Recently, the drug marketing authorization application for the JAK1 inhibitor amaxitinib sulfate tablets (SHR0302 tablets) was accepted by the State Food and Drug Administration. This product is suitable for adult patients with severe alopecia areata. At present, no JAK1 inhibitor self-developed by domestic companies has been approved for marketing. In addition to the indications for alopecia areata, the marketing authorization application for Amaxitinib Sulfate Tablets has been accepted by the State Food and Drug Administration for three indications, namely: moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, and ankylosing spine. inflammation and moderate to severe active rheumatoid arthritis. In June 2024, the main research endpoint of the Phase III clinical trial of Emmaxitinib Sulfate Tablets reached the superiority standard preset in the protocol. This study is a randomized, double-blind, and placebo-controlled Phase III study to evaluate the effectiveness and safety of amaxitinib sulfate tablets ...
Organiser:Reed Sinopharm Exhibitions Time:October 12 – 15, 2024 address:No. 1 Zhancheng Road, Heping Community, Fuhai Street, Bao’an District, Shenzhen Exhibition hall:Shenzhen World Exhibition & Convention Center (New Hall) Product range: Medical Imaging Area: Radiology products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Area: Hybrid operating rooms, integrated operating room systems, surgical instruments, anesthesia machines, ventilators, monitors, operating room engineering, surgical lights, ceiling-mounted towers, etc. In Vitro Diagnostic Area: Overall laboratory solutions, clinical diagnostic equipment, diagnostic reagents, POCT, home diagnostic equipment, etc. Rehabilitation and Physiotherapy Area: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physical therapy equipment, medical high-frequency equipment, etc. Orthopedics Area: Orthopedic implants, surgical instruments and equipment, bone power tools, and other orthopedic-related products covering three main categories: joints, trauma, and spine. Medical Information Technology Area: System integrators, mobile healthcare, medical management, quality control, clinical hospital information management systems, IT equipment providers for ...
Shanghai, China & JERSEY CITY, N.J. – April 8, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception from the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study (NCT05352516) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia®) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia®) every six months. The primary efficacy endpoint ...
Neuroendocrine carcinomas, such as neuroendocrine prostate cancer and small-cell lung cancer, originate in hormone-releasing cells and can develop in various organs, including the prostate and lungs. While they are not the most prevalent cancer type in these organs, they often have a poor prognosis and limited therapeutic options. Current treatments for these cancers include chemotherapy, radiation, and immunotherapy combinations. Neuroblastoma, predominantly found in young children, develops from immature nerve cells, often in the adrenal glands or nerve tissue along the spine, chest, abdomen, or pelvis. Despite treatment efforts, these therapies only extend survival by a few months, underscoring the need for better therapeutic targets and less invasive diagnostic approaches for these malignancies. Investigators from the UCLA Health Jonsson Comprehensive Cancer Center (Los Angeles, CA, USA) have identified UCHL1, a protein found in aggressive neuroendocrine carcinomas and neuroblastoma, as a potential molecular biomarker for diagnosing these cancers and predicting and monitoring ...
Globus Medical is laying off staff after the company merged with spine specialist Nuvasive. In California alone, the company is cutting more than 150 positions, according to documents reviewed by MedTech Dive. Nuvasive said it “will be laying off a number of its employees” in San Diego, where it was headquartered, according to a Jan. 3 notice shared with MedTech Dive by the California Employment Development Department. The affected employees were notified in the first week of January, and their last day of employment will be March 5, according to the document. Nuvasive’s San Diego office will remain open. A Globus spokesperson said the company is restructuring but declined to say how many positions were affected. “As part of our ongoing integration, we recently announced some organizational restructuring across the combined company in support of our committed synergy delivery,” the spokesperson wrote in an email. The California notice included a ...
CMEF(full name: China International Medical Equipment Expo) was founded in 1979, held twice a year in the spring and autumn, after more than 40 years of innovation and development, has become the world's leading covering the whole industry chain, scientific and technological innovation, new product launch, business docking, brand communication, academic exchange, trend insight, education and training in one of the medical health technology platform. With the theme of "Innovation and Technology leading the Future", this year's CMEF covers tens of thousands of whole-department and whole-industry chain product technologies and solutions for medical imaging, in vitro diagnosis, medical electronics, medical optics, hospital construction, operating room, disinfection sensor control, medical consumables, orthopedic medical robots, etc.
Researchers from the French National Institute of Health and Medical Research, the French National Center for Scientific Research and the University of Bordeaux in France, along with Swiss researchers and neurosurgeons, have successfully designed and tested a spinal stimulation implant to treat Parkinson’s disease. Conducted in collaboration with the Swiss Federal Institute of Technology in Lausanne and the Lausanne university and hospital (UNIL CHUV), the implant was tested to correct disabling gait disorders, which are associated with 90% of people living with advanced Parkinson’s and are often resistant to treatment. Parkinson’s disease is a neurodegenerative condition which progressively damages and leads to a loss of nerve cells in parts of the brain. Gait disorders are commonly caused by weakness of the hip and lower extremity muscles, such as cerebral palsy, muscular dystrophy and spinal muscular dystrophy. The implant directly stimulates nerve cells in the spinal cord responsible for controlling leg ...
BY SEAN WHOOLEY The Mobi-C cervical disc. ZimVie (Nasdaq: ZIMV)+ announced today that the first U.S. patient received its new 4.5mm Mobi-C cervical disc. Mobi-C became the first cervical disc approved for one and two levels by the FDA in 2013. Ten years later, in August of this year, ZimVie picked up FDA approval for a smaller height for the device. The updated 4.5mm Mobi-C comes in seven footprints to match patient anatomy. Dr. Gregory D. Lopez of Midwest Orthopaedics at Rush in Chicago implanted the first of these devices in the U.S. on Oct. 30. “The 59-year-old patient presented with a significantly collapsed C5-6 disc, and the new lower profile Mobi-C implant allowed me to avoid over-distracting the facet joints,” Lopez said in a news release. “The 4.5mm height Mobi-C makes it possible for me to offer pain relief and motion preservation to more of my patients with cervical ...
BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
A study presented today at the Society of NeuroInterventional Surgery’s (SNIS) 20th Annual Meeting indicated that it may be possible to use a less invasive technique to identify the gene mutations responsible for some arteriovenous malformations (AVMs) in pediatric patients. AVMs, including vein of Galen malformations, which are usually diagnosed soon after birth, are tangled blood vessels that disrupt blood flow and oxygen circulation, and are most often found in the brain and spinal cord. These vessels can rupture and cause brain hemorrhage, stroke, and brain damage for children and adults. Many complex AVMs in children are caused by a few specific gene mutations, but it’s difficult to find out which mutation is responsible (and, therefore, which treatment to use) without taking a surgical biopsy of the AVM. A surgical biopsy comes with a risk of brain bleeding. As a result, researchers in Australia opted to try using “liquid biopsy”-;taking ...
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