The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
A research project led by the University of Liverpool has been awarded over £6m by Unitaid, a global health initiative to prevent, diagnose and treat major diseases in low- and middle-income countries (LMICs) and to advance long-acting therapeutics to treat or prevent tuberculosis, malaria and hepatitis C. First launched in 2020, the LONGEVITY project aims to ensure that therapeutics for these conditions are easily accessible in LMICs as part of the University of Liverpool’s Centre of Excellence for Long-acting Therapeutics (CELT). To date, the project has already accomplished preclinical proof of concept for long-acting medications for tuberculosis, an infectious disease caused by a bacterium that affects the lungs, and a therapy for the hepatitis C virus, which can lead to liver infection. Caused by a parasite transmitted through bites of infected mosquitoes, malaria is responsible for an estimated 247 million cases, according to the World Health Organization’s 2022 World Malaria ...
A project being led by King’s College London (KCL) has received funding from the Department for Science, Innovation and Technology (DSIT) totalling £100,000 to create a platform to boost artificial intelligence (AI)-assisted healthcare for cancer diagnosis. The PharosAI project will develop a platform for AI researchers and companies to access cancer-related datasets to train AI in healthcare settings. One of 12 teams awarded as part of the DSIT’s Research Venture Catalyst Programme, the project will comprise researchers from KCL, Guy’s and St Thomas’s Trust, Bart’s Cancer Institute and Bart’s Health Trust. The platform will help researchers and companies develop, evaluate and deploy NHS-quality AI for cancer diagnosis, offering AI clinical evaluation, deployment, standards validation services and educational programmes. According to the project proposal, researchers aim to develop a data refinery sourced from over 50,000 patient samples from King’s Health Partners Cancer Biobank and the Breast Cancer Now Tissue Bank to ...
Don Tracy, Associate Editor The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets. Johnson & Johnson (J&J) announced that it has agreed to terms on acquiring Shockwave Medical, an intravascular lithotripsy (IVL) technology company focused on coronary artery disease (CAD) and peripheral artery disease. According to J&J, the deal is a part of its strategy to enhance the profile of its MedTech division, with an emphasis on the area of cardiovascular intervention. Shockwave Medical’s IVL technology is described as a minimally invasive treatment for calcified artery diseases that can also lead to reduced blood flow, pain, or heart attacks. Under terms of the deal, J&J is expected to acquire all outstanding shares of the company for $335.00 per share in cash.1 “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, ...
The World Health Organization (WHO) has announced the launch of a generative artificial intelligence (AI)-powered digital health promoter prototype ahead of World Health Day on 7 April. Celebrated annually, World Health Day draws attention to a specific health topic of concern to people globally. This year’s theme, ‘My Health, My Right’, champions the right of everyone, everywhere to have access to quality health services, education and information. The Smart AI Resource Assistant for Health (SARAH) will comprise new language models and cutting-edge technology to engage users across major health topics, including healthy habits and mental health. SARAH aims to provide an additional tool for people to learn their rights to health, by supporting them in developing a better understanding of risk factors for some of the leading causes of death worldwide, including cancer, heart disease, lung disease and diabetes. In addition, the AI assistant can help individuals access up-to-date information ...
myTomorrows has announced a new partnership with a UK-based charity, brainstrust, to support individuals living with brain cancer. The partnership will help equip patients with knowledge of relevant treatment options, participation in clinical trials and access to pre-approved drugs, while supporting clinicians when recruiting patients to relevant clinical trials. Brain tumours affect around 80,000 people in England, with only 12% of patients surviving beyond five years of their diagnosis. As part of the agreement, the charity will provide its patient network with timely, up-to-date and useful information surrounding credible and accessible clinical trials, along with myTomorrow’s expertise and support. In addition, myTomorrow’s trained patient navigators will play a key role as a single point of contact to help guide patients with brain tumours and their loved ones, as well as healthcare professionals, through medical care and help them make the best decisions during their treatment journey. Using a GDPR-compliant ISO ...
CellVoyant – an AI biotechnology spin-out from the University of Bristol – has announced a £7.6 million funding round. Led by Octopus Ventures – with additional participation from Horizons Ventures, Air Street Capital and Verve Ventures – the funding represents the first stage in commercialising CellVoyant’s first of its kind AI and imaging platforms. Meanwhile, the company now aims to enable the rapid development of novel cell therapies. Stem cells unlock a wide range of treatment possibilities that have not historically been available to patients. Indeed, current treatments tend to act on the body’s existing cells, while stem cells have the potential to develop into different cell types in the body – replacing dysfunctional cells or regenerating damaged tissues and organs. CellVoyant’s platform combines advanced AI with live cell imaging to address pain points. The technology can extract spatial and temporal information in real-time from hundreds of millions of cells. ...
Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai Hospital, New York, US, to investigate the use of CK0804, a T-regulatory cell therapy for myelofibrosis. The collaboration aims to explore the therapeutic potential of CK0804, an allogeneic, cord blood-derived T-regulatory cell product enriched with C-X-C chemokine receptor type 4. The research will be led by Ronald Hoffman, director of the Myeloproliferative Disorders Research Program at the Tisch Cancer Institute, Mount Sinai. CK0804 uses Cellenkos’ CRANE technology to create disease-specific cell therapy products. This approach allows CK0804 cells to preferentially target inflamed bone marrow. Cellenkos chief operating officer Tara Sadeghi stated: “We are very excited by our collaboration with Mount Sinai and eagerly anticipate gaining a deeper understanding of [how] mechanisms of CK0804 Tregs work in myelofibrosis, especially to decrease inflammation. “CK0804 is already in a Phase I clinical trial to examine its safety ...
Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical. The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and ...
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