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Bausch + Lomb re-ups 'Faces of Glaucoma' campaign to raise awareness of the eye disease (Fierce Pharma)
With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi (Fierce Pharma)
Klick Health swoops in to acquire life sci market access agency Peregrine (Fierce Pharma)
Medtech
Wearable maker ActiGraph acquires assets from Biofourmis to boost clinical trial offerings (STAT)
Philips sells small chipmaking subsidiary, Telegraaf reports (Reuters)
Outset Medical to pay down debt after raising nearly $300M (MedTech Dive)
Government, Regulatory & Legal
The long history of distrust for American insurance companies (STAT)
AI Adoption In Pathology Is Lagging: Funding And Clinical Standardization Needed (MedTech Insight)
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.