media – Page 151 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What information should be provided for the analytical performance evaluation data of in vitro diagnostic reagent products?

Drugdu.com expert’s response: The analytical performance evaluation documents of in vitro diagnostic reagent products are crucial files ensuring the quality and accuracy of reagent products. To comprehensively evaluate the analytical performance of reagent products, the following information is typically required: I. Basic Information Registrant Name: Clarifies the responsible entity for easy traceability by regulatory authorities. Product Name: Ensures the accuracy of the reagent product being evaluated. II. Performance Evaluation Scheme and Requirements Evaluation Method: Detailed description of the adopted evaluation method, including experimental design, operational steps, etc. Evaluation Requirements: Clearly defined evaluation standards and judgment criteria. III. Reagent Information Name, Batch Number, Expiry Date: These details facilitate tracing the reagent’s source and quality, ensuring the evaluated reagent is within its validity period and of stable quality. Calibrator and Control Material Information: If calibrators and control materials are used, their relevant information should also be provided to ensure the accuracy and ...
- Source: drugdu
- 397
- January 17, 2025
Some people are falling behind in the field of autoimmune TCE

Since 2024, TCE in the field of autoimmune has become completely popular. Overseas pharmaceutical companies continue to bet on this field, and domestic TCE has also become popular, giving birth to two huge transactions in the history of domestic Biotech going overseas, including Tongrun Bio and Merck reaching an acquisition of CD3/CD19 bispecific antibodies, with a down payment of US$700 million, second only to BMS and Baili Tianheng’s cooperation on bispecific ADC; and GSK’s acquisition of Enmu Bio’s CD3/CD19/CD20 trispecific antibody CMG1A46, with a down payment of US$300 million, which is also at a relatively high level. The popularity of autoimmune TCE is a fact, but it is undeniable that this field is also full of unknowns. On January 10, IGM Biosciences, which transformed from tumor to autoimmunity, suffered a blow: the core pipeline CD20xCD3 bispecific antibody IGM-2323 showed a disappointing depth of B cell depletion in the field of ...
- Source: drugdu
- 189
- January 16, 2025
The failure of “snake swallowing elephant” perspective Haier Bio and Shanghai RAAS’s endogenous and exogenous development

After more than a year of twists and turns, the reorganization drama of Haier Bio and Shanghai RAAS ended in termination. On the evening of January 6, 2025, both parties successively issued announcements on the resumption of trading of the company’s stocks. Looking back on this merger and acquisition, the eye-catching thing is “snake swallowing elephant”. On December 20, 2024, Haier Bio and Shanghai RAAS signed the “Absorption Merger Intention Agreement”. Based on the closing stock price of the day, the market value of the two companies was approximately 11.2 billion yuan and 47.9 billion yuan respectively. Regarding the reason for the termination, Haier Bio announced that the transaction structure was relatively complex, and after repeated discussions and consultations among all parties, a specific plan recognized by all parties concerned has not yet been formed. In order to effectively safeguard the interests of listed companies and investors, the two parties ...
- Source: drugdu
- 432
- January 16, 2025
The anti-corruption storm in the pharmaceutical industry will continue to deepen in 2025

On January 8, the Communiqué of the Fourth Plenary Session of the 20th Central Commission for Discipline Inspection of the Communist Party of China was officially released. The document clearly pointed out that as the final year of the 14th Five-Year Plan, the tasks of discipline inspection and supervision in 2025 are particularly important, especially in the fields of medicine and medical insurance funds, where the governance of corruption is clearly listed as a priority. On January 10, Yang Shanhua, chief accountant of China National Pharmaceutical Group Co., Ltd., was investigated. On the same day, the Hainan Provincial Commission for Discipline Inspection and Supervision announced the news that three staff members of the pharmaceutical and health system were investigated. Among them, Xiao Meifang, director of the laboratory department of Hainan Provincial Women and Children’s Medical Center, was suspected of serious violations of discipline and law. This is also the first ...
- Source: drugdu
- 314
- January 16, 2025
Stem cell therapy opens a new era

Recently, NMPA conditionally approved the listing of China’s first mesenchymal stem cell therapy, Amymetose Injection, through the priority review and approval process. Coincidentally, this is also after the FDA approved the marketing of Ryoncil, the first mesenchymal stem cell therapy, on December 18, 2024. The two drugs were approved only 15 days apart, and the indications are both for hormone-refractory acute graft resistance. Host disease. The FDA and NMPA have successively approved the first stem cell drugs, indicating that innovative stem cell drugs have arrived. The tortuous road Looking back at the development and application history of Ryoncil cell drug, we can find that its road to market in the United States was extremely difficult. It took 5 and a half years from the first application in 2019 to the final approval. During this period, I received 2 CRL (application rejection) letters and was in danger of being stranded. It ...
- Source: drugdu
- 609
- January 16, 2025
MEDICA 2025

Organiser：MEDICA Time：November 17 – 20, 2025 Address：Stockum Church Street 61, D-40474, Dusseldorf, Germany Exhibition hall：Dusseldorf Exhibition Center Product range: Medical Equipment: Medical electronic instruments, ultrasound equipment, X-ray equipment, medical optical instruments, clinical laboratory analytical instruments, dental equipment and materials, hemodialysis equipment, respiratory equipment, hospital ward and operating room equipment, emergency room equipment, hospital office equipment, laboratory equipment, etc. Disposable Consumables: Disposable medical supplies, dressings and hygienic materials, various surgical instruments, etc. Medical Devices: Medical and healthcare devices, home healthcare products, physiotherapy, plastic surgery techniques, etc. Medical Peripherals: Information and communication technology, medical services, publications, etc. About MEDICA 2025： The MEDICA Trade Fair in Dusseldorf, Germany, is the largest and most authoritative exhibition for hospitals and medical equipment in the world. With its irreplaceable scale and influence, it ranks first among medical trade exhibitions globally. Held annually in Dusseldorf, Germany, it displays a wide range of products and services ...
- Source: drugdu
- 519
- January 16, 2025
2025 medical device global exhibition summary

The medical device industry has always been a crucial component of the healthcare sector, with a series of significant offline exhibitions held annually to provide professionals with an opportunity to stay informed about the latest technologies and trends, establish business connections, and promote industry development. In 2025, the medical device field will once again welcome a series of notable exhibitions, offering a rare chance for professionals and medical technology enthusiasts alike. Below is a preliminary compilation of medical device exhibition information for 2025 by Drugdu.com, which we are now sharing with you: January Arab Health Jan. 27-30 Exhibitiors：4200 Dubai February MD&M West Feb. 4-6 Exhibitiors：700 California Medical Expo Feb. 15-17 Exhibitiors：750 Calcutta March Xi ‘an West International Medical Equipment Exhibition Mar. 6-8 Exhibitiors：1300 Xi’an CDMEE Mar. 7-9 Exhibitiors：1200 Chengdu CMEE Mar. 15-17 Exhibitiors：2000 Shandong MEDICAL FAIR INDIA Mar. 27-29 Exhibitiors：419 Greater Noida KIMES Mar. 20-23 Exhibitiors：1200 Seoul April CMEF ...
- Source: drugdu
- 479
- January 15, 2025
2025 Biopharmaceutical global exhibition summary

With the continuous innovation and development in the field of biopharmaceuticals, 2025 will continue to witness a series of industry-specific exhibitions. These exhibitions will provide an excellent opportunity for professionals in the biomedical field to explore the latest scientific research achievements, technological innovations, and industry trends. Whether you are involved in research, pharmaceuticals, biotechnology, or an entrepreneur seeking potential business opportunities, these exhibitions will offer you abundant insights and business prospects. Therefore, in this issue, Drugdu.com has compiled a summary of exhibition information for most of the pharmaceutical industry worldwide in 2025. January DUPHAT Jan. 7-9 Exhibitiors：1100 Dubai Pharmapack Jan. 22-23 Exhibitiors：268 Paris February Asia Pharma Expo Feb. 12-14 Exhibitiors：800 Dacca INTERPHEX Week Osaka Feb. 25-27 Exhibitiors：308 Osaka March Medical Japan Mar. 5-7 Exhibitiors：1400 Osaka Infarma Mar. 25-27 Exhibitiors：430 Madrid April Interphex US Apr. 1-3 Exhibitiors：460 New York CPhI Japan Apr. 9-11 Exhibitiors：712 Tokyo Korea Chem / Korea PHARM & BIO Apr. ...
- Source: drugdu
- 272
- January 15, 2025
IPO Radar | Losing 1 billion yuan in one year, Maiwei Biotechnology seeks A+H listing, how long can it survive relying on external “blood transfusion”?

Maiwei Biology (688062. SH) seems to have taken every step very accurately. This company, founded in May 2017, was listed on the Science and Technology Innovation Board on January 18, 2022. This success was not only due to the registration system reform at that time, but also closely related to the country’s encouragement policies for emerging industries such as science and technology innovation and biomedicine. In this context, Maiwei Biotechnology, like many other innovative pharmaceutical companies of the same period, has achieved its listing plan even without commercial products and revenue. In 2024, with the further implementation of the “National Nine Measures” policy, the A-share IPO market has ushered in a stricter review environment, leading to an overall market downturn. At the same time, due to the further relaxation of overseas listing policies for mainland enterprises and the listing conditions for Hong Kong stocks, it has stimulated the willingness ...
- Source: drugdu
- 337
- January 15, 2025
Johnson&Johnson’s new drug, Edatinib, has been approved for market in China | Medical Early Reference

NO.1 and Huang Medicine’s new lung cancer drug, Savotinib, have been approved for new indications On January 13th, the official website of the National Medical Products Administration (NMPA) of China announced that the application for the new indication of Savotinib tablets by Hehuang Pharmaceutical has been approved. Sevotinib is a highly selective oral MET inhibitor. According to a previous press release from Hehuang Pharmaceutical, the drug has been approved for the treatment of locally advanced or metastatic non-small cell lung cancer in adult patients with mesenchymal epithelial transition factor (MET) exon 14 mutation. Comment: Hehuang Pharmaceutical has made breakthroughs in the field of innovative drugs in recent years. At the beginning of the year, the company transferred the shares of its subsidiary company that operates traditional Chinese medicine products, further focusing on innovative medicine business. Johnson&Johnson’s new cancer drug, Edatinib, has been approved for marketing in China Johnson&Johnson announced that ...
- Source: drugdu
- 348
- January 15, 2025

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