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MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●MHRA approves new biosimilar●AstraZeneca Q1 results exceed forecast●NICE updates TA guidance for oncology●Roche launches Phase III rare disease trial●FDA grants breakthrough therapy designation●UK Biobank releases genomic dataset●GSK acquires clinical-stage biotech firm●EMA recommends novel gene therapy●

MHRA Approves Obecabtagene Autoleucel for Relapsed B-Cell Leukaemia

The MHRA has authorised obecabtagene autoleucel for relapsed B-cell leukaemia. Discover what the FELIX trial showed and what NHS access now requires.

Tom Okafor, Clinical Trials Correspondent|27 July 2026|9 min read

Regulatory

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…

Dr. Eleanor Vance, Regulatory Affairs Editor·14 July 2026·8 min read

News

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.…

Dr. Eleanor Vance, Regulatory Affairs Editor·13 July 2026·9 min read

Regulatory

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)…

Dr. Eleanor Vance, Regulatory Affairs Editor·8 July 2026·9 min read

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Research

Affidea accelerates its UK growth through strategic partnership with LIPS Healthcare

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.

Priya Raghavan, Biotech & Markets Analyst·27 July 2026·5 min read