Shanghai, China, April, 17th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma. Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fourth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in ...
Artificial intelligence (AI) algorithms are increasingly being utilized in various clinical settings, such as dermatology. These algorithms are developed by training a computer with hundreds of thousands or millions of images of various skin conditions, each labeled with details like the diagnosis and patient outcomes. Through a process known as deep learning, the computer learns to identify patterns in the images that are indicative of specific skin diseases, including cancers. Once sufficiently trained, the algorithm can suggest potential diagnoses based on new images of a patient’s skin. However, these algorithms do not operate in isolation; they are used under the supervision of clinicians who evaluate the patient, make their own diagnostic assessments, and decide whether to follow the algorithm’s recommendations. Now, a new study led by researchers at Stanford Medicine (Stanford, CA, USA) has found that AI algorithms, which utilize deep learning, can enhance the accuracy of diagnosing skin cancers. ...
Mike Hollan Users will be able to access DeepScribe’s documentation platform through AWS. DeepScribe announced that its ambient AI clinical documentation software is available as a purchasing option on Amazon’s AWS Marketplace.1 This includes the entirety of Deepscribe’s platform, including Customization Studio, Clinical Moments, and Real-Time. Healthcare organizations will have the ability to deploy ambient AI that integrates directly with their HER. In a press release, DeepScribe co-founder and COO said, “Our inclusion in the AWS Marketplace is made possible by our work with AWS as well as the integrity of our enterprise-ready AI clinical documentation solution. The increased accessibility will enable enterprise healthcare organizations to consolidate their cloud spend and more easily deploy DeepScribe to address the critical issue of clinician burnout as it automates clinical documentation, improves efficiency, and allows greater focus on delivering patient care.” In the same press release, Deepscribe’s co-founder and CEO Akilesh Bapu said, ...
The Securities Association of China plans to take strict self-discipline measures and have “zero tolerance” for bribery. Recently, the Securities Association of China plans to amend some provisions of the “Securities Association of China Implementation Measures for Self-Discipline Measures” to thoroughly implement the Party Central Committee’s decision-making and deployment on insisting on investigating both bribery and bribery, and severely punish bribery in the capital market with a “zero tolerance” attitude . Recently, companies such as Dashanlin and Huayu Software were punished for bribery by their units, thus becoming negative examples in the capital market. Racing to gain acreage on the commercial battlefield and seeking fame in the capital market is the current situation of Da Shen Lin (603233.SH). On the evening of April 12, an announcement released by Dashenlin showed that the company received a “Criminal Judgment”. Its subsidiary Maoming Dashenlin Chain Pharmacy Co., Ltd. (referred to as “Maoming Subsidiary”) ...
Recently, the State Administration for Market Regulation issued a work plan to organize and carry out special actions on advertising supervision in the field of people’s livelihood across the country from April to November 2024. Among them, the first thing to bear the brunt is to maintain a high-pressure and severe crackdown on illegal medical beauty advertising. The document emphasizes that the release of medical beauty advertisements should be strictly regulated, and illegal behaviors such as publishing medical beauty advertisements without advertising review, creating anxiety about appearance, and exaggerating the effects of medical beauty will be severely cracked down on. Seriously investigate and deal with the behavior of platforms, live broadcast rooms, beauty anchors, and celebrities publishing illegal medical beauty advertisements in live broadcast marketing. No.9 Observation will continue to observe the medical beauty industry and the general health industry. Under the strong supervision of the medical beauty industry by ...
On April 9, 2024, Beijing Sinovac Biotech Ltd., a subsidiary of Sinovac Holdings Biotechnology Ltd. (Sinovac Biotech), obtained the approval for registration of the 5-dose Sabin Strain Inactivated Polio Vaccine (Vero Cells) (hereinafter referred to as the 5-dose sIPV) developed by Sinovac Biotech Ltd. from the National Drug Administration (NDA) for the prevention of polio caused by the poliovirus types I, II and III. (hereinafter referred to as “sIPV”) received the approval of drug registration from the State Drug Administration (NMPA) for the prevention of poliomyelitis caused by poliovirus types I, II and III (commonly known as “polio”), and is suitable for the immunization of children aged 2 months and above. Compared with the single-dose sIPV vaccine, the 5-dose sIPV vaccine can significantly reduce the global immunization cost, and has been listed as an urgently needed variety in the WHO Polio Eradication Action Plan, and the launch of Sinovac Biotech ...
Dr Reddy’s Laboratories announced the launch of the drug-free non-invasive migraine management wearable device Nerivio in Germany through its step-down subsidiary betapharm. The launch marks the company’s entry into digital therapeutics in Europe. Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Nerivio was presented in 2023 by Dr Reddy’s at the DGN Kongress organised by the German Association of Neurology in Berlin, and the 17th European Headache Congress held in Barcelona, Spain. Dr Reddy’s will present and launch Nerivio during the Neurological Association of South Africa annual congress on April 17, 2024, in the presence of Dr Stewart Tepper, Professor of Neurology at the Geisel School of Medicine – Dartmouth, and Vice President, New England Institute for Neurology and Headache. In May 2024, Nerivio will also be presented at International Headache Society 2024 iHEAD meeting in Berlin, Germany. In subsequent ...
Sanna Uskela et al., at North Karelia Central Hospital-Heart Center, Finland, conducted a retrospective single-center registry study that focused on the use of drug-coated balloon (DCB)-only strategy for treating de novo left main coronary artery disease. This study is significant as it addresses a treatment approach that has not been extensively studied before, particularly in the context of high bleeding risk (HBR) patients. The study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using the DCB-only strategy between August 2011 and December 2018. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups based on whether the lesion preparation was done according to the international consensus group guidelines. Key findings from the study include: (1) The study included 66 patients with a ...
The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
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