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The Supplemental Applications of HANDAYUAN(adalimumab injection) for the New Indications Approved by the NMPA

Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases [1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases [2]. It has been proven that many autoimmune diseases such as ...
- Source: drugdu
- 131
- May 24, 2024
Novel Inexpensive, Shelf-Stable, Easy To Use Tests Bring Lab-Level Precision at POC

One of the most critical measurements in healthcare is the blood cell count, which can provide insights into a range of conditions from infections and autoimmune diseases to cancer. Traditionally, collecting a sample for this test involves a blood draw that must be performed at a clinic and analyzed in a centralized clinical laboratory. This requirement can be a significant barrier for homebound individuals or those living in remote areas. Now, researchers have simplified the process to just a finger prick, with blood collected on a paper-dried blood spot card that can be mailed to a lab for analysis, including measurement of white blood cell counts. Researchers at Tufts University (Medford, MA, USA) are developing methods to perform these tests that significantly reduce costs and increase accessibility. They are utilizing a widely available resource: paper. Their groundbreaking paper-based tests for personal health monitoring do away with the need for costly ...
- Source: drugdu
- 106
- May 24, 2024
New Tool Enables Better Classification of Inherited Disease-Causing Variants

Whole genome and exome sequencing are increasingly available for clinical research, aiding in the detection of inherited genetic variants that may cause various diseases. The American College of Medical Genetics-Association for Molecular Pathology (ACMG-AMP) provides regularly updated guidelines to help clinicians assess whether germline variants are likely related to a patient’s disease. However, automated tools often struggle to stay current with these updates. A new tool has now been developed that allows researchers to annotate variant data from large-scale studies with clinically relevant classifications for risks of childhood cancer and other diseases, aligning older applications with the latest guidelines. This tool is freely available to the research community. Developed by a team including scientists from Children’s Hospital of Philadelphia (CHOP, Philadelphia, PA, USA), the tool, named Automated Germline Variant Pathogenicity (AutoGVP), incorporates germline variant pathogenicity annotations from the ClinVar database and variant classifications from a modified version of InterVar. AutoGVP ...
- Source: drugdu
- 143
- May 24, 2024
Allying With Patients to Make Every Cure Possible

To win the battle against rare diseases, drug developers must work hand-in-hand with patients. By Sharon KingMy colleagues and I were privileged earlier this year to meet with a caregiver and a young patient living with a rare form of pediatric cancer, who shared their stories and inspiring words of encouragement for the biopharmaceutical industry. Their message resonated with all who were there: Together we are working toward a world where every cure is possible. It’s a big vision. Every day, more than 400 million people around the world are battling a rare disease. Many of those people are facing a scarcity of treatment options, often limited to drug regimens that haven’t been updated in decades and that do little to cure the illness or even slow down the progression of symptoms. Patient communities have long known that working together is the key to making progress, and they have created ...
- Source: drugdu
- 85
- May 24, 2024
Durect’s Larsucosterol Receives FDA Breakthrough Therapy Designation for Severe Alcohol-Associated Hepatitis

Don Tracy, Associate Editor Moving forward, Durect plans on incorporating feedback from the FDA in the design of a Phase III trial. DURECT Corporation announced that the FDA has granted Breakthrough Therapy Designation (BTD) to larsucosterol, a medication that aims to treat patients with severe alcohol-associated hepatitis (AH). According to the company, the designation is based on positive results from the Phase IIb AHFIRM trial, which demonstrated positive safety and efficacy outcomes, with the first portion of data being announced last year, while additional clinical data is expected to be presented at the. European Association for the Study of the Liver (EASL) Congress next month.1 “We’re pleased with the FDA’s decision to grant Breakthrough Therapy designation to larsucosterol, as it further recognizes its potential to save the lives of AH patients,” said James E. Brown, DVM, President, CEO, DURECT, in a press release. “AH has a high mortality rate and ...
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- 86
- May 24, 2024
Qinghai Province includes nine assisted reproductive projects in medical insurance, with a reimbursement rate of 50%

The Qinghai Provincial Medical Insurance Bureau announced on the 22nd that Qinghai Province will include nine assisted reproductive projects in the medical insurance reimbursement scope, and employees and urban and rural residents will be reimbursed at a rate of 50%. In order to further optimize Qinghai Province’s fertility support policies and reduce the burden of related fertility medical expenses on insured people, the Qinghai Provincial Medical Insurance Bureau recently issued a document to include assisted reproductive projects in the scope of medical insurance reimbursement. It is reported that, based on full consideration of the affordability of medical insurance funds, Qinghai Province has included nine assisted reproductive projects in the scope of medical insurance reimbursement and reasonably determined service prices. When insured persons undergo assisted reproductive treatment in outpatient clinics, employees and urban and rural residents will be reimbursed at a rate of 50%. The service will not occupy the payment ...
- Source: drugdu
- 114
- May 24, 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
- 93
- May 24, 2024
New ‘plug and play’ system to offer novel way of delivering vaccines and treatments

The nanocage technology combines both mRNA and traditional virus-based vaccines to create virus-like efficacious vaccines A new technology developed by researchers from King’s College London (KCL) could provide a new way of delivering drugs to advance next-generation treatments to prevent and treat a variety of diseases. Published in the nanotechnology journal Small, the ‘plug and play’ technology could also lead to new therapeutics that act as both a vaccine and a drug, preventing disease and symptoms. For over two decades, a common protein called ferritin, which manages iron in all organisms, has been used to create vaccines and deliver anticancer drugs, as well as other medicines, to the body. Until now, scientists have been unable to develop a universal approach to delivering a wide range of medicines due to the protein’s unique method of self-assembly. “The inability to easily control the assembly of natural protein nanocages like ferritin has been ...
- Source: drugdu
- 141
- May 24, 2024
UK lung cancer study demonstrates further evidence on importance of CT screening

Currently the third most common cancer in the UK, lung cancer affects 40,000 people annually Researchers from the University of Liverpool and Queen Mary University of London have demonstrated further evidence of the benefits of lung cancer screening across socioeconomic groups in a new study published in Lancet Regional Health Europe. Funded by the National Institute for Health Research’s Health Technology Assessment programme, the new evidence published also illustrates the importance of screening for individuals who live in areas of economic deprivation. Affecting around 40,000 people every year in the UK, lung cancer is currently the third most common cancer in the country and the leading cause of cancer worldwide, accounting for an estimated 1.8 million deaths globally. In the study, researchers examined the long-term outcomes of recruited participants from across the socioeconomic spectrum to assess the impact of socioeconomic status on a variety of factors, including initial recruitment, selection ...
- Source: drugdu
- 92
- 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
- 86
- May 23, 2024

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