EMA Expert Panel Consultation for Medical Devices Adds an Orphan Pathway

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

At the World Health Summit in Berlin, speakers from the European Commission, Japan, Africa, the Asian Development Bank and industry argued that health is a strategic economic asset, and asked how to persuade finance ministries. #SyenzaNews #HealthEconomics

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.

Health utilities for multiple sclerosis fall with disability, and progressive forms score lowest. A UK cohort of 5,772 patients gives modellers EQ-5D and cost inputs by MS type and EDSS band. #SyenzaNews #MarketAccess

The EU’s ACT EU advice pilot for clinical trial applications becomes permanent in January 2027, with updated sponsor guidance.

Uptake of new cancer medicines in Europe still varies, with a three-fold gap between countries in 2023.

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

The CSIR FuturePHARMA facility in Tshwane aims to turn South African research into medicines made locally.

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