BioStem Lands 2026 CMS Status Quo Coverage for Skin Grafts
CMS places BioStem’s VENDAJE products in a 12-month status quo category, preserving DFU and VLU reimbursement through 2026 while evidence review continues.
Athithi
ENvue’s UroShield Secures UK NHS Reimbursement
ENvue Medical’s UroShield Kit is added to the NHS Drug Tariff Part IX, enabling nationwide reimbursement and triggering early commercial orders in the UK.
Dren Bio, Sanofi Expand $1.8B B-Cell Depletion Alliance
Dren Bio has expanded its strategic collaboration with Sanofi in a deal worth up to $1.8 billion, advancing next-generation B-cell depletion therapies and reinforcing deep-remission strategies in autoimmune disease.
Sobi Buys Arthrosi to Broaden Gout Franchise and Push Into Chronic Inflammation
Swedish orphan-drug specialist Sobi has agreed to acquire Arthrosi, a privately held biotech focused on next-generation gout therapies
Merck Canada and pCPA Complete WINREVAIR Negotiations, Advancing Public Reimbursement Pathway for PAH
Sotatercept Nears Public Coverage After National Pricing Deal Merck Canada has completed national pricing negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR (sotatercept), marking a significant milestone in the therapy’s journey toward broad public reimbursement across Canada. The agreement, announced on November 20, 2025, positions the first-in-class activin signaling inhibitor one step closer to … Read more
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.
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.