Federal legislation is the best opportunity to compel pharmacy benefit managers (PBMs) to change. Neither a major Federal Trade Commission (FTC) settlement nor reforms at the state level have fixed market distortions. But the upcoming US midterm elections in November...
As Head of R&D at a Swiss cosmetics laboratory, I read a lot of the evidence behind the cosmetic actives that brands ask us to put in their formulas. The same pattern keeps turning up. A well-cited in-vitro mechanism gets marketed as if it were a proven clinical...
Bepirovirsen NHS access is undecided. Hibsago won FDA approval on 20 October 2026, but the UK has no authorisation. Here is what NICE and MHRA must do.
Dostarlimab rectal cancer won FDA accelerated approval on 19 October 2026. Wales supports use; NICE and the MHRA have yet to decide.
Medical device manufacturers have long relied on third-party technology. Generative AI, however, presents new challenges for manufacturers of AI medical devices, who may have little influence over how the external model is developed. The technology may be outside of...
The FDA rare disease framework sets no timetable yet. See what the 14 October 2026 white paper proposes and what to watch next.
Not yet, and no UK date has been set. The US FDA approved atezolizumab (Tecentriq) on 8 October 2026 for stage III dMMR colon cancer. NICE has an appraisal in scoping, with no publication date. The emc product summary for Tecentriq 1,200 mg lists six indications....
A digital twin commissioned to mirror a manufacturing process is, by design, built to keep learning. It ingests live sensor data, recalibrates its internal parameters, and narrows the gap between what it predicts and what the physical process is actually doing. That's...
I like to call myself a conduit between ancient healing wisdom and modern life. I came to the US thirty years ago to be trained as a pathologist, but I grew up among generations of herbalists. My family roots and my research background have shaped how I view the...
For most of the past three decades, validating a computerised system in a GMP facility has usually meant paper. Teams compiled binders of test scripts, wet-ink signatures and printed screenshots. That model is now under pressure, and digital validation in life...
The resignation of Anthropic researcher Jacob Coxon has brought renewed attention to the risks of increasingly powerful artificial intelligence. According to the Associated Press, Coxon warned that competitive pressure was overtaking safety considerations at leading...
Cosmetics regulation rarely makes it onto the radar of pharma, biotech, or medical device professionals. It probably should, at least for the next few years. The European Union is in the middle of building two overlapping restriction regimes, one for PFAS and one for...
Daiichi Sankyo and Merck have withdrawn a United States application for ifinatamab deruxtecan. The move takes a prospective small cell lung cancer treatment out of the American regulatory queue. The companies announced the withdrawal by Business Wire at 4:30pm Eastern...
A United States advisory panel has recommended approval of a multi-cancer early detection blood test. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met on 23 September 2026. It reviewed GRAIL’s Galleri test. The assay reads...
When a life sciences organization struggles during a regulatory inspection or quality audit, the first reaction is fairly predictable: people point to evolving regulatory expectations, expanding documentation requirements, or the complexity of maintaining compliance...
Obesity drug access in the UK now runs along two tracks that rarely meet. One is a publicly funded NHS rollout of tirzepatide (Mounjaro), phased over as long as 12 years. The other is a private market that has grown far faster. A UCL survey estimates that about 1.6...
Telix Pharmaceuticals has agreed to buy ITM Isotope Technologies Munich SE. Telix describes ITM as the largest supplier of lutetium-177 by revenue. The deal places that radioisotope supply business inside a therapeutics developer. Telix issued the joint announcement...
Xenon Pharmaceuticals submitted the azetukalner NDA to the US Food and Drug Administration on 17 September 2026. The filing covers focal seizures in epilepsy. The same announcement disclosed a voluntary pause on new enrolment in the company’s depression studies. Xenon...