October 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) expects the new UK clinical trial regulation framework to be implemented by January 2026. It will ensure patients and their safety are the focus of all clinical trials:
A study by SkyQuest Technology projects that the global clinical trials market will be worth $102.12 billion by 2031, with a CAGR of 8.7% between 2024-2031. The growth will be driven by sedentary lifestyles causing increases in diseases such as genetic mutations, diabetes, malaria, HIV, tuberculosis and obesity. A sample report is available:
A slightly less bullish study by Straits Research values the global clinical trials market size as $50.02 billion in 2023, and estimates it will reach $85.37 billion by 2032, growing at a CAGR of 6.12% between 2024-2032. A sample report is available:
A new immunotherapy treatment regimen (nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD)) provided a significant survival rate in advanced Hodgkin lymphoma patients, Phase III trial data shows. The lead study investigator was Dr Jonathan Friedberg, MMSc, University of Rochester Medical Center, US. Summary here:
The US Food and Drug Administration (FDA) has published guidance for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials (e.g. telehealth visits , in-home visits, and visits with local health care providers).
Download here: www.fda.gov
ResearchAndMarkets.com is offering a new report The ‘India Clinical Trials Market, By Region, Competition, Forecast & Opportunities, 2020-2030’. The market was valued at $2.05 billion in 2024 and is anticipated to project impressive growth in the forecast period with a CAGR of 8.64% through 2030:
Pharmaceutical Technology has compiled a Buyer’s Guide list of companies that assist with clinical research, including assistance for formulation development, pre-clinical trials, clinical manufacturing, clinical trials, and regulatory services. It also includes contract research organisations (CROs). The guide is free (sign-up required):
www.pharmaceutical-technology.com
It will be easier to recruit over-65s in the UK into clinical trials for conditions like cancer, cardiovascular disease, diabetes, Parkinson’s, Alzheimer’s and stroke thanks to a technology-based initiative from healthtech company Cera:
New life science research buildings will be built on Cambridge Biomedical Campus: two six-storey laboratory and office buildings, called 2000 and 3000 Discovery Drive, off Dame Mary Archer Way. We continue to believe there is no need for clustering in the Life Sciences industries – and additional concentration in water-stressed Cambridgeshire is entirely unnecessary.
www.cambridgeindependent.co.uk
The World Health Organisation (WHO) has released guidance to improve the design, conduct and oversight of clinical trials in countries of all income levels. A PDF of the guidance is available:
A UK challenge study of unvaccinated volunteers who contracted mild COVID-19 showed significant memory and executive function decline lasting up to a year, despite no reported subjective symptoms. A PDF of the study is available:
August 2024
The massive and increasing scale of healthcare industry data breaches makes it essential that Pharma companies invest in the right cyberinfrastructure to protect patient data and continue clinical trial operations, and that they partner with companies that offer robust redaction and data-safeguarding services:
In clinical trials, a single high dose of the psychedelic psilocybin (25 mg) has demonstrated rapid and sustained symptom relief in depression, addiction, and end-of-life anxiety:
Canadian company InMed Pharmaceuticals has released preclinical data indicating its proprietary, small molecule compound, INM-901, has the potential for disease-modifying effects and to reverse neuronal damage associated with Alzheimer’s disease:
Yet another new life science and research development has been approved for the Westbrook Centre off Milton Road in Cambridge, UK, after water usage concerns were addressed by the developer:
www.cambridgeindependent.co.uk
Dr Yemi Akala, an Early Phase Clinical Trials Fellow based at Leicester’s Hospitals, asks whether decentralised clinical trials can become mainstream for cancer:
Ireland’s Minister for Health, Stephen Donnelly, has announced the formation of a National Clinical Trials Oversight group tasked with developing strategies to increase the number of clinical trials conducted in Ireland:
Türkiye is emerging as a significant player in clinical trials. The country’s alignment with European Union regulations, despite not being an EU member, provides an additional layer of credibility for international collaborations:
The UK’s health and social care secretary, Wes Streeting, has announced that the NHS will push forward with a clinical trial to establish evidence on puberty blockers, after the High Court ruled an emergency ban on them was lawful:
Boehringer Ingelheim has acquired drug discovery and development company Nerio Therapeutics in a $1.3bn deal to strengthen its immuno-oncology portfolio:
www.pharmaceutical-technology.com
The European Federation of Pharmaceutical Industries and Associations (EFPIA), has commended inclusion of a “dedicated life sciences strategy”, including the introduction of the European Biotech Act in 2025, in the Political Guidelines (PDF) for the Next European Commission 2024-2029.
The Medicines & Healthcare products Regulatory Agency (MHRA) has approved a first-in-class drug, capivasertib (Truqap), in combination with fulvestrant, for treating the most common type of advanced breast cancer following a successful international Phase III trial:
Obesity drugs are driving revenue growth in the world’s top biopharmaceutical companies, following the decline in demand for Covid-19 products:
www.pharmaceutical-technology.com
July 2024
An assessment of how the UK’s new Labour government will support the clinical trials industry:
The Revised CTIS Transparency Rules as adopted by the European Medicines Agency (EMA) now apply, and will impact patients, health care professionals and sponsors:
The US Food and Drug Administration (FDA) has released a draft guidance ‘Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies’, detailing the requirements for diversity action plans for certain clinical trials:
Pharmaceutical company Gilead has announced that its new pre-exposure prophylactic (PrEP) injectable medication lenacapavir has passed a Phase III clinical trial. The twice-yearly injectable medication protected cisgender women from HIV in 100% of cases:
Leeds Teaching Hospitals NHS Trust has proudly announced the remarkable and life-changing outcomes of its clinical trials. Between April 2023 and March 2024, the Trust enrolled 25,695 participants across 760 active studies, with an additional 22,113 participants engaged in National Institute for Health and Care Research (NIHR) portfolio studies:
In June, the European Medicines Agency’s human medicines committee (CHMP) recommended ten new products for approval and granted therapeutic extensions for eleven drugs. In the last six months, the watchdog approved 57 new medicines and new indications for 40 existing products:
A new MediMab Biotherapeutics facility has opened at Abingdon Science Park, furthering its offering of immuno-oncology drugs and strengthening its network of local biopharmaceutical companies. The Park is over 500,000 sq ft, and is home to companies such as Genefirst, Sherlock Biosciences, Akamis Bio, Penlon, Scilogica and Oxdevice:
Eli Lilly has revealed results from the SURMOUNT-OSA Phase III clinical trials where tirzepatide lowered the severity of moderate-to-severe obstructive sleep apnea in obese adults irrespective of positive airway pressure (PAP) therapy status:
The My Name’5 Doddie Foundation set up by the late Scottish rugby legend Doddie Weir is investing more than £500,000 in motor neuron disease clinical trials. The investment will be spread across multiple UK centres:
Clinical trials have been initiated to test whether the epilepsy drug stiripentol, which targets lactate, makes chemotherapy work again, and for longer, in people with stomach cancer who have become resistant to treatment:
Leading industry publication in biotech and pharma, BioPharma Dive, highlights ten clinical trials to watch in the second half of 2024:
The Indian Council of Medical Research (ICMR) has selected four institutions to build a network of Phase I clinical trial units (CTUs) across the country:
June 2024
The conclusion in the final report from the seven-year inquiry into the UK infected blood scandal is that patients - including haemophiliac children enrolled in clinical trials - were knowingly exposed to risks between 1970 and 1991. 30,000 people were infected with hepatitis C and HIV, a medical catastrophe that could have been avoided:
Takeda and Pfizer have announced a positive Phase III HD21 trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for patients with newly diagnosed Hodgkin lymphoma:
Thousands of cancer patients in England are gaining fast-tracked access to trials of personalised cancer vaccines following the launch of NHS England’s new Cancer Vaccine Launch Pad (CVLP):
The Southampton Clinical Trials Unit, based at the University of Southampton’s Centre for Cancer Immunology, is running the CVLP programme nationally:
India’s TheraNym Biologics Pvt Ltd, a wholly-owned subsidiary of Aurobindo Pharma, has entered into a master service agreement with Merck Sharpe & Dohme Singapore for contract manufacturing of biologicals for the domestic and international markets:
Visiongain’s report ‘Decentralised Clinical Trials Market Report 2024-2034’ values the global market at $9,231.3 million in 2024. This is expected to register a CAGR of 7.6% from 2024 to 2034 on the back of growing demand for ‘real-world evidence’ (data gathered outside the controlled confines of clinical trials, often sourced from electronic health records, claims databases, wearables, and patient-reported outcomes):
Charles River Laboratories, headquartered in Wilmington, MA, and Sanofi are collaborating on a project in which virtual control animals will take the place of live ones in preclinical research. The project will utilise a vast, historical database of study parameters:
Moderna and partner Merck & Co have announced that their mRNA cancer vaccine in combination with therapy Keytruda improved survival rates in a mid-stage study in patients with melanoma (combination therapy survival rate of 96%, compared with 90.2% on Keytruda alone):
A new report, "Global Cell and Gene Therapy Clinical Trials Market Analysis & Forecast to 2024-2034" predicts that the global cell and gene therapy clinical trials market will reach $43.17 billion by 2034 with a CAGR of 14.81% - a rise from $9.45 billion in 2023:
UK-based Celadon Pharmaceuticals Plc, that specialises in the development, production, and sale of cannabis-based medicines for non-cancer chronic pain caused by e.g. fibromyalgia, multiple sclerosis and arthritis, is seeking up to 5,000 participants in a main clinical trial:
New Phase III trial results show AstraZeneca’s human monoclonal antibody IMFINZI® (durvalumab) has demonstrated statistically significant and clinically meaningful improvements in survival rates in lung cancer, reducing the risk of death by 27% versus placebo:
europeanpharmaceuticalreview.com
May 2024
With a UK general election likely this year, the National Health Service is the second most important issue for voters, but how are the three main political parties responding:
www.clinicaltrialsarena.com/features/explainer-uk-election-2024-healthcare-outlook
The UK Secretary of State has granted permission on appeal for 425 new homes plus five buildings including for life sciences R&D on land north of Cambridge North Station, as it would support the government’s vision for the city:
The US Environmental Protection Agency (EPA) is banning many uses of methylene chloride, but it will remain legal for producing refrigerant chemicals, batteries for electric vehicles, plastic and rubber manufacturing, as well as military and other federal use. It will also remain legal for uses such as pharmaceuticals and food which are overseen by the Food and Drug Administration (FDA):
www.theguardian.com/environment/2024/apr/30/epa-methylene-chloride-ban
Researchers from UCLA have discovered a vaccine effective in rats against the tropical disease melioidosis which causes 89,000 fatalities a year. It is so dangerous it is classified as a Tier 1 Select Agent of bioterrorism. The next stage is to test in a second animal model:
www.emergingrisks.co.uk/major-breakthrough-made-in-bioterrorism-fight
Worldwide Clinical Trials, a leading global, full-service contract research organisation, has been recognised for excellence in all five categories in the 2024 CRO Leadership Awards based on direct survey feedback from pharmaceutical and biotech professionals:
Paris-based startup Klineo has raised €2mn for its AI platform that connects doctors and patients directly with relevant clinical trials on skin cancer, breast cancer, and lymphoma:
thenextweb.com/news/startup-bags-e2m-cancer-clinical-trials-more-accessible
A legal action has been launched by about 75 claimants against AstraZeneca over a rare side effect of Vaxzevria, its covid-19 vaccine. Millions of people had no complications from the vaccine, but a tiny number developed vaccine-induced thrombotic thrombocytopenia which involves blood clots along with abnormally low platelet levels:
www.bmj.com/content/380/bmj.p725
Following positive results from the Phase III BENEGENE-2 study, the US Food and Drug Administration (FDA), has approved Pfizer’s gene therapy BEQVEZ™ to treat the rare blood disorder haemophilia B in some adults:
www.europeanpharmaceuticalreview.com/news/227752/novel-haemophilia-b-gene-therapy-approved
Over the past 10 years, clinical trials in India have become easier, more accessible and accelerated, and top multinationals are increasingly looking at the country as their base for clinical trials:
Hammersmith Medicines Research, which undertakes clinical trials with healthy volunteers, is seeking participants for paid trials on treatment resistant depression, autism spectrum disorder, mild to moderate asthma, Crohn’s disease, schizophrenia, inflammatory conditions such as rheumatoid arthritis, and Alzheimer's disease:
Australia-based biopharma company MindBio Therapeutics Corp. has obtained approvals for two clinical trials in women’s menstrual health using its proprietary LSD drug, MB22001:
Myeloma Patients Europe (MPE) has launched the English version of the Myeloma and AL Amyloidosis European Clinical Trial Navigator to facilitate the search of clinical trials for myeloma, monoclonal gammopathy of undetermined significance (MGUS), smouldering multiple myeloma (SMM) and AL amyloidosis:
April 2024
Free visitor registration is now open for the inaugural London Biotechnology Show which will take place at Olympia West on 8-9 May 2024:
A report by Roots Analysis has highlighted how the outsourcing of manufacturing activities to contract manufacturers is facilitating more streamlined and efficient pharmaceutical drug development:
europeanpharmaceuticalreview.com
Bharat Biotech International Ltd and Biofabri have begun adult clinical trials in India to evaluate the safety, immunogenicity and efficacy of MTBVAC - the first vaccine against tuberculosis derived from a human source. TB kills over 1.6mn people and infects 10mn+ worldwide each year:
The CRO Clario (formerly ERT and Bioclinica) has acquired AI company ArtiQ to integrate AI into respiratory clinical trials:
According to Virtue Market Research, in 2023 the Global AI in Clinical Trials Market was valued at $1.8 Billion, and is projected to reach a market size of $8.27 Billion by 2030. Over the forecast period of 2024-2030, the market is projected to grow at a CAGR of 21%:
Germany aims to improve its global ranking for biopharmaceutical production and R&D in terms of the number of clinical trials it conducts with a new Act, the Medical Research Act (Medizinforschungsgesetz). The country fell from 2nd to 6th place worldwide between 2016 and 2021:
India-based Veeda Clinical Research has acquired Heads, a European CRO with 25 locations in Europe, North America and the Asia Pacific. Heads manages all phases of clinical trials, particularly for biotechs and pharmas specialising in haematology and oncology:
The 14th Annual Outsourcing in Clinical Trials Europe 2024 conference will take place at Hyatt Regency Barcelona Tower, Barcelona, Spain on 7-8 May 2024:
As part of the commitment to achieving the Grand Challenge 2 (“Delivering Automated Just-In-Time Clinical Supply”) by the UK-based Centre for Process Innovation (CPI), CME Automation Systems is testing a new multi-product modular automation line, known as PACE, at the Medical Manufacturing Innovation Centre (MMIC) in Strathclyde:
pharmaceuticalmanufacturer.media
Since 31 January 2023 all applications for new clinical trials have had to be submitted under the legal framework of the Clinical Trials Regulation (Regulation EU/536/2014, CT Regulation). By 31 January 2025 all clinical trials that have been authorised under the former CT Directive and have at least one active clinical trial site on that date will have to be transitioned to the CT Regulation:
Sweden‘s life sciences industry is witnessing a continued increase in export values. At SEK 152.5 billion, exports of pharmaceuticals reached 7.3% of Sweden’s total export value, an almost 10% increase since 2022.
europeanpharmaceuticalreview.com
March 2024
A new report from Straits Research projects the Global Clinical Trials Software Market will reach $3,947.13mn by 2031, growing at a CAGR of 15.55%. This is partly attributable to new clinical trial methods making clinical research more cost-effective:
Straits Research also report that the global paediatric clinical trials market size is estimated to reach $22.69 billion by 2030, growing at a CAGR of 5.24 %:
The most recent monthly data from the EU Trials Tracker dates from 2 March 2024. See which universities and pharmaceutical companies are reporting the results of their clinical trials, and which aren't. Due to Brexit, as of 1 January 2021 the UK no longer registered trials on the EUCTR:
A new clinical trials report from PA Consulting suggests biopharma companies are not keeping pace with changing public attitudes. Some 65% of Americans are willing to share their medical data across multiple studies if it could help accelerate the development of new treatments:
Oncology CRO Sarah Cannon Research Institute (SCRI), has signed a deal with AstraZeneca to provide clinical trial solutions for the Big Pharma's clinical cancer trials in the U.S. The partnership will enhance US enrollment and streamline data collection:
The negotiation of a “pandemic treaty” to set the rules for international cooperation in future public health crises, due to be ratified at May’s World Health Assembly in Geneva, is mired in dispute. African nations want pharmaceutical companies to pay an annual fee to support sharing of new pathogen information, plus access to any resulting medical products – but Big Pharma won’t agree:
India has conducted the first human clinical trial of gene therapy for ‘haemophilia A’:
The McKinsey Action 9 Fireside Chat series panel discussion on accelerating clinical trial diversity can be heard here:
Panellists included representatives from McKinsey, the FDA, Pfizer, and Yale School of Medicine.
Over 18% of the global population lives in Africa, but less than 3% of clinical trials are conducted there. Experts at the Clinical Trial Supply (CTS) Europe meeting say there are opportunities to expand – particularly in South Africa, Nigeria, Egypt, Tanzania, and Ghana:
www.pharmaceutical-technology.com
A clinical trial that will assess whether the anti-inflammatory drug dapansutrile could help treat Parkinson’s disease will be carried out with 36 patients at Addenbrooke’s Hospital, Cambridge, UK. Parkinson’s is the fastest-growing neurological condition in the world:
www.cambridgeindependent.co.uk
The REACT study by Imperial College London of 112,964 patients with Long Covid has demonstrated a measurable impact on memory and cognition a year after Covid-19 infection:
Patient enrollment is now complete for a clinical trial of 4B Technologies’ AI-discovered Amyotrophic Lateral Sclerosis (ALS) drug supported by Insilico Medicine, an American biotechnology company based in Hong Kong. ALS, also known as Lou Gehrig’s disease or motor neurone disease, is currently always fatal:
A patient has recovered from terminal prostate cancer after enrolment in a clinical trial testing a precision therapy that combined niraparib, a cancer drug that inhibits cancer cells from repairing damaged DNA, and abiraterone, a hormone therapy:
PCM Trials has acquired EmVenio to enhance recruitment and retention of underrepresented minority groups in decentralised clinical trials. In January, PCM Trials also completed the acquisition of Netherlands-based Clinical Trial Service (CTS) to broaden its global capabilities:
February 2024
A reminder that all ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025, the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU:
Training and supporting materials are available from the European Medicines Agency (EMA) to help users of the CTIS comply with their legal obligations:
Research on the global Clinical Trials Management System (CTMS) market indicates a value of $1.26 bn in 2023, and an anticipated to exponential compound annual growth rate (CAGR) of 16.65%, reaching $3.71bn by 2030:
Sano Genetics in Cambridge, UK, has raised $11.4m to shorten the duration – and, therefore, costs - of clinical trials by using AI software to recruit participants:
In related news, consultant Stephen Wunker examines ‘The Promise and Challenge of Deploying AI in Clinical Trials’ using Yseop (pronounced EasyOp), which has offices in Paris, New York and Lyon, as a case study:
Arena International has released the 2024 Edition of its ‘Clinical Trials Supply Handbook’ with features on clinical trials’ operations and logistics, supply chain technology, and cold chain strategies, and a supplier directory:
The FDA has published draft guidance directing clinical trial sponsors to include race and ethnicity information on their proposed product labelling. Once finalised, this will replace the 2016 draft guidance ‘Collection of Race and Ethnicity Data in Clinical Trials’:
The 25th Clinical Trial Supply (CTS) Europe conference will take place in Barcelona from 6th to 7th March. Pharmaceutical and Biotech companies will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations:
2024A meta-analysis of c. 500 clinical trials which took place in New Jersey, USA, from 2017 to 2022 shows increased equity of race/ethnicity reporting and inclusivity of clinical trials, although more needs to be done to ensure that the demographic numbers in these trials match U.S. Census values:
Results from a Phase III, randomised, placebo-controlled clinical trial of the immunotherapy drug Pembrolizumab have - for the first time in fifty years - demonstrated an overall survival benefit from an adjuvant therapy in kidney cancer:
europeanpharmaceuticalreview.com
Cancer specialist Associate Professor Craig Underhill is leading a program to improve cancer outcomes in regional Victoria, Australia, by 2025 by giving patients access to new treatments via participation in clinical trials:
Sandoz, a former division of Novartis, is now a standalone company. It will continue to focus on developing generic and biosimilar medicines for the European medicines market, while Novartis plans to drive its business forward with a strategic focus on innovative medicines:
europeanpharmaceuticalreview.com
January 2024
UK Tech News asked health tech leaders for their predictions on what we can expect in the UK’s health tech sector in 2024:
Ten clinical trials to watch in the first half of 2024. Study results from Vertex, Alnylam and Roche could either speed or stall biotech’s recent momentum:
A look at the potential implications for pharma and biopharma companies operating in Europe of the proposed revisions to EU pharma legislation announced by the European Commission:
europeanpharmaceuticalreview.com
In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation as part of the 2020 Pharmaceutical Strategy for Europe. They impact pharma and biopharma companies operating in Europe. Amendments have since been submitted. This is a very useful overview:
europeanpharmaceuticalreview.com
Johnson & Johnson has agreed to buy drug developer Ambrx Biopharma for $2 billion to gain access to antibody drug conjugates (ADC) which act as “guided missiles” to target cancer cells and minimise damage to healthy tissue:
Novartis has shared positive results from a phase 3 ASC4FIRST head-to-head trial comparing Scemblix (asciminib) against tyrosine kinase inhibitor (TKI) treatment in newly-diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in the chronic phase:
A look at how clinical trials for rare diseases can be made less complex, costly, and inefficient through the use of virtual collaboration solutions:
A nationwide Taiwanese clinical trial involving more than 3 million pregnancies has discovered that benzodiazepine use during pregnancy was associated with a 69% increased risk of miscarriage:
Analysis of electronic medical record data from more than 1.8 million patients in the USA has found a lower risk of new and recurrent suicidal thoughts in those taking Novo Nordisk's Ozempic or Wegovy (semaglutide) compared to those using other weight loss or diabetes medications:
reuters.com
A free report from leading CRO Novotech looks at the latest developments in research for HIV, including long-acting injectables, vaccines, and gene editing. The global HIV clinical trial landscape since 2018 spans over 1,000 trials, led by Asia-Pacific, then Europe and North America:
