Latest News — Page 2

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

Clinical trials authorised across the EU and EEA fell 13.5% between the pre-pandemic years and 2022 to 2025, and the drop lands hardest on academic sponsors. Biologics now feature in nearly half of all new trials. #SyenzaNews #clinicaltrials #HTA #MarketAccess

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

Rare disease care in Europe is settled in national capitals, not in Brussels. At #EHFG2026, Austria’s Claas Röhl, Czechia’s Markéta Foldyna Hellová, Italy’s Giulia De Ponte and MetabERN’s Maurizio Scarpa set out where national policy delivers and where families still do the coordinating. #SyenzaNews

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

ADSE’s October table cuts 119 maximum unit prices for hospital chemotherapy and drops prior authorisation from seven cancer medicines, including osimertinib. The workbook and the communiqué do not agree on the count. #SyenzaNews #MarketAccess #oncology

HHS and ARPA-H have launched SURPASS, a program to rebuild clinical trials around real-time analysis, shared control groups and automated site operations. Three companion projects, STACK, COMMONS and CINCH, take on site capacity, national data infrastructure and patient navigation. Clinical development still takes more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time. #SyenzaNews #ClinicalTrials #MarketAccess #HealthEconomics

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

Portugal cancer drug delays average 926 days from EU approval, against 655 days across the EU. The figures on the oncology patient journey also show 50.8% of patients have gone without medication at least once, and two of the country’s three screening programmes remain below the 90% coverage target. #SyenzaNews #oncology #MarketAccess #healthpolicy

The Bureau of Industry and Security has named nine product classes and 19 jurisdictions that can ship specialty medicines into the United States at a zero tariff, while the 100 percent Section 232 duty reaches most patented pharmaceuticals on 29 September 2026. Companies arguing an urgent U.S. health need now have a defined route to apply. #SyenzaNews #MarketAccess #PharmaceuticalTariffs

Zorginstituut Nederland has ruled that the Inreda AP stays out of the Dutch basic package. The DARE trial found no clinically relevant gain in glucose control or quality of life, serious adverse events were about three times more common, and half of the patients stopped using the device. #SyenzaNews #MedTech #MarketAccess #HealthEconomics

Eli Lilly and Company has set a parity target for its diabetes and obesity medicines: treat as many people in low- and middle-income countries as in high-income countries by 2040. The commitment carries no price mechanism, so progress will be judged against Lilly’s own annual Sustainability Report. #SyenzaNews #globalhealth #pharmaceuticals #MarketAccess

A National Press Foundation briefing on drug prices and workforce shortages: separate list price from net price, ask which goal a policy serves, and check whether more clinicians really mean more appointments. #SyenzaNews #HealthEconomics #MarketAccess

Germany drug pricing policies are now the subject of a US Section 301 investigation. AbbVie’s chief counsel, Perry Siatis, has filed written evidence and testified that government price setting, mandatory rebates and reimbursement restrictions undercut the incentives that fund new medicines. He also cites a German-French working group on keeping innovative medicines available. #SyenzaNews #MarketAccess #DrugPricing #HEOR

A randomized trial in 268 men awaiting radical prostatectomy found AI preoperative communication cut GAD-7 anxiety scores and nearly halved surgeon consultation time. The AI answered 2,847 of 3,507 patient questions. #SyenzaAI #SyenzaNews #MarketAccess #ProstateCancer #AIinHealthcare