media – Page 36 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

New neuro-sensing technique captures brainwaves from within veins

Researchers at The University of Osaka have developed a groundbreaking, minimally invasive method for recording brain activity through blood vessels. This technique could potentially transform the diagnosis and treatment of neurological conditions like epilepsy and paving the way for advanced brain-computer interfaces. It eliminates the need for invasive open-brain surgery, offering a safer and more accessible way to monitor and stimulate brain function. Current methods for directly measuring brain activity require invasive procedures, either removing part of the skull to place electrodes on the brain surface or inserting electrodes directly into brain tissue. While non-invasive methods like EEG exist, they lack the precision needed for detailed analysis. This new method bridges the gap, offering high-fidelity recordings without the risks associated with traditional invasive approaches. The research team, led by Professor Takufumi Yanagisawa used a catheter to insert ultra-thin wire electrodes into the cortical and deep veins of pig brains. They ...
- Source: drugdu
- 121
- September 22, 2025
Why Mosquitos Might Be Attracted To You

By Deanna Neff HealthDay ReporterSATURDAY, Sept. 20, 2025 (HealthDay News) — Researchers in the Netherlands turned a major music festival into an unexpected laboratory to investigate a question that has long puzzled scientists and bug-bitten individuals alike: What makes some people more irresistible to mosquitoes than others? For three consecutive days at the Lowlands festival in Biddinghuizen, Netherlands, scientists set up a unique pop-up research site inside a series of shipping container laboratories. Instead of waiting for their favorite band, hundreds of festivalgoers lined up to volunteer for the “Mosquito Magnet Trial,” a study designed to measure their personal attractiveness to the insects. Inside the make-shift lab from 9 a.m. to 10 p.m. each day, groups of participants rested their arms against transparent acrylic boxes that had caged mosquitoes. As the insects responded to the human scent, a camera and computer system recorded mosquito movements and calculated a unique attraction ...
- Source: drugdu
- 85
- September 22, 2025
【EXPERT Q&A】What are the difficulties in applying for CE under the EU in vitro Diagnostic (IVDR) regulation?

Drugdu.com expert’s response: I. Complex Classification Rules The IVDR expands the risk classification of in vitro diagnostic products from four categories (e.g., List A/B under IVDD) to four classes (A-D), with criteria spanning sample types (e.g., saliva, skin tissue) and disease risks (e.g., infectivity, mortality). For example: Class D devices (e.g., HIV or COVID-19 test kits) require submission of a Clinical Performance Study Plan (CPSR) and independent testing by EU Reference Laboratories (EURLs). Class C devices (e.g., tumor biomarker tests) necessitate enhanced performance evaluations and clinical evidence reviews. Challenge: Insufficient understanding of classification rules may lead to errors in technical documentation or clinical strategies, requiring costly compliance adjustments. Elevated Clinical Evidence Requirements The IVDR mandates more comprehensive clinical evidence, including: Scientific Validity: Verification of the product’s correlation with specific diseases, conditions, or parameters. Analytical Performance: Demonstration of sensitivity, specificity, and other metrics through laboratory testing. Clinical Performance: Validation of intended use via real-world data. Case ...
- Source: drugdu
- 118
- September 22, 2025
【EXPERT Q&A】What are the functions of the FDA’s consensus standards for medical devices and how can they be queried?

Drugdu.com expert’s response: I. Functions: Regulating Safety and Effectiveness of Medical Devices and Accelerating Market Access Ensuring Safety and Effectiveness The consensus standards recognized by the FDA provide clear specifications for the design, testing, and clinical evaluation of medical devices through scientifically validated test methods, acceptance criteria, and risk management processes. For example, biocompatibility standards (such as the ISO 10993 series) stipulate safety testing requirements for materials in contact with human tissues, ensuring that products do not trigger toxicity or allergic reactions. Streamlining Regulatory Processes Manufacturers who can demonstrate that their products comply with FDA-recognized consensus standards can reduce redundant testing and document submissions, thereby shortening the pre-market review time. For instance, in a 510(k) application, products that meet consensus standards can expedite approval through “substantial equivalence” demonstration. Enhancing Industry Transparency Consensus standards offer a unified framework for performance indicators and labeling instructions, facilitating the understanding of product characteristics by ...
- Source: drugdu
- 151
- September 19, 2025
Zhengda Tianqing targets 9.2 billion yuan drug

On September 15, the injectable degarelix acetate (Qinglishu) independently developed by Zhengda Tianqing obtained the drug registration certificate issued by the National Medical Products Administration (NMPA) for use in prostate cancer patients who require androgen deprivation therapy. As the original drug in this category, degarelix acetate (fermonger)’s global sales exceeded US$1.3 billion (approximately RMB 9.2 billion) in 2024. Is Zhengda Tianqing, the “pioneer in anti-tumor innovation”, brewing a blockbuster drug? 01 Approved for listing in three locations The original developer of Degarelix Acetate for Injection is Ferring Pharmaceuticals. As a selective gonadotropin-releasing hormone receptor (GnRHR) antagonist, the clinical value of Degarelix Acetate in the treatment of prostate cancer has long been recognized worldwide. This drug can effectively reduce the release of gonadotropin and testosterone by reversibly binding to the GnRH receptors in the pituitary gland, thereby inhibiting the growth and spread of prostate cancer cells from the root. Especially in ...
- Source: drugdu
- 187
- September 18, 2025
Announcement on the Holding Subsidiary Obtaining Medical Device Registration Certificate

September 17th, Meikang BioAccording to the announcement, the company’s holding subsidiary Jiangxi Meikang Shengde Biotechnology Co., Ltd. recently obtained the ” Medical Device Certificate of the People’s Republic of China” issued by the Jiangxi Provincial Drug Administration.Registration Certificate ( In Vitro DiagnosticThe product names are: tissue plasminogen activator-inhibitor 1 complex detection kit (chemiluminescent immunoassay), thrombin-antithrombin complex detection kit (chemiluminescent immunoassay), thrombomodulin detection kit (chemiluminescent immunoassay), plasmin-α2 plasmin inhibitor complex detection kit (chemiluminescent immunoassay). https://finance.eastmoney.com/a/202509173516207639.html
- Source: drugdu
- 115
- September 18, 2025
Plans to invest RMB 42.74 million in Wuhan Huajiyuan to advance clinical trials of the therapeutic antihypertensive vaccine (HJY-ATRQβ-001) project

Meijing AI News, September 17, Saili Medical(603716.SH) announced plans to increase capital by 42.7429 million yuan in its subsidiary, Wuhan Huajiyuan Biotechnology Development Co., Ltd. Upon completion of the capital increase, the company’s stake in Wuhan Huajiyuan will increase to 41%. Concurrently, the company’s actual controller, Wen Wei, plans to acquire a 10% stake in Wuhan Huajiyuan shareholder Sun Danping for 27.2 million yuan, at a post-capital valuation of 272 million yuan. The company and its actual controller, Wen Wei, will contribute a total of 69.9429 million yuan in this transaction. The target company will be consolidated as a controlled subsidiary of the company in 2026. All parties agreed to actively advance the various phases of clinical trials for the target company’s therapeutic antihypertensive vaccine (HJY-ATRQβ-001) project and work together to develop the target company’s business. Upon completion of the capital increase, all parties pledged to actively conduct research and ...
- Source: drugdu
- 115
- September 18, 2025
Eli Lilly wins again! Oral weight loss drug outperforms oral sirolimus in head-to-head tria

Eli LillyTwo star weight loss pillsThe “one-on-one” battle has spread to the field of oral drugs, and the pressure has been put on Novo Nordisk.. On September 17, Eli Lilly announced positive top-line results from the Phase III ACHIEVE-3 study. The 52-week study compared orforglipron (12 mg and 36 mg) with oral semaglutide (7 mg and 14 mg) in terms of glycemic control and weight loss across four active treatment groups. At 52 weeks, orforglipron achieved its primary endpoint and all key secondary endpoints across all dose groups, demonstrating superiority over oral semaglutide in terms of improvements in glycated hemoglobin (A1C) and weight. Orforglipron is an oral small molecule GLP-1 receptor agonist from Eli Lilly , and Rybelsus is an oral GLP-1 drug from Novo Nordisk . The aforementioned study was a head-to-head comparison. A head-to-head study can be considered a direct comparison of the two drugs’ efficacy and safety. ...
- Source: drugdu
- 152
- September 18, 2025
VIETNAM MEDIPHARM EXPO

Organiser: Vietnam VIETFAIR Time：November 27–29, 2025 address：91 Tran Hung Dao Street, Hoan Kiem District, Hanoi, Vietnam Exhibition hall：Cultural Friendship Palace Product range: Medical Products: Medical equipment and instruments, medical consumables, medical dressings, surgical equipment, emergency rescue equipment, diagnostic medical devices and supplies, otorhinolaryngological equipment, dental products, equipment and supplies, medical and health products and devices, technical equipment for medical institutions and laboratories, medical information and technology exchange, beauty instruments, etc. Pharmaceutical Equipment: Pharmaceutical production equipment and technologies, pharmaceutical packaging equipment, pharmaceutical packaging materials, systems for pharmaceutical production, cleaning, disinfection, and formulation, etc. Laboratory Equipment: Optical instruments and equipment, microscopes, optical image processing systems, electronic measuring instruments, multimeters, electron probes, electronic simulation systems, single-chip microcomputer development systems, image analysis and processing systems, etc. Analytical Instruments: Optical analyzers, mass spectrometers, spectrometers, chromatographs, wave spectrometers, frequency spectrometers, various portable instruments, surface analyzers, nuclear analyzers, elemental analyzers, process analyzers, composition analyzers, injection analyzers, ...
- Source: drugdu
- 147
- September 18, 2025
Hengrui’s breakthrough hepatitis B therapy arrives

On September 15, the CDE official website announced that Hengrui Medicine’s new generation of liver-targeted hepatitis B virus siRNA drug HRS-5635 injection is planned to be included in the breakthrough therapy variety for the treatment of chronic hepatitis B. Chronic hepatitis B (CHB) is a chronic inflammatory liver disease caused by persistent infection with the hepatitis B virus (HBV). According to the World Health Organization, 254 million people worldwide were living with chronic HBV infection in 2022, with approximately 1.2 million new infections. In China, a major country with a high incidence of CHB, epidemiological data from 2020 estimated that there were approximately 75 million HBV carriers, of whom approximately 30 million were infected but unaware. Of those diagnosed, 17 million required antiviral treatment, but only 3 million received it. In addition, HBV infection significantly increases the risk of developing cirrhosis and liver cancer. The proportion of cirrhosis and liver ...
- Source: drugdu
- 236
- September 17, 2025

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