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【EXPERT Q&A】What are the requirements for naming in vitro diagnostic reagents?

Drugdu.com expert’s response: The naming of in vitro diagnostic reagents must follow a series of clear requirements to ensure the standardization, accuracy, and ease of understanding of the names. These requirements mainly include the following points: Ⅰ. Naming Structure The product name of in vitro diagnostic reagents typically consists of three parts: Name of the Substance Being Tested: This is the target substance that the reagent detects, and the name should accurately reflect the characteristics of the substance being tested. Purpose: Describes the purpose of the reagent, such as “assay kit,” “quality control material,” etc. This part helps users understand the specific application of the reagent. Method or Principle: Explains the method or principle of the reagent’s detection, such as “magnetic bead-based chemiluminescent immunoassay,” “fluorescent PCR method,” “fluorescent in situ hybridization,” etc. This information is usually listed in parentheses to provide additional technical details. Ⅱ. Specific Naming Rules Quantitative vs. Qualitative ...
- Source: drugdu
- 40
- November 18, 2024
Chiatai Tianqing won the first place

In 2024, 207 varieties passed/are deemed to have passed the consistency evaluation in October, involving 203 companies (counted as group companies), of which 47 companies passed multiple varieties, and Zhengda Tianqing Pharmaceutical Group Co., Ltd. had the largest number of varieties passed. Chiatai Tianqing ranked first in the “number of varieties passed by the company” 1. Overall situation In October, a total of 207 varieties passed/are deemed to have passed the consistency evaluation: 151 varieties were deemed to have passed the consistency evaluation when they were launched as newly registered classified generic drugs; 59 varieties passed the evaluation with supplementary applications for generic drug consistency evaluation, an increase of 20 varieties compared to September. According to the statistics of the approval documents for marketed drugs, 12 varieties were launched in October as newly registered classified generic drugs, and the first was deemed to have passed the consistency evaluation, and 3 ...
- Source: drugdu
- 59
- November 16, 2024
“Two new Chinese medicines” approved for clinical trials

According to the CDE official website, two new traditional Chinese medicines have obtained implicit permission for clinical trials. They are the Category 2.3 new drug “Xuesaitong Soft Capsules” from China Resources Shenghuo and the Category 1.1 new drug “Jiuwei Zhengxiao” from the Institute of Clinical Basic Medicine of the China Academy of Chinese Medical Sciences. Particles”. Xuesaitong soft capsule: carotid atherosclerosis Xuesaitong soft capsule has the functions of activating blood circulation, removing blood stasis, unblocking meridians and activating meridians, and its main component is total saponins of Panax notoginseng. Currently, this drug has been approved for use in the meridian recovery period of ischemic stroke (cerebral infarction) caused by blood stasis blockage. Symptoms include hemiplegia, numbness on one side of the body, crooked mouth and tongue, and slurred speech. This time, China Resources Shenghuo’s Class 2.3 new Chinese medicine “Xuesetong Soft Capsule” has obtained another implied clinical trial license, which ...
- Source: drugdu
- 61
- November 16, 2024
Breaking news! The CEO of a global orthopedic giant may be dismissed

Recently, according to the British “Mail on Sunday report”, the global orthopedic giant Smith & Nephew has received a severe warning from shareholders due to its poor performance. Smith & Nephew’s shareholders have lost patience with the strategic development speed of CEO Deepak Nath and declared that if the company’s performance cannot be improved, Deepak Nath will be dismissed and Smith & Nephew will also face the split of the orthopedic department. It is reported that Smith & Nephew’s stock price has fallen by as much as 44% in the past five years. As this year’s performance has not yet “cleared up”, shareholders’ emotions are difficult to appease, further putting pressure on Deepak Nath. Century-old enterprise faces crisis Smith & Nephew was founded in the UK in 1856. This old company with a long history of more than 100 years has three main businesses: orthopedics, sports medicine and otolaryngology, and ...
- Source: drugdu
- 50
- November 16, 2024
Global product revenue exceeds 7 billion yuan! BeiGene’s third quarter report is released

On the evening of November 12, BeiGene released its third quarter 2024 U.S. stock performance report and A-share main financial data announcement. In the third quarter, BeiGene continued its strong growth momentum, achieving revenue of 7.139 billion yuan, a year-on-year increase of 26.9%. Global product revenue reached 7.079 billion yuan, a year-on-year increase of 65.1%. The overall performance is eye-catching . In the first three quarters of 2024, BeiGene’s total operating revenue reached 19.136 billion yuan, a year-on-year increase of 48.6%. Products continue to increase in volume at a high speed, with product revenue of 18.986 billion yuan in the first three quarters, a year-on-year increase of 72.9%. Whether it is total revenue or product revenue, the first three quarters have exceeded last year’s full-year revenue of 17.423 billion yuan, and the performance is very eye-catching. According to the U.S. stock financial report, BeiGene’s financial situation continues to improve, with ...
- Source: drugdu
- 53
- November 16, 2024
Tilpodide reduces the risk of diabetes progression by 94%

On November 13, 2024, Lilly announced the latest follow-up data of Phase III clinical SURBOUNT-1 of Tilpolide in the treatment of pre diabetes patients with obesity or overweight. The follow-up time was up to 3 years (176 weeks), and the data were also published in the New England Medical Journal. After 176 weeks of treatment, the proportion of patients who progressed to type 2 diabetes in the Tilpodide treatment group and the placebo control group was 1.2% and 12.6% respectively, and the risk of progression to type 2 diabetes was reduced by 94%. After 17 weeks of drug withdrawal, the rates of progression to type 2 diabetes were 2.4% and 13.7%, respectively, and the risk of progression to type 2 diabetes was reduced by 88%. After drug withdrawal, the proportion of patients who progressed to type 2 diabetes increased rapidly, indicating that the disease progression was delayed but may not ...
- Source: drugdu
- 44
- November 16, 2024
Yuandong Biotechnology applies for market launch of this new anticoagulant drug

Recently (November 7th), the official website of the China National Center for Drug Evaluation (CDE) showed that Chengdu Yuandong Biopharmaceutical Co., Ltd.’s application for the marketing of injection grade naprolimus mesylate, classified as Class 3, has been accepted. According to public information, the indications of this product are for the treatment of acute pancreatitis, chronic pancreatitis with acute exacerbation, postoperative acute pancreatitis, acute pancreatitis after pancreatography, and acute traumatic pancreatitis; Used for the treatment of disseminated intravascular coagulation (DIC); 3. Used to prevent blood clotting during extracorporeal circulation. Naprolimus mesylate is a strong and broad-spectrum serine protease inhibitor. This product was first launched in Japan for the prevention and treatment of disseminated intravascular coagulation (DIC), improvement of acute symptoms of pancreatitis, and anticoagulation during extracorporeal circulation. In March 2020, according to overseas media reports, Professor Junichiro Inoue of the Medical Research Institute of the University of Tokyo and others issued ...
- Source: drugdu
- 47
- November 16, 2024
Global orthopedic giant CEO may be dismissed

Recently, according to the Mail on Sunday report in the UK, global orthopedic giant Smith&Nephew has received a stern warning from shareholders due to poor performance. Smith&Nephew’s shareholders have lost patience with CEO Deepak Nath’s strategic development speed, claiming that if the company’s performance cannot be improved, Deepak Nath will be dismissed and Smith&Nephew will also face the splitting of its orthopedic department internally. It is reported that the stock price of Xerox Hui has dropped by up to 44% in the past five years. With this year’s performance still not “clear up”, the emotions of shareholders are difficult to calm, further putting pressure on Deepak Nat. Century old enterprises face crisis Shi Lehui was founded in the UK in 1856, a well-established company with over a hundred years of history. Its main businesses include orthopedics, sports medicine and otolaryngology, and advanced wound management. Currently, Shi Lehui is at the ...
- Source: drugdu
- 53
- November 15, 2024
Johnson&Johnson Medical Technology, organizational restructuring

Recently, Johnson&Johnson Medical Technology has made organizational adjustments to its surgical division. Starting from January 1, 2025, the Surgery Division will be reorganized into six major departments: Minimally Invasive and Energy Surgery Division, Wound Closure Division, Biosurgery Division, Surgical Product Expansion Division (i.e. Wide Area Market Division), Strategic Marketing Division, and Robotics and Digitalization Division. 01. Adjustment of the Organizational Structure of the Surgical Division Given the rapid changes in policy environment and the new trend of market competition, Johnson&Johnson Medical Technology firmly believes that the Surgical Division’s continued leadership in the market in the new era is an important cornerstone for winning the Chinese market and the future. To this end, the company has launched the “Yaoying 2030” surgical division strategy, aiming to accelerate the transformation of the GTM model and cover more customers and patients with better and faster services. In the new stage of development, Johnson&Johnson Medical ...
- Source: drugdu
- 61
- November 15, 2024
Uncovering the truth of AbbVie’s $8.7 billion lesson

M&A is a metaphysics, with heaven on one side and hell on the other, tempting prominent names to enter. The latest to enter “hell” is AbbVie. On November 11, AbbVie announced that emraclidine, the “ace project” acquired by acquiring Cerevel for $8.7 billion at the end of last year, failed to reach the expected endpoint in two Phase II studies for schizophrenia, which cast a shadow on its future. As soon as the news came out, AbbVie’s stock price plummeted 12.57%, and its market value evaporated by more than $40 billion overnight. Once, this merger and acquisition was a “model” in the industry. From the first acquisition invitation to the final acquisition of Cerevil, AbbVie took less than two months. Fast, accurate, and ruthless, it foreshadowed AbbVie’s determination to deal with the patent cliff. But now, everything is coming to nothing. This once again allows us to see the “variables” ...
- Source: drugdu
- 52
- November 15, 2024

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