Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 17, 2024, Capricor Therapeutics, a biotechnology company developing transformed cell and exosome therapies for the treatment of rare diseases, announced that it had signed a binding term sheet with Nippon Pharma. The terms state that Nippon Pharma will commercialize and distribute Capricor’s main asset, deramiocel, in Europe for the treatment of Duchenne muscular dystrophy (DMD). Capricor will receive a $15 million equity investment at a 20% premium and a $20 million advance payment upon signing the final agreement. The potential milestone amount is as high as $715 million, with product revenue accounting for double digits. The total ...
Organiser:Reed Exhibitions Time:April 9th – 11th, 2025 address:3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall:Tokyo Big Sight International Exhibition Center Product range: From antibody-based medicines to nucleic acids, peptides, and other middle-molecule medicines, to gene and cellular therapies; Cutting-edge technologies in biotechnology development, including outsourced technologies and devices, among others. About bioLIVE: bioLIVE, the Japan International Biotechnology Exhibition for Life Sciences, abbreviated as the Japan Biotech Exhibition, is held annually and is Japan’s premier biotechnology exhibition. The previous edition of the exhibition was held at the Tokyo Big Sight International Exhibition Center, occupying an exhibition area of 12,000 square meters, with 268 participating companies and attracting 9,500 industry visitors.
Recently, Kelun Pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical’s chemical drug “Bupivacaine Liposome Injection” was approved for marketing by the National Medical Products Administration (trade name Bruco®), which was approved according to Class 3 chemical drugs and deemed to have passed the generic drug quality and efficacy consistency evaluation. Kelun Pharmaceutical’s Bruco® is the second bupivacaine liposome injection product to be launched in China. Hengrui Medicine’s bupivacaine liposome injection generic drug (trade name: Aihengping) was approved in November 2022. It is the world’s first generic drug and also the first long-acting postoperative analgesic drug to be launched in China. In July this year, Aihengping was approved for marketing by the FDA, becoming the world’s first manufacturer to obtain generic drug approval for this variety in the United States. Behind the successful breakthroughs of domestic pharmaceutical companies is the growing market demand in the field of long-acting postoperative analgesic preparations ...
Vice Minister Huang Guo of the National Drug Administration recently revealed that the agency is leading the modernization of drug regulation through information technology. The administration continues to implement the Smart Drug Regulation Action Plan, focusing on building an integrated system for the registration and approval of drugs, medical devices, and cosmetics. This initiative aims to fulfill the “efficient handling of single transactions” requirement, achieving seamless cooperation throughout the entire process from acceptance and review to approval and certification. As a result, the volume of online acceptance and the rate of timely conclusions have steadily increased, significantly enhancing the quality and efficiency of reviews and approvals. Currently, all government service matters handled by the National Drug Administration have been transitioned to 100% online processing, and all enterprise-related certificates at the bureau level have been fully digitized. The total number of electronic certificates issued has exceeded 170,000, allowing enterprises to access ...
With the tenth batch of national procurement about to start, we are once again standing at a new starting point in history, ready to welcome this new wave of reforms in the pharmaceutical industry. On January 9, 2024, the National Medical Security Work Conference was held in Beijing. It was mentioned that the centralized procurement should be promoted to “expand and improve quality”. A new batch of national organized centralized procurement of drugs and consumables will be carried out, and the selected varieties in the centralized procurement will be continued after the expiration of the agreement, so that the total number of national and provincial centralized procurement drugs will reach at least 500, an increase of 50 compared with 2023. In May, the National Medical Insurance Administration issued the “Notice on Strengthening Regional Coordination to Improve the Quality and Expand the Scope of Centralized Procurement of Medicines in 2024”, which ...
On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-action inhibitor targeting interleukin 23 (IL-23) approved for the treatment of active ulcerative colitis, further solidifying Johnson & Johnson’s leadership in the field of inflammatory bowel disease. Guselkumab is the first approved interleukin 23 (IL-23) inhibitor in the world, selectively binding to the p19 subunit of IL-23 to inhibit its interaction with the IL-23 receptor. It has shown strong efficacy for various autoimmune diseases; it can block IL-23 while also binding to the CD64 receptors on cells that produce IL-23. It is currently approved for the treatment of plaque psoriasis, active psoriatic arthritis, and UC. Furthermore, in June 2024, Johnson & Johnson submitted a supplemental Biologics ...
Over the past decade, the cross-border medical intermediary industry has experienced a boom, followed by a sharp decline during the pandemic. It has only been after the pandemic that the industry began to recover, but very few companies have managed to endure to this point. Recently, the company Shengnuo Yijia announced a partnership with the Hong Kong Yanghe Medical Group, launching a patient service center in the Yanghe facility to assist critically ill patients from mainland China in seeking medical treatment in Hong Kong. Previously, Shengnuo Yijia focused on bringing patients to the U.S., U.K., Japan, and other overseas regions for treatment. Now, they are increasing efforts to explore the Hong Kong medical market. How should we view this change? According to Shengnuo Yijia Chairman Cai Qiang, cross-border medical services have entered their next phase. The key question remains: Where are the new opportunities in this industry? Seeking Treatment in ...
F Lab is suitable for a wide range of applications, such as feasibility studies, quality control, and troubleshooting during production. The powder analyzer can be used to check the tableting process of a formulation. Users can test raw materials under special conditions and compare various formulations. The compact device can even detect changes in the mineral mixture due to compositional changes. This powder analyzer is therefore a great support for the development of new products. The powder analyzer can be automated and is available in two models: the F Lab 5 with a pressing force of 5 kN for tablets up to 10 mm in diameter, and the F Lab 10 with a pressing force of up to 10 kN for tablets up to 15 mm in diameter. Depending on the customer’s needs, the device can be combined with an automatic data evaluation and display program and other analysis equipment. ...
Drugdu.com expert’s response: The registration requirements for Active Pharmaceutical Ingredients (APIs) in Mexico typically involve a separate registration process, rather than simply being associated with the registration of the final dosage form. This is because APIs, as the essential components of dosage forms, have a direct impact on the quality, safety, and efficacy of the final product. Registration Requirements for APIs in Mexico Approval from the Mexican Ministry of Health: The export of APIs to Mexico requires approval from the Mexican Ministry of Health. This signifies that APIs must comply with Mexico’s local pharmaceutical regulations and standards. COFEPRIS Registration: Manufacturers of APIs need to register with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is the primary agency under the Mexican Ministry of Health responsible for regulating drugs, medical devices, cosmetics, and hygiene products. During the registration process, companies must submit a range of documents, including but not limited ...
Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Lilly said that the company had completed the $800 million Kinsale factory expansion project to increase the production of its obesity and diabetes drugs Mounjaro and Zepbound. At the same time, the pharmaceutical company will also invest $1 billion to build a factory in Limerick to increase the production of biopharmaceutical raw materials, especially Kisunla, a drug approved by the FDA to treat Alzheimer’s disease two months ago. The production of active pharmaceutical ingredients is expected to begin in 2026. Lilly stated that Limerick’s expansion will add tools for artificial intelligence, automated robots, and machine learning to the website. ...
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