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BIA thought leadership takes centre stage with two key reports published: last week saw the release of 'From innovation to impact: unlocking patient access to innovative rare disease medicines', and today 'UK cell and gene therapy: driving efficiencies and innovation' celebrates real-world UK success.

The BioIndustry Association (BIA) released From Innovation to Impact: Unlocking Patient Access to Innovative Rare Disease Medicines, calling for new pathway to give UK patients access to innovative rare disease medicines.

Autolus Therapeutics plc, an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the National Institute for Health and Care Excellence (NICE) has published draft guidance recommending AUCATZYL® (obecabtagene autoleucel, or “obe-cel”) for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (≥26 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

Novo Nordisk announced the submission of a sNDA to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity. Under the CNPV expedited program, review is expected within 1–2 months following the FDA’s acceptance of the filing.

The UK’s used nuclear materials will be recycled to create an evergreen supply of new precision cancer medicines, offering hope for patients with previously untreatable cancers.

London Life Sciences Week kicked off last night with a buzzing reception at Somerset House and we’re looking forward to a jam-packed week of networking and events. Great to see the incredible hard work from the BIA and L&P teams come to life – shining a global light on the incredible UK ecosystem. At the same time, we’re seeing the UK take a leading role in pro-innovation regulation, from last week’s enactment of the Precision Breeding Act to Lawrence Tallon’s insights on the MHRA’s proportionate, strategic future approach, and now need the government to invest in the sector and ensure the commercial environment enables the UK to build on this world-beating foundation.

BIA’s influence and connect were out in force last week – grasping a timely opportunity to get our key Autumn Budget asks across impactfully to the Chancellor with the clear backing of over 200 member CEOs, and putting on a dynamic, pro-innovation Future of UK Regulation conference, featuring MHRA and NICE CEOs amongst other key stakeholders.

As discussion around the Autumn Budget heats up, BIA is leading a unified call to the Chancellor to back the science, the entrepreneurs and the life sciences industry that can fuel transformational growth for the UK economy. Our sector letter highlights key growth levers and indeed the barriers that hold the sector back in already challenging global conditions. 

LinkGevity featured in Financial Times 5-part global series on Longevity companies. The article highlights how LinkGevity’s pioneering work on Anti-Necrotic technology is opening new frontiers in medicine, with potential for systemic healthspan regeneration.

A new paper published in the British Journal of Clinical Pharmacology sets out a roadmap for designing the next generation of system-level medicines - drugs that deliver the sweeping system-wide health benefits seen with GLP-1s such as Ozempic and Wegovy, but without their biological trade-offs and side effects.

The UK biotech financing numbers for Q3 are out, showing validation of UK assets but a sector under strain from prolonged global headwinds. Time to double down on investment in innovation as a driver for growth and deploy Industrial Strategy plans with urgency.

Medannex Ltd (Edinburgh) announced the presentation of the first clinical data from the ongoing Phase 1b study of MDX-124, at the European Society for Medical Oncology (ESMO) Congress 2025.

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Medannex's novel therapy MDX-124, for the treatment of biliary tract cancer (BTC). The FDA’s decision is based on emerging clinical data from the ongoing first-in-human Phase 1b ATTAINMENT clinical trial, which shows promising efficacy signals in patients treated with MDX-124 monotherapy. Durable disease control and tumour shrinkage have been observed in several BTC patients, with no significant side effects. 

This is the first-ever autoimmunity study to evaluate a potential functional cure that targets the antigenic source – the origin of autoimmune disease.

First non-hormonal menopause treatment approved for use in the UK by the MHRA, with early-stage development at Stevenage Bioscience Catalyst

Microbiotica announces that patient recruitment is complete in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients.

Rinri Therapeutics is focused on transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, providing new therapeutic options for the treatment of this major global unmet medical need.