RefleXion overcomes 'unprecedented hurdles' to land FDA nod for biology-guided radiotherapy tech (Fierce)
Diagnostic firms turn to restructuring in bid to preserve cash: Goldman (MedtechDive)
EU Opening Pandora’s Box With Data Act, Warns Medical Imaging Body COCIR (MedtechInsight)
Government, Regulatory & Legal
PTAB Again Axes Cochlear Implant IP After Vidal Remand (Law360)
Sanofi responds to patent spat with Amgen as Supreme Court arguments set for March (Endpoints)
DC appeals court revives case accusing pharmas of financing terror attacks (Endpoints)
Centene warns of hit to fast-growing Medicare Advantage business next year (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.
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Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.