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The “trend” and “newness” behind Roche Pharmaceuticals’ layout of smart healthcare in China

Never underestimate the power of the tide. “AI+ empowerment” is becoming an important engine to promote the expansion of new quality productivity in various industries, and the medical and health system is no exception. For the medical and health system, improving productivity and efficiency while reducing the cost of patients and healthcare systems is an eternal topic. This also means that the greatest potential of AI+ healthcare lies not only in the application of one or two scenarios, but in assisting and optimizing medical services in all aspects, and completely rewriting the order of all links of “diagnosis and treatment”. At this year’s CIIE, through the display of Roche, the industry leader, we can see that this trend is already very obvious: AI is penetrating in multiple dimensions to meet the individualized diagnosis and treatment needs of patients and change the direction of the tide in multiple fields. Although many ...
- Source: drugdu
- 49
- November 12, 2024
Ascentage Pharmaceuticals’ Bcl-2 Inhibitor to be Reviewed for Priority

On November 4, according to the official website of CDE, Suzhou Ascentage Pharmaceuticals Co., Ltd. (hereinafter referred to as “Ascentage Pharmaceuticals”) proposed a priority review for the Class 1 new drug APG-2575 tablets, which is intended for patients with refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. APG-2575 is a Bcl-2 selective inhibitor independently developed by Ascentage Pharmaceuticals. It can restore the normal apoptosis process of cancer cells by selectively inhibiting Bcl-2 protein, thereby achieving the purpose of treating tumors. It is understood that APG-2575 is the first locally developed Bcl-2 inhibitor to enter the clinical stage in China. It is also the second in the world and the first in China to see clear efficacy and enter the key registration clinical stage. At present, the drug has broad potential for single-drug and combination therapy in the treatment of various blood tumors and solid tumors. To date, APG-2575 has received ...
- Source: drugdu
- 63
- November 9, 2024
【EXPERT Q&A】IVD self-test products apply for EU CE, need to pay attention to what?

Drugdu.com expert’s response: When applying for the CE certification for IVD self-test products in the EU, attention should be paid to the following aspects: Ⅰ. Understanding the IVDR Regulatory Requirements Regulatory Content: IVD self-test products need to comply with the regulations of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Product Classification: According to the IVDR, IVD products are classified into four risk categories: A, B, C, and D. Self-test products, which typically involve patients performing their own tests, may fall into higher risk categories, requiring special attention to relevant audit requirements. Ⅱ. Preparing Technical Documentation Completeness: Technical documentation should include product instructions, technical specifications, validation reports, quality control manuals, etc., and should be organized and numbered according to the order specified in Appendix II of the IVDR. Accuracy: The content of the documentation should be accurate and reflect the true performance and safety of the product. ...
- Source: drugdu
- 58
- November 8, 2024
Haichen Pharmaceutical Approved for Additional Injection Specification of Labetalol Hydrochloride 150mg

On November 6, Haichen Pharmaceutical (300584) announced that it has received approval for the addition of a new specification for injection of Labetalol Hydrochloride 150mg through a supplemental drug application. The company recently received a notification from the National Medical Products Administration, approving the addition of the 150mg specification based on the already approved 50mg specification, and is considered to have passed the consistency evaluation. The registration classification of this approval is for chemical drugs, with the manufacturing enterprise being the company itself. The approval number is H20247263. The addition of the new specification will involve changes to the production process, which must be implemented within six months from the date of approval. Labetalol Hydrochloride injection is a novel ultra-short-acting beta-blocker, clinically suitable for the emergency treatment of various rapid cardiac arrhythmias. In 2023, this product generated sales revenue of 267 million yuan, accounting for 51.59% of the company’s total ...
- Source: drugdu
- 43
- November 8, 2024
Kejun Pharmaceuticals Completes B+ Round of Phased Financing

On October 31, Shanghai Kejun Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Kejun Pharmaceutical”) announced the completion of its B+ round of phased financing. This round of financing was led by Guoxin Innovation Equity, and other major investors included Aeon Group and Infinity Capital, and the original investor Honghai Capital also continued to make additional investments. Qidian Capital served as the financial advisor for this round of financing and will continue to provide financing services to Kejun Pharmaceutical in the future. Kejun Pharmaceutical stated that the funds raised from this financing will be used to accelerate the clinical development of CG-0255, a core product in the cardiovascular field. About Kejun Pharmaceutical Kejun Pharmaceutical was established in Zhangjiang, Shanghai in 2018, focusing on the treatment of cardiovascular and cerebrovascular diseases and antiviral diseases, and focusing on the research and development of small molecules and nucleic acid drugs. At present, Kejun ...
- Source: drugdu
- 52
- November 7, 2024
Aimei Vaccine’s 13-Valent Conjugate Pneumococcal Vaccine Obtains Production License and Market Registration Submitted

On November 1, Aimei Vaccine announced that it has submitted a drug market registration application for its self-developed 13-valent conjugate pneumococcal vaccine to the National Medical Products Administration. The results from a completed Phase III clinical study show that Aimei’s 13-valent conjugate pneumococcal vaccine has demonstrated good immunogenicity and safety, meeting the clinical preset objectives. Aimei’s wholly-owned subsidiary, Aimei Biotechnology Co., Ltd., has obtained the corresponding drug production license for this product. The 13-valent conjugate pneumococcal vaccine has been referred to as the “king of global vaccines” and has been the world’s top-selling vaccine for ten consecutive years. Pfizer’s 13-valent conjugate pneumococcal vaccine (Prevnar 13®) is the best-selling vaccine globally and has frequently ranked among the top ten best-selling drugs worldwide. According to Pfizer’s 2023 annual report, global sales of Pfizer’s pneumococcal conjugate vaccine were approximately $6.44 billion in 2023. Over the years, the global sales of the 13-valent conjugate ...
- Source: drugdu
- 43
- November 4, 2024
Is the turning point of “Cosmic Pharmaceutical Factory” coming?

In 2022, Pfizer’s annual revenue exceeded $100 billion, making it the world’s largest pharmaceutical company in terms of revenue. However, as the COVID-19 pandemic quickly receded, revenue fell by 41% in 2023, and revenue ranking also dropped from first to fourth. Recently, the well-known radical investment institution Starboard Value invested $1 billion in Pfizer. What changes will this bring to this pharmaceutical giant? In 1849, Charles Pfizer and Charles Erhart founded Pfizer in New York, initially focusing on the production of chemical products. During World War II, Pfizer successfully mass-produced penicillin and launched oxytetracycline, officially entering the pharmaceutical industry. Since then, Pfizer has continued to expand through research and development and mergers and acquisitions, launched blockbuster drugs such as Norvasc and Viagra, and gradually became a leading global pharmaceutical company. Since the 21st century, Pfizer has topped the list of the top 50 pharmaceutical companies in the world (Pharm Exec ...
- Source: drugdu
- 64
- November 2, 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
- 61
- October 31, 2024
“Plan B” for Chinese pharmaceutical companies to go overseas

Weighing the risks is the primary issue that all pharmaceutical companies need to consider when going overseas. The cost of going overseas is not cheap. Not to mention the time cost required to build overseas clinical, promotion, and registration experience, the capital cost is the top priority. BeiGene provides a good reference: although it has seen the dawn of profitability, this is based on the total loss of nearly 50 billion yuan in the past five years; Legend Biotech’s overseas cost is not low either. It is estimated that it has spent at least 1 billion US dollars since the establishment of the Xidaqiolunsai project. Industry insiders commented that this is far more expensive than imagined. From the perspective of capital investment alone, it can be asserted that there are not many pharmaceutical companies that can play the two cards of “local + going overseas” at the same time. To ...
- Source: drugdu
- 71
- October 30, 2024
The second day of the 2024 National Negotiations | Hengrui, CSPC Pharmaceutical, Qilu Pharmaceutical, AstraZeneca…appeared! Antidiabetic and tumor drugs may be the focus

The 2024 National Medical Insurance Negotiations entered the second day. Beijing was sunny. On this day, antidiabetic and tumor drugs were the highlights. On the second day of the National Negotiations, Huang Bin, Vice President of AstraZeneca China, and Xia Yu, founder, chairman, president and CEO of Kangfang Bio, appeared at the National Negotiations. On the morning of October 28, the companies participating in the negotiations included AstraZeneca, Hengrui, Xinlitai, Hisun, CSPC Pharmaceutical, etc.; in the afternoon, Zhejiang Jingxin Pharmaceutical, Union Qilin, Beijing Novartis, Luye Pharmaceutical, Jiangsu Hausen, Bristol-Myers Squibb, Qilu, Changchun Jinsai, Zejing Bio, Hengrui, Novo Nordisk, etc. were present. Some on-site observers said that anti-tumor, antidiabetic and other chronic disease drugs were the protagonists of the second day of the National Negotiations. The National Medical Insurance Administration has carried out adjustments to the medical insurance drug list for six consecutive years, adding a total of 744 drugs to ...
- Source: drugdu
- 57
- October 30, 2024

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