Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.
The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said.
A trio of European cancer vaccine specialists have filed progress reports, with advances in technology and targeting, fresh infusions of cash, and off-the-shelf products moving into the clinic. Six years on from its formation, Ervimmune closed a series A at €17 million (US$19.9 million) to drive forward clinical development of lead program Ervac-01. Accession Therapeutics Ltd. raised a further £30.5 million (US$40.4 million) from its existing investors, following dosing of four patients with Trocept-01. And Infinitopes Ltd. added $15.4 million to its seed round, as it finalizes preparations for a phase I/IIa trial of the lead product ITOP-1.
Neuropsychiatry specialist, Exciva GmbH raised €51 million (US$59.9 million) in a series B round to fund a phase II/III trial of Deraphan, a combination therapy for treating agitation in patients with Alzheimer’s disease.
A new systematic review and meta-analysis of studies looking at a possible association between Tylenol (acetaminophen) use in pregnancy and neurodevelopmental disorders in children concludes there is no evidence of any meaningful risk. The study was carried out by researchers in the U.K., Italy, Sweden and Norway, in response to U.S. Secretary of Health and Human Services Robert Kennedy saying last September that there is a link. Unless medically necessary, it is “irresponsible” to take Tylenol during pregnancy, Kennedy said.
The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
Microbiome specialist Enterobiotix Ltd. is in the throes of raising a new round of funding for a phase IIb trial after reporting positive results from the phase IIa study of EBX-102-02, an oral therapy for irritable bowel syndrome (IBS).
There was an upbeat message for cell and gene therapy companies in the 2026 industry update presented as the J.P. Morgan Healthcare Conference opened on Monday, with Tim Hunt, CEO of the Alliance for Regenerative Medicine, telling delegates that after lean years of learning, adapting and setbacks, the sector is now self-sustaining.
Moving away from a one-size-fits-all approach, the U.S. FDA's CBER released details Jan. 11 about how it’s leveraging its growing experience with cell and gene therapies (CGTs) to exercise greater regulatory flexibility in chemical, manufacturing and control requirements for the products.
Newco Tecregen AG has raised CHF10 million (US$12.5 million) to advance a novel way of regenerating the thymus in order to boost T-cell production and stimulate recovery of the immune system following stem cell transplants and chemo- and radiotherapy.