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Ceribell’s Neonatal US Clearance Sets Up 2026 Growth Amid China Pressures
Ceribell’s algorithm analyzes EEG data collected through a headcap equipped with sensors can identify subclinical events unnoticed without continuous monitoring.
Medtech Insight - December 1, 2025
Quick Listen: Scrip’s Five Must-Know Things
This week: 2027 medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J’s Alzheimer’s asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas’s Padcev's first big win in bladder cancer study.
Scrip - December 1, 2025

Quick Listen: Scrip’s Five Must-Know Things
This week: 2027 medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J’s Alzheimer’s asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas’s Padcev's first big win in bladder cancer study.
Scrip - December 1, 2025

Ceribell’s Neonatal US Clearance Sets Up 2026 Growth Amid China Pressures
Ceribell’s algorithm analyzes EEG data collected through a headcap equipped with sensors can identify subclinical events unnoticed without continuous monitoring.
Medtech Insight - December 1, 2025

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?
FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?
HBW Insight - November 30, 2025

US Makes First Reformulated Ranitidine Approval Since Withdrawal, Starting With Rx Tablets
In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.
Generics Bulletin - November 28, 2025
Denosumab LOE Looms In Europe As Yet More Approvals Roll In
After the recent onset of European biosimilar competition to aflibercept, the next big biologic LOE on the horizon in Europe is denosumab. Several more approvals have just arrived for rivals to Prolia and Xgeva, setting up a fiercely competitive market once biosimilars launch imminently.
Generics Bulletin - November 28, 2025
Aeon Secures Funding As FDA Sets New Date For Botox Biosimilar Review
Aeon’s cash infusion and upcoming FDA session, now rescheduled for early next year, positions firm to push ABP-450 biosimilar closer to market entry.
Generics Bulletin - November 28, 2025

Inside Regeneron’s 3-Million-Sample Bet On Collaborative Genomics
By offering free sequencing and embracing radical openness with global partners, Regeneron Genetics Center has gathered over 3 million samples, leading to the identification of over 30 drug targets now in Regeneron’s pipeline.
In Vivo - November 25, 2025