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North America

Coverage of the United States and Canada: coverage determinations, drug pricing policy, regulatory decisions and the assessment bodies that inform them.

328 articles in this topic.

Articles in this category

AI operating room scheduling: LLM agent teams reach feasible plans

10/16/2026

AI operating room scheduling: LLM agent teams reach feasible plans

How can AI-powered scheduling transform operating room efficiency and deliver major cost savings? Recent advancements are enabling hospitals to optimize resource allocation, reduce cancellations, and streamline workflows through intelligent automation. Discover how this technology is reshaping surgical operations and improving financial outcomes. #SyenzaNews #AIinHealthcare #HealthcareInnovation #ai #DigitalTransformation
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Most favored nation drug pricing: why US patient groups push back

10/16/2026

Most favored nation drug pricing: why US patient groups push back

The National Health Council says importing foreign price controls through most favored nation pricing will not serve American patients.
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FDA Rare Disease Framework Initiative Would Tailor Review to Small Populations

10/15/2026

FDA Rare Disease Framework Initiative Would Tailor Review to Small Populations

What steps is the FDA taking to accelerate rare disease treatments? The FDA’s new Rare Disease Framework Initiative aims to streamline regulatory pathways, enhance collaboration with sponsors, and improve patient access to innovative therapies. Explore how this could reshape drug development for underserved patient populations. #SyenzaNews #regulatoryaffairs #drugdevelopment #innovation #healthcarepolicy
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Semaglutide for Opioid Use Disorder: $13.3M Trial Planned in Allegheny County

10/15/2026

Semaglutide for Opioid Use Disorder: $13.3M Trial Planned in Allegheny County

Researchers and Allegheny County plan a $13.3 million trial of weekly semaglutide to reduce opioid and alcohol use and justice involvement.
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Individualised Genetic Therapies Test Regulation, Payment and HTA

10/13/2026

Individualised Genetic Therapies Test Regulation, Payment and HTA

OHE's A Dose of Economics explores why medicines made for one patient challenge regulation, payment and HTA.
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The Strategic Health Economy: Why Finance Ministries Still See Health as a Cost

10/12/2026

The Strategic Health Economy: Why Finance Ministries Still See Health as a Cost

At the World Health Summit in Berlin, speakers from the European Commission, Japan, Africa, the Asian Development Bank and industry argued that health is a strategic economic asset, and asked how to persuade finance ministries. #SyenzaNews #HealthEconomics
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EpiScreen epilepsy detection model beats specialists on routine clinical notes

10/9/2026

EpiScreen epilepsy detection model beats specialists on routine clinical notes

A University of Minnesota model fine-tuned on routine clinical notes separated epileptic from psychogenic seizures with an AUC of up to 0.875, and helped neurologists lift their own accuracy by up to 14.3 percentage points. #SyenzaNews #epilepsy #AI #digitalhealth #MarketAccess
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FDA Grants Rhapsido First Symptomatic Dermographism Approval

10/8/2026

FDA Grants Rhapsido First Symptomatic Dermographism Approval

Novartis has won the first FDA approval for symptomatic dermographism. Rhapsido (remibrutinib) is now cleared for adults whose hives and itch stay uncontrolled on H1 antihistamines, with 29.3% of patients achieving complete hive resolution at Week 12 against 14.0% on placebo. #SyenzaNews #dermatology #MarketAccess
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PhRMA’s GLOBE Drug Pricing Lawsuit Seeks to Block the Medicare Rule

10/8/2026

PhRMA’s GLOBE Drug Pricing Lawsuit Seeks to Block the Medicare Rule

PhRMA has sued HHS and CMS over the GLOBE rule, arguing the agency has no authority to tie Medicare Part B drug payments to the prices paid in 19 other countries. The complaint leans on the major questions doctrine and a statutory ban on quality-adjusted life years. #SyenzaNews #MarketAccess #pharmaceuticals #healthcarepolicy #drugpricing
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Epcoritamab R-CHOP DLBCL combination cuts progression risk 51% in Phase 3

10/7/2026

Epcoritamab R-CHOP DLBCL combination cuts progression risk 51% in Phase 3

Genmab and AbbVie report topline Phase 3 results in which epcoritamab plus R-CHOP cut the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma, the first positive readout for a bispecific combination in the first-line setting. #SyenzaNews #DLBCL #bispecifics #oncology #MarketAccess
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BD US Government Partnership Commits $19 Billion to US Manufacturing

10/7/2026

BD US Government Partnership Commits $19 Billion to US Manufacturing

BD has agreed a $19 billion partnership with the US Government to expand American manufacturing of essential medical consumables. The deal includes $3 billion for production sites, roughly 5 billion more units a year and Section 232 tariff relief tied to milestones. #SyenzaNews #MedTech #MarketAccess
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Lundbeck Europe strategy leans on regional partners as patents expire

10/6/2026

Lundbeck Europe strategy leans on regional partners as patents expire

Lundbeck is trading scale for depth. Michala Fischer-Hansen, EVP for Europe and international markets, explains why 51 affiliates became 22, why a fifth of revenue now goes to R&D, and why US price pressure can decide where a medicine launches. #SyenzaNews #MarketAccess #brainhealth #pharma
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