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Hengrui’s Thiotepa for Injection for Pre-treatment of Hematopoietic Stem Cell Transplantation Approved for Marketing

Recently, Hengrui Pharmaceuticals has received the Certificate of Drug Registration issued by the State Drug Administration, which approves Thiotepa for Injection (Trademark: Ruihang®, two specifications of 15mg and 100mg) to be listed in Class 3 of the Chemical Drugs, with the indication of “This product is suitable for the pre-treatment of allo-HSCT for children with β-thalassemia major (<18 years of age)”. The indication of the product is “This product is suitable for allogeneic hematopoietic stem cell transplantation (allo-HSCT) pretreatment for children (<18 years old) with beta-thalassemia major”. Thiotepa for injection is the first generic product in China and has been approved for sale in the United States and Europe. Thiotepa is the first Thiotepa product approved for transplantation preconditioning in China. Beta-thalassemia (β-thalassemia for short) is a common hemolytic disease in clinic, and there are about 300,000 patients with severe and intermediate β-thalassemia in China at this stage.1 Currently, the ...
- Source: drugdu
- 99
- March 27, 2024
CanSinoBio’s Quadrivalent Conjugate Vaccine Launches Phase III Clinical Trial in Indonesia

Recently, CanSinoBio’s Quadrivalent Conjugate Vaccine (QCV) initiated a Phase III clinical trial in Indonesia and completed the enrollment of the first subject. The clinical trial aims to evaluate the safety and immunogenicity of the vaccine in people aged 18-55 years. Currently, rheumatic encephalitis remains a serious challenge in global public health, and vaccination is the most cost-effective and efficient way to prevent it.2022 In June, CanSinoBio’s self-developed Mannhexin®, Asia’s first tetravalent rheumatic encephalitis conjugate vaccine, was officially approved for marketing, which fills the gap of China’s lack of high-end rheumatic encephalitis vaccines in this field. This clinical trial will expand the applicability of the quadrivalent conjugate vaccine to adults. According to the statistics, the incidence of epidemic epidemic is found in all age groups, among which the incidence rate is higher in children under 5 years old. Usually, the incidence rate of epidemic encephalitis decreases with age, but the incidence ...
- Source: drugdu
- 122
- March 27, 2024
CSPC obtains clinical approval for semaglutide weight loss indication

On March 25, CSPC Pharmaceutical Group (1093.HK) announced that the semaglutide injection developed by the group has been approved by the National Medical Products Administration of the People’s Republic of China to conduct the clinical trial in China for weight management indication in overweight or obese adult patients on the basis of calorie diet reduction and increased physical activity. It is also the second indication for this product to be approved for clinical trials after blood sugar control in adults with type 2 diabetes. Semaglutide injection is currently the most significant product in the field of weight loss and is still growing rapidly with broad market prospects. The raw materials used in this product are completely prepared through chemical synthesis, using advanced synthesis, purification and characterization technologies. The raw materials prepared are of higher purity, avoiding host proteins and other immunogenic substances introduced during the biological fermentation process, and ensuring ...
- Source: drugdu
- 105
- March 27, 2024
MHRA warns of unsafe counterfeit anti-choking devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not comply with device regulations and could cause harm. It is estimated that over 10,000 counterfeit or unbranded anti-choking devices, also known as airway clearance devices, choking rescue devices or emergency first aid devices, have been purchased by the public within the last two years based on listings found across online marketplaces like Amazon and eBay, and drop-shipping websites. There are currently two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA to be used after Basic Life Support protocols have been attempted and failed. Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to resolve the blockage and may worsen the situation by pushing obstructions further down the airway passage. ...
- Source: drugdu
- 94
- March 27, 2024
Novo Nordisk’s Awiqli receives CHMP recommendation to treat diabetes in adults

Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
- Source: drugdu
- 102
- March 27, 2024
【EXPERT Q&A】What is the QSR820 Quality System? What is the relationship with ISO13485?

Drugdu.com expert’s response: The US QSR820 quality system refers to the Quality System Regulation issued by the United States Food and Drug Administration (FDA) for medical devices. This regulation, also known as the Medical Device Quality System Standard, sets forth the quality management system requirements that medical device manufacturers must follow to ensure the safety and effectiveness of medical devices. QSR820 covers various aspects including design controls, production controls, equipment calibration, quality audits, record-keeping, etc. ISO13485 is the medical device quality management system standard published by the International Organization for Standardization (ISO). It bears some similarities to QSR820 as both are quality management system standards for the medical device industry aimed at ensuring product quality and safety. However, ISO13485 is an international standard applicable to medical device manufacturers globally, whereas QSR820 is a regulatory standard mandated by the FDA specifically for medical devices marketed in the United States.
- Source: drugdu
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- March 27, 2024
CPhI South East Asia 2024

Organiser: Informa Markets Time:10 – 12 July 2024 address：60 New Ratchadapisek Road Klongtoey Bangkok 10110 Thailand Exhibition hall: Queen Sirikit National Convention Center Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Packaging equipment: pharmaceutical machinery, packaging machinery, packaging materials, pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning, disinfection configuration and laboratory instrument system Pharmaceutical products: various proprietary Chinese medicines, Western medicines, new drugs, various raw materials, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese medicine, herbs, animal and plant extracts, veterinary drugs, food ingredients and additives, etc About CPhI South East Asia ： Thailand Pharmaceutical Raw Materials Exhibition (CPhI South East Asia) is the most authoritative pharmaceutical raw materials exhibition in ...
- Source: drugdu
- 203
- March 26, 2024
Coin-Sized Device Rapidly Isolates Blood Plasma for Quicker and More Precise Clinical Diagnoses

Identifying biomarkers for various cancers and diseases often relies on cell-free DNA, RNA, and extracellular vesicles. Traditionally, separating blood plasma to detect these markers requires centrifugation, spinning blood to isolate cells from plasma. Yet, even after multiple centrifugation cycles, some cells and platelets remain in the blood plasma, potentially releasing unwanted biological materials that can affect diagnostic accuracy. Researchers have now developed a compact, coin-sized chip capable of extracting blood plasma directly from a sample within 30 minutes, resulting in a more convenient and user-friendly option than the currently laborious centrifugation method. The chip named ExoArc, developed by scientists at Nanyang Technological University (NTU, Singapore), offers a one-step solution to achieve over 99.9% purity by efficiently removing blood cells and platelets. This advance promises quicker and more reliable clinical analysis of critical biomarkers. To demonstrate its utility, the team developed a portable prototype device (measuring 30cm x 20cm x 30cm) ...
- Source: drugdu
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- March 26, 2024
Testing Method Could Help More Patients Receive Right Cancer Treatment

Cancer treatment isn’t always a one-size-fits-all solution, but the field of cancer research is making strides in matching patients with the most effective treatments for their specific conditions. A groundbreaking study now points to a significant finding related to testing that could enable thousands of cancer patients to receive the precise treatment they need. The research led by the University of Oklahoma (Oklahoma City, OK, USA) compared the effectiveness of immunohistochemistry (IHC) and next-generation sequencing (NGS) tests in newly diagnosed cancer patients to guide their treatment plans. These tests target the detection of high levels of microsatellite instability, a condition indicating the DNA’s diminished capacity to correct replication errors. Identifying microsatellite instability is crucial, particularly in colon and endometrial cancer patients, as it marks a higher likelihood of a positive response to immunotherapy, which enhances the immune system’s ability to fight cancer, compared to other treatments. IHC detects the absence ...
- Source: drugdu
- 106
- March 26, 2024
Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

Don Tracy, Associate Editor Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings. Merck revealed that its Phase III KEYLYNK-006 clinical trial, which tested a combination of Keytruda and Lynparza for the treatment of a subset of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), failed to meet the primary endpoint of improving overall survival (OS) and progression-free survival (PFS). According to the company, its trial compared Keytruda combined with chemotherapy with an additional round of Keytruda plus Lynparza vs. Keytruda with chemotherapy followed by maintenance chemotherapy. However, the safety profiles for both treatments were reported to be consistent with previous findings. Moving forward, Merck said that it plans on continuing to analyze data to share at a later date.1 “As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring Keytruda-based combinations and ...
- Source: drugdu
- 158
- March 26, 2024

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