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Jixing Announces that the National Medical Products Administration has accepted the New Drug Marketing Authorization Application for Aficamten Tablets

October 18, 2024, Shanghai, China – Jixing Pharmaceuticals (hereinafter referred to as “Jixing”), a biotechnology company committed to bringing innovative science and drugs to patients suffering from serious life-threatening cardiometabolic diseases, today Announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration has officially accepted the new drug marketing application for Aficamten tablets for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is a new generation of selective small molecule cardiac myosin inhibitor under development. Its treatment of oHCM has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and the China National Medical Products Administration. This new drug marketing application is based on the positive results of the pivotal global Phase 3 clinical study SEQUOIA-HCM. A total of 282 patients with obstructive HCM were enrolled in SEQUOIA-HCM. The study results showed that treatment with Aficamten significantly improved patients’ exercise capacity ...
- Source: drugdu
- 73
- October 24, 2024
Sufficient Supply of Influenza Vaccines in Shandong; Elderly Vaccination Rate at 54.57%

On October 22, the Shandong Provincial Government Information Office held a press conference to introduce the province’s efforts in enhancing the integration of healthcare and elderly care, as well as promoting healthy aging. It was reported that Shandong currently has a sufficient supply of influenza vaccines, having completed 2.67 million doses of vaccinations, with elderly individuals accounting for 54.57% of those vaccinated. As the weather turns colder, infectious diseases such as influenza and pneumonia enter their peak season, and the elderly are a major susceptible group. It was noted that over 3,200 medical institutions in Shandong have activated a real-time monitoring and reporting network for infectious diseases, focusing particularly on the incidence of diseases among the elderly and other key populations. Vaccination against influenza and pneumonia not only reduces infection risks but also effectively lowers the incidence of severe cases, making it one of the primary measures for the prevention ...
- Source: drugdu
- 67
- October 24, 2024
Arab Health

Organiser：Informa Markets Time： January 27 – 30, 2025 Address：Sheikh Zayed Road Convention Gate Dubai, UAE – United Arab Emirates Exhibition hall：Dubai World Trade Centre Product range: Medical Devices & Equipment: Medical electronic equipment, medical ultrasound equipment, medical X-ray equipment, medical optical instruments, clinical laboratory analysis instruments, dental equipment and materials, operating room, emergency room, and consulting room equipment and appliances, disposable medical supplies, medical dressings and hygienic materials, various surgical instruments, medical healthcare equipment and supplies, traditional Chinese medicine instruments and rehabilitation appliances, hemodialysis equipment, anesthesia and respiratory equipment, etc. Household Healthcare Products & Small Healthcare Devices: Household health and wellness products, small household diagnostic, monitoring, and treatment instruments, rehabilitation/physiotherapy instruments and supplies, electronic medical instruments, dental appliances, hospital office supplies, sports medicine supplies. Bulk Drugs, Proprietary Chinese Medicines, Pharmaceuticals & Healthcare: Therapeutic, rehabilitative, and healthcare products and supplies with Oriental medicine characteristics. About SLAS： The Arab Health Exhibition ...
- Source: drugdu
- 70
- October 24, 2024
【EXPERT Q&A】What is the process for registering apis in Saudi Arabia?

Drugdu.com expert’s response: Ⅰ. Preliminary Preparation and Research Before initiating the registration process, you need to: Conduct in-depth market research: Study the pharmaceutical market in Saudi Arabia to understand local demand for APIs, market size, and potential growth opportunities. Technical assessment: Evaluate whether your API product meets the quality and technical standards of Saudi Arabia. This includes assessments of production processes, quality control, stability, and other aspects. Regulatory familiarization: Thoroughly familiarize yourself with the registration requirements and processes of the Saudi Food and Drug Authority (SFDA) to ensure your product meets all relevant regulations. Ⅱ. Document Preparation and Submission Prepare registration documents: According to SFDA requirements, prepare complete registration documents, including product specifications, production process descriptions, quality control documents, stability study data, etc. Translation and notarization: If your documents are not in Arabic, they need to be translated into Arabic and notarized. Submit the application: Submit the registration application and ...
- Source: drugdu
- 68
- October 23, 2024
75.4 billion! Abbott’s Q3 performance exceeded expectations

Yesterday (October 17th), Abbott announced its third quarter 2024 financial report on its official WeChat account. Abbott’s global sales in the third quarter reached 10.6 billion US dollars (approximately 75.48 billion yuan), with an organic growth of 8.2% and a reported sales growth of 4.9%. Based on the brilliant performance in this quarter, Abbott said that after excluding the impact of COVID-19 testing products, the company expects global sales to achieve an organic growth of 9.5% to 10.0% in 2024, and diluted earnings per share after adjustment for the whole year may be between 4.64 and 4.70 dollars, the median of the range is higher than the previous estimate. Continuous growth achieved through multiple business operations According to the financial report, Abbott’s multiple departments have achieved business growth. Among them, the medical device department achieved double-digit growth, with global sales reaching $4.7 billion in the third quarter, an organic growth ...
- Source: drugdu
- 74
- October 23, 2024
7 Innovative Medical Devices Enter Special Review Process

Recently, the National Medical Products Administration’s Device Review Center released the results of the special review application for innovative medical devices (No. 9 of 2024), intending to approve 7 innovative medical device projects to enter the special review process.1. Liver low-temperature perfusion system: Hangzhou Lepusheng Medical Technology Co., Ltd Hangzhou Lepusheng Medical Technology Co., Ltd. (hereinafter referred to as Lepusheng Medical) was founded in 2016, focusing on the independent research and development of advanced medical devices for the protection, preservation, repair, and transportation of transplanted organs. It is committed to becoming a domestic benchmark and a global leading solution provider in the field of organ perfusion preservation and resuscitation. Since its establishment, Lepusheng Medical has made breakthroughs in core technologies such as organ perfusion protection and transport repair, and is opening up a new model for organ protection in China. The research and development focus of Lepusheng Medical is on ...
- Source: drugdu
- 71
- October 23, 2024
Cell Stem Cell | Drug Sensitivity and Resistance Atlas of Sarcoma

Writing | My Best Friend Old Red Riding Hood Sarcoma is a rare heterogeneous stromal tumor. They mainly occur in bones and soft tissues, and have a particularly severe impact on young patients [1-3]. In the United States, about 13000 cases of soft tissue sarcoma and 4000 cases of osteosarcoma are diagnosed every year. Although the incidence rate is very low, the mortality rate is still high. For example, osteosarcoma is the third leading cause of cancer death in patients under the age of 20. The treatment plan varies depending on the subtype and stage of the disease, including surgical resection, chemotherapy, targeted systemic therapy, and in some cases, radiation therapy [4,5]. Although significant progress has been made in specific subtypes, current treatment methods rarely cure them. The overall 5-year survival rate for soft tissue sarcoma is 65%, and the overall 5-year survival rate for bone cancer is 50% -60% ...
- Source: drugdu
- 64
- October 23, 2024
The mechanism by which G protein mutations lead to excessive activation of T cells through non classical pathways

Writing | Snow Moon G protein coupled receptors (GPCRs) guide cellular responses to environmental signals, including hormones, neurotransmitters, and chemokines. This process is achieved through a complex biochemical cycle mediated by heterotrimeric G protein. After GPCR binds to the ligand, the G α subunit binds to GTP, becomes active, and separates from the G β – γ complex and GPCR. The separated G α – guanosine triphosphate (GTP) and free G β – γ initiate downstream signaling, including the generation of second messengers, biochemical interactions, and ion channel changes. The GTPase activity of G α hydrolyzes GTP to guanosine diphosphate (GDP), thereby terminating signal transduction and allowing Gabg to reassemble with GPCRs, enabling cells to respond to reactivation of GPCRs. In the G α protein family, the Gai/o family includes inhibitory subtypes that regulate biological responses by inhibiting the production of cyclic adenosine monophosphate (cAMP) by adenyl cyclase AC. AC ...
- Source: drugdu
- 74
- October 23, 2024
RNA editing pioneers fought a comeback

“CRISPR gives way, RNA editing therapies are going to speed up.” This is the title of an article published in “Nauter” in February this year (“Move over, CRISPR: RNA-editing therapies pick up steam”). RNA editing technology, which is coming to the fore, is seen as having the potential to surpass CRISPR due to its safer and more flexible characteristics. The technology is in its infancy, and the bets of MNCs such as Eli Lilly and GSK have once pushed its popularity to a climax. However, Wave, an RNA editing pioneer founded in 2012, took more than 10 years to push its first RNA editing project WVE-006 into clinical trials. During this period, due to the clinical failure of other nucleic acid drugs, Wave’s stock price fell from a high of US$56 per share to around US$1 per share, and market expectations were no longer there. After years of silence, a ...
- Source: drugdu
- 72
- October 23, 2024
Astellas wins a belated victory

On October 18, the FDA announced the approval of the Claudin18.2 monoclonal antibody Vyloy (zolbetuximab) for marketing, and will use it as the first-line treatment for adult patients with locally advanced unresectable or metastatic gastric cancer with Claudin18.2-positive tumors, and HER2-negative gastroesophageal junction adenocarcinoma. With the announcement of this good news, zolbetuximab officially became the first anti-Claudin18.2 drug approved by the United States. This means that Astellas has taken the lead in this hot target. In the past few years, Claudin18.2 has been a hot target in the field of oncology, attracting the interest of giants such as AstraZeneca, Merck, and Moderna. Of course, the entrants also include many domestic pharmaceutical companies. However, in the face of many entrants, Astellas’s “defending” ability has also been extremely demanding. At present, it may not be easy for it to maintain its leading position. Zolbetuximab has always attracted much attention, and the core ...
- Source: drugdu
- 66
- October 23, 2024

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