Search Results for “EC” – Page 189 – media

【EXPERT Q&A】What is the role, definition, and inquiry of the FDA Consensus Standard for medical devices?

Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
- Source: drugdu
- 76
- October 2, 2024
PNAS | Chen Junjie/Jiang Kuirong/Feng Xu/Jiang Dadi Team Collaborates to Reveal the Key Role of MGA in Tumor Immune Escape

Immune escape is one of the important features of cancer progression and a core challenge that affects the effectiveness of immunotherapy. Although immune checkpoint inhibitors (ICI) have achieved significant success in certain cancers, the overall response rate in solid tumors is still very limited. Exploring the mechanism of tumor immune escape in depth, discovering new targets, and improving ICI efficacy through combination therapy have become one of the key directions of current tumor immune research. On September 19, 2024, Professor Jiang Kuirong and Professor Feng Xu from the First Affiliated Hospital of Nanjing Medical University, together with Professor Chen Junjie and Professor Jiang Dadi from the MD Anderson Cancer Center of the University of Texas in the United States, published a research paper entitled In vivo CRISPR screens identify Mga as an immune target in triple negative breast cancer online on PNAS magazine, systematically expounded the core route of immune ...
- Source: BioArt
- 76
- October 1, 2024
A large number of pharmacies have withdrawn from medical insurance

So far, a large number of pharmacies have withdrawn from medical insurance. In September alone, Inner Mongolia has inspected 636 designated medical institutions and 1,661 retail pharmacies, imposed administrative penalties on 34, and suspended or terminated medical insurance agreements for 1,023; Xinjiang terminated the medical insurance service agreements of 162 designated medical institutions; 3 retail pharmacies in Tongling, Anhui terminated the medical insurance service agreements, and 1 medical institution in Yongxin, Jiangxi cancelled its medical insurance designated qualification… Earlier, similar situations also occurred in pharmacies in Zhoukou, Henan, Heyuan, Guangdong, Dezhou, Shandong, Fangshan, Beijing, Shaoyang, Hunan, Kunshan, Jiangsu, etc. The reasons for pharmacies to withdraw from the medical insurance service agreement vary, most of which are “actively applying”, “due to their own business reasons”, “illegal and irregular”, “due to failure to handle relevant procedures, no incurrence or approval of settlement expenses for more than six months”, etc. Pharmacies have ...
- Source: https://mp.weixin.qq.com/
- 64
- October 1, 2024
The “No.1 Chinese hepatitis C drug” is looking for a new engine

Recently, Ascletis announced that its independently developed small molecule GLP-1R agonist ASC30 is undergoing two Phase I clinical trials in the United States for the treatment of obesity with monthly subcutaneous injections and daily oral tablets. With the launch of these two Phase I clinical trials, Ascletis has officially entered the field of weight loss drugs. This is another highlight of the pipeline after Ascletis announced in April this year that it would focus on the development of core non-alcoholic steatohepatitis (NASH) drugs. Urgent need for a new engine Like most biotechs, Ascletis has also been moving forward by trial and error. However, Ascletis is luckier than most biotechs. It has become famous for its first local original hepatitis C drug Ganovo, which not only broke the monopoly of multinational companies such as Gilead, AbbVie, Bristol-Myers Squibb, and Merck in the domestic hepatitis C drug market, ...
- Source: https://news.yaozh.com/archive/44305.html
- 69
- October 1, 2024
A Rehearsal for Overcoming AIDS

Starting in June 2024, global scholars concerned with HIV prevention will focus their attention on Gilead’s antiviral drug, lenacapavir. At that time, Gilead released the latest data from the PURPOSE 1 trial, which demonstrated that lenacapavir, when administered via two annual injections, resulted in zero infections compared to daily oral PrEP medications. This suggests that, in the absence of successful vaccine development, lenacapavir could potentially serve as a long-lasting preventive alternative. However, whether the results of the PURPOSE 1 trial were a coincidence or a certainty remains unanswered. In September, Gilead further presented results from the PURPOSE 2 trial, indicating a higher likelihood of certainty. The results showed that 99.9% of participants in the lenacapavir group did not contract HIV, representing a 96% reduction in infection risk compared to the placebo group. This might signal that we are approaching an era of highly effective HIV prevention. 01 / The ...
- Source: https://caifuhao.eastmoney.com/news/20240925115315100512370?from=guba&name=5YyW5a2m5Yi26I2v5ZCn&gubaurl=aHR0cHM6Ly9ndWJhLmVhc3Rtb25leS5jb20vbGlzdCxiazA0NjUsOTksai5odG1s
- 64
- October 1, 2024
Medexpo Tanzania

Organiser：EXPOGROUP Time：October 9 – 11, 2024 Address：Aga Khan Diamond Jubilee Hall, P.O.Box 7750, Malik Road, Upanga West, Dar es Salaam, Tanzania Exhibition hall：Aga Khan Diamond Jubilee Hall Product range: Hospital Equipment & Supplies: Patient Rehabilitation & Wellness Services, Hospital Furniture & Management, IT & Telecommunication, Ambulances & Transportation Equipment, Surgical Gowns, Medical Consumables, Water Treatment Equipment, Cleaning Equipment & Services, Biotechnology, etc. Medical Devices & Laboratory Equipment: Respiratory Devices, Imaging Equipment, Surgical Instruments & Supplies, Diagnostic Equipment & Instruments, Dialysis Equipment, EEG & ECG Machines, Endoscopes & Accessories, UV & IR Radiation Equipment, Thermotherapy Devices, Ultrasound Diagnostic Equipment, Heating Systems, Cardiac Catheterization Equipment, Medical Lighting Products, MRI Scanners, Oxygen Supply Equipment, Sterilization & Disinfection Equipment, Urinary Catheters, Colposcopes, Disposable Items, Cryosurgical Equipment, Laser Surgical Equipment, Laser Therapy Devices, Lithotripsy Machines, Laboratory Equipment & Supplies, etc. Dental Equipment: Dental Tools, Equipment, Surgical Instruments, Dental Care Products & Medicines, Artificial Teeth ...
- Source: drugdu
- 83
- October 1, 2024
Merck’s first GMP grade cell culture medium production line in China has been commercialized and put into operation

Merck, a globally leading technology company, announced on July 12th that it has successfully commercialized its first GMP grade cell culture medium (CCM) production line in China. Merck has invested approximately 6.6 million euros in its manufacturing base located in Nantong, an industrial hub in the Yangtze River Delta region, in an effort to meet the growing demand in the Chinese market for high-quality customized cell culture media (used in fields such as biopharmaceuticals, vaccines, and new therapies). This localized commercial production can enable Chinese customers to reliably and efficiently obtain Merck’s highly reputable customized cell culture medium products and services. With its rich and professional formula experience and knowledge, Merck can produce high-quality customized cell culture media and innovative solutions based on specific formulas, ensuring batch uniformity and production efficiency of products. Merck Life Sciences China Managing Director Wu Bo said, “This investment further expands Merck’s business territory and ...
- Source: drugdu
- 94
- September 30, 2024
Jianjia Robot applies to withdraw its IPO application documents

On September 26th, the Shanghai Stock Exchange announced that Hangzhou Jianjia Robot Technology Co., Ltd. (hereinafter referred to as Jianjia Medical) has applied to withdraw its application for listing and therefore decided to terminate the review of its public offering of shares and listing on the Science and Technology Innovation Board. It is reported that Jianjia Robot applied for an IPO on the Science and Technology Innovation Board on April 2, 2023. After a round of inquiries, the Shanghai Stock Exchange reviewed and focused on issues such as orthopedic and dental implant surgical robots, market space, and core technologies. It takes one and a half years from application to termination. Yesterday, Jianjia Robot terminated its IPO, and another equipment company’s attempt to go public failed. The winter of IPO for equipment companies continues. When will spring come? Jianjia Robot has great potential for the future Jianjia Robot was founded in ...
- Source: drugdu
- 95
- September 30, 2024
【EXPERT Q&A】What is the latest development of FIC drugs?

Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
- Source: drugdu
- 74
- September 30, 2024
A historic night in the treatment of schizophrenia

On September 26, the field of schizophrenia ushered in a historic moment, when KarXT developed by Karuna was approved by the FDA for marketing. This means that Bristol-Myers Squibb’s tens of billions of bets have succeeded in their first battle. On December 22 last year, Bristol-Myers Squibb spent $14 billion to acquire Karuna for KarXT. KarXT has been approved for marketing, and there is another winner – Zai Lab. Currently, Zai Lab owns the rights to KarXT in Greater China. Considering that there are more than 8 million schizophrenia patients in China, and the introduction cost of Zai Lab is not high, it is expected to obtain sufficient profits. Of course, all this can only be said to have settled, and is not surprising. Most of the existing schizophrenia treatments are old varieties approved in the 1990s. KarXT does not rely on dopaminergic or serotonergic pathways and is the first ...
- Source: drugdu
- 65
- September 30, 2024

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