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First Patient Dosed in Phase I Clinical Trial of Degu Insulin Liraglutide Injection

Tong Hua Dong Bao Pharmaceutical Co., Ltd (hereinafter referred to as the “Company”) has initiated the Phase I clinical trial in China after receiving the notification of approval for the clinical trial of Degu Insulin Liraglutide Injection from the State Drug Administration and has recently successfully completed the first case of patient dosing. The completion of Phase I clinical trial of Degu Insulin Liraglutide Injection is another significant progress in the development of GLP-1RA compound formulation of insulin analog, which will further enhance the competitiveness of the Company in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has ...
- Source: drugdu
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- May 16, 2024
【EXPERT Q&A】What does the 4-digit number next to the CE mark on medical devices mean?

Drugdu.com expert’s response: The 4-digit number next to the CE mark on medical devices indicates the Notified Body identification number (or Module D number). These digits identify the Notified Body that has certified the device’s quality management system. It signifies the registration number of the certifying body, indicating that it has assessed the quality management system of the medical device and confirmed its compliance with the relevant European Union directive requirements. This number is crucial for tracking the validity of the certification and for regulatory purposes.
- Source: drugdu
- 159
- May 16, 2024
J&J’s Megadyne discontinues pediatric electrode pad after burn reports

Dive Brief Johnson & Johnson’s Megadyne business has discontinued a pediatric electrode pad after receiving reports of patients being burned during procedures where the device was used. The electrode pad is included in a line of products that were part of a Megadyne recall in December. At that time, the J&J unit restricted the use of four products in patients under the age of 12, but it did not change instructions for one device designed for people who weigh 0.8 to 50 pounds. J&J, which announced the recall Friday, is discontinuing the product indicated for use in people weighing up to 50 pounds after tests on the causes of four reported injuries found a combination of factors that could result in burns. Dive Insight Physicians use Megadyne Mega Soft electrode pads to prevent the risk of burns in procedures that use electrosurgical instruments. When the devices are in place, currents ...
- Source: drugdu
- 85
- May 15, 2024
Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues

Breast cancer remains a major cause of cancer-related mortality among women. Breast-conserving surgery (BCS), also known as lumpectomy, is the removal of the cancerous lump and a small margin of surrounding tissue. This procedure is typically advised for women with early-stage breast cancer or small tumors, as it conserves more of the breast tissue compared to a mastectomy. After undergoing BCS, it is critical to verify that all cancerous cells have been removed to decide if additional surgery is necessary. This verification involves a tumor margin assessment, which examines the edges of the excised tissue (tumor margins) to check for residual cancer cells. Conventionally, this assessment entails staining the tissue samples with dyes and inspecting them under a microscope to differentiate between healthy and cancer cells. However, new optical imaging techniques have emerged as quicker alternatives for conducting these assessments. A group of researchers from the United States, including members ...
- Source: drugdu
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- May 15, 2024
FDA Grants Priority Review Biologics License Application to Dupixent Add-On Maintenance for the Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis

Don Tracy, Associate Editor Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled. Regeneron and Sanofi announced that the FDA has granted Priority Review to their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP) and whose condition is inadequately controlled. With the treatment already approved for adults with CRSwNP, the FDA is expected to make a final decision on the sBLA for the expanded indication by September 15, 2024.1 According to the companies, the application is supported by efficacy data from SINUS-24 and SINUS-52, two trials that showed major improvements in nasal congestion/obstruction severity, nasal polyp size, sense of smell, and a reduction in the need for systemic corticosteroids or surgery. In 2019, Regeneron first released the results of both trials, ...
- Source: drugdu
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- May 15, 2024
Understanding Payer Perceptions

Tasmina Hydery, PharmD With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount. Tasmina Hydery, PharmD, Associate Director, Market Access and Healthcare Consulting, Cencora Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months. The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.1 Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers ...
- Source: drugdu
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- May 15, 2024
NHS reduces long waits for cancer care and achieves faster ambulance responses

For the second month in a row, the NHS has met the 28-day faster diagnosis target for cancer The NHS has announced, for the second month in a row, that it has met the 28-day faster diagnosis target for cancer as well as faster ambulance responses to call outs compared to March 2024. The announcement builds on targeted national support for NHS trusts in reducing variation across the country and speeding up diagnosis for patients, while also bringing down the backlog of patients waiting for diagnosis or treatment from the COVID-19 pandemic. New published data has shown that the number of patients waiting more than 62 days for care is now at its lowest ever since the end of April 2020, reducing by almost 20,000 patients since the post-pandemic peak. In addition, almost 77% of people referred or screened received a definitive diagnosis or were all clear within four weeks, ...
- Source: drugdu
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- May 15, 2024
MHRA’s AI Airlock to address challenges for regulating AI medical devices

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI). In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023. It highlighted that the regulator is considering the opportunities and risks of AI from three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that produces evidence-based decisions that impact public and patient safety, where evidence is often supplied by third parties. The new sandbox for AI as a ...
- Source: drugdu
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- May 15, 2024
Chiatai Tianqing Enrolls Subjects in a Clinical Study of TQB2223 Injection in Combination with Paanoprilumab for the Treatment of Lymphoma, Lung Cancer and Nasopharyngeal Carcinoma

Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a nationwide Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQB2223 Injection in combination with Paanoprilumab in subjects with advanced malignant tumors. The study has been approved by the State Drug Administration (Notification No. 2023LP00274) and passed the center’s ethics, and is now recruiting nationwide. Trial drug profile TQB2223 injection is a lymphocyte activation gene-3 monoclonal antibody (LAG-3), registered as therapeutic biological product class 1. LAG-3, as an immune checkpoint, is expressed in activated T cells, NK cells, B cells and plasmacytoid dendritic cells, etc., and can negatively regulate T cells, which plays an important role in the maintenance of homeostasis of the body’s immune system and the promotion of tumor immune escape. LAG-3 monoclonal antibody can block the LAG-3 ligand on the cell surface, enhance the secretion of cytokines and exert anti-tumor immunity. Pavelizumab is a PD-1 monoclonal ...
- Source: drugdu
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- May 15, 2024
Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

On May 13, 2024, GlaxoSmithKline (“GSK”) announced that ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration (“SDA”) for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare (“ViiV”), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China (“SDA”) for HIV-1 pre-exposure prophylaxis (“PrEP”) in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections (“STIs”) in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release. Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. ...
- Source: drugdu
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- May 15, 2024

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