EU Finalizes Landmark Pharma Reform to Reset Access and Incentives
The EU reaches a landmark deal on pharmaceutical reform, reshaping regulatory exclusivity, supply obligations, generic entry, and incentives for priority antibiotics.
Industry Trends
BioMarin to Acquire Amicus for $4.8B in Rare Disease Deal
BioMarin will acquire Amicus Therapeutics for $4.8B in cash, adding Galafold and Pombiliti + Opfolda and accelerating rare-disease revenue growth.
CMS Confirms 2026 Coverage for MTF’s AmnioBand, AlloPatch
CMS confirms Medicare coverage for MTF Biologics’ AmnioBand Membrane and AlloPatch Pliable under updated LCDs for diabetic foot and venous leg ulcers starting 2026.
Netherlands Moves to Cut Mental Health Wait Times for 2026
The Dutch Healthcare Institute prioritizes group therapy and preventive mental health care to reduce long wait times under its 2026–2028 appropriate care agenda.
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.
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.
Medline Raises $6.26B in 2025’s Biggest IPO
Medline has raised about $6.26B in an upsized IPO, surpassing CATL’s listing to become 2025’s largest debut.
CMS Reopens National TAVR Coverage Review at Edwards’ Request
CMS has accepted Edwards Lifesciences’ request to reopen the national coverage determination for TAVR, launching a review that could expand access to asymptomatic patients and ease procedural barriers by late 2026.
BMS Signs $1.1B Multispecific Antibody Deal With Harbour
Bristol Myers Squibb has entered a global collaboration with Harbour BioMed worth up to $1.1B to discover and develop next-generation multispecific antibodies, strengthening its early-stage immunology and oncology pipeline.
Genentech Strikes $1.1B Cancer AI Deal With Caris
Genentech has signed a multi-year oncology collaboration with Caris Life Sciences worth up to $1.1B, tapping the techbio’s AI-driven tumor database to discover new solid-tumor targets as year-end dealmaking accelerates.