February 2025
The latest government data on the number of scientific procedures involving living animals (not the number of animals) carried out in GB in 2023 show a decrease of 3% from the previous year – 2.68 million, the lowest number since 2001:
The UK experienced a notable increase in advanced therapy clinical trials in 2024, reaching 187 ongoing trials. This marks a 7% rise from the previous year. Particularly, phase I trials saw an approximate 70% increase, growing from 24 to 41:
In January 2026, Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 are expected to come into force. They mark a pivotal shift in how clinical trials are conducted in the UK. Here are some of the changes and their potential impact:
Evolving research plans, regulatory guidance and an increasingly diverse pool of investigational drugs await the clinical trial sector in 2025:
The Clinical Trials Arena Excellence Awards Winners have been announced. For the list, plus key trends, see the full report [registration required for download]:
The U.S. Food and Drug Administration (FDA) ended 2024 with 50 new drug approvals, down from 55 in 2023:
After a successful phase four trial, the US FDA has approved Johnson & Johnson’s Spravato nasal spray, the first-ever stand-alone therapy for treatment-resistant depression. Derived from ketamine, the drug is restricted to clinics where the patient is monitored for two hours:
The FDA has approved Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use:
Antibiotics, antivirals, vaccinations and anti-inflammatory medication are associated with reduced risk of dementia, according to new research by the universities of Cambridge and Exeter that looked at health data from over 130 million individuals:
The biopharma industry outlook on 2025: Uncertainty and change. The Trump administration is bringing new instability to a sector already grappling with a shaky market and competition from China:
According to Arizton’s latest research report, the global clinical trials outsourcing market is growing at a CAGR of 7.19% during 2023-2029, with specialised CROs shaping the future:
January 2025
A reminder: only days left. All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025:
Singularity Hub look at what is poised to take the leap from breakthrough to clinical approval in 2025:
Similarly, BioPharma Dive identifies 10 clinical trials to watch in the first half of 2025 that could help the biotechnology sector regain its footing after a shaky 2024:
Prasinezumab, an experimental therapy drug for Parkinson’s disease that Roche has been developing for more than a decade, has shown mixed results in its Phase 2 key clinical trial. However, Roche announced that there were enough positive signs to merit further exploration:
In the Clinical Trials Software Market - Focused Insights 2024-2029" report, the Clinical Trials Software Market was valued at $1.26bn in 2023, and is projected to reach $3.13bn by 2029, rising at a CAGR of 16.38%, driven by rapid development in clinical trials and the increasing attention toward patient-centric approaches.
Duvakitug, an experimental antibody drug co-developed by Teva and Sanofi, has met its main objectives in a Phase 2 trial. Around half of people with ulcerative colitis who received a high dose of the drug saw their symptoms resolve after 14 weeks, versus just over 20% of those on placebo:
Researchers in Pharmaceutical Sciences from the University of Michigan, USA, ask whether Artificial Intelligence can revolutionise drug development. They conclude it is a tool that, when used wisely and competently, could help address the root causes of drug failure in clinical trials and streamline the process:
Clinical trials in 2025 will be beset by rising costs and uncertain regulations while also benefiting from new technologies and expansion of site networks, predicts Velocity Clinical Research CEO and President Dr. Paul Evans:
The UK’s desirability as a clinical trial location is improving, reversing its previously downward trajectory, according to the Association of the British Pharmaceutical Industry (ABPI). It jumped from 411 trials in 2022 to 426 in 2024. However, much of this growth lies with Phase III trials:
A major new research hub, the UK Quantum Biomedical Sensing Research (Q-BIOMED), led by UCL and the University of Cambridge, has been launched with £24mn in funding from UK Research and Innovation (UKRI) and the National Institute for Health and Care Research (NIHR). It is the first quantum research hub to be dedicated to healthcare or life sciences:
www.clinicalservicesjournal.com
Amgen’s Imdyllytra (tarlatamab), an antineoplastic agent delivered by intravenous infusion, has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with small cell lung cancer (SCLC), a rapidly-progressing primary lung cancer:
Sanofi has published a new report, ‘Breathe Equal: Policy Recommendations to Reduce the Burden of COPD’, calling for solutions to tackle the urgent challenge of chronic obstructive pulmonary disease (COPD), affecting 2% of the UK population, with many undiagnosed:
It has been over two years since the US Supreme Court’s decision to overturn the 1973 Roe versus Wade decision, the constitutional protection for abortion. These restrictions have ethical, legal, and practical implications for everyone involved in clinical trials:
A statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before the UK parliament in December 2024. New measures governing how clinical trials are carried out in the UK should make them more streamlined, flexible, and transparent, the Medicines and Healthcare Products Regulatory Agency (MHRA) has said:
www.europeanpharmaceuticalreview.com & https://www.sciencemediacentre.org
The Global Clinical Trials Connect Conference 2025: Connecting Minds, Advancing Trials, Uniting the Clinical Research Community, will be held from 28-29 May 2025 in London (venue to be announced):
www.researchandmarkets.com/reports/6021303/global-clinical-trials-connect
The Asia-Pacific (APAC) region is leading in global Parkinson’s disease clinical trials with 44% of trials, according to Novotech’s Parkinson’s Disease- Global Clinical Trial Landscape (2024) report. Within APAC, China has had the majority share with 56% of Parkinson’s disease trials since 2019. North America hosted 26%; Europe hosted 25%; and the rest of the world hosting the remaining 5%.
