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【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
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- November 8, 2024
PCR new legend debuts at CIIE! Roche Diagnostics releases LightCycler® PRO

Today, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Roche Diagnostics China announced that its new molecular detection platform LightCycler® PRO System real-time fluorescence quantitative PCR instrument* (hereinafter referred to as “LightCycler® PRO”) was officially launched in China. Wang Feng, Senior Director of Roche Diagnostics China – Life Sciences Department, Marcus Droege, CEO of TIB Molbiol, James Lee, Global Senior Product Manager of Roche Diagnostics, and other guests attended the LightCycler® PRO launch conference. “As a global leader in in vitro diagnostics, Roche Diagnostics has always empowered scientific research with cutting-edge innovative technologies and led the development of the industry. LightCycler® PRO is another breakthrough innovation in the field of molecular testing. It can achieve 7-channel multiplex testing and has powerful advantages such as accuracy, high efficiency, flexibility, and ease of use. We hope that this time, with the help of the CIIE, it will officially ...
- Source: drugdu
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- 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
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- November 8, 2024
The world’s first, created in China! Weekly insulin preparation Novozyme® debuts at CIIE, to be launched at the end of the month

On November 6, at the 7th China International Import Expo (hereinafter referred to as “CIIE”), Novo Nordisk held a press conference and announced that the world’s first weekly insulin formulation, Novozymes® (insulin Efficacy Injection), which was exhibited for the first time at this CIIE, will be commercially launched in China at the end of November 2024 for the treatment of type 2 diabetes in adults, ushering in the era of weekly insulin treatment. Professor Peng Yongde, head of the Department of Endocrinology and Metabolism at the First People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine, said: “Insulin therapy is still an indispensable and important cornerstone in the diabetes management pathway. As a key component, basal insulin strives to better meet clinical treatment needs to help patients start treatment in a timely manner, improve treatment compliance, increase treatment continuity, and improve patient satisfaction.” Insulin “from day to week” ...
- Source: drugdu
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- November 8, 2024
Cell Drug Conjugates – An Innovative Drug Delivery System

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, ...
- Source: drugdu
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- November 7, 2024
Cytokines

Preface B cells are the only cell type capable of differentiating into antibody secreting cells (plasma cells), and they can also present antigens to T cells and produce cytokines. By producing cytokines, B cells affect multiple aspects of immunity: cytokines derived from B cells, including lymphotoxins, are crucial for the individual development, homeostasis, and activation of secondary lymphoid organs, as well as the development of tertiary lymphoid tissue in ectopic sites; Other cytokines derived from B cells, such as interleukin-6 (IL-6), interferon – γ, and tumor necrosis factor, can affect the development of effector cells and memory CD4+T cell responses; Finally, B cells can regulate inflammatory immune responses by secreting IL-10 and IL-35, and “regulatory B cells” are the main source of inhibitory cytokines derived from these B cells in the body. The role of B cells in tissue development and repair Lymphatic organogenesis is mainly regulated by lymphoid tissue ...
- Source: drugdu
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- November 7, 2024
Siemens Healthineers plans to sell some of its shares

Recently, according to Reuters, Ralf Thomas, Chief Financial Officer of Siemens (SIEGn. DE), stated that Siemens may sell some of its shares in Siemens Healthineers (SHLG. DE), Siemens Energy (ENR1n. DE), and Fluence (FLNC. O) to help raise funds for its acquisition of Altair. On October 30th, Siemens signed the final acquisition agreement with AI software leader Altair, with a transaction amount of up to 10.6 billion US dollars (approximately 75 billion yuan), setting a record for the largest merger and acquisition transaction in Siemens Group’s history (excluding the merger of the spin off business Siemens Healthineers). The combination of Altair’s capabilities in simulation, high-performance computing, data science, and artificial intelligence with Siemens Xcelerator (industrial software) will create the world’s most complete portfolio of artificial intelligence design and simulation products, “said Siemens President and CEO Boren 01. Siemens official response Siemens, a century old manufacturing giant originating from Europe, was ...
- Source: drugdu
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- November 7, 2024
6 innovative drugs expected to receive FDA approval in November

According to the expected target date of PDUFA, it is expected that in November, the US FDA will make regulatory decisions on the approval of six innovative drugs. This article will introduce these therapies. Active ingredient: Zenocutuzumab Indications: NRG1 positive non-small cell lung cancer (NSCLC) or pancreatic cancer Company Name: Merus Zenocutuzumab is a bispecific antibody targeting HER2 and HER3, which exhibits potential therapeutic efficacy against NRG1+cancer by uniquely binding to HER2 and effectively blocking the interaction between HER3 and NRG1 or NRG1 fusion protein. Preclinical studies have shown that zenocutuzumab can strongly inhibit the formation of HER2/HER3 heterodimers, thereby suppressing oncogenic signaling pathways, preventing tumor cell proliferation, and blocking tumor cell survival. Clinical studies have shown that it has anti-tumor activity in various types of NRG1+cancer. According to the mid-term data from the recently released Phase 1/2 clinical trial, zenocutuzumab has shown persistent efficacy in the treatment of advanced ...
- Source: drugdu
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- November 7, 2024
CIIE Observation | Eli Lilly’s Two “Focuses”

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 ...
- Source: drugdu
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- November 7, 2024
MNCs in China, looking for a new era of survival philosophy

Multinational pharmaceutical companies are under increasing pressure. Especially when the US market, the world’s largest pharmaceutical market, has undergone tremendous changes due to the Inflation Reduction Act, the importance of the Chinese market has once again been highlighted. However, all signs indicate that it is becoming increasingly difficult to get a bigger piece of the pie in the Chinese market. In recent years, the reform policies introduced by the state at the pharmaceutical level have exceeded the changes in the previous decades. The continued advancement of medical reform policies such as medical insurance negotiations and national centralized procurement, coupled with the epidemic, anti-corruption, capital winter, local generic drugs, and the rise of innovative forces, have intensified the challenges of the entire industry. Therefore, we see that the past two years have become a strategic turbulence period for MNCs in China. While tapping the potential of the domestic market, they are ...
- Source: drugdu
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- November 7, 2024

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