Regulatory22 October 2026
What Touchlight's Cell-Free DNA Manufacturing Licence Covers
Touchlight's cell-free DNA manufacturing won a CPHI award, but what do the MHRA certificate and FDA Drug Master File actually say? We read both documents.
Regulatory20 October 2026
FDA Approves Atezolizumab for Stage III dMMR Colon Cancer
The FDA approved atezolizumab for stage III dMMR colon cancer on 8 October 2026. Here is what the ATOMIC trial numbers actually show — and what remains unknown.
Clinical Trials5 October 2026
What the New UK Clinical Trials Regulations Mean for Sponsors
The UK's new clinical trials regulations enter force 28 April 2026. Here is what the notification scheme, combined review, and results disclosure obligations mean for sponsors and CROs.
Treatments28 September 2026
Biocon Pertuzumab Biosimilar Pebrilzo Wins CHMP Opinion
Biocon's pertuzumab biosimilar Pebrilzo has received a positive CHMP opinion — the first monoclonal antibody biosimilar under the EMA's tailored clinical development approach for HER2-positive breast cancer.
Regulatory21 September 2026
OS Therapies Project Orbis MHRA Osteosarcoma Signal
MHRA asked OS Therapies to bring OST-HER2 into Project Orbis and accepted literature-derived historical controls in resected metastatic osteosarcoma. The procedural precedent matters more than the candidate, and every load-bearing fact is the sponsor's.
Therapies13 August 2026
NICE Moves Type 2 Diabetes First-Line Therapy to SGLT2
NICE NG28 now recommends SGLT2 inhibitors as first-line therapy alongside metformin for most adults with type 2 diabetes, prioritising cardiorenal protection from diagnosis.
Cancer10 August 2026
Modular RNA Nanoparticles Could Recast Cancer Delivery
Modular RNA nanoparticles from the University of Nottingham show breast tumour gene knockdown and influenza protection in mice — could this platform transform oncology delivery?
General29 July 2026
UK MHRA Agility Reform Drives Clinical Trial Innovation
The Medicines and Healthcare products Regulatory Agency (MHRA) is poised to implement the most significant overhaul of British clinical research in 20 years. Effective 28 April 2026, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (Statutory Instrument…
Regulatory14 July 2026
What the New UK Clinical Trials Regulations Mean for Sponsors
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, signed into law in April 2025 and entering into force on 28 April 2026, represent the most substantial revision to the UK clinical trial regulatory framework since the original 2004 Regulations…
News13 July 2026
JAK1 Inhibitor Selectivity and What It Means for Prescribers
The Janus kinase family comprises four intracellular tyrosine kinases JAK1, JAK2, JAK3, and TYK2 that transduce signals from a broad range of cytokine receptors to downstream transcription factors, principally the signal transducer and activator of transcription (STAT) proteins.…
Research9 July 2026
How GLP-1 Receptor Agonists Reduce Cardiovascular Risk
GLP-1 receptor agonists reduce cardiovascular risk through overlapping receptor-mediated and metabolic mechanisms. Explore the trial evidence and biology behind the benefit.
Regulatory8 July 2026
How NICE Evaluates Orphan Drugs Under the HST Programme
For most licensed medicines that reach the NHS in England, the route to routine clinical use runs through the NICE single technology appraisal (STA) process: a structured assessment of clinical and cost-effectiveness that applies a cost-per-quality-adjusted-life-year (QALY)…