Regulation & Policy

A new study on the economic impact of pharmaceutical innovation in Europe shows sustained benefits across society, according to EFPIA, the European industry federation. Data from the study, released on 22 June, shows that between 2014 and 2024 Europe’s investment of €11.67 billion in new medicines returned more than five times the amount in social, economic and hospital cost savings – equating to €66 billion in total. This figure includes more than €9 billion in direct hospital savings. Key findings include:

The US Food and Drug Administration issued new draft guidance on 29 May about how companies can reduce the use of animals in drug testing – this time for cancer medicines. Entitled, Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products, the guidance recommends new criteria for general toxicology studies, including when animal testing may be unnecessary because there is no binding or pharmacologic activity.

The European Medicines Agency, in coordination with the African Medicines Agency and national regulators in Africa, started talks in early June about organising clinical trials to evaluate possible vaccines and therapies against Ebola disease caused by the Bundibugyo virus. The virus is currently circulating in the Democratic Republic of Congo and Uganda and was declared a public health emergency of international concern by the World Health Organization on 17 May. As of 18 June, the WHO had reported just over 900 cases of the disease and approximately 235 deaths.

The US Food and Drug Administration has approved a new carbapenem antibiotic from GSK Plc to treat complicated urinary tract infections – the first oral treatment of its kind for the disease. The authorisation, announced on 17 June, is for Utebzi (tebipenem pivoxil), a broad-spectrum carbapenem antibiotic of the beta-lactam class. The treatment will be available as a tablet, in addition to its availability as an in-hospital intravenous therapy.

uniQure NV has reached an agreement with the US Food and Drug Administration to proceed with a marketing authorisation application for its gene therapy for Huntington’s disease, a rare, inherited neurodegenerative disorder. The application is expected to be filed in the third quarter of this year, the company announced on 17 June.

US-based POP Biotechnologies Inc has announced that the Coalition for Epidemic Preparedness Innovations (CEPI) is to provide up to $9.7 million in additional funding to help advance the company’s SNAP (Spontaneous Nanoliposome Antigen Particle) protein vaccine platform into a Phase 1 clinical trial. The deal builds on an initial $1.5 million investment from CEPI announced in July 2025, which supported early-stage research into the technology.

Following a European Commission announcement in March of a proposed new legal framework for start-up companies, Germany has reportedly lifted its opposition to giving more powers to an EU financial regulator – an important step towards creating a capital markets union. According to The Financial Times, the German finance minister Lars Klingbeil signalled his support for the centralised supervision of a unified capital market, which would effectively mean ceding powers from the German regulator to the European Securities and Markets Authority (ESMA), based in Paris.

The Coalition for Epidemic Preparedness Innovations (CEPI) has announced funding for three experimental Bundibugyo ebolavirus vaccine candidates currently in preclinical development. Bundibugyo is the ebolavirus species responsible for the current outbreak in the Democratic Republic of Congo ad Uganda, but no licensed vaccine is currently available for this species, and none is in clinical development.

The World Health Organization has determined that the current outbreak of Ebola disease caused by Bundibugyo virus in the Democratic Republic of the Congo (DRC) and Uganda constitutes a public health emergency of international concern (PHEIC), but does not meet the criteria of a pandemic emergency. The determination was announced in a statement dated 17 May 2026.

It is not realistic to expect increased investment in medicines research in the EU or quicker access to new treatments for its citizens if member states insist on the lowest possible prices and highest government rebates, according to Nathalie Moll, Director General of Efpia, the European Federation of Pharmaceutical Industries and Associations. Ms Moll’s comments follow the publication of Efpia’s annual WAIT (Waiting to Access Innovative Therapies) report, which showed a picture of widening inequality among member states.