Breast cancer remains a predominant global health challenge for women, with late-stage diagnosis being a key contributor to its high mortality. This is particularly pronounced in low-resource settings where access to advanced, costly diagnostic tools is limited. There is a pressing need for affordable, non-invasive, and accessible diagnostic strategies. This review underscores the significant potential of hematological and biochemical serum markers as pivotal tools to bridge this diagnostic gap, offering insights into diagnosis, prognosis, and therapeutic monitoring for breast cancer. Hematological markers associated with breast cancer Hematological markers, derived from routine and inexpensive tests like the complete blood count (CBC), provide a window into the body’s physiological and pathological state, including systemic inflammation and immune response, which are hallmarks of cancer. Formed elements: Studies consistently show significant alterations in the cellular components of blood in breast cancer patients. These include decreases in hemoglobin (Hb) and red blood cell (RBC) counts ...
Aidoc announced its completion of a pivotal study for its multi-triage device, powered by the CARE Foundation Model, designed to detect and prioritize double-digit abdominal conditions within a single solution.1 Following completion of this study, Aidoc submitted its CARE-powered breakthrough-designated device for FDA approval after the device displayed high levels of accuracy in a wide range of abdominal findings.1 “Broad foundation models are the path to expanding clinical AI across care delivery, but only if we raise the safety and quality bar beyond anything the field has seen,” said Elad Walach, CEO and co-founder of Aidoc. “Accuracy that works for one finding won’t hold for many. CARE delivers precision that limits false positives and elevates only what matters, avoiding the noise that has hindered physician adoption. Built for broad, real-world practice, this submission positions Aidoc for a historic first in presumably the most comprehensive CAD.” What is Aidoc’s CARE-powered multi-triage ...
On November 17, Reuters reported that Johnson & Johnson announced it will acquire privately held oncology therapy research company Halda Therapeutics for $3.05 billion in cash . This acquisition aims to further expand Johnson & Johnson’s business footprint in the treatment of solid tumors and prostate cancer. Halda Therapeutics ‘ core drug candidate, HLD-0915, is currently in early to mid-stage development and is primarily intended for the treatment of prostate cancer. In addition to its core pipeline, the company has several early-stage experimental therapies for breast cancer, lung cancer, and other types of cancer, creating a highly complementary pipeline with Johnson & Johnson’s oncology business. It is worth noting that this is Johnson & Johnson ‘s second major acquisition this year. In January of this year, Johnson & Johnson acquired Intra-Cellular Therapies , a neuropharmaceutical research and development company, for $14.6 billion , continuing to deepen its presence in key ...
China Securities News (Reporter Deng Zhen) On November 28th, the Shanghai Securities News learned from Wanbangde that the company has been deeply engaged in the research and development of new drugs for Alzheimer’s disease (AD) for many years, always committed to developing new therapeutic drugs for global AD patients. Currently, the II/III phase key registration clinical trial of the company’s Selonyma Hydrochloride Controlled-release Tablets (FN12) is progressing smoothly. This clinical study is the largest Alzheimer’s disease registration study known in China. The company actively collaborates closely with CRO companies (contract research organizations for pharmaceutical development) to strive to obtain more effective data as soon as possible to verify the efficacy and safety of the drug. Existing data shows that Selonyma Hydrochloride Controlled-release Tablets have good safety. Selonyma, at an appropriate dose, can significantly improve the cognitive function of patients. At the same time, preclinical research shows that Selonyma not only ...
The US Medicare regulatory agency announced that it has renegotiated the prices of 15 expensive drugs and obtained significant discounts, including the popular weight-loss drug semaglutide; ② The US federal government will purchase semaglutide at a monthly price of $274, while the drug’s list price is $959 per month. On Tuesday local time (November 25th), the US Medicare regulatory agency announced that it has renegotiated the prices of 15 expensive drugs and obtained significant discounts, including the popular weight-loss drug semaglutide, which is produced by the Danish pharmaceutical company Novo Nordisk. It is reported that the discount rates for these 15 drugs range from 38% to 85%, and the new prices will come into effect in 2027. The US federal government will purchase semaglutide at a price of $274 per month (the commercial name for weight loss is Wegovy, and for diabetes it is Ozempic), while the original price of ...
Zhongzheng Intelligent Finance and HUTCHMED (00013) announced on November 27th in the morning that the latest and updated data of several of the company’s independently developed compounds will be presented at the ESMO Asia Annual Meeting to be held in Singapore from December 5th to 7th, 2025, and at the American Society of Hematology (ASH) Annual Meeting to be held in Orlando, USA from December 6th to 9th. Specifically, the first human clinical trial results of the anti-CD47 monoclonal antibody HMPL-A83 for the treatment of advanced solid tumors, as well as the results of the II phase part of the FRUSICA-2 registration study of the combination of fuyiquitini and xindili monoclonal antibody for second-line treatment of locally advanced or metastatic renal cell carcinoma, will be announced at the ESMO Asia Annual Meeting; the results of the II phase part of the II/III phase study of sorvatinib combined with carlimilizumab and ...
On November 26th, Beijing University Pharmaceutical (000788.SZ) issued an announcement regarding abnormal stock trading. The company noticed that there might be a high incidence of influenza in some regions recently, which has drawn attention from the capital market. After self-examination, the company’s related influenza drugs have not yet been organized for production and sales. It is expected that for a considerable period of time in the future, this will not have any impact on the company’s operating performance. https://finance.eastmoney.com/a/202511263575631671.html
China Securities News, Shanghai Stock Exchange: After the United States, Zhifei Biology has once again obtained a European patent certificate. The company announced on November 27 evening that its wholly-owned subsidiary, Beijing Zhifei Lvyu Biological Pharmaceutical Co., Ltd., recently received an invention patent certificate issued by the European Patent Office. The patent name is COMBINATION VACCINE AGAINST RESPIRATORY SYNCYTIAL VIRUS INFECTIONS AND IMMUNE RESPONSE INDUCTION METHOD THEREOF, which is a combination vaccine against respiratory syncytial virus infections and a method for inducing immune response. The patent number is EP4032548, and the estimated expiration date of the patent right is August 11, 2041. It is learned that this invention patent was obtained by Zhifei Lvyu in collaboration with Beijing Jiaotong University during the development of a respiratory syncytial virus (RSV) vaccine. The RSV vaccine developed through this collaborative development has already obtained patent authorization in China, Russia, and the United States. ...
South Finance Intelligence News, November 27th: Hengrui Pharma (stock code: 01276.HK) announced that recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. and its subsidiaries Suzhou Shendiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Pharmaceutical Co., Ltd., and Shanghai Shendi Pharmaceutical Co., Ltd. have received the approval notice for clinical trials from the National Medical Products Administration regarding Injection HRS-7058 Capsule, HRS-7058 Tablets, SHR-9839(sc), Adabeleli Monoclonal Antibody Injection, Bevacizumab Injection, Injection SHR-A2102. These approvals allow for the conduct of clinical trials. Specifically, it is an II-phase clinical study of HRS-7058 combined with anti-tumor drugs in subjects with solid tumors. SHR-9839 is a company-developed humanized antibody drug, intended for the treatment of advanced solid tumors. As of now, the cumulative R&D investment for this project is approximately 72.31 million yuan. Adabeleli Monoclonal Antibody Injection is a company-developed humanized anti-PD-L1 monoclonal antibody. As of now, the cumulative R&D investment for this project is approximately 969 million yuan. ...
Drugdu.com expert’s response: The General Safety and Performance Requirements (GSPR) in the EU Medical Device Regulation (MDR) (2017/745) and In Vitro Diagnostic Regulation (IVDR) (2017/746) constitute the core framework for ensuring the safety and effectiveness of medical devices and in vitro diagnostic medical devices. The GSPR requirements permeate the entire lifecycle of medical devices, encompassing design, manufacturing, clinical evaluation, labeling, and post-market surveillance. The specific content is as follows: I. Chapter Division of GSPR The GSPR requirements are detailed in Annex I of the MDR and IVDR and are divided into three chapters: Chapter 1: General Requirements for Risk-Based Management Medical devices must operate in accordance with their intended design and must not endanger the health or safety of patients, users, or third parties. Risks must be minimized as much as possible, and the degree of reduction must not negatively impact the risk-benefit ratio. Manufacturers are required to establish, ...
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