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Evidence-based coverage of pharmaceutical development, regulatory affairs, and biotech innovation

General21 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)…

Clinical Trials29 June 2026

UK sets pathway for in vivo CRISPR gene editing trials

The UK is advancing in vivo CRISPR gene editing beyond ex vivo models. Explore regulatory signals, lipid nanoparticle delivery, and NHS reimbursement challenges.

Research10 June 2026

Amyloid therapies reach limits as multi-target strategies advance

The approval of amyloid-targeting monoclonal antibodies by the MHRA marked a clear regulatory and scientific milestone in Alzheimer’s disease treatment. These agents demonstrated that disease-modifyin

Research7 May 2026

Microgravity helps find new antimicrobials for superbugs

Microgravity is increasingly recognised as a valuable tool for antimicrobial discovery due to its impact on microbial interactions, competition, and adaptation. Evidence from the International Space S

Research5 January 2026

Personalised medicines: the new frontier, the rise of CRISPR-based therapies in oncology

The first regulatory approvals for a CRISPR-based medicine in the UK and EU marked a turning point for genomic medicine and set expectations for oncology. In 2023, the MHRA licensed exagamglogene auto

Research2 December 2025

The Role of Cathepsin B (CTSB) in Immune Response Studies

Cathepsin B (CTSB) is a lysosomal cysteine protease that plays a key role in protein turnover, antigen processing, and immune regulation. It is widely expressed across mammalian tissues. Recent resear

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