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New ADLM Guidance Provides Expert Recommendations on Clinical Testing For Respiratory Viral Infections

Respiratory tract infections, predominantly caused by viral pathogens, are a common reason for healthcare visits. Accurate and swift diagnosis of these infections is essential for optimal patient management. In light of the COVID-19 pandemic, there have been significant advancements in laboratory medicine, enhancing the testing capabilities for respiratory viruses. These advancements include the use of diverse sample types and the introduction of various new testing methods. However, these developments have also created a need for greater educational efforts on how best to utilize these novel testing options. Addressing this need, a new guidance document has been released, offering expert advice on essential aspects of clinical testing for respiratory viral infections, aiming to maximize the benefits of recent technological advances in this rapidly evolving field. This guidance has been formed by a multidisciplinary team of clinical microbiologists and infectious disease clinicians convened by the Association for Diagnostics & Laboratory Medicine (ADLM, ...
- Source: drugdu
- 87
- May 29, 2024
Biocon partners with Handok to commercialise Liraglutide in South Korea

Biocon announced the signing of an exclusive licensing and supply agreement with Handok, a pharma company in South Korea, for the commercialisation of its vertically integrated, complex drug product, Synthetic Liraglutide. Liraglutide is an injection in a pre-filled pen, used in the treatment of chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. Under the terms of this agreement Biocon will undertake the development, manufacturing and supply of the drug product, and Handok will be responsible for obtaining regulatory approval and commercialisation in the South Korean market. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, said “We are pleased to enter into this strategic partnership with Handok, which will enable patients in South Korea dealing with weight management to gain access to our GLP-1 peptide drug product, Synthetic Liraglutide.” YoungJin Kim, Chairman of Handok, commented, “Liraglutide is an important drug product for treating diabetes ...
- Source: drugdu
- 91
- May 29, 2024
Cure Genetics Announced Promising Safety and Efficacy Data of CAR-NKT Product CGC729 for RCC at ASGCT 2024

SUZHOU, China, May 23, 2024 /PRNewswire/ — On May 10, 2024, Cure Genetics announced the safety and efficacy data of their CAR-NKT product, CGC729, for patients with relapsed and refractory metastatic renal cell carcinoma (R/R mRCC) in an oral presentation at the 27th Annual Meeting of the American Society for Gene & Cell Therapy (ASGCT) in Baltimore. This marked the first-in-human trial using CAR-NKT therapy for R/R mRCC, demonstrating a good safety profile and encouraging anti-tumor activity. This phase I dose-escalation clinical trial was conducted at Fudan University Shanghai Cancer Center using a single-arm, 3+3 design to evaluate the safety and efficacy of CGC729 at three dose levels (DL1: 5 x 106/m2; DL2: 1.5 x 107/m2; DL3: 4.5 x 107/m2) in the treatment of R/R mRCC patients who had at least two lines of prior therapy. As of April 2024, five patients were enrolled and received a single infusion of ...
- Source: drugdu
- 114
- May 27, 2024
Positive Results Achieved in Phase III Study of Benmosubimab in Combination with Anlotinib for First-Line Treatment of Advanced Renal Cell Carcinoma

Recently, Chiatai Tianqing Pharmaceutical Group’s randomized, open, positive drug-parallel controlled, multicenter Phase III clinical study of Benmelstobart (TQB2450), a Class 1 innovative biologic drug, in combination with Anlotinib, a Class 1 innovative drug, for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma (RCC) has completed the protocol-prescribed interim analysis of the ETER100 study. ETER100 study) has completed the protocol-prescribed interim analysis, and the Independent Data Monitoring Committee (IDMC) has determined that the primary study endpoint of progression-free survival (PFS, based on independent imaging assessment) has met the protocol-prescribed superiority cut-off, and that the secondary endpoint of overall survival (OS) has shown a trend toward benefit. The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration of China regarding the marketing application for this indication, and has obtained the CDE’s consent to submit a marketing application for the addition of this new ...
- Source: drugdu
- 129
- May 27, 2024
Gerresheimer to acquire Blitz LuxCo Sarl, for EUR 800 million

Gerresheimer Glas GmbH, an indirect subsidiary of Gerresheimer AG, has signed a purchase agreement with funds advised by Triton for the acquisition of Blitz LuxCo Sarl, the holding company of the Bormioli Pharma Group (Bormioli Pharma). The purchase price is based on a determined enterprise value of around EUR 800 million, which corresponds to an adj. EBITDA multiple of around 10 Bormioli Pharma, has 9 production sites in Europe. The Group generates revenues of around EUR 370 million and an adj. EBITDA margin of around 21 per cent. Bormioli Pharma has a complementary portfolio of pharmaceutical primary packaging made of glass and plastic, as well as closure solutions, accessories, and dispensing systems. With this acquisition, Gerresheimer strengthens its European footprint with additional production sites, especially in Southern Europe, and underpins its market position as a leading full-service provider and global partner for the pharmaceutical and biotech industries. The acquisition is ...
- Source: drugdu
- 117
- May 27, 2024
Innovative Fundus Disease Drug Busilixumab Completes First Injections in Mainland Public Hospitals, Benefiting More Fundus Disease Patients

Recently, Guangdong Provincial People’s Hospital successfully completed the injection of the innovative drug Busiliximab, which is also the first batch of injection of this drug in public hospitals in mainland China. Relying on the “Hong Kong-Macau Pharmaceutical and Device Access” policy, Busiliximab has been approved for urgent clinical use in designated medical institutions in the Greater Bay Area. This new generation of anti-VEGF (vascular endothelial growth factor) drugs in public hospitals will enhance the accessibility of innovative therapies and benefit more patients with fundus diseases. China has more than 40 million patients with endophthalmic disease, and is in urgent need of new drugs to break through the treatment dilemma. The number of patients with fundus diseases in China is increasing, with the potential number of patients with fundus diseases reaching 40 million. The most common of them are diabetic retinopathy and age-related macular degeneration, in addition to many other types ...
- Source: drugdu
- 139
- May 25, 2024
Focusing on intelligent pharmaceutical manufacturing, Nanchang, Jiangxi, promotes high-quality development of the biopharmaceutical industry

Recently, when I walked into the disposable medical supplies production workshop of Nanchang Ruiao Jucheng Biotechnology Co., Ltd. located in Nanchang Economic and Technological Development Zone, Jiangxi Province, I saw the workers on the intelligent production line skillfully carrying out product inspection, assembly, packaging and other tasks, and the scene was full of bustling production. It is understood that Nanchang Ruiao Jucheng Biotechnology Co., Ltd. is a high-tech enterprise specializing in biotechnology research, development and production . “At present, the company’s production orders have been scheduled until November, and the products are in short supply. In order to meet the production needs of orders, we have carried out targeted expansion by adding new production lines.” Zhou Bin, chairman of Nanchang Ruiao Jucheng Biotechnology Co., Ltd., introduced. At present, the company has built instrument production workshops and reagent production workshops, which can produce 100 flow cytometers and 5 million diagnostic kits ...
- Source: drugdu
- 83
- May 24, 2024
World’s First One-Minute Hepatitis C Antibody Test Facilitates Quick Triage

Rapid and accurate testing is crucial in the fight against Hepatitis C. Hepatitis C blood testing determines whether someone has been infected with the Hepatitis C virus. Having regular access to testing helps ensure the prompt identification of potential Hepatitis C infections and facilitates immediate linkage to care, thus helping to reduce further transmission. Now, the first one-minute Hepatitis C antibody test can prove to be an excellent tool in managing this disease. The INSTI HCV Antibody Test from bioLytical Laboratories (Richmond, BC, Canada) is the world’s first one-minute test that detects antibodies to the Hepatitis C virus, which are substances released into the bloodstream upon infection. The test includes procedural control for IgG and IgM and can identify HCV genotypes 1 through 6, delivering results in as little as 60 seconds. It is both highly accurate and affordable, designed for ease of use. This fully portable system does not ...
- Source: drugdu
- 79
- May 23, 2024
Groundbreaking CRISPR Screen Technology Rapidly Determines Disease Mechanism from Tissues

Thanks to over a decade of advancements in human genetics, scientists have compiled extensive lists of genetic variations linked to a wide array of human diseases. However, understanding how a gene contributes to disease is quite different from knowing how to treat the disease. Each risk gene can affect multiple cell types, and pinpointing how these cell types—and even individual cells—influence a gene and its role in disease progression is crucial for developing effective treatments. Now, a new CRISPR screen method allows for the rapid analysis of brain cell types associated with key developmental genes, providing insights into the genetic and cellular mechanisms underlying various neurological disorders at an unprecedented level. Developed at Scripps Research (La Jolla, CA, USA), the new technique, called in vivo Perturb-seq, utilizes CRISPR-Cas9 technology combined with single-cell transcriptomic analysis as a readout to measure the effects of genomic alterations on individual cells. By employing CRISPR-Cas9, ...
- Source: drugdu
- 83
- May 23, 2024
FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

Don Tracy, Associate Editor Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK. Biocon Biologics announced that it has received FDA approval for Yesafili (aflibercept-jbvf), a biosimilar to Eylea (aflibercept). According to the company, Yesafili is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of several ophthalmic conditions such as neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Prior to being approved by the FDA, Yesafili was cleared in the United Kingdom back in November, while European approval came in September. Additionally, it is expected to launch in Canada by July 1, 2025.1 “The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic ...
- Source: drugdu
- 86
- May 23, 2024

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