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Novartis plans to give priority review to two “nuclear medicine-related products”

Today (September 24), CDE plans to include Novartis’ Lutetium [177Lu] Texivirpitide Injection and Radioactive Drug Gallium [68Ga] Gozertide Injection Preparation Kit in the priority review. According to the CDE official website, both drugs are based on the “Opinions of the National Medical Products Administration on Reforming and Improving the Management System for the Review and Approval of Radioactive Drugs” (National Medical Products Administration Drug Note [2023] No. 20) and the “Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)”. After review, they comply with the “Drug Registration Management Measures” and the “Announcement of the National Medical Products Administration on the Release of the “Breakthrough Therapeutic Drug Review Work Procedures (Trial)” and other three documents (No. 82 of 2020). The requirements are agreed to be included in the priority review and approval procedure according to the priority review scope “(VI) Other circumstances prescribed by the National Medical Products Administration for priority ...
- Source: drugdu
- 66
- September 28, 2024
Medtronic and Siemens Healthineers reach a major collaboration

On September 25, local time, at the 39th Annual Meeting of the North American Spine Society (NASS) held in Chicago, Medtronic announced that it has established a partnership with Siemens Healthineers to explore opportunities to further expand advanced preoperative and postoperative imaging technologies for spine care. Medtronic and Siemens Healthineers plan to bring the Siemens Healthineers Multitom Rax™ imaging system to market and integrate the platform into Medtronic’s spine surgery AiBLE™ ecosystem. The two companies also hope to collaborate on technology development, marketing and commercial activities to improve clinical outcomes. Multitom Rax™ can be used for musculoskeletal diseases, including spinal patients. Multitom Rax™ features standing, weight-bearing imaging, cone beam CT and supine x-ray capabilities, supporting Medtronic’s commitment to improving standards of care across the care continuum. Skip Kiil, president of Medtronic CranioSpinal Technology, said: “The collaboration with Siemens Healthineers advances our commitment to reduce variability and improve outcomes for spinal ...
- Source: drugdu
- 71
- September 28, 2024
Johnson & Johnson closes two business units

On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
- Source: drugdu
- 68
- September 28, 2024
Brief Bioinform | Li Shiliang/Li Honglin team develops AI method GR pKa value prediction for small molecules based on retention mechanism

Zhiyao Bang The following article is from DeDrug, authored by Li’s Lab On August 22, 2024, the team of Professor Li Shiliang/Li Honglin from East China University of Science and Technology/East China Normal University published a research paper titled “GR pKa: A message feeding neural network with retention mechanism for pKa prediction” in the journal Briefing in Bioinformatics. This paper introduces an innovative deep learning model GR pKa for predicting the pKa values of small chemical molecules. This model combines multiple fidelity learning, quantum chemistry features, and retention mechanisms to achieve rapid and accurate prediction of pKa values of small chemical molecules, providing a powerful new tool for research in the fields of chemistry and pharmacy. Research background In the process of drug discovery and design, the acid-base dissociation constant (pKa) of molecules has a significant impact on the characteristics (absorption, distribution, metabolism, excretion, and toxicity) and biological activity of ...
- Source: drugdu
- 79
- September 27, 2024
Yuanruida ® The application for marketing authorization for the treatment of relapsed or refractory large B-cell lymphoma has been officially accepted

Juventas Biotech On September 26, 2024, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Heyuan Biotechnology (Tianjin) Co., Ltd. (referred to as “Heyuan Biotechnology”) had launched its first CAR-T cell therapy product, Yuanruida ® The application for marketing authorization for the new indication of (Nakiolenza Injection) has been officially accepted, with acceptance number CXSS2400104, for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or above systemic therapy. This is after the recurrence or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults ® The second indication for submitting a new drug listing application domestically. This new drug listing application is based on a single arm, open label, multicenter critical clinical study (NCT04586478) jointly led by the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) and Ruijin Hospital ...
- Source: drugdu
- 86
- September 27, 2024
Winner Medical acquires GRI for approximately $120 million

On September 23rd, Steady Medical officially announced the successful acquisition of 75.2% equity in Global Resources International, Inc. (GRI) for approximately $120 million (approximately RMB 840 million) in cash. The first international controlling stake acquisition project of Steady Medical has landed, and low value consumables leader Whale Swallows Global Medical Consumables Giant GRI has opened up a new growth point for Steady Medical overseas. Borrowing a ship to set sail, entering a new stage of global production Founded in 1991, Steady Medical achieved coordinated development in the medical and consumer sectors through two major brands, “Winner Steady Medical” and “Purcotton Era”. On September 17, 2020, Steady Medical officially listed on the ChiNext board. Over the years, Steady Medical has continuously innovated and expanded its industry boundaries, covering multiple fields such as healthcare, personal care, home care, maternal and child care, and home textiles and apparel. Its products have obtained EU ...
- Source: drugdu
- 83
- September 27, 2024
Fosun Pharma achieves 100% control

On the same day of signing the Equity Transfer Agreement, Fosun Kate and Kite revised the original license agreement. According to the revised content, Fosun Kate has obtained exclusive rights to develop, produce, and commercialize Yikaida and Brexu Cel (Fosun Kate’s ongoing project FKC889) within the Kite license area (mainland China, Hong Kong, and Macau) and field (cancer treatment field). Kite will receive a tiered royalty fee of 7% to 13% of drug sales. For Fosun Kate’s pipeline assets, Kite has the right to receive a sales royalty of 2% to 4%. In addition, Fosun Pharma will increase its capital by $10 million in addition to the $27 million equity acquisition, to strengthen Fosun Pharma’s layout in the biopharmaceutical field. It is reported that four CAR-T therapies, including Achilles’ heel injection, have submitted application information in the upcoming 2024 national medical insurance negotiations. Kite, Fuxing Medicine and Gilead 2017 is ...
- Source: drugdu
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- September 27, 2024
Chinese Scientists Achieve Functional Cure for Type 1 Diabetes Using Stem Cell Regeneration Therapy

Chinese scientists have made a breakthrough in the treatment of major diseases using induced pluripotent stem cells, achieving the first functional cure for Type 1 diabetes through stem cell regeneration therapy. The research team, composed of the groups led by Shen Zhongyang and Wang Shusen from Tianjin First Central Hospital, Deng Hongkuai from Peking University and Changping Laboratory, and Zhejiang Ruipu Chenchuang Technology Co., Ltd., utilized chemical reprogramming techniques to induce pluripotent stem cells to create insulin-producing beta cells. These cells were then transplanted into a Type 1 diabetes patient, resulting in a clinically functional cure. The findings were published on the evening of September 25 in the international prestigious journal — Cell. https://finance.eastmoney.com/a/202409263191732155.html
- Source: drugdu
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- September 27, 2024
Jacobs’ Pan-KRAS inhibitor approved for clinical trial in the US

September 23, 2024 – The clinical trial application (IND) for Pan-KRAS inhibitor JAB-23E73 independently developed by JACOBIO was approved in the United States, and a Phase I/IIa clinical trial for advanced solid tumors will be conducted in the United States. The IND application for China has been submitted, and clinical trials will be conducted in China simultaneously after approval. KRAS is widely present in a variety of tumor mutations. 23%-25% of cancer patients have KRAS mutations. About 2.7 million new tumor patients with KRAS-related mutations each year are expected to benefit from Pan-KRAS inhibitors. JAB-23E73 can inhibit both active and inactive KRAS, and has no significant inhibition on HRAS and NRAS. As an oral KRAS inhibitor, JAB-23E73’s preclinical data showed good pharmacokinetic properties. JACOBIO is committed to providing patients with breakthrough treatment options. The company’s research projects are based on the six major tumor signaling pathways of KRAS, tumor immunity, ...
- Source: drugdu
- 72
- September 27, 2024
The CSRC encourages cross-border mergers and acquisitions of unprofitable assets, a new path for Biotech to enter the capital market?

On September 24, Wu Qing, chairman of the CSRC, said at a press conference of the State Council that in order to further stimulate the vitality of the merger and reorganization market, the CSRC has studied and formulated the “Opinions on Deepening the Reform of the Merger and Reorganization Market of Listed Companies” (“Six Mergers and Acquisitions”, hereinafter referred to as the “Opinions”), including supporting listed companies to transform and upgrade to new quality productivity, encouraging industrial integration, improving regulatory tolerance, and improving the transaction efficiency of the reorganization market. Among them, it is clearly stated that listed companies are strongly supported to carry out cross-industry mergers and acquisitions and acquisitions of unprofitable assets based on transformation and upgrading. This means that unprofitable biotech companies may usher in a new path to enter the capital market. At the meeting, Wu Qing said that mergers and acquisitions are major events in ...
- Source: drugdu
- 93
- September 27, 2024

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