North America

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

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

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

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

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

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

Vaxcyte's VAX-31 met every prespecified primary endpoint in the OPUS-1 Phase 3 trial in adults, including superiority for the three serotypes unique to the vaccine. The 31-valent candidate now heads toward a BLA filing in 2028. #SyenzaNews #vaccines #pneumococcal #MarketAccess

Jaypirca becomes the first non-covalent BTK inhibitor cleared for previously untreated CLL/SLL in the United States. BRUIN CLL-313 showed a hazard ratio of 0.20 against bendamustine plus rituximab, but the comparator is not the drug class that dominates first-line care. #SyenzaNews #MarketAccess #oncology #CLL

US group health plans and issuers must rebuild their public price files under the Transparency in Coverage final rule: quarterly publication, an 11-claim threshold for out-of-network data, a new utilization file and attestation, and consumer phone disclosure from January 2027. #SyenzaNews #MarketAccess #PriceTransparency #HEOR

FDA approval of the Autus Size-Adjustable Valve gives children with congenital pulmonary valve disease a pulmonary valve that can be widened as they grow, from 13 millimeters to 22 millimeters. The evidence base is 62 patients and six months of follow-up. #SyenzaNews #medicaldevices #pediatrics #MarketAccess

A once-weekly selective amylin agonist added to tirzepatide cut 23.3% of body weight in 367 adults with obesity and type 2 diabetes, against 14.8% for tirzepatide 15 mg alone. Lilly plans Phase 3 of a co-formulated EloraTZP by the end of 2026. Discontinuation rates that reach 27% in the highest-dose arm will be the detail payers study first. #SyenzaNews #obesity #type2diabetes #MarketAccess

OMB has opened a request for information on domestic and near shore manufacturing of the ASPR 86 essential medicines. Manufacturers have until 26 October 2026 to declare idle capacity, set out new plant plans, and name the unit price they need to stay viable. #SyenzaNews #MarketAccess #pharmaceuticalmanufacturing