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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.

337 articles in this topic.

Articles in this category

Intismeran Adjuvant Melanoma Trial Cuts Recurrence Risk by 42%

10/23/2026

Intismeran Adjuvant Melanoma Trial Cuts Recurrence Risk by 42%

Merck and Moderna report a 42% reduction in recurrence or death for intismeran plus KEYTRUDA in resected stage IIB-IV melanoma, with full data at ESMO 2026. #SyenzaNews #melanoma #MarketAccess
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FDA Launches Neuroscience Medical Product Development Program

10/23/2026

FDA Launches Neuroscience Medical Product Development Program

The FDA has launched the Neuroscience Advancement and Innovation Nexus, starting with an Alzheimer's Prevention Accelerator. #SyenzaNews #Alzheimers #MarketAccess
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Clinical AI governance framework guides AI tool evaluation

10/23/2026

Clinical AI governance framework guides AI tool evaluation

A new npj Digital Medicine article in press from SCPMG proposes the C-TACT clinical AI governance framework, with weighted lifecycle scorecards and its limits stated.
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CagriSema Weight Loss in Women: Menopause Stages in REDEFINE 1

10/21/2026

CagriSema Weight Loss in Women: Menopause Stages in REDEFINE 1

Two post hoc REDEFINE 1 analyses show CagriSema weight loss in women held across premenopausal, perimenopausal and postmenopausal stages. #SyenzaNews #obesity #MarketAccess
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Emvistegrast in ulcerative colitis hits Phase 2 primary endpoint

10/20/2026

Emvistegrast in ulcerative colitis hits Phase 2 primary endpoint

Gilead's once-daily oral emvistegrast met the primary endpoint in Phase 2 SWIFT ulcerative colitis data, with 66% clinical response at Week 12 versus 37% on placebo. #SyenzaNews #biotechnology #MarketAccess
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Jemperli rectal cancer approval may let some patients skip standard treatment

10/20/2026

Jemperli rectal cancer approval may let some patients skip standard treatment

FDA grants accelerated approval for Jemperli in locally advanced rectal cancer, based on interim AZUR-1 results. #SyenzaNews #oncology #MarketAccess
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Reinforcement learning rTMS for depression treatment

10/19/2026

Reinforcement learning rTMS for depression treatment

Reinforcement learning rTMS for depression: a new npj Digital Medicine study tests protocol recommendations against clinician choices in 1,609 adults.
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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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