Latest News — Page 3

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Medicare GLP-1 Bridge Tops 500,000 Users in Its First Two Months
US Medicare is paying for obesity GLP-1s for the first time, and more than 500,000 seniors signed up in the first two months. Our latest breaks down the $245 price, the $50 copay, and what it means for Lilly and Novo Nordisk. #SyenzaNews #MarketAccess #GLP1 #Medicare

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EMA Pre-Submission Pilot Adds Earlier Dialogue to Curb Premature Filings
EMA’s voluntary pre-submission pilot opens in September 2026. It adds earlier, more structured dialogue between applicants, rapporteurs and the Agency to curb premature filings. #SyenzaNews #MarketAccess #RegulatoryAffairs

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Autoimmune CAR-T Safety Faces Its First Serious Test
Novartis and Bristol Myers Squibb have paused autoimmune CAR-T trials after inflammatory events and three deaths, putting the immune-reset thesis to its first real safety test. #SyenzaNews #CellTherapy #AutoimmuneDisease #MarketAccess

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US healthcare market access: what four operators told Canadian healthtech founders
CTS’s Global Horizon panel brought four US operators to Montréal to explain why the US healthcare market rewards commercial readiness over good technology, and what founders can do about it. #SyenzaNews #MarketAccess #HealthTech

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Korea AI Basic Healthcare Strategy Targets Global Biohealth Leadership
South Korea is putting AI at the centre of its healthcare agenda, pairing the new AI Basic Healthcare Strategy with a USD 30.4 billion biohealth export target. Vice Minister Lee Hyung Hoon sets out the vision in an interview with PharmaBoardroom. #SyenzaNews #SouthKorea #Biohealth #DigitalHealth #MarketAccess

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Nirmatrelvir-Ritonavir Long COVID Treatment Shows No Benefit in RECOVER-VITAL
The RECOVER-VITAL trial found nirmatrelvir-ritonavir offered no benefit for long COVID across cognitive, autonomic, or exercise symptoms. The study also shows why placebo controls matter: a large share of the placebo group improved on their own. #SyenzaNews #LongCOVID #ClinicalTrials #MarketAccess

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FDA Authorizes Stryker SportSuite Vision, First Surgical Application for Apple Vision Pro
FDA has authorized Stryker SportSuite Vision, the first surgical application built for Apple Vision Pro. The De Novo clearance is narrow: hip arthroscopy display, used alongside standard monitors. #SyenzaNews #DigitalHealth #MedTech #FDA #AppleVisionPro

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EMA Scientific Advice Hits Record Volumes as Agency Plans Agile Pilot
EMA scientific advice volumes hit a record in the first half of 2026. The agency is planning pre-payment at submission, an agile advice pilot for 2027, and a regulatory sandbox workshop in September. #SyenzaNews #EMA #MarketAccess #DrugDevelopment

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Remibrutinib Relapsing Multiple Sclerosis: REMODEL Trials Cut Relapse Rates
Novartis’ oral BTK inhibitor remibrutinib met its primary endpoint in the Phase III REMODEL-1 and REMODEL-2 trials, cutting annualized relapse rates versus teriflunomide in relapsing multiple sclerosis. #SyenzaNews #MultipleSclerosis #MarketAccess #Neurology

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Portugal private health insurance premiums average €466 a year, up 9.1%
Portuguese private health insurers cleared €1 billion in six months as premiums climbed 9.1% to €466 a year. #SyenzaNews #HealthInsurance #Portugal #MarketAccess

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US Expands MFN Drug Pricing to 26 Manufacturers
The United States has added nine more manufacturers to its most-favored-nation drug pricing program, taking the total to 26 companies that now cover 89% of the branded drug market. #MarketAccess #DrugPricing #Pharma

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Cipla TQB2102 Licensing Deal Brings Sino Biopharm’s HER2 ADC to India and South Africa
Cipla has licensed Sino Biopharm’s HER2 biparatopic ADC TQB2102 for India, South Africa and five other emerging markets. The deal caps at USD 123 million plus double-digit royalties, with access to HER2-low breast cancer as the core case. #SyenzaNews #Oncology #MarketAccess #DrugDevelopment

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Linking Drug and Diagnostic Policy Pathways to Reach Patients Most Likely to Benefit
Insurers are spending billions on breakthrough medicines, but the tests that decide who gets them are still an afterthought. Kathryn Phillips lays out four reforms to link drug and diagnostic policy pathways. #SyenzaNews #diagnostics #healtheconomics #MarketAccess

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AI Models Near Perfect Scores on German Medical Licensing Exams
A new benchmark in npj Digital Medicine finds frontier AI models at near-perfect accuracy on German medical licensing exams, yet image questions still cut their scores far more than for students. #SyenzaNews #AIinHealthcare #DigitalHealth

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South Africa TB Vaccine Registration Plan Awaits Phase 3
South Africa is preparing to register and introduce a new tuberculosis vaccine if late-stage Phase 3 trials succeed. Cabinet confirmed the plans this week and welcomed a Serum Institute of India agreement to manufacture TB vaccines for global distribution.
#SyenzaNews #globalhealth #clinicaltrials #MarketAccess

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Fifth Circuit Upholds Medicare Drug Price Negotiation Program
The Fifth Circuit affirmed the constitutionality of the Medicare drug price negotiation program, rejecting claims from NICA, the Global Colon Cancer Association, and PhRMA. #SyenzaNews #DrugPricing #MarketAccess #Pharma

