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AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis (PMLive)
Gene therapy for sickle cell disease: progress and competition (BioPharmaDive)
Biohaven beats expectations with fast sales of migraine drug (BioPharmaDive)
Ovid shuffles C-suite, lays off staff in wake of PhIII Angelman syndrome fail (Endpoints)
Agenus to move California operations to new biomanufacturing cluster in Vacaville (Endpoints)
Muna raises $73M to go after Alzheimer's, Parkinson's and MS (Fierce)
With LentiGlobin cleared by FDA, bluebird lifts EU marketing hold on gene therapy using the same delivery mechanism (Endpoints)
Often-passed plant in Colorado has a new owner, who's already operating nearby (Endpoints)
Medtech
IVD Regulation 'Correction' Published In EU Official Journal (MedtechInsight)
Alpha Tau hops aboard the SPAC train with $367M deal to take its tumor-blasting tech public (Fierce)
Natural Cycles snags FDA clearance to use wearable temperature data in its fertility algorithm (mobihealthnews)
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers (FDA)
Government, Regulatory & Legal
EU Parliament Wants Two-Tier Database To Monitor Drug Supplies (Pink Sheet)
Stryker inks $15M settlement to resolve Conformis patent dispute (MedtechDive)
A VALID Argument: Proposed Legislation Would Reshape Regulation of Diagnostics (FDA Law Blog)
Fed. Circ. Appears Split On Novartis' MS Drug Patent (Law360)
Judge Blasts J&J Unit For 'Tactical' Silence In Drug IP Fight (Law360)
IP Forecast: Daiichi Sankyo Unit Takes Drug Rival To A Jury (Law360)
Avanos Medical Inc. to Pay $22 Million to Resolve Criminal Charges Related to the Fraudulent Misbranding of Its Microcool Surgical Gowns (FDA)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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.