring AI to the operating room (MedTech Dive)
Intuitive details launch plan for new da Vinci 5 robot (MedTech Dive)
Feeling the Heat (or Cold) – New Draft Guidance Addresses Requirements for Devices that Produce Thermal Effects (FDA Law Blog)
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development (MedTech Insight)
Government, Regulatory & Legal
UnitedHealth appears to be upping loan offers to providers, after Change cyberattack (STAT)
Supreme Court questions restricting government efforts to limit Covid-19 misinformation (STAT)
Novo Nordisk Foundation backs effort to build supercomputer with Nvidia (Endpoints)
UnitedHealth says advanced over $2 bln in payments to providers (Reuters)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.