Search Results for “EC” – Page 224 – media

【EXPERT Q&A】How many classes are medical devices divided into?

Drugdu.com expert’s response: Medical devices are typically categorized into three classes as follows: Class I Medical Devices: These devices pose a low level of risk and can ensure their safety and effectiveness through routine management. They are generally the basic and relatively safe medical tools commonly used in daily medical practice. Class II Medical Devices: This class of devices carries a moderate level of risk and requires stricter management measures to ensure their safety and effectiveness. They may involve certain usage risks, necessitating specialized personnel for supervision and control. Class III Medical Devices: These devices pose a high level of risk and necessitate the implementation of exceptionally stringent control measures to guarantee their safety and effectiveness. They are predominantly used for sustaining patient life, with many requiring entry into the human body, thereby harboring heightened risks that necessitate more rigorous supervision and monitoring. The classification of medical devices into these ...
- Source: drugdu
- 110
- July 17, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 94
- July 16, 2024
New Blood Test Aims to Improve Management of Multiple Sclerosis

Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative condition where axonal loss leads to irreversible neurological damage and disability. Currently, approximately 2.8 million people globally are affected by MS, though this figure is likely underestimated due to underdiagnosis in underserved and remote areas lacking adequate neurological care and imaging facilities. While no cure exists for MS, available treatments aim to reduce the frequency of relapses, which are linked to nerve cell damage and the progression of the disease. There is a critical need for an accessible, affordable, and accurate blood test that can detect early signs of neuronal injury and disease activity. The neurofilament light chain (NfL) protein has been identified as a key biomarker for nerve cell damage. Now, a new blood test that measures levels of NfL could facilitate earlier detection of MS-related neuronal injury and improve disease management. Siemens Healthineers (Forchheim, Germany), in collaboration with Novartis ...
- Source: drugdu
- 82
- July 16, 2024
Researchers awarded £1.5m for national dementia inequalities network

The ESRC EquaDem Network Plus aims to improve disparities in diagnosis and care Dementia researchers from the University of Liverpool have been awarded £1.5m to establish the first-ever national network for dementia inequalities in diagnosis and care. The new network is just one of four dementia networks that have benefited from £5.5m funding from the Alzheimer’s Society, the Economic and Social Research Council (ESRC) and the National Institute for Health and Care Research (NIHR). Affecting more than 944,000 people in the UK, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. For those living with the condition, as well as their unpaid carers, many inequalities can often be faced when accessing care and obtaining an assessment and diagnosis. The University of Liverpool’s Institute of Population Health’s senior research fellow, Dr Clarissa Giebel, will lead the network in collaboration with Dame Louise ...
- Source: drugdu
- 98
- July 16, 2024
New policy review reveals ten cancer challenges facing new UK government

Macmillan Cancer Support estimates that cancer affects over three million people in the UK A new policy review produced by cancer doctors and experts from across the UK, including King’s College London (KCL), has revealed the ten biggest cancer challenges facing the new UK government. Published in the Lancet Oncology, the review highlights the time-critical issues impacting the delivery of cancer care services by the NHS, which should be urgently addressed via a comprehensive national cancer control plan. It is estimated that there are more than three million people living in the UK with cancer, according to Macmillan Cancer Support, with breast cancer being the most prevalent, accounting for more than 55,000 people. The authors said that the NHS in the UK is behind other countries and, if not prioritised, could add additional strain to the healthcare system, widen social inequality and weaken economic recovery. The review highlighted several ongoing ...
- Source: drugdu
- 66
- July 16, 2024
MSD closes $1.3bn EyeBio acquisition, plans pivotal trial for lead asset

Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
- Source: drugdu
- 55
- July 16, 2024
How Leaders Can Empower Their People to be Their Best

By Spencer Gore If you wish for your team to be diligent, innovative, and collaborative, you must first exhibit these traits yourself Having the drive, desire, and ability to be the best starts with believing you can achieve something. As the saying goes, “If you think you can, you possibly will. If you think you can’t, you definitely won’t.” Since founding the European Medical Journal (EMJ) and most recently the American Medical Journal (AMJ), I’ve seen firsthand that the success of these organizations hinges on the strength and cohesion of their teams. As a leader, fostering a high-performing team goes beyond traditional management techniques. It requires continuous empowerment, instilling a growth mindset, and encouraging self-belief. A mindset for our future leaders that has been transformative is “be the leader you wish to follow.” This involves setting the standard for behavior, work ethic, and collaboration, encouraging team members to strive to ...
- Source: drugdu
- 83
- July 15, 2024
Merck Sharp & Dohme Animal Health Completes Acquisition of Leyland Animal Health Aquatic Business

Rowe, NJ, USA, July 9, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, NJ, USA) announced today that its Animal Health division has completed the acquisition of the aquatic business of Gift Blue Animal Health. The acquisition strengthens Merck Sharp & Dohme Animal Health’s position in the aquaculture industry, enabling it to promote fish health, welfare and sustainability across all aspects of aquaculture, conservation and fisheries. Rick DeLuca, President of Mercer Animal Health, said: “With the completion of this acquisition, we are well positioned in the aquaculture industry with a strong and comprehensive portfolio of products covering warm water aquaculture, cold water aquaculture, vaccines, antiparasitic treatments, water conditioners and nutritional supplements. We are excited to welcome our new colleagues to Merck Sharp & Dohme Animal Health and look forward to working together towards our shared goal of ‘Science for Healthier ...
- Source: drugdu
- 82
- July 15, 2024
Healey platform data to pave phase III path for Prilenia’s pridopidine

Developing disease-modifying treatments for amyotrophic lateral sclerosis (ALS), a rare and aggressive disease, has proven challenging. The high failure rate in ALS clinical trials is often attributed to the disease’s unclear etiology and complex pathophysiology. At the 10th Congress of the European Academy of Neurology (EAN) 2024, Prilenia Therapeutics presented promising results from the additional analyses of the Phase II Healey ALS Platform Trial evaluating pridopidine in ALS patients. The positive results will pave the way for the Phase III trial of pridopidine, says GlobalData. Erela Dana, Director of Neurology at GlobalData, comments, “The Healey ALS Platform Trial aims to accelerate the path to approval for ALS drugs by testing drugs simultaneously and adoptively. Given the challenges in developing treatments for this disease, the platform trial is anticipated to find an effective therapy more quickly, with fewer total participants and fewer participants on placebo.” GlobalData forecasts that the ALS market ...
- Source: drugdu
- 112
- July 15, 2024
Indegene collaborates with Microsoft to promote use of GenAI in global life sciences companies

Indegene announced a strategic collaboration with Microsoft to empower global life sciences companies to scale up the adoption of purpose-built, enterprise-grade Generative AI services, thereby driving faster innovation at scale. Indegene and Microsoft have aimed to develop resources in highly specialised and skilled medical and technology tools to co-innovate generative AI services and workflows across commercial, medical, regulatory, and clinical functions. Some of the key use cases the strategic collaboration focuses on in the first phase, include: Content Super App: Using Azure OpenAI Service, the modular content value chain simplifies content creation and tagging for life sciences companies. This integrated approach offers a holistic view of the content value chain, enabling greater velocity, personalized content, and adoption of new conversation form factors. It also streamlines creative and video transformation while effectively engaging healthcare professionals (HCPs), patients and payers Future-ready medical content value chain: Generative AI capabilities are revolutionising the medical ...
- Source: drugdu
- 77
- July 13, 2024

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