Search Results for “aging” – Page 35 – media

Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues

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 ...
- Source: drugdu
- 89
- May 15, 2024
FDA Grants Priority Review Biologics License Application to Dupixent Add-On Maintenance for the Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis

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, ...
- Source: drugdu
- 85
- May 15, 2024
Understanding Payer Perceptions

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 ...
- Source: drugdu
- 79
- May 15, 2024
CDMEE 2024

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, ...
- Source: drugdu
- 143
- May 14, 2024
Avoiding the Digital Age is Hurting Research Efforts

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 ...
- Source: drugdu
- 74
- May 14, 2024
Sanofi signs $1.2bn licensing agreement for Novavax’s Covid-19 vaccine

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 ...
- Source: drugdu
- 71
- May 14, 2024
The Impact of Micropayments in Clinical Trials

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) ...
- Source: drugdu
- 103
- May 13, 2024
FDA posts final guidance on remanufacturing medical devices

Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
- Source: drugdu
- 104
- May 13, 2024
【EXPERT Q&A】What does FDACFR21 in the United States refer to?

Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
- Source: drugdu
- 162
- May 13, 2024
Securing Audience Measurement in Pharma Marketing

Ray Kingman The industry must find a way to balance consumer privacy and a return on investment in pharma marketing. Promoting advances in pharmaceuticals is full of challenges. From recruiting clinical trial participants, to engaging patients with their permission at the point of care, to creating brand lift and awareness, the marketing landscape for pharma presents both logistical and regulatory obstacles when it comes to constructing and executing a successful marketing program. Identity, and how it is managed, presents special challenges for audience targeting and especially measurement of campaign performance in an evolving identity resolution environment. Across our multi-channel, multi-platform and multi-media landscape the signals that avail us for targeting and measurement are often impeded by the requirement to block or exercise restraint when it comes to sensitive data and patient privacy rights. Building privacy-compliant audiences for pharma campaigns takes special care, but identifying audience engagement that measures campaign outcomes ...
- Source: drugdu
- 89
- May 10, 2024

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