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 ...
A new report from the Access to Medicine Foundation calls for urgent changes in research and development (R&D) to ensure new antibiotics and antifungals reach patients facing drug-resistant infections. The report examines five late-stage antimicrobial projects targeting severe drug-resistant pathogens, revealing that structured advance planning for access and stewardship is not yet standard among companies. Four out of five companies—GSK, Pfizer, Innoviva, and Venatorx—are conducting clinical trials involving children, aiming to improve access for paediatric patients. Despite these efforts, only five low- and middle-income countries (LMICs)—China, India, Mexico, South Africa, and Thailand—have concrete commitments for drug registration. Many of the remaining 108 LMICs with high burdens of targeted diseases lack such commitments. The report underscores the need for partnerships and licensing agreements to enhance access in LMICs. SMEs have pursued wider access through collaborations, like those with the Global Antibiotic Research and Development Partnership (GARDP). However, the report finds that ...
Sucralfate is used to treat stomach ulcers,GERD, radiation proctitis, and stomach inflammation and to prevent stress ulcers. Strides Pharma Science (Strides) recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation and to prevent stress ulcers. Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India. https://www.expresspharma.in/strides-receives-usfda-approval-for-sucralfate-oral-suspension-1gm-10-ml
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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