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:
