The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.
Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease.
Galapagos NV is about to bury its recent turbulent past and sail off for the future with its $3 billion cash pile and the new name of Lakefront Biotherapeutics NV. The foundation for the transition was laid earlier this month in an arrangement with Gilead Sciences Inc., holder of 25% of Galapagos’ equity, to “co-parent” the assets of Ouro Medicines LLC, which Gilead is acquiring for up to $2.17 billion.
Data presented at the 2026 American Academy of Dermatology (AAD) meeting have put the spotlight on the arrival of target-selective oral therapies that are set to challenge injected biologics in terms of efficacy, while offering greater convenience and improving access to treatment.
As expected, the EMA is recommending withdrawal of the mpox indication for Siga Technologies Inc.’s tecovirimat, whilst maintaining its approval as a treatment for smallpox, cowpox and adverse reactions to vaccinia vaccines.
Newco Idel Therapeutics GmbH has closed a €9 million (US$10.4 million) seed round to advance the development of a technology for delivery of cytotoxic drugs directly into the cytosol of tumor cells.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications.
Newco Immutrin Ltd. has raised £65 million (US$86.9 million) in a series A to take its lead antibody program through to clinical proof of concept in transthyretin amyloid cardiomyopathy.
Laigo Bio BV has extended its seed round to €17 million (US$19.8 million), after making progress with translating its novel E3 ubiquitin ligase targeted protein degradation technology toward the clinic.
Scientists at Great Ormond Street Children’s Hospital in London have reported a new advance for tissue engineered grafts in a lab-grown esophagus that has sufficient muscle regeneration to coordinate peristalsis, enabling the recipient to swallow. The aim is to generate grafts that can be used to treat babies born with the rare congenital condition esophageal atresia, in which the esophagus fails to connect to the stomach, usually forming a close pouch instead.
