Innovative Tech

EMA has updated its business process for expert panel consultations on high-risk medical devices. The revision, effective 12 October 2026, adds orphan device advice as a new sub-process. #SyenzaNews #MedicalDevices #MarketAccess #HTA

Insulin analogue cost-effectiveness studies for adults with type 1 diabetes mostly point the same way: the newer products usually come out ahead of human insulin. A new systematic review says that headline rests on thinner ground than it looks. The paper, by Shiwa Yaghoubi Bina, Steve Njokuocha and the T1D Economic Evidence Synthesis Group, has been accepted for Value in Health. The version available now is a pre-proof, so figures could still change at copyediting. The World Health Organization funded […]

OHE's A Dose of Economics explores why medicines made for one patient challenge regulation, payment and HTA.

AI is entering every stage of medical training. A new npj Digital Medicine Perspective maps how to integrate it responsibly across UGME, GME and CME.

Halozyme has won a Keytruda SC injunction in the Netherlands, ordering MSD to stop supplying the subcutaneous form of pembrolizumab in eight European markets. The case turned on how the patent's stability test is measured, and the injunction lapses country by country if a national court invalidates its part of EP 2 797 622. #SyenzaNews #oncology #patentlitigation #MarketAccess

A new European Observatory toolkit says biosimilar uptake policies only work as a mix. Denmark pushed adalimumab biosimilars past 90%, Ireland shared €10 million of savings with clinical teams, and Finland cut reimbursement spending by €42 million. #SyenzaNews #Biosimilars #MarketAccess #HealthPolicy

MedTech Europe's Facts & Figures 2026 lands a split verdict on the European medtech industry 2026: record employment, near-record patent filings and a 77.4% EPO grant rate on one side; 1.8% market growth, a world market share down to 25.6% and the first fall in company numbers on the other. Digital reimbursement keeps expanding, led by Germany's 59 DiGA. #SyenzaNews #medtech #MarketAccess #digitalhealth

The CDRH FY 2027 guidance list is out. AI-enabled device software and change control plans top the A-list, 510(k) reform sits Under Construction, and comments close on November 30, 2026. #SyenzaNews #medicaldevices #FDA #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

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