Evidence-based coverage of pharmaceutical development, regulatory affairs, and biotech innovation
MHRA has reinforced valproate pregnancy restrictions for women of childbearing potential. Learn what the Pregnancy Prevention Programme requires of prescribers and pharmacists.
By Tom Okafor, Clinical Trials Correspondent
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…
By Dr. Eleanor Vance, Regulatory Affairs Editor
Affidea, the pan-European provider of community-based clinics and diagnostics, has announced a strategic partnership and co-investment with LIPS Healthcare, the UK's largest private consultant-led multi-specialty group.
By Priya Raghavan, Biotech & Markets Analyst
The MHRA has authorised obecabtagene autoleucel for relapsed B-cell leukaemia. Discover what the FELIX trial showed and what NHS access now requires.
By Tom Okafor, Clinical Trials Correspondent
AI-guided target identification is now mandatory in London's pharma R&D pipelines, compressing lead optimisation to 14 months and pushing Phase 1 success rates above 80%. Read on.
By James Whitfield, Manufacturing & Supply Chain Writer
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
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.…
By Dr. Eleanor Vance, Regulatory Affairs Editor
GLP-1 receptor agonists reduce cardiovascular risk through overlapping receptor-mediated and metabolic mechanisms. Explore the trial evidence and biology behind the benefit.
By Dr. Eleanor Vance, Regulatory Affairs Editor
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
DTP3 multiple myeloma development targets a cancer-restricted NF-kB survival switch. Could this first-in-class peptide open a new lane for relapsed and refractory patients?
By Tom Okafor, Clinical Trials Correspondent
The MHRA has granted first-in-world approval for belantamab mafodotin combination regimens in relapsed myeloma, supported by landmark DREAMM-7 and DREAMM-8 Phase 3 trial data.
By Megan Liu, Digital Health Reporter
Most UK medical cannabis products are unlicensed specials. Here is how they are made, imported, regulated and dispensed under a traceable, accountable supply chain.
By James Whitfield, Manufacturing & Supply Chain Writer
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