After four months of deliberation, the European Medicines Agency (EMA) has “changed its mind” on Lencanermab. On November 14, the EMA Committee for Medicinal Products for Human Use (CHMP) announced that after re-examining Lencanermab, it recommended approval of Lencanermab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease, suitable for apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. According to regulations, the European Commission is expected to make a final ruling on the marketing authorization application for Lencanermab within the next 67 days. Of course, the European Commission is not in a good position to raise objections, so it is equivalent to approval. Although we had expected this result four months ago, it can be imagined that there were a lot of discussions in the middle. Foreign media commented that “EMA’s attitude towards Lencanermab has reversed 180 degrees.” This time, after Eisai/Biogen submitted the subgroup ...
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 ...
Recently, Asia Pacific Pharmaceuticals issued the “Announcement on the Progress of Liquidation and Cancellation of Joint Ventures”. A Biotech company that it established with an investment of approximately RMB 35.84 million in 2019 has completed the deregistration procedures. Asia Pacific Pharmaceuticals is mainly engaged in pharmaceutical manufacturing and CRO service businesses, covering chemical pharmaceutical preparations, chemical APIs, and pharmaceutical research and development. Its main products include roxithromycin capsules, cephalexin capsules, azithromycin dispersible tablets, and azithromycin for injection. The Biotech business area that was deregistered and liquidated this time was the new track that Asia Pacific Pharmaceuticals first contacted at the time – industrial hemp. It is reported that according to the different mass concentrations of tetrahydrocannabinol (THC) contained in hemp, hemp can be divided into industrial hemp, intermediate hemp, and recreational hemp. Industrial hemp refers to hemp with a THC content of less than 0.3%, which does not show psychoactive ...
In recent years, cell drug conjugates (CDCs) have gradually become a hot topic in medical research as an emerging drug delivery system. On July 1, 2024, Professor Gu Zhen and others from Zhejiang University published a review paper titled “Cell Drug Conjugates” in the Nature Journal of Biomedical Engineering. The article deeply explores the principles, preparation methods, and applications of this technology in cancer and immune diseases. This article will explain the content of the literature in detail, taking you to understand the core and prospects of this innovative technology. 01 What are cell drug conjugates (CDCs)? Cell drug conjugates are a complex that combines live cells and therapeutic drugs, capable of simultaneously exerting the functions of both, particularly suitable for the treatment of complex diseases such as cancer and autoimmune disorders. Unlike traditional drug delivery systems such as liposomes, nanoparticles, etc., CDCs utilize the physiological characteristics of cells, ...
Today, the seventh CIIE opened grandly in Shanghai. Every year, the CIIE is an excellent opportunity for global pharmaceutical companies to showcase their latest research and development results and expand international markets, and it is also a core window for insight into Chinese market opportunities. This year will be no exception. So, let’s take a look at Eli Lilly, a pharmaceutical company with nearly 150 years of history, and its latest thinking. As an all-around warrior, this year Eli Lilly focused on displaying its latest progress in key global disease areas such as diabetes, obesity, Alzheimer’s disease and anti-tumor. In the big and comprehensive layout, Eli Lilly also revealed its two major focuses of development in China: diabetes and obesity, and Alzheimer’s disease. At this CIIE, Eli Lilly focused on displaying tirpotide. This is not surprising. As Eli Lilly’s flagship product, tirpotide is one of the most competitive GLP-1 drugs ...
Parkinson’s disease is a common neurodegenerative disorder characterized by movement disorders, autonomic dysfunction, and sleep cognitive problems, affecting nearly 6 million people worldwide. Its neuropathological features include the loss of dopaminergic neurons and the aggregation of alpha synuclein within cells. Although neuroinflammation involving glial cells and immune cells is believed to be related to the pathogenesis of Parkinson’s disease, further research is needed to determine whether these pathways are associated with sporadic diseases. In addition, the relative contributions of neurons and glial cells in Parkinson’s pathology are still unclear. Although single-cell technology, including multi omics analysis, is gradually becoming a popular method for studying neurodegenerative diseases, these tools are only now beginning to be applied in Parkinson’s disease research, especially utilizing human brain tissue. On October 30, 2024, the Zhang Le research group at Yale University published a research paper titled “Single cell transcriptomic and proteomic analysis of Parkinson’s disease ...
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 ...
Cell, an international authoritative scientific journal, recently published a pioneering achievement from multiple research teams in China – the first time to use stem cell regeneration therapy to functionally cure type 1 diabetes. The research team used chemical reprogramming technology to induce pluripotent stem cells to prepare islet cells, and transplanted them to a type 1 diabetes patient, achieving clinical functional cure effect. So, how is it successful to induce stem cells to prepare pancreatic islet cells? Is functional cure truly a cure? Will stem cell technology be the key to conquer diabetes in the future? What is the difference between functional cure and cure Diabetes is a thorny disease, and its biggest harm to patients is that there are many clinical complications, which may lead to cardiovascular disease, nervous system damage, kidney disease, eye disease, foot disease, and so on. Diabetes ranks ninth among the world’s ten leading ...
The board of directors and all directors of our company guarantee that there are no false records, misleading statements or significant omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content. Recently, Tianjin Hengrui Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received approval from the National Medical Products Administration (hereinafter referred to as the “NMPA”) to issue a “Drug Clinical Trial Approval Notice” for fluoride [18F] metoprolol injection, and will conduct clinical trials in the near future. Basic information of drugs Drug Name: Fluorine [18F] Metoprolol Injection Form: Injection Application Matters: Clinical Trial Acceptance Number: CYHL2400142 Approval Conclusion: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the Fluorine [18F] Metoprolol Injection accepted on July 9, 2024 meets the relevant requirements for ...
On September 26, the field of schizophrenia ushered in a historic moment, when KarXT developed by Karuna was approved by the FDA for marketing. This means that Bristol-Myers Squibb’s tens of billions of bets have succeeded in their first battle. On December 22 last year, Bristol-Myers Squibb spent $14 billion to acquire Karuna for KarXT. KarXT has been approved for marketing, and there is another winner – Zai Lab. Currently, Zai Lab owns the rights to KarXT in Greater China. Considering that there are more than 8 million schizophrenia patients in China, and the introduction cost of Zai Lab is not high, it is expected to obtain sufficient profits. Of course, all this can only be said to have settled, and is not surprising. Most of the existing schizophrenia treatments are old varieties approved in the 1990s. KarXT does not rely on dopaminergic or serotonergic pathways and is the first ...
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