The US Food and Drug Administration issued new draft guidance on 29 May about how companies can reduce the use of animals in drug testing – this time for cancer medicines.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.
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.
Ona Therapeutics SL, a 2019 spin-out from a Spanish research institute and foundation, has raised $86.6 million from venture capitalists to advance a portfolio of early-stage antibody-drug conjugates (ADCs) for refractory cancers. The Series B round was co-led by Columbus Venture Partners of Spain and Mérieux Equity Partners of France. They were joined by the existing Spain-based investors Alta Life Sciences and Asabys Partners and Bpifrance, the French public investment bank.
Collaborative networks have been a driving force for innovation across the life sciences for decades. They connect universities, governments and venture capitalists to create conditions for the launch of new companies. The ecosystem around the Massachusetts Institute of Technology in Cambridge, US, is probably the best-known incubator of new companies. Less common are ecosystems focused on a single therapeutic area. This is the unique feature of a new cluster in France called The Hive and Campus Grand Parc, located in outer Paris.
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.
AstraZeneca Plc has reported positive results in two Phase 2b trials for a candidate obesity and diabetes drug with potentially broad applications for cardiometabolic and kidney diseases. The drug, elecoglipron, is a small molecule GLP-1 receptor agonist that can be taken as a pill. It was in-licenced from Eccogene (Shanghai) Co Ltd in 2023 to be the backbone of AstraZeneca’s prospective treatments for obesity and weight-related diseases. By taking a broad therapeutic approach, the company argues that it could chart a new path for obesity treatment in the future.
Abivax SA has confirmed plans to submit a new drug application for obefazimod, its candidate product for ulcerative colitis, to the US Food and Drug Administration late in the fourth quarter. This follows results from a Phase 3 trial that showed strong efficacy. The small molecule drug upregulates a microRNA known as miR124 in order to stabilise the immune response in patients with ulcerative colitis, a disease that affects the colon.
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.
Eli Lilly and Co has announced plans to invest up to $3.83 billion to buy three companies developing candidate vaccines, effectively charting new territory in the field of infectious disease. Announced on 26 May, the acquisitions include Curevo Inc and Vaccine Company Inc of the US, and LimmaTech Biologics AG of Switzerland.