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Highly Accurate Blood Test Detects Pancreatic Cancer Early in At-Risk Patients

Pancreatic ductal adenocarcinoma (PDAC), the most prevalent type of pancreatic cancer, is highly lethal but can potentially be cured with surgery and modern treatments. There is a pressing need for a simple, quick, and accessible blood test to diagnose pancreatic cancer early in at-risk individuals. Now, a new pancreatic cancer detection test offers significantly improved accuracy, fulfilling this need and potentially boosting survival rates for these patients. Immunovia AB (Lund, Sweden) has reported enhanced outcomes for its next-generation test aimed at detecting early-stage PDAC in high-risk individuals. In April 2024, the company shared positive outcomes from the preliminary model-development study of its innovative pancreatic cancer detection test. This study incorporated 624 patient samples collected from 13 distinct clinical sites, including 129 samples from patients diagnosed with stage 1 or 2 PDAC and 495 control samples, primarily from individuals at elevated risk for hereditary and/or familial pancreatic cancer. The control group ...
- Source: drugdu
- 80
- August 7, 2024
FDA Approves Expanded Indication for Octapharma’s Fibryga for Patients Experiencing Bleeding Due to Acquired Fibrinogen Deficiency

By Don Tracy, Associate Editor Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.The FDA has approved an expanded indication for Octapharma’s Fibryga, a lyophilized human fibrinogen concentrate now indicated for patients experiencing bleeding due to acquired fibrinogen deficiency (AFD). According to the company, this approval marks a significant advancement over cryoprecipitate, the current standard of care, by providing a faster and more precise treatment option for severe bleeding episodes. Additionally, the regulatory action makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.1 “In the surgical theater, time matters. And confidence matters. This expanded FDA approval of fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently,” said Flemming Nielsen, president, Octapharma USA, ...
- Source: drugdu
- 89
- August 7, 2024
Bayer Looks to Expand Kerendia’s Label to Heart Failure After Phase 3 Win

Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
- Source: drugdu
- 69
- August 7, 2024
University of Hong Kong creates app to detect heart valve diseases by checking chest sounds

The University of Hong Kong has developed a mobile app for members of the public to detect heart valve diseases, with researchers hoping the innovation can help prevent delays in diagnosing and treating such conditions. A clinical study involving more than 350 patients found accuracy levels for the artificial intelligence-based software were as high as 81 per cent, close to those achieved by cardiologists using stethoscopes. Such diseases can occur when heart valves fail to open and close properly, resulting in abnormal blood flow. Symptoms include shortness of breath, dizziness and swollen feet. Professor Joshua Ho Wing-kei of the university’s biomedical sciences school noted on Wednesday that life-threatening heart valve diseases currently affected about 10 per cent of the world’s population above the age of 70. “Valvular heart disease is often hidden and many only seek medical help when their condition has become serious,” he said. “We hope patients can ...
- Source: drugdu
- 75
- August 7, 2024
Hong Kong pupils studying abroad urged to get jabs against life-threatening infection

• Britain and other popular school destinations have reported rise in cases of meningococcal infection Hong Kong parents have been urged to get their children vaccinated against a life-threatening bacterial infection if they are heading overseas to study, following an uptick in cases in Britain and other popular school destinations. The Society of Hospital Pharmacists of Hong Kong made the call on Sunday after a survey it conducted earlier found that most parents were unaware of the health risks of meningococcal infection, to which young children and youths were vulnerable. Its survey in late February revealed that about half of the 110 parents who planned to send their children abroad to study did not know about meningococcal disease and had misconceptions about the potentially fatal infection. Society president So Yiu-wah said many parents had underestimated the health risks of the infection, with 30 per cent thinking it could be treated ...
- Source: drugdu
- 63
- August 7, 2024
ETH Zurich researchers reveal how colorectal cancer cells colonise the liver

Researchers from ETH Zurich, Switzerland, have revealed how colorectal cancer cells colonise the liver, which could help to develop future treatments that can be a hindrance to the formation of often fatal metastases. The study published in Nature Cell was led by Andreas Moor, an assistant professor in the department of biosystems science and engineering at ETH Zurich. Currently the third most common cancer type worldwide and the second most common cause of cancer death, colorectal cancer, otherwise known as bowel cancer, occurs when abnormal cells start to divide and grow in an uncontrolled way in the large bowel and back passage. In most cases of fatal cancer, metastasis is the most likely cause, which occurs when the primary tumour has sent out cells and invaded other organs of the body. With no current treatment to prevent the metastatic process, researchers tested on genetically modified mice and discovered that a ...
- Source: drugdu
- 71
- August 7, 2024
New study reveals certain bacteria are toxic for head and neck cancer

Researchers from Guy’s and St Thomas’ and King’s College London (KCL) have revealed a certain type of bacteria is toxic for head and neck cancer and could potentially lead to better outcomes for patients. Published in Cancer Communications, the research was funded by Guy’s Cancer Charity and Cancer Research UK through the City of London Cancer Centre. Currently the sixth most common cancer globally, head and neck cancers affect around 1,000 people in the UK every month. When analysing head and neck cancer patients, the team found that those who harboured higher levels of Fusobacterium, which is usually associated with the progression of bowel cancer, had a better prognosis than those with lower levels of the bacteria. In total, there was a 70% to 99% reduction in the number of viable cancer cells in head and neck cancer cell cultures after being infected with the bacterium, as it destroys the ...
- Source: drugdu
- 80
- August 7, 2024
KOREA PHARM & BIO

Organiser：KOREA PHARM & BIO Time：April 22nd – 25th, 2025 address：217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Korea Exhibition hall：KINTEX Product range: Pharmaceuticals: Pharmaceutical Raw Materials, Active Pharmaceutical Ingredients (APIs), Pharmaceutical Fine Chemicals, Intermediates, Pharmaceutical Additives, Pharmaceutical Dosage Forms, Natural Extracts, Biotechnology, Pharmaceutical Outsourcing and Services, Laboratory Equipment, Pharmaceutical Manufacturing Equipment, etc. Chemicals: Chemical Raw Materials, Chemical Equipment, Instrumentation, Automation Control Technology, Heat Exchangers, Crystallization, Gas Absorption, Drying, Filtration, Centrifugal Separators, Dust Collection, Chemical Reactors, Crushers, Mixers, etc. Cosmetics: Cosmetic Raw Materials, Cosmetic Additives, Functional Materials, Natural Extracts, etc. About KOREA PHARM & BIO： KOREA PHARM & BIO is one of the most influential pharmaceutical and biotechnology exhibitions in Korea and Asia. It is jointly organized by the Korea Food and Drug Administration (KFDA), Korea Pharmaceutical Manufacturers Association (KPMA), and Kyungyon Exhibition Company in Korea.
- Source: drugdu
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- August 7, 2024
【EXPERT Q&A】What do regulatory and non-regulatory markets mean?

Drugdu.com expert’s response: Drug regulatory market and non-regulatory market are two relative concepts, and they have significant differences in the regulation, production and sale of drugs. Ⅰ. Pharmaceutical Regulatory Market The pharmaceutical regulatory market can be understood as one that adheres to the standards and guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These markets typically operate under stringent legal and regulatory frameworks, imposing rigorous oversight on drug research and development, production, and sales. Specifically, the pharmaceutical regulatory market necessitates that drugs comply with relevant quality and safety standards and undergo rigorous approval processes before being marketed and sold. In such markets, government regulatory authorities rigorously supervise and manage drugs to ensure their quality and safety. Ⅱ. Unregulated Market The unregulated market, on the other hand, refers to markets that operate in violation of local laws and regulations. These markets ...
- Source: drugdu
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- August 7, 2024
FDA Grants Accelerated Approval to Adaptimmune Therapeutics’ Tecelra for Adults with Synovial Sarcoma Who Have Undergone Prior Chemotherapy

By Don Tracy, Associate Editor Regulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the United States.The FDA has granted accelerated approval to Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel), an engineered cell therapy that targets resectable or metastatic synovial sarcoma in adults who have undergone prior chemotherapy and are HLA-A*02 positive with MAGE-A4 antigen expression. The treatment, which was approved based on results from the SPEARHEAD-1 trial, marks the first engineered cell therapy for a solid tumor cancer to be approved in the United States, according to the company.1 “The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy ...
- Source: drugdu
- 95
- August 6, 2024

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