France

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

Obefazimod has been heralded as a potential blockbuster for ulcerative colitis and there will be great interest in the readout of Phase III induction trials in the third quarter of this year.

A new methodology for measuring pharmaceutical company carbon footprints could lead to a single standard for producing these calculations that is applicable to all medicines sold in France, said the industry association, Leem. However, it warned that there remains uncertainty about how the methodology will work in practice.

Swiss firm Molecular Partners and French national offshoot Orano Med have partnered to develop a potent new class of radiopharmaceuticals.

Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.

Generics Bulletin reviews the latest regulatory developments across the world.

France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.

HAS, the French health technology assessment body, has issued positive recommendations for several orphan drugs, including for Vyloy, which was provisionally rejected for reimbursement in the UK last year.

Debate on how to manage drug spending continues in France despite an ongoing disagreement between industry and the government about whether there was €1.2bn overspend on medicines in 2024.

Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.