The case for GLP-1s in adolescents with obesity now rests on several randomised trials and two marketing authorisations. Real-world data are growing too. That evidence shows substantial reductions in body mass index over 56 to 68 weeks. It says much less about years...
Divarasib approval cannot yet be dated. Roche has not announced a filing after the Krascendo 1 phase 3 results at ESMO 2026.
No filing for Imdelltra Imfinzi approval in first-line maintenance had been announced on 26 October 2026. DeLLphi-305 showed a hazard ratio for death of 0.42.
A low out-of-specification (OOS) assay result does not always originate in the analytical laboratory. In pharmaceutical manufacturing, an OOS investigation must consider laboratory testing, raw material properties, manufacturing instructions and process execution...
AI is creating new opportunities across the pharmaceutical industry, but not every organisation is equally equipped to capitalise on them. The differentiator is not simply access to AI, but digital maturity; the strength of the infrastructure underpinning it. Those...
Dostarlimab rectal cancer won FDA accelerated approval on 19 October 2026. Wales supports use; NICE and the MHRA have yet to decide.
Ionis Pharmaceuticals and Otsuka Pharmaceutical reported positive topline results on 22 September 2026 from the Phase 3 FUSION study. The trial tested ulefnersen in amyotrophic lateral sclerosis caused by mutations in the fused in sarcoma gene. Ionis describes the...
As a life scientist you might not have considered a business education. You are good at what you do, you may have no ambition to run a company or sit at a boardroom table. So why spend time on business fundamentals? The honest answer is that deep technical expertise...
Few classes of medications have changed the perioperative conversation as quickly as glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Originally developed primarily for the management of type 2 diabetes, GLP-1 therapy is now widely used for obesity and metabolic...
It’s been an extraordinary two years for anyone working in pharma commercialization, with the macro environment shifting meaningfully under the feet of all those sitting on the commercial side of pharma or building in digital health with pharma partnership...
In pharmaceutical manufacturing, quality control testing is often the point at which a product gets its final analytical assessment. But from my experience in pharmaceutical quality control, one principle is worth emphasizing: QC testing is essential, but QC testing...
The semaglutide patent expiry of March 2026 has now had six months to work. The evidence is uneven. In India, prices fell by up to 70% within weeks. In Canada, generic pens reached pharmacies in May. In China, not one generic has been approved. Readers in the United...
Orforglipron (Foundayo) is now available in the UK following The Medicines and Healthcare products Regulatory Agency (MHRA) approval on 10 August, making the UK the first European country to license it for weight management and type 2 diabetes. The first oral...
The camizestrant approval granted by the US Food and Drug Administration on 4 September 2026 sets an oncology precedent. It is the first US clearance of a cancer therapy triggered by a resistance mutation found in blood. The agency made that claim itself. The trigger...
When results from the phase 2 EMBRAZE trial were published in Nature Medicine in June, apitegromab’s combination with tirzepatide became the most visible evidence yet that pharmacological muscle preservation during GLP-1 treatment might be achievable.¹ But...
A lab result is only the beginning I have spent close to 20 years developing pharmaceutical, nutraceutical and consumer health products. One lesson has followed me through almost every role: a formula can work beautifully in the laboratory and still become a problem...
The avacopan UK suspension took effect on 1 September 2026. The Medicines and Healthcare products Regulatory Agency stopped supply of the medicine to new patients that day. It also signalled its intention to revoke the UK marketing authorisation on 1 March 2027. The...
On 26 August 2026, SK Biopharmaceuticals agreed to license an epilepsy platform from Biohaven. Sixteen days earlier, Jazz Pharmaceuticals agreed to buy an epilepsy biotech outright. Same disease area, same month, two opposite structures. The licensing versus...