May 2025
Two recent announcements show the UK Government’s intent to improve the UK as a location for clinical research and boost the life sciences sector. This article summarises the announcements and provides context:
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were officially signed into UK law on 10 April 2025, marking a significant development in the clinical trials framework (the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR)). There is now a twelve month implementation period, after which the new regulations will take full effect:
An international phase 3 clinical trial shows that patients with certain locally advanced head and neck cancers benefit from the addition of the immunotherapy drug pembrolizumab (brand name Keytruda) to standard-of-care therapy. This is yet another success for pembrolizumab, first approved by the FDA in 2014 for advanced melanoma and since approved for lung, colorectal, and cervical cancers plus lymphoma:
Amid upheaval targeting transgender health, vaccine hesitancy and more, the U.S. National Institutes of Health is ripping away research grants, reportedly halting more than 100 clinical trials. The sweeping cuts have also upended clinical trials globally: https://www.sciencenews.org/article/clinical-trials-halted-trump-nih In related news, the Trump administration’s Section 232 of the Trade Expansion Act of 1962 investigation into pharmaceuticals covers finished generic and non-generic drugs, active pharmaceutical ingredients (APIs), key starting materials, medical countermeasures and derivative products provided by other nations:
Following the VS Hospital scandal in Ahmedabad, India is likely to require State authorities to have access to information about clinical trials in their state, including the drugs, diagnostics, medical devices or biologicals, trial sites, and investigators:
timesofindia.indiatimes.com The background to the VS Hospital illegal clinical trials scandal is here:
Following MHRA approval, Stablepharma Ltd has commenced a Phase 1 clinical trial with its fridge-free tetanus and diphtheria vaccine, SPVX02, at the National Institute for Health and Care Research (NIHR) at Southampton Clinical Research Facility:
On 28 April 2025, Parliament debated e-petition 705384 seeking to ban immediately the use of dogs in scientific and regulatory procedures:
By 2040, an estimated 28 million new cases of cancer will be diagnosed every year globally, up from around 20 million in 2020. Advances in diagnosis and treatment must keep up with the growing burden of cancer, and clinical trials are an important part of such work:
Researchers in Norway have identified a promising oral drug combination that may stop the replication of enteroviruses, a group of viruses responsible for illnesses ranging from the common cold to type 1 diabetes:
The 12th Annual Clinical Trials in Oncology West Coast meeting will take place in Burlingame, California on 14–15 May. It will cover the unique challenges with oncology trials, patient recruitment and engagement strategies, and diversity initiatives:
April 2025
Pharma company leaders in the UK have warned the government that, unless there are dramatic reforms to the voluntary rebate scheme (VPAG) – which this year will require companies to make payments of between a quarter and a third of revenues from the sale of branded medicines to the NHS – the UK's plan to make life sciences a pillar of its growth economy will fail:
An answer from the Department for Environment, Food and Rural Affairs to a written question from Ruth Jones, Labour MP for Newport West and Islwyn, on progress made by the Department on establishing a chemicals strategy; and whether this strategy will help phase out animal testing:
AstraZeneca’s rare disease drug eneboparatide has met the primary endpoint in a Phase III trial in patients with chronic hypoparathyroidism. The company bought eneboparatide through the acquisition of Amolyt Pharma in July 2024:
A new paper on the importance of attaining proportional representation by ethnicity in clinical trials as reflected by disease burden or the census:
Forth Therapeutics in Edinburgh, which is developing treatments for fibrosis, is one of three successful applicants for funding from European life sciences investor Sofinnova Partners (backed by Pfizer Ventures, Amgen and Bristol Myers Squibb):
Newly released Phase III data illustrate potential of three drugs being investigated as treatments for plaque psoriasis from pharmaceutical companies Biocon Biologics, UCB and Johnson & Johnson:
europeanpharmaceuticalreview.com
The trust that runs Ealing Hospital, Northwick Park Hospital and Central Middlesex Hospital in Park Royal, LNWH, has been awarded £7mn funding by the Commercial Research Delivery Centre (CRDC) to help double its clinical trials from 20 to 40 a year by 2029. A further 20 trusts have also received CRDC funding:
Grifols has announced positive results from its phase 2/3 clinical trial evaluating the efficacy and safety of intravenous immunoglobulin (IVIG), specifically Flebogamma® 5% DIF, to treat post-polio syndrome (PPS):
Amgen has started two phase 3 trials for its experimental monthly weight loss injection, MariTide. One trial is on 3,500 people with obesity or who are overweight without Type 2 diabetes, while the second is on 999 obese or overweight patients who have Type 2 diabetes:
Cell and gene therapy (CGT), which offers potential cures for previously untreatable conditions, is in its infancy in India. This article looks at the unique hurdles facing startups and research institutions:
The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, is launching the next phase of its project to measure and reduce the carbon footprint of clinical trials:
March 2025
AstraZeneca has scrapped plans to invest £450m in expanding a vaccine manufacturing plant in Merseyside, UK, blaming a reduction in government support:
The US is no longer the global leader in clinical trials, having been overtaken by China:
President Trump’s dismantling of the U.S. Agency for International Development has resulted in clinical trials being abandoned around the world. This includes two trials in England for an experimental malaria vaccine:
Johnson and Johnson has cancelled its Phase III randomised, double-blind, placebo-controlled E.mbrace study examining Sanofi’s investigational vaccine ExPEC for extraintestinal pathogenic Escherichia coli (E. Coli) after underwhelming results:
MediWound has commenced a Phase III VALUE trial to assess its bioactive debridement therapy, EscharEx, for treating venous leg ulcers. The trial will take place across 40 European and US sites, and enrol 216 subjects:
Mumbai-based company Aveo Pharmaceuticals is illegally exporting highly addictive opioids to West Africa and driving major public health crises in countries including Ghana, Nigeria, and Cote D'Ivoire, a BBC Eye investigation has revealed:
Johnson and Johnson’s fully subcutaneous Tremfya (guselkumab) has shown a second round of success in ulcerative colitis (UC), with 27.6% of patients achieving clinical remission in a Phase III trial:
Labcorp is to spin off its wholly-owned Clinical Development business to the company shareholders, resulting in two independent, publicly traded companies: Labcorp, an international laboratory business of routine and esoteric labs; and the Clinical Development business will be a CRO providing Phase I-IV clinical trials:
In 2024, the NIHR Biomedical Research Centre at the Royal Marsden have successfully recruited patients across the UK for 28 clinical trials, four trials in Europe and two trials globally:
Moderna was the biggest industry sponsor of clinical trials in the UK in 2023/24. Twenty percent of participants in industry-sponsored clinical research were enrolled in a Moderna trial during this period, an increase from 14% in 2022/23:
europeanpharmaceuticalreview.com
Infection by the COVID-19 virus substantially increases the incidence of neurological disease, heart attack and stroke. With c. 6% of U.S. adults suffering from long COVID, more well-designed clinical trials are desperately needed to help these millions of people return to normal life:
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%.
