January 2026
An overview of 2025, a turbulent year for the pharmaceutical industry:
New data from Cell and Gene Therapy (CGT) Catapult shows continued growth in advanced therapy clinical trials in the UK for 2025, with the number of early-stage trials remaining high. The number of ongoing advanced therapy clinical trials reached 193 in 2025, with 56% being early-stage trials and 80% being commercially sponsored:
The UK Home Office publishes detailed annual statistics on the use of animals in science, including procedures for acute and sub-toxicity testing methods such as LD50 (Lethal Dose 50) and LC50 (Lethal Concentration 50). According to the latest published figures for 2024, there were 11,992 procedures in this category; the statistics include a breakdown by species: https://www.theyworkforyou.com/wrans/?id=2025-12-03.96751.h&s=%28Chemicals+OR+CRO+OR+Pharmaceuticals%29#g96751.r0. In related news, the UK government is committed to non-animal alternatives in science and has published a strategy to support their development, validation and adoption:
www.gov.uk/government/publications
Two groundbreaking studies published in the Nature Medicine journal suggest faecal microbiota transplants (FMT) can dramatically improve cancer treatment. The first study shows that the toxic side effects of drugs to treat kidney cancer could be eliminated with FMT. The second study suggests FMT is effective in improving the response to immunotherapy in patients with lung cancer and melanoma:
India has made key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in line with the directions of Prime Minister Narendra Modi. The amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country:
At the 2025 American Society of Clinical Oncology annual meeting, researchers presented results of a large Phase 3 clinical trial that led to the approval of inavolisib which significantly improved survival rates among patients with hormone receptor-positive breast cancer who are resistant to standard endocrine therapy. A limitation of the study is that it enrolled only 0.6% Black patients, with more men enrolled than Black women – a moral failure and bad science:
The Functional Gut Clinic (FGC), a provider of specialist gastrointestinal diagnostics, has announced the launch of its dedicated GI Clinical Trials establishing the organisation as the UK’s first boutique, end to end clinical research provider focused exclusively on digestive health:
www.clinicalservicesjournal.com
New data from the UK medicines regulator, the MHRA, has shown an increase in clinical trial activity in the country, after years of decline, which it says shows that the promise of reforms following Lord O'Shaughnessy’s report is already starting to have an effect:
Vortex Biotech Holdings Limited has announced the opening of its advanced laboratory facilities at Manchester Science Park. The new site significantly enhances R&D and commercial delivery capacity and strengthens the company’s position as a leader in liquid biopsy technologies for precision oncology:
A major UK clinical trial has shown that adding the corticosteroid dexamethasone to standard antiviral treatment for encephalitis (brain inflammation), caused by herpes simplex virus (HSV) does not improve long-term outcomes overall. However, early use may lead to better recovery, and the treatment is safe for patients with suspected encephalitis:
www.clinicalservicesjournal.com
The UK’s Medical Research Council Centre of Research Excellence in Clinical Trial Innovation (MRC CoRE CTI), which is being set up in partnership with the National Institute for Health and Care Research, will receive £50 million over 14 years with the ambition of transforming the clinical trial landscape:
For the first time in a while, the biotechnology industry starts a new year with momentum, much of it fuelled by clinical trial results. BioPharma Dive selects ten to watch in the first half of this year:
The European Commission has released plans intended to accelerate clinical trial approvals across the EU and cut costs by as much as 80–90% through the use of AI-enabled trials. EU average clinical trials take well over 100 days; in the UK, it’s c. 60 days. The aim is to drive that down to 47–50 days on average:
Clinical development accelerator Quotient Sciences and CRO Lindus Health are joining forces to create a streamlined one-stop- shop process for clients to advance from first-in-human (FIH) up to pivotal trials:
In a free virtual panel, industry experts will discuss practical examples and considerations for applying AI in pharma’s clinical trials. Date: 26 March 2026, Time: 3 PM GMT:
Democrat Governor Maura Healey has written to U.S. Health and Human Services Secretary Robert F. Kennedy Jr. to demand that he restore funding cuts to the National Institutes of Health (NIH) that have stopped 380 clinical trials and impacted more than 74,000 patients nationally, including 18 clinical trials and 13,000 patients in Massachusetts:
A review of an inclusive recruitment strategy that was adopted during the ‘Live Well with Parkinson’s’ trial, funded by the NIHR’s Programme Grants for Applied Research Programme:
Two of the largest clinical trials of their kind have shown that a daily dose of oral semaglutide did not delay progression of the neurodegenerative disease Alzheimer’s:
Analysis commissioned by the Department of Science, Innovation and Technology (DSIT) has found positive outcomes for UK research projects backed by the Horizon R&D programme. UK researchers secured £6.8 billion in funding through nearly 11,000 projects via the Horizon 2020 programme (H2020) from 2014-2020, including for clinical trials:
The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad. The proposal is designed to incentivize U.S. drug development by tacking on higher fees for those not running phase 1 trials in the country:
