On December 16th, during the 18th Asia-Pacific Symposium on Hypertension, the National Launching Meeting of Sacubitril Valsartan Sodium Tablets (trade name: Yixintan®), which is exclusively commercialized by Fosun Pharmaceuticals and researched, developed and manufactured by Nanjing Fangshenghe Pharmaceuticals, was held grandly in Shanghai. The approved indications of Yixintan® (sacubitril valsartan sodium tablets) are for use in adult patients with chronic heart failure (NYHA class II-IV, LVEF ≤ 40%) with reduced ejection fraction, to reduce the risk of cardiovascular death and hospitalization for heart failure; and for the treatment of essential hypertension. The product is a first-line drug for the treatment of heart failure and hypertension with an innovative crystalline form with independent intellectual property rights. After the launching ceremony, a press conference on the national launching of Yixintan® was held, in which experts appeared and answered questions from the media about the current situation of cardiovascular prevention and treatment, the ...
Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
Colorectal cancer (CRC) stands as the second leading cause of cancer-related deaths in the U.S. and is particularly prevalent in men under 50. Notably, there’s been a shift in CRC affecting younger individuals, with 20% of cases in 2019 occurring in people 54 and younger, a rise from 11% in 1995. Additionally, there has been an increase in advanced disease incidence, particularly in individuals under 65. A significant number of CRC cases and deaths can be prevented through regular screening, surveillance, and quality treatment. Now, a new technology offers convenient at-home test collection with the highest sensitivity available for non-invasive CRC screening. Geneoscopy Inc. (St. Louis, MO, USA) has developed a multi-target stool RNA (mt-sRNA) biomarker panel for detecting precancerous lesions and colorectal cancer. RNA, a dynamic molecule crucial for protein synthesis, adapts to disease conditions and regulates numerous genes in cellular processes. Changes in RNA pathways are linked to ...
BY SEAN WHOOLEY Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as director of neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan. All three patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms. Imperative Care reported all three patient discharges from the hospital within 48 hours on an aspirin-only antiplatelet regimen. The company reported no device- or procedure-related complications, including clot formation. “The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” said Sakai said in a news release. “I am encouraged ...
BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
Drugdu.com expert’s response: Entering the business of pharmaceutical intermediates involves several key steps and considerations: 1.Industry Understanding Comprehensive Research: Understand the pharmaceutical industry, focusing on the role and demand for intermediates in drug production. Market Trends and Needs: Identify current trends, future projections, and specific needs within the market for pharmaceutical intermediates. 2.Regulatory Compliance Regulatory Knowledge: Familiarize yourself with the regulatory environment, including quality standards and certifications like Good Manufacturing Practice (GMP). Licensing and Permits: Obtain necessary licenses and permits required for manufacturing and trading pharmaceutical intermediates. 3.Business Plan and Strategy Business Model Development: Develop a clear business model, including target market, business scale (local, national, international), and value proposition. Financial Planning: Prepare a detailed financial plan covering startup costs, operational expenses, and revenue projections. 4.Supply Chain and Manufacturing Manufacturing Setup: Decide whether to manufacture in-house or outsource. If manufacturing, ensure the setup meets industry standards. Supplier and Customer ...
On December 13, 2023, Fosun Pharma announced that its medical device subsidiary has signed a cooperation agreement with Insightec on December 12, to establish a joint venture in China, Fosun Insightec Medical Technology Company Limited* (hereinafter referred to as “Fosun Insightec”). Fosun Insightec will focus on the commercialization, clinical application and research of the Magnetic Resonance Guided Focused Ultrasound (MRFU) Brain Therapy System (i.e. Magnetic Wave Knife Brain Therapy System) in China, which will help Parkinson’s Disease patients and patients with idiopathic tremor to regain a high quality of life. In addition, Fosun Meditech plans to establish strategic partnerships with a number of medical centers in China to further explore the potential application of the Magnetic Wave Knife in neurological diseases and benefit a wider range of patients. Mr. Liu Yi, Senior Vice President of Fosun Pharma and Chairman and CEO of the Medical Device Division, said that he is ...
(Shanghai, China, December 14, 2023) Japan’s Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen) in a global multicenter Phase III clinical trial project in Africa and Southeast Asia for a new anti-malarial drug, artemether benfluorex amodiaquine triple combination formulation, led by Fosun Pharmaceuticals (“the project “) invests approximately US$3.3 million (approximately JPY500 million1 ) to advance the development and launch of this new drug. The Project will be jointly conducted by Fosun Pharma, Marubeni Corporation of Japan, the Mahidol-Oxford Research Center for Tropical Medicine in Thailand, a division of the University of Oxford (“MORU”), and the Medicines for Malaria Foundation (“MMV”), and this is the first time that the GHIT Fund has invested in a research project led by a According to GHIT, the drug candidate could address the widespread Plasmodium artemisinin partial resistance (ART-R) problem in the ...
Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
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