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the wind rises, accelerates, and accelerates again

The development story of tumor drugs is always so similar: the early stage may be endless suffering, but after countless failures and dashed hopes, once there is a breakthrough, the progress is often unexpected. This is the development of drugs for the treatment of small cell carcinoma (SCLC). SCLC was first discovered about 100 years ago, but it was not until 1968 that the medical community discovered its neuroendocrine origin and finally clearly distinguished it from other lung cancers. In the 1980s, the treatment of platinum-containing chemotherapy combined with chest radiotherapy gradually became clear and became the basic treatment for small cell lung cancer. Although the combination of etoposide and carboplatin/cisplatin (EP) has been the standard treatment for SCLC until now; but we can also clearly see that the battle against small cell lung cancer has entered an accelerated stage. In May of this year, Amgen’s DLL3/CD3 dual antibody Tarlatamab ...
- Source: drugdu
- 92
- November 1, 2024
【EXPERT Q&A】What are the general procedures for CE certification?

Drugdu.com expert’s response: The process for obtaining CE certification generally includes the following steps: Ⅰ. Preliminary Preparations Determine Product Category and Directive: Firstly, it is necessary to determine the product category and the applicable CE directive. Different categories of products may be subject to different directives and standards, such as the Low Voltage Directive (LVD), Machinery Directive (MD), Electromagnetic Compatibility Directive (EMC), etc. Prepare Technical Documentation: Based on the requirements of the applicable directive, prepare the necessary technical documentation. These documents should be detailed, accurate, and meet the requirements of the directive. Technical documentation typically includes product specifications, design drawings, user manuals, circuit diagrams, block diagrams and wiring diagrams, lists of key components or raw materials, etc. Ⅱ. Select Certification Body and Submit Application Select Certification Body: Choose a qualified and experienced certification body for CE certification assessment. The certification body will test and evaluate the technical documentation and samples ...
- Source: drugdu
- 78
- November 1, 2024
CPHI Middle East

Organiser：Informa Markets Time：December 10 – 12, 2024 Address：306-1-1-King Abdullah Rd, King Abdullah Dt., Riyadh 11564, Saudi Arabia Exhibition hall：Riyadh International Convention & Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretic and Analgesic Drugs, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-infectives, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Pharmaceutical Raw Materials Pharmaceutical Machinery: Pharmaceutical Machinery, Packaging Machinery, Packaging Materials, Production Equipment and Technology for Pharmaceuticals, Pharmaceutical Packaging Equipment, Pharmaceutical Packaging Materials, Pharmaceutical Production, Cleaning, Sterilization Equipment, and Laboratory Instrument Systems Pharmaceutical Products: Various Proprietary Chinese Medicines, Western Medicines, New Drugs, Specialty Drugs, Various APIs, Chemical Pharmaceuticals, Pharmaceutical Intermediates, Biopharmaceuticals, Traditional Medicines, Chinese Herbal Medicines, Herbal Medicines, Plant and Animal Extracts, Veterinary Medicines, Food Ingredients and Additives, etc. About CPHI Middle East： CPHI Middle East, the Pharmaceutical Ingredients Exhibition in ...
- Source: drugdu
- 122
- October 31, 2024
Medtronic announces a Chief Medical Officer from Cleveland Medical Center

On October 28, 2024, Medtronic announced the appointment of Dr. Matthew Kroh as Chief Medical Officer for Advanced and General Surgery Technologies. Dr. Matthew Crowe is the Vice President of Innovation and Technology at the Cleveland Clinic Digestive Disease and Surgery Institute. He is the director of the Department of General Surgery, Endoscopic Surgery, and Foreintestinal Surgery. 01. Surgical Laparoscopic Specialist at Cleveland Medical Center Cleveland Clinic is one of the world’s most renowned medical institutions, founded on February 28, 1921. In the 2017-2018 ranking of the best hospitals in the United States, Cleveland Clinic ranked second overall, only behind Mayo Clinic. Among them, cardiac surgery and urology are ranked first in the United States; General surgery, rheumatology, and nephrology rank second. Dr. Matthew Crowe is from Cleveland Medical Center. According to the official website of the Cleveland Clinic, Dr. Matthew Crowe is the Vice President of Innovation and Technology ...
- Source: drugdu
- 62
- October 31, 2024
The hearing aid industry has a huge gap

In the current Chinese medical device industry, competition is extremely fierce, and many fields have become saturated, making it difficult to find new growth points or development space. But this set of data shows that there is a huge resource gap in the intervention of hearing loss in the elderly population in China. According to the “China Elderly Hearing Loss and Hearing Aid Application Survey” released by Tmall Health, Beijing Hearing Association, and Sonova Group, there is one professional hearing service provider for every 90000 people in China, which is much lower than the United States (9000:1). This huge gap not only reflects the scarcity of human resources allocation in this field in China, but also reflects the large scale of the population with hearing loss. 1. There are 120 million elderly people with hearing loss, and the wearing rate of hearing aids is less than 5% Hearing loss is ...
- Source: drugdu
- 65
- October 31, 2024
Consumables traceability code will be rolled out nationwide

Today (October 29) at 9:00 am, the National Medical Insurance Bureau held a national medical insurance drug and consumables traceability information collection and application release interpretation activities. At the Cyber Blue Medical Device Conference, it was learned that as of October 28, 32 provincial medical insurance information platforms have fully carried out the collection of drug and consumables traceability codes, and 3.127 billion drug and consumables traceability code data have been collected, involving 296,800 designated medical institutions and 497,200 designated retail pharmacies. More than 60% of medical institutions and 99% of pharmacies have carried out the collection of traceability codes. The National Medical Insurance Bureau has made it clear that it will continue to promote the application of drug and consumables traceability codes in the future, so that every link of drug and consumables from production, transportation to sales can be monitored and recorded in a timely manner, and use ...
- Source: drugdu
- 82
- October 31, 2024
The third day of the national negotiations! Oncology drugs and traditional Chinese medicines are on display, Pfizer, China Resources Sanjiu, Jianmin, Dizhe…

On October 29, the 2024 national negotiations entered the third day, and a group of companies such as Yangtze River, Yiling, China Resources Sanjiu, Jichuan, and Jianmin took their traditional Chinese medicine varieties to the stage. Before entering the venue in the afternoon, the overall atmosphere on the scene was relatively relaxed. When the staff of the Medical Insurance Bureau called the roll, some company representatives did not respond in time. Other company representatives joked, “Okay, automatically give up,” and everyone laughed. At the scene, many representatives of traditional Chinese medicine companies showed strong confidence in their products, and mentioned the advantages of traditional Chinese medicine over chemical medicine in the treatment of the same disease during the conversation. At the same time, this year’s national negotiations focus on “high-quality, cost-effective innovation” and also apply to traditional Chinese medicine. A representative of a traditional Chinese medicine company with exclusive varieties ...
- Source: drugdu
- 72
- October 31, 2024
Hengrui Medicine plans to be listed on the Hong Kong Stock Exchange?

According to overseas media Bloomberg, Jiangsu Hengrui Medicine Co., Ltd. is considering a second listing in Hong Kong next year. People familiar with the matter said that the company is discussing potential share sales with consultants, which may raise at least US$2 billion (about HK$15.5 billion). This news has attracted widespread attention. In response, Hengrui Medicine said that it “would not comment” on the rumor.Affected by this news, Hengrui Medicine’s stock price has fluctuated significantly, and its current market value is about RMB 300 billion (US$43 billion). In recent years, “A+H” stocks have continued to expand. With the listing of Midea Group on the Hong Kong Stock Exchange on September 17, there are currently 150 companies that have successfully achieved “A+H” dual listings. Among them are many biopharmaceutical companies, including innovative pharmaceutical companies: Innovent Biologics, Fudan Zhangjiang, CanSino Biologics, Rongchang Bio, Junshi Biosciences, BeiGene, etc., traditional pharmaceutical companies: Shanghai Pharmaceuticals, ...
- Source: drugdu
- 82
- October 31, 2024
Huiyu Pharmaceuticals was the first company to pass the review for its “Detoxification Injection”

From October 14 to October 20, a total of 59 varieties passed/are deemed to have passed the consistency evaluation. During the same period, 88 varieties applied for consistency evaluation. Huiyu Pharmaceutical: Acetylcysteine Injection According to the official website of NMPA, Huiyu Pharmaceutical’s acetylcysteine injection was approved for marketing on October 16. The specifications approved this time are: 30ml: 6g, and the indications are detoxification of acute acetaminophen poisoning, used to prevent or alleviate liver damage caused by its overdose. Acetylcysteine is a precursor of reduced glutathione (GSH) and is an oxygen free radical scavenger in the body. The mechanism of its liver protection is still unclear, and may be related to maintaining or restoring glutathione levels. In addition, acetylcysteine may also play a liver protection role by improving hemodynamics and oxygen transport capacity and expanding microcirculation. As of now, Huiyu Pharmaceutical’s acetylcysteine injection is the first and only product of ...
- Source: drugdu
- 68
- October 31, 2024
【EXPERT Q&A】What is the impact on the industry that IVD registration certificates can be bought and sold?

Drugdu.com expert’s response: The impact of the tradability of IVD (In Vitro Diagnostic) registration certificates on the industry is multifaceted, encompassing the following aspects: Ⅰ. Facilitating Industry Consolidation Rapid Acquisition of Product Lines: Companies can quickly acquire new product lines by purchasing registration certificates, without the need for research and development from scratch, significantly shortening the time to market. Accelerating the Expansion of Large Enterprises: Large enterprises may rapidly expand their market share by acquiring registration certificates from smaller enterprises, further consolidating their market position. Ⅱ. Enhancing Research and Development Efficiency Focusing on R&D and Registration: Research institutions can concentrate more on product research and development, as well as registration, without worrying about subsequent production and sales issues. Shortening Product Cycles: By selling registration certificates to manufacturing enterprises, research institutions can obtain returns faster, thereby allocating more funds and resources to new research and development projects, further shortening the time ...
- Source: drugdu
- 74
- October 30, 2024

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