Aspect Imaging has secured 510(k) clearance for the commercialisation of its neonatal brain and head magnetic resonance imaging (MRI) device from the US Food and Drug Administration (FDA).
Ultrasound imaging serves as a noninvasive method to locate and monitor cancerous tumors effectively. However, crucial details about the cancer, such as the specific types of cells and genetic mutations involved, typically require invasive biopsies, which can cause harm. Now, a research team has developed a new method to utilize ultrasound for gently extracting this genetic information. Researchers at the University of Alberta (Edmonton, AB, Canada) have been investigating the use of intense ultrasound in releasing biological indicators of disease, or biomarkers, from cells. These biomarkers include elements like miRNA, mRNA, DNA, and various genetic mutations, all of which are critical for identifying the cancer type and guiding treatment decisions. The ultrasound technique releases these biomarkers from the cells into the bloodstream, where they reach concentrations high enough to be detected. This enables oncologists to identify and track the cancer’s status or response to treatment through blood samples instead of ...
Engineers from the Massachusetts Institute of Technology (MIT) have developed a new technique using magnetic resonance imaging (MRI) to detect light deep in the brain, which could benefit future studies of the development and communication of brain cells. Published in Nature Biomedical Engineering, the new technique could help researchers explore the inner workings of the brain, such as changes in gene expression, anatomical connections between cells or how cells communicate with each other. Commonly, scientists label cells with bioluminescent proteins that glow to allow them to track the growth of a tumour or measure changes in gene expression that occur as cells differentiate. Known as bioluminescence, the novel technique uses MRI to observe the dilation of a protein in the brain’s blood vessels to pinpoint the source of light. The team came up with a method to transform the blood vessels of the brain into light detectors to find a ...
Breast cancer remains a major cause of cancer-related mortality among women. Breast-conserving surgery (BCS), also known as lumpectomy, is the removal of the cancerous lump and a small margin of surrounding tissue. This procedure is typically advised for women with early-stage breast cancer or small tumors, as it conserves more of the breast tissue compared to a mastectomy. After undergoing BCS, it is critical to verify that all cancerous cells have been removed to decide if additional surgery is necessary. This verification involves a tumor margin assessment, which examines the edges of the excised tissue (tumor margins) to check for residual cancer cells. Conventionally, this assessment entails staining the tissue samples with dyes and inspecting them under a microscope to differentiate between healthy and cancer cells. However, new optical imaging techniques have emerged as quicker alternatives for conducting these assessments. A group of researchers from the United States, including members ...
Don Tracy, Associate Editor Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled. Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.1 According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, ...
Tasmina Hydery, PharmD With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount. Tasmina Hydery, PharmD, Associate Director, Market Access and Healthcare Consulting, Cencora Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months. The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.1 Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers ...
Organiser:Sichuan Hospital Association, Sichuan Medical Device Industry Association, Sichuan Rehabilitation Medical Association Time:26- 28 September 2024 address:198 Century City Road, Chengdu City, Sichuan Province Exhibition hall: Chengdu Century City new international Convention and Exhibition Center Product range: Medical equipment exhibition area: imaging equipment, in vitro diagnostic reagents and instruments, disinfection sensor series, medical electronic equipment, medical vehicles, operating rooms and emergency equipment, medical consumables and surgical consumables, medical maintenance accessories and consumables, etc Medical Examination Exhibition area: Medical analysis system, genetic and life science instruments, laboratory case equipment and consumables, pre-examination equipment and consumables, blood collection management system and transfusion supplies, blood and cell analysis system, pre-examination equipment accessories and maintenance consumables, etc Rehabilitation and well-being exhibition area: sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, sensory interactive equipment, assistive devices, etc. Sensory integration training equipment, equipment and supplies for the disabled, rehabilitation physiotherapy equipment, ...
Mike Hollan Pharmaceutical ExecutivePharmaceutical Executive: May 2024 Mike Hollan, Assistant Managing Editor, Pharmaceutical Executive When it comes to developing new drugs and therapies, there is obviously nothing more important than data. Countless bits of data are collected for each medication before it hits the market, and researchers continue to collect data after that. Even before the modern technology boom, data was a key component of the life sciences industry. In the modern world, data is more valuable than ever. New technologies, such as AI and machine learning algorithms, are capable or collecting, sorting, and analyzing bits of data at a faster rate than ever before. Researchers across almost every industry are seeing the benefits and discovering new ways to innovate based on these discoveries. In the life sciences industry, this data is being used for everything from drug development, market analysis, and even scheduling sales reps calls. It’s undeniable that ...
Sanofi has signed a $1.2bn licensing agreement with Novavax to co-commercialise its stand-alone adjuvanted Covid-19 vaccine. Starting in 2025, the drugmaker will co-commercialise the vaccine worldwide, except for in countries such as India, South Korea, and Japan where Novavax already has existing partnerships in place. As per the “co-exclusive” agreement, Sanofi will also support certain R&D, regulatory, and commercial expenses. The American vaccine company has faced tough times in the post-Covid-19 landscape, going as far as to issue a “going concern” warning in 2023 about its ability to continue operating. At the time, Novavax said it was subject to “significant uncertainty” concerning future sales and funding from the US Government. Following the deal with Sanofi, the removal of this warning was noted in Novavax’s first quarter 2024 financial results and operational highlights released today. Novavax CEO John Jacobs told CNBC that the agreement with Sanofi would allow it to lift ...
Micropayments provide an additional incentive for patients to complete required tests, procedures, and diary entries, ensuring that sites, sponsors, and CROs are able to collect the required data needed to complete a clinical trial on time and on budget. By Tanya Kogan on May 10, 2024 Clinical trials today require more patient involvement than ever before. Yet longer, more frequent site visits or participation that requires extensive travel can impact a patient’s willingness to participate in and remain in a clinical trial over the long term. As a result, patient recruitment and retention can be a challenge for sites and pharmaceutical companies, especially when the target patient population is small or geographically dispersed. Sadly, the average dropout rate across clinical trials is 30 percent. With the increasing need for consistent and accurate patient data, sponsors and sites are investing in electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessment (eCOA) ...
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