PharmaFocus Today – Page 80 – media

UCL begins first UK deep brain stimulation study for children with rare epilepsy

Lennox-Gastaut syndrome affects up to 5% of children living with paediatric epilepsy A new study sponsored by University College London (UCL) has begun, making it the UK’s first ever deep brain stimulation (DBS) trial for children with epilepsy. In collaboration between Great Ormond Street Hospital, UCL, King’s College London, the University of Oxford and Amber Therapeutics, the Children’s Adaptive Deep brain stimulation for Epilepsy Trial (CADET) pilot intends to recruit three additional patients living with Lennox-Gastaut syndrome (LGS). Affecting around 50 million people worldwide, epilepsy is a neurological condition where sudden bursts of electrical activity in the brain cause seizures or fits. Affecting up to 5% of children with paediatric epilepsy, LGS is a rare and severe form of epilepsy that is characterised by repeated seizures that begin early in life. The study will investigate the safety of a cranially-mounted DBS device called the Picostim with software called DyNeuMo-1, manufactured ...
- Source: drugdu
- 74
- July 1, 2024
IHI’s new funding round to include topics on CVD and arthritis

The initiative’s proposals aim to tackle current challenges in health research and innovation The Innovative Health Initiative (IHI) has launched a new call for proposals, which include topics on cardiovascular disease (CVD) and arthritis, as part of the total budget worth €96.5m to tackle challenges in health research and innovation. As part of the total budget, Horizon Europe, the EU’s research and innovation programme, has contributed €47.6m, while an additional €40.9m comes from the IHI’s industry members, as well as €8.1m from IHI contributing partners. Dr Niklas Blomberg, executive director, IHI, commented: “This call for proposals is an excellent opportunity to be part of ambitious projects tackling major challenges in health research and innovation.” The IHI aims to identify and create models, interventions and best practices to improve the management of CVD in Europe’s cities, covering healthcare delivery, individual lifestyle changes and the living environment. It will include five pilot ...
- Source: drugdu
- 97
- July 1, 2024
FDA shares draft guidance on clinical trial diversity action plans

Dive Brief The Food and Drug Administration published draft guidance on Wednesday for diversity action plans intended to increase enrollment of underrepresented groups in clinical trials. A year-and-a-half after Congress passed legislation requiring clinical trial diversity action plans, the agency explained which device trials must meet the requirements and presented a timeline for implementation. The draft is open for feedback for 90 days, giving sponsors a chance to comment on the FDA’s interpretation of legal requirements such as the need to share enrollment goals in the plans. Dive Insight Congress passed a law in 2022 that would require drug- and device-makers to submit diversity action plans to the FDA. Per the law, the FDA was required to publish draft guidance clarifying the format and content of the diversity action plans by Dec. 29, 2023. In the draft, the FDA says that, while the Act “refers to clinical studies broadly,” it ...
- Source: drugdu
- 107
- July 1, 2024
Philips BiPAP recall now linked to 65 deaths, 952 injuries

UPDATE: June 28, 2024: Philips spokesperson Lu Yu wrote in an emailed statement that Philips does not recognize the number of reported injuries and deaths in yesterday’s FDA notice, and is in dialogue with the agency. The company said it has received reports of 10 serious injury and seven deaths over a 12-year period between 2011 and 2023 for the A30 and A40 devices. No reports of serious patient harm have been reported with the V30 devices, Philips said. Philips’ recall of bilevel positive airway pressure (BiPAP) machines has now been linked to reports of 952 injuries and 65 deaths, according to a Food and Drug Administration notice posted Thursday. Philips began a recall of its V30, A30 and A40 BiPAP machines in March because a false alarm can cause the devices to shut down. The company updated its instructions for use, but is not removing the affected devices from ...
- Source: drugdu
- 67
- July 1, 2024
Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma

Don Tracy, Associate Editor Reportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma. Results from the IMROZ Phase III trial show that Sanofi’s Sarclisa (isatuximab-irfc) in combination with standard-of-care therapy comprised of lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death by 40% compared to a solo VRd regimen in patients with newly diagnosed transplant-ineligible multiple myeloma (MM). According to the company, the data represents the first time an anti-CD38 monoclonal antibody combined with VRdsupported a significant improvement in progression-free survival (PFS) for these patients. “The significant progression-free survival (PFS) benefit observed with Sarclisa combination therapy compared to VRd is important and encouraging for patients with newly diagnosed multiple myeloma. Effective frontline therapy has the potential to modify the course of the disease, which ...
- Source: drugdu
- 67
- July 1, 2024
The Financial Potential of Convertible Notes in the Pharmaceutical Sector

These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. By Jaylon M. ReynoldsIn the realm of biotech and pharmaceuticals, fundraising often plays a pivotal role in driving innovation and progress. Biotech and pharmaceutical companies, whether private startups or established public firms, frequently turn to convertible notes as a strategic financial instrument. These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. Convertible notes are utilized, structured, valued, and accounted for in various ways within the context of the biotech and pharmaceutical industries. Private companies For burgeoning private biotech and pharmaceutical firms, navigating the journey from research and development to commercialization can be financially demanding. Convertible notes offer a flexible financing solution, providing companies with the necessary capital to fuel their operations ...
- Source: drugdu
- 67
- July 1, 2024
New AI-System Detects Breast Cancer with Almost 100% Accuracy

Breast cancer represents 30% of all new cancer diagnoses in women annually, with projections from the American Cancer Society indicating that 42,500 women will succumb to the disease in 2024. Researchers have now developed a new artificial intelligence (AI) architecture capable of detecting breast cancer with a remarkable 99.72% accuracy, demonstrating the potential to redefine digital pathology. This development follows a previous initiative by the same research team at Northeastern University (Boston, MA, USA) which launched a web-based AI application aimed at diagnosing prostate cancer more efficiently and accurately. These projects are part of a broader effort to establish an online platform that allows physicians to utilize advanced AI techniques for diagnosing various cancers. For the breast cancer project, the research team utilized the publicly accessible Breast Cancer Histopathological Database, which includes images of both malignant and benign breast tissues. Leveraging this resource, they built an ensemble deep learning model ...
- Source: drugdu
- 99
- June 29, 2024
Semi-Automated System Rapidly Identifies Pathogenic Genetic Variant Causing Rare Diseases

Many patients with rare diseases (50-75%) do not receive a diagnosis after genomic sequencing, often due to insufficient information on the variants identified. Reassessing data over time with new genetic insights can improve diagnostic rates. However, reanalyzing genetic data in clinical laboratories is often hampered by time and resource limitations. Now, a novel semi-automated system enables rapid reanalysis of unresolved rare disease cases by regularly comparing patient genomic data with the latest global research findings, aiming to identify elusive disease-causing genetic variants. Developed by Mayo Clinic researchers in 2022 (Rochester, MN, USA), the system, named RENEW (REanalysis of NEgative Whole-exome/genome data), incorporates an advanced filtering system that scans new genetic data to identify the variants responsible for a patient’s condition. A recent study demonstrated RENEW’s effectiveness, providing likely diagnoses for 63 out of 1,066 previously undiagnosed cases. RENEW can review each of the 5,741 prioritized genomic variants in about 20 ...
- Source: drugdu
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- June 29, 2024
Eli Lilly, OpenAI Strike Collaboration Agreement Seeking to Discover New Antimicrobials to Fight Drug-Resistant Bacteria

Don Tracy, Associate Editor The collaboration with OpenAI is part of Lilly’s strategy to combat drug-resistant pathogens through its Social Impact Venture Capital Portfolio. Eli Lilly and Company and OpenAI have agreed to terms on a deal to leverage generative artificial intelligence (AI) for discovering new antimicrobials to combat drug-resistant bacteria. According to Lilly, antimicrobial resistance (AMR) poses a significant risk throughout the world, especially in low- and middle-income countries. Additionally, the misuse and overuse of antimicrobials in humans, animals, and plants are the primary influences for developing drug-resistant pathogens, amplifying AMR in the process.1 “Our collaboration with OpenAI represents a groundbreaking step forward in the fight against the growing but overlooked threat of antimicrobial resistance,” said Diogo Rau, EVP, chief information and digital officer, Lilly, in a press release. “Generative AI opens a new opportunity to accelerate the discovery of novel antimicrobials and the development of custom, purpose-built technologies ...
- Source: drugdu
- 115
- June 29, 2024
Level Up Your Self Love, Check Your Status

Don Tracy, Associate Editor As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness. Today is National HIV Testing Day (NHTD) and as part of this year’s theme, “Level up your self-love: check your status,” individuals across the United States are being encouraged to get tested to show value, respect, and compassion for each other by taking charge of our health and wellness, according to the Centers for Disease and Control Prevention (CDC). “HIV testing is an essential entry point for services such as PrEP for those without HIV, and HIV treatment for those who have HIV,” reports the CDC. “Testing programs have been critical contributors to the 12% decrease in estimated HIV infections from 2018 to 2022, and a major factor contributing to ongoing disparities in HIV is a lack of ...
- Source: drugdu
- 93
- June 29, 2024

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