NICE Issues Two Major 2025 Approvals: Vutrisiran for ATTR-CM and Aucatzyl CAR-T for R/R B-ALL
NICE has issued two major decisions: recommending vutrisiran for adult ATTR-CM and approving Aucatzyl CAR-T for relapsed or refractory B-ALL in adults.
Athithi Verma
NICE Recommends Nanox.AI’s Spine-Fracture Detection Tools for Early Value Assessment Across NHS Hospitals
NICE has recommended Nanox.AI’s HealthOST and HealthVCF for Early Value Assessment, enabling NHS hospitals to deploy the AI tools for three years while gathering evidence on their value in detecting vertebral fragility fractures. The decision marks an important step in advancing AI-driven early detection of osteoporosis.
ConcertAI’s TeraRecon Launches DETECT to Align AI Imaging With Reimbursement and Clinical Workflow
ConcertAI’s TeraRecon division has launched DETECT, an AI-first platform designed to close the gap between imaging innovation and reimbursement.
Germany Updates Emergency-Care Tiers as IQWiG Questions Daratumumab Benefit in Smoldering Myeloma
Germany issued two significant regulatory updates: the G-BA expanded its emergency-care tier system by adding a new “non-participation” level, and IQWiG reported that daratumumab shows no proven survival benefit in smoldering multiple myeloma due to flaws in the comparator arm of the AQUILA study.
CMS Sets National Pricing for Vesiflo’s inFlow Device, Expanding Access for Women With Permanent Urinary Retention
CMS has set national pricing for the inFlow Voiding Prosthesis in the 2026 Medicare fee schedule, expanding access to the only alternative to lifelong catheter use for women with permanent urinary retention.
NICE Issues New Updates on AI Cancer Detection, Sepsis Care, and Breast Cancer Drug Appraisal
NICE has published three updates spanning diagnostics, acute care, and oncology: conditional support for AI tools that detect bowel cancer polyps, new sepsis guidelines emphasizing tailored treatment, and the termination of a trastuzumab deruxtecan appraisal after no company evidence submission.
B. Braun to Pay $38.5M in DOJ Settlement Over Allegedly Faulty Knee Implant and False Claims
The DOJ has finalized a $38.5 million settlement with B. Braun’s Aesculap unit over allegations involving an early-failing knee implant that triggered false claims to Medicare and Medicaid.
CMS Sets 2026 Medicare Premiums and Deductibles as Costs Rise and Policy Changes Take Effect
CMS Sets 2026 Medicare Premiums and Deductibles as Cost Pressures Mount and Regulatory Fixes Temper Increases The Centers for Medicare & Medicaid Services (CMS) has released the 2026 Medicare Parts A and B premiums, deductibles, and income-related adjustment amounts, outlining another year of steady cost increases across the program. While the updates reflect predictable inflationary … Read more
Novo Nordisk Cuts Wegovy and Ozempic Self-Pay Price to $199 in New Access Push
Novo Nordisk has introduced a $199 introductory price for Wegovy and Ozempic starter doses, alongside a permanent drop in monthly self-pay costs to $349.
EMA, CHMP NOVEMBER 2025 MEETING: TEN NEW APPROVALS, FOUR INDICATION EXTENSIONS
CHMP’s November 2025 meeting delivered 10 new drug approvals, four indication extensions, and several high-profile withdrawals, highlighting continued momentum in gene therapy, oncology, immunology, and diagnostics.