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【EXPERT Q&A】How is the quality inspection and quarantine carried out in the import and export industry?

Drugdu.com expert’s response: In the import and export industry, quality inspection and quarantine procedures are typically carried out by the relevant national authorities, and the process generally includes the following steps: Declaration: Importers or exporters are required to submit necessary declaration documents and information to the customs or inspection and quarantine authorities, including descriptions of goods, quantities, values, etc. This information is used for preliminary assessment and registration by customs or inspection and quarantine authorities. Inspection and Quarantine: Before goods enter or leave the port, customs or inspection and quarantine authorities conduct inspections and quarantine procedures. This involves examining the appearance, quality, quantity, packaging, etc., of the goods and conducting necessary testing, inspection, disinfection, etc. Certification Documents: Based on the inspection and quarantine results, customs or inspection and quarantine authorities issue corresponding certification documents, such as quarantine certificates, quality certificates, etc. These certification documents are usually required to be presented to ...
- Source: drugdu
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- March 8, 2024
Automated Multiplexing Molecular Diagnostic Platform Revolutionizes Infectious Disease Diagnostics

A new fully automated multiplexing molecular diagnostic platform offers an innovative and cost-effective testing approach by allowing customization of tests along with the ability to process and pay for desired results, thus enabling laboratories to maximize testing efficiencies. Diasorin’s (Saluggia, Italy) new LIAISON PLEX platform provides complete flexibility for the customization of syndromic panels and helps overcome the challenge of the “one size fits all” approach faced by clinical laboratory staff for infectious disease syndromic diagnostics. Custom panels enable adjustments in response to seasonal changes and updates in clinical guidelines, helping prevent unnecessary and costly over-testing – a common issue with fixed, broad syndromic panels currently in use. The user-friendly, fully automated sample-to-answer system offers a streamlined workflow and room-temperature stable consumables, simplifying storage and transport logistics. Additionally, it requires just two minutes of hands-on time per sample and can deliver results in less than two hours. The LIAISON PLEX, ...
- Source: drugdu
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- March 8, 2024
New Testing Strips to Make Rapid Antigen Testing as Powerful as PCR Testing

During the onset of the pandemic, individuals experiencing symptoms had to endure lengthy queues for lab-based PCR testing and then wait around two days for the results, to confirm if they were infected with the COVID-19 virus. This process was not only inconvenient but also involved complex and costly logistics, contributing to testing delays and increasing the risk of spreading the disease. Now, a newly developed biosensing technology enables the creation of gene test strips that can match the quality of traditional lab-based tests. The new technology developed by a team of biomedical engineers at UNSW Sydney (Sydney, Australia) offers test strips that are as accurate as lab-based PCR tests, with the added advantage of quick, on-site disease detection. Described by the researchers as having “PCR in your pocket,” this advancement holds potential for broad applications in biomedical and environmental diagnostics across various sectors, including food, agriculture, and biosafety management. ...
- Source: drugdu
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- March 8, 2024
ViiV Healthcare Reveals Positive Results from Phase I Trial for a Potential Longer-Acting HIV Treatment

Don Tracy, Associate Editor Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.Image Credit: Adobe Stock Images/alexskopjeViiV Healthcare has announced promising results from a Phase I study on a new formulation of cabotegravir (Apretude), known as cabotegravir ultra long-acting (CAB-ULA) for HIV pre-exposure prophylaxis (PrEP). Findings suggested that CAB-ULA is well-tolerated and has a pharmacokinetic profile supportive of extended dosing intervals. According to a company press release, the formulation allows dosing intervals of four months, resulting in a reduction of clinical visits for HIV patients.1 “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said Kimberly Smith, MD, MPH, head of research and development, ViiV Healthcare, in the press release. “ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the ...
- Source: drugdu
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- March 8, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
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- March 8, 2024
BIO-THERA’s Class 1 New Drug BAT7205 (PD-L1/IL-15) for Injection Approved for Clinical Trials in Locally Advanced or Metastatic Solid Tumors

BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
- Source: drugdu
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- March 8, 2024
Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines

Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
- Source: drugdu
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- March 8, 2024
Researchers aim to ensure future AI healthcare monitoring systems are free of gender bias

The project will train a newly developed AI system on data collected from participating men and women Researchers from the University of Glasgow’s James Watt School of Engineering are aiming to ensure that artificial intelligence (AI)-based healthcare monitoring systems in the future are free of gender bias, to improve care for both men and women. For 18 months, the project will examine the potential for gender bias in healthcare AI and discover ways to ensure that AI-supported treatment remains equitable. The use of cutting-edge sensors is currently being investigated to track the rhythms of patients’ hearts and lungs without requiring them to wear monitoring devices or be recorded on video cameras. The team aims to address and ensure that its AI component is properly trained and capable of making the correct judgements without bias towards one gender of patients. Supported by £8,200 in funding from the Université Paris Dauphine-PSL’s Women ...
- Source: drugdu
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- March 8, 2024
Researchers use collected stem cells to grow cell models to advance prenatal medicine

CDH affects one in 5,000 babies born in the UK, impacting the foetus’ development of vital organs Researchers from University College London (UCL) and Great Ormond Street Hospital (GOSH) have developed a new approach to observing human development in late pregnancy to potentially monitor and treat congenital conditions before birth. Published in Nature Medicine, the study used collected stem cells from late pregnancy to create and grow cell models, known as organoids, to retain babies’ biological information. The study of stem cell organoids aims to facilitate the monitoring of foetal development in late pregnancy, model disease progression and test new treatments for diseases including congenital diaphragmatic hernia (CDH). Affecting one in 5,000 babies born in the UK, CDH occurs when there is a hole in the diaphragm, which can lead to the foetus’ bowel, stomach or liver being moved into the chest cavity during pregnancy. Researchers extracted and characterised live ...
- Source: drugdu
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- March 8, 2024
The United States prohibits the flow of data to China and other countries, and clinical trials in the United States are challenged again?

Recently, U.S. President Joe Biden officially signed the “Executive Order on Preventing Countries of Concern from Obtaining Extensive Sensitive Personal Data of U.S. Citizens and U.S. Government-Related Data,” calling for measures to be taken to prevent “bad actors” and “countries of concern” from abusing data related to the United States. Various types of data about citizens, including genomic data, biometric data, personal health data, geolocation data, financial data and other types of personally identifiable information. The executive order may pose new challenges to Chinese life sciences companies operating in the United States. The order requires the Departments of Justice, Homeland Security, Health and Human Services, Veterans Affairs and other agencies to take a variety of actions over the next 12 months, including: Ministry of Justice: Regulations will be enacted to govern cross-border transfers of large-scale data related to genomics, biometrics, personal health data, geolocation and the above areas, including a ...
- Source: drugdu
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- March 8, 2024

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