January 2022
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Pfizer’s Paxlovid pill as a COVID-19 treatment. It takes the form of an antiviral medicine and is a combination of active ingredients PF-07321332 and ritonavir:
It is likely that the disease multiple sclerosis (MS) is a complication of infection by the Epstein-Barr virus. The breakthrough findings have arisen from a dataset of 62 million serum samples taken from over 10 million US military personnel over two decades:
UK Covid testing megalabs “a mistake” in surge:
Dr Ruth March and Dr Julia Thompson, both working at AstraZeneca's Cambridge headquarters, have been awarded OBEs in the New Year Honours for their roles in responding to the Covid-19 pandemic:
A self-amplifying mRNA second generation SARS-CoV-2 vaccine booster aimed at tackling multiple variants of the virus has shown promise in inducing a comprehensive immune response in first results of a phase one trial:
AstraZeneca has announced that preliminary trial data showed that its Covid-19 shot, Vaxzevria, generated an increase in antibodies against the Delta, Omicron and other variants when given as a third booster dose:
As more people are vaccinated, there are dwindling numbers of COVID-19 patients to evaluate. Going forward, carrying out clinical trials is going to be much more complicated:
A new report “Global Market for Contract Research Organization (CRO) Services” shows stellar growth for the market,, particularly for services in clinical trials between Phases II and IV, which account for approximately 60% of total CRO revenue:
The COVID mRNA vaccines manufactured by Pfizer-BioNTech and Moderna drew upon long-buried discoveries made in the hopes of ending past epidemics:
Pfizer, Moderna, Regeneron and many other healthcare companies presented at the 40th annual J.P. Morgan Healthcare Conference and outlined their plans to continue fighting COVID this year:
February 2022
The Clinical Trial Regulation (CTR) came into force in the European Union on 31 January 2022 and, with it, the Commission guidelines on Good Manufacturing Practice for investigational medicinal products for human use (more commonly known as the revised Annex 13 of EU GMP). The new EU CTR will not be applicable in the UK where requirements will remain unchanged pending completion of the consultation on new proposals for the future of UK clinical trial legislation:
Cambridge data company Qureight has raised £1.5 million in seed funding to develop what is described as the world’s only AI-powered platform dedicated to complex diseases. The technology has the potential to reduce dramatically the costs of bringing life-saving drugs to the market and shorten clinical trials:
The Novavax Covid jab has become the fifth approved for use in the UK and is licensed as a two-dose schedule for over-18s. It involves molecules from a rare South American tree and cells from the immune systems of moths. A worldwide clinical trial of 50,000 participants found it to be 100% effective in preventing “moderate and severe disease” from the coronavirus:
www.nursinginpractice.com/clinical/vaccinations-and-infections/two-dose-novavax-covid-vaccine-approved-for-use-in-uk and www.pressandjournal.co.uk/fp/lifestyle/health-and-wellbeing/3790254/how-does-novavax-covid-vaccine-work
On 27 January Moderna announced that volunteers had received the first doses of its experimental mRNA-based HIV vaccine, mRNA-1644, as part of a phase 1 trial to test the safety and efficacy of this approach:
www.gavi.org/vaccineswork/could-mrna-vaccines-protect-against-hiv
In a ground-breaking development for paralysed people, the revolutionary peptide-based injectable NV-291 treatment for spinal cord injury is set to undergo Phase II clinical trials in Chicago later this year:
www.healtheuropa.eu/big-boost-for-nervgens-phase-ii-clinical-trials/112797
Advances in imaging that can map a virus's atomic structure offer new hope in treating some of the trickiest diseases, such as the deadly Crimean-Congo haemorrhagic fever:
COVID-19 diagnostics, therapeutics and vaccines are powerful reminders: health technologies can help to shape the way in which societies control disease. The first step in achieving that is a clearer articulation of what R&D in the global public interest is:
www.nature.com/articles/d41586-022-00324-y
Eurofins Clinical Testing Lux Snarl, a subsidiary of Eurofins Scientific, has acquired Genetic Testing Service SC, the market leader in specialised genetic testing in Vietnam:
www.businesswire.com/news/home/20220209005807/en
Data from human trials of India’s first home-grown mRNA COVID-19 vaccine, which is being developed by Pune-based Gennova Biopharmaceuticals, are likely to be presented to authorities for evaluation by the end of this month, with the product launched before April:
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) is publishing a three-part blog reflecting on learnings about prioritising the processing and reviewing of all applications for COVID-19 therapeutics and vaccines trials during the pandemic.
This is part 1: mhrainspectorate.blog.gov.uk/2022/02/08/regulators-experience-of-clinical-trials-during-the-covid-19-pandemic-part-1-our-initial-response
The industry is moving rapidly to embrace decentralized clinical trials (DCTs), but there are key areas of uncertainty as to how DCTs sit within the legal and regulatory framework. This article from Baker McKenzie looks at some aspects to be aware of, but should not be construed as legal advice:
patentlawyermagazine.com/wp-content/uploads/2022/02/LSL_Issue-6_interactive.pdf
April 2022
Big pharma sponsors of clinical trials are putting hundreds of studies on hold in Russia, Ukraine and Belarus as the conflict continues:
The virtual clinical trials market is worth $8bn and growing at a rate of more than 10% annually as CROs rush to add decentralized capabilities, according to Medi-Tech Insights:
AstraZeneca has received UK regulatory approval for its long-acting COVID-19 antibody treatment Evusheld. The British-Swedish drugmaker plans even greater drug development success at its new £1bn research lab in Cambridge which, with 16 labs and 2,200 scientists, will become the biggest science lab in Britain along with the Francis Crick Institute in London when fully occupied:
After global clinical trials, an anti-inflammatory therapy identified using artificial intelligence has been shown to reduce deaths in patients hospitalised with COVID-19 by 13%. Baricitinib is an oral JAK inhibitor owned by Eli Lilly and approved for rheumatoid arthritis:
The clinical research industry has set recruitment of diverse patient populations in its sights, yet trial teams still often struggle to hit such targets. Katherine Vandebelt, global head of clinical innovation with Oracle Health Sciences, speaks about the obstacles on the path and how they might be overcome:
A report from Research and Markets looks at The “Clinical Trials Software Market: Distribution by Type of Deployment, Type of Delivery, Features of software and Geographical Regions, Industry Trends and Global Forecasts, 2022-2035”. The software enables trial participants to take part from home rather than traveling to a study location:
An interview with Dr. Paresh Malhotra, Consultant Neurologist at Imperial College Healthcare NHS Trust and Divisional Director, Northwest London NIHR Clinical Research Network, about what the future holds for patient centricity within clinical trials and the benefits of this approach:
The Starlab Group, a European supplier of laboratory products with a UK division, has conducted a survey of more than 200 laboratory employees from the UK, Germany, Austria, Italy and France to assess the challenges they face. The results can be accessed from this article:
Global Health Drug Discovery Institute (GHDDI) in Beijing is expected to start clinical trials for two small molecule COVID-19 drugs this year as Omicron once again strikes Chinese cities:
Fujifilm Toyama Chemical Co. has announced a pause in enrolment, as of the end of March, in the Phase III clinical trial in Japan of its anti-influenza drug Avigan Tablet (favipiravir), targeting patients infected with COVID-19 because of the recent spread of the Omicron variant that has lower symptom severity rates:
The UK’s private testing laboratory network must be maintained as COVID-19 tests reduce, says Cambridge Clinical Laboratories CEO, Dr Anthony Cooke, speaking after being announced as chair of the scientific advisory board for The Laboratory and Testing Industry Organisation:
Health officials are closely monitoring a new recombinant (hybrid) coronavirus variant - Deltacron- carrying genes from both the delta and omicron variants, but experts believe it is “probably not going to elevate to a variant of concern level.”
Cancer, diabetes, Alzheimer’s, heart disease, ageing, and severe COVID-19 have all been linked to damage from inflammation. Now scientists are working to find new drugs that may revolutionize treatments for dozens of diseases:
Nagasaki University and Kirin Holdings Co. in Japan have started a clinical study to investigate the effect of using Lactococcus lactis strain Plasma (LC-Plasma), which has the function of enhancing the immune response, to relieve COVID-19 symptoms:
Microbiotica, a Cambridge-based healthtech company that has created an artificial intelligence platform to develop personalised medicines, has secured £50mn in a Series B funding round. It will conduct clinical trials later this year for two of its microbiome-based therapeutics in immuno-oncology and ulcerative colitis:
A recent non-peer-reviewed study explored neutralization of SARS-CoV-2 Omicron variant by sub-unit vaccine boosters and concluded that an additional booster vaccination using Omicron-RBD proteins could improve the human humoral immune response against the SARS-CoV-2 WT and emerging VOCs:
Clinical trials are underway in the USA to understand the efficacy of treating the root cause of Alzheimer’s before symptoms start. The drugs under scrutiny are all antibodies that have been developed to target and clear amyloid-β proteins in the brain:
Actigen, based in St John’s Innovation Centre, Cambridge, is leading clinical trials for a pioneering new therapy, GNR-055, that could transform the treatment of MPS II (Hunter syndrome), a serious rare disease affecting one in 100,000–170,000 births. Actigen’s clinical trial work forms part of a global strategic partnership with international pharmaceutical company Generium who manufactures one of the COVID-19 vaccines:
June 2022
At the World Economic Forum in Davos, Pfizer Inc. has pledged to provide 23 vaccines and medicines, including cancer and inflammatory disease treatments, to 45 low-income countries around the world on a non-profit basis:
American national pharmacy chain Walgreens has announced the launch of a clinical trial business, with the aim of leveraging its presence in diverse communities to increase racial and ethnic diversity in clinical trials. Some 20 percent of drugs have a variation in responses across ethnic groups, yet 75 percent of clinical trial participants are white, while only 11 percent are Hispanic and fewer than 10 percent are Black and Asian:
The UK’s Health Research Authority is calling for the closure of clinical trials that are not viable in order to free up precious NHS resources for those that can be completed. Evaluation of studies that may be ended is being undertaken by the NIHR Clinical Research Network (CRN): transparimed.org/single-post/dhsc-hra-clinical-trial. The NIHR notes that these activities align with its document ‘Saving and Improving Lives: the future of UK clinical research delivery’ published March 2021:
www.gov.uk/government/publications/the-future-of-uk-clinical-research-delivery
A new market study published by Global Industry Analysts Inc., "Contract Research Outsourcing - Global Market Trajectory & Analytics", shows the industry experiencing rapid growth to 2026 with the mounting pressure on pharma and biotech companies to lower costs and augment productivity:
Moderna Inc. is testing potential vaccines against monkeypox in pre-clinical trials as the disease spreads in the United States and Europe:
A buyer has been found for the 'world-class' pharmaceutical complex owned by Novartis in Grimsby. US-based International Process Plants has taken it on under new subsidiary Humber Industrials Ltd:
www.grimsbytelegraph.co.uk/news/grimsby-news/buyer-novartis-grimsby-outlines-what-7126327
A report from the National Academies of Sciences, Engineering, and Medicine mandated by Congress and sponsored by the National Institutes of Health (NIH) concludes that underrepresentation of ethnic and racial groups in US research and clinical trials compounds the disparities in health outcomes in these groups and should be corrected urgently:
The report, "Contract Research Organization (CROs) Services Market by Type (Early phase, Clinical, Lab, Consulting), Therapeutic Area (Oncology, Infectious Disease, Neurology, Immunology, Hematology, Vaccines), End User - Global Forecast to 2027" predicts the global CRO services market will grow at a CAGR of 11.0% to 2027, with the data management services segment accounting for the highest growth rate:
According to new preclinical data from the University of Oxford, AstraZeneca’s Evusheld, AZD7442, retains potent neutralising activity against Omicron BA.2, the current dominant circulating variant, and neutralises all emerging variants tested to date:
www.pmlive.com/pharma_news/results_released_from_new_study_of_astrazenecas_covid-19_antibody_1449249
Abundant SAR-CoV-2 research publications are now available to help researchers identify COVID-19 repurposing drugs; and it is possible to validate these associations from evidence extracted from clinical trials designed to study these drugs:
www.mdpi.com/1999-4923/14/3/567
Cambridge Design Partnership has conducted a study of lateral flow tests to assess why they use so much plastic and how they can be made sustainable, with results that could affect the billions of tests that will be made as a commercial product sold to the public rather than being made available via the NHS in the next couple of years:
July 2022
More than 18,000 cases of monkeypox from 78 countries have been reported to the World Health Organisation, with more than 70% of cases identified in Europe and 25% in the Americas. The virus has also claimed its first lives outside Africa - one in Brazil and two in Spain:
The lack of diversity in clinical trials unfairly skews American medicine and costs billions of dollars a year in early deaths and poor health. The scope of the problem was laid out in a new report Improving Representation in Clinical Trials and Research. Building Research Equity for Women and Underrepresented Groups from the National Academies of Sciences, Engineering, and Medicine (free here):
In 2018 and 2019, multiple Alzheimer's and dementia trials ended earlier than planned. A multidisciplinary workgroup convened by the Alzheimer’s Association® in the USA has released 17 recommendations for clinical trial sponsors, researchers and staff about how to better communicate with study participants when trials stop sooner than expected:
Oxford Cannabinoid Technologies has announced clinical trial dates for its two products. Compound OCT461210, for neuropathic and visceral pain, will enter phase 1 trials in Q1 2023, and OCT 130401, an inhaled treatment for trigeminal neuralgia, will enter the clinic in Q3 this year. CRO Simbec Research will carry out phase 1 testing:
In a Viewpoint paper published in Communications Medicine, people who have been involved in clinical trials in a variety of roles discuss how clinical trial participants can be involved in clinical trials and how their involvement can maximise trial success and improve the patient experience:
Biotech Axcella Therapeutics is in discussions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a registrational trial of AXA1125 in the UK and USA in patients experiencing moderate-to-serious fatigue with long Covid-19. Regulatory conversations with the US Food and Drug Administration (FDA) will begin in the “near term”:
The US Food and Drug Administration (FDA) is inching closer to allowing human clinical trials for inter-species organ transplants, known as xenotransplants, specifically pig-to-human:
Amazon is developing cancer vaccines in collaboration with the Fred Hutchinson Cancer Research Center, and it recently launched an FDA-approved phase 1 clinical trial (of 20 participants over the age of 18) evaluating “personalised vaccines” for melanoma and breast cancer:
A lack of comprehension and monitoring of the ClinicalTrials.gov may be hindering access to trial information, holding up drug study results, and undermining rules designed to promote transparency. But neither the agencies nor staff overseeing the database routinely monitor individual trial records for veracity, and many studies could be in violation of US reporting regulations:
COVID-19 has put the UK in the grip of psychological crisis with the numbers suffering from distress twice as high as they were before the pandemic, according to the latest findings of The Covid-19 Rapid Survey of Adherence to Interventions and Responses (CORSAIR) study, led by University College London and King’s College London:
December 2022
As of 1 October, it was no longer possible to use the eSUSAR website as a means of expediting suspected unexpected serious adverse drug reactions (SUSARs) from clinical trials to the European Eudravigilance Clinical Trial Module, as eSUSAR was decommissioned by the Medicines and Healthcare products Regulatory Agency (MHRA):
Trinity Investment Management have acquired the Grafton Centre, Cambridge, and are consulting on proposals to re-develop the area into a combination of new life sciences research/laboratory, retail and community amenity space. Cambridge saw £1.21bn of life science related capital raised in 2020 but growth is constrained by lack of lab space:
cambridgeindependent.co.uk & graftoncentreconsultation.co.uk
The life sciences sector team of global law firm DLA Piper has created a Guide to the main privacy-related issues arising within clinical trials in 25 jurisdictions including extraterritorial applicability of legislation; legal ground for processing personal data; and key-coded clinical trial data:
A research paper evaluates the impacts of COVID-19 on clinical research in a research-intensive NHS Trust in London and how the embedded research system was adapted and repurposed to support the COVID-19 response:
journals.plos.org/plosone/article?id=10.1371/journal.pone.0256871
Roche has announced its drug, Gantenerumab, showed no clear benefit in twin trials which explored its impact on memory, problem solving and other cognitive skills in people with early stage Alzheimer’s:
The first clinical trials of the Tecovirimat (also known as Tpoxx) monkeypox treatment have been started in the UK by academics from the University of Oxford who were behind the Covid Recovery trial. They are hoping to recruit 500 people:
IQVIA has entered a long-term partnership with Clalit Health Services to open the first Prime Site in Israel. Clalit operates 14 hospitals and over 1,600 primary care clinics in Israel, and IQVIA provides a software as a service-based (SaaS) clinical data analytics platform for clinical trials:
Australian biotechnology company Vaxxas has announced the start of its Phase I clinical trial of a needle-free COVID-19 vaccine, delivered via a high-density microarray patch (HD-MAP), giving potential coverage of all major SARS-CoV-2 variants. If successful in further clinical trials the vaccine patch could be available as early as 2025:
The European Pharmaceutical Review rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022 which took place from 5-7 November:
europeanpharmaceuticalreview.com
President Joe Biden has issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing:
According to Grand View Research, the global healthcare contract research organisation (CRO) market size is expected to reach USD 74.7 billion by 2030. The market is expected to expand at a CAGR of 6.5% from 2022 to 2030:
Sobi has received emergency use authorisation from the US Food and Drug Administration for the use of arthritis drug Kineret (Anakinra) in the treatment of COVID-19 related pneumonia. The authorisation was based on a Phase 3 trial on hospitalised patients needing supplemental oxygen which showed reduced progression to respiratory failure and mortality:
