Regulatory21 September 2026· 8 min read
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.
By Dr. Eleanor Vance, Regulatory Affairs Editor
Regulatory9 September 2026· 8 min read
What the evidence shows about BPC-157 and tendons
More than 100 animal studies suggest BPC-157 helps tendons heal, yet as of 2026 not a single controlled human trial has tested whether it works in people. A US advisory panel has voted to loosen access all the same.
By Tom Okafor, Clinical Trials Correspondent
Regulatory14 July 2026· 8 min read
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…
By Dr. Eleanor Vance, Regulatory Affairs Editor
Regulatory8 July 2026· 9 min read
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)…
By Dr. Eleanor Vance, Regulatory Affairs Editor