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Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
- 113
- April 17, 2024
Unique Metabolic Signature Could Enable Sepsis Diagnosis within One Hour of Blood Collection

Sepsis is a life-threatening condition triggered by an extreme response of the body to an infection. It requires immediate medical intervention to prevent potential death or lasting damage. Delay in diagnosing patients with sepsis or septic shock is linked with heightened mortality and morbidity, emphasizing the critical need for prompt diagnosis to improve survival rates. Now, new research findings promise faster diagnosis and better outcomes for sepsis and septic shock patients. In the study led by Murdoch University (Perth, Australia), researchers successfully used blood plasma metabolic phenotyping to accurately diagnose sepsis or septic shock within an hour of collecting blood samples. This method marks a significant improvement over traditional pathogen culturing techniques, which may take days to yield results. According to the researchers, metabolic signatures were the key to the breakthrough. The study involved the analysis of blood plasma samples collected from 152 patients admitted to the Intensive Care Unit ...
- Source: drugdu
- 94
- April 17, 2024
DeepScribe Brings Ambient AI to AWS Marketplace

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, ...
- Source: drugdu
- 110
- April 17, 2024
Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
- Source: drugdu
- 82
- April 17, 2024
Da Shenlin was fined 4 million for bribery, Ke Jinlong was sentenced to nearly 1.9 billion, fixed increase failed, gross profit margin dropped to 37%

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”) ...
- Source: drugdu
- 160
- April 17, 2024
its hospitals frequently violate the law in advertising, and are repeatedly fined for illegal use of medical insurance funds

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 ...
- Source: drugdu
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- April 17, 2024
Francis Crick researchers reveal pathways linking intestinal inflammation and colitis

Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis The study, published in Nature Immunology, could help identify new ways to treat inflammatory bowel disease (IBD). Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people in the UK, according to Crohn’s & Colitis UK. In this study, researchers deleted two proteins, c-Maf and Blimp-1, from T cells in mice to understand their role in maintaining gut health via IL-10. Mutations in the cytokine IL-10 or its receptor can result in IBD in children and it has previously been shown that c-Maf and Blimp-1 can drive the activity of the IL-10 gene in T cells. They found that, when combined with an environmental trigger – an infection with the Helicobacter hepaticus bacterium – IL-10 activity in T cells was reduced and ...
- Source: drugdu
- 82
- April 17, 2024
Nine UCL researchers secure £560m in research funding from ERC

Approximately 14% of the competition-submitted proposals were selected to receive funding Nine researchers from University College London (UCL) have secured nearly £560m in funding from the European Research Council’s (ERC) Advanced Grants to advance researchers in fields including biochemistry, nanotechnologies and regenerative medicine. Approximately 14% of the competition-submitted proposals were selected for funding, comprising 255 researchers, and could create over 2,000 new jobs. Set up in 2007 by the EU, the ERC has been funding research via the Advanced Grant to universities and research centres across 19 EU member states and associated countries, including the UK, Germany and France. The funding will be used for projects including the study of the roles of priority proteins in cellular quiescence and ageing, the thymus gland’s functions within the immune system and lung cancer. UCL professor Charles Swanton from the UCL Cancer Institute, along with UCL professor Paola Bonfanti and senior group leader ...
- Source: drugdu
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- April 17, 2024
A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. By Frank VinluanWhen it comes to evaluating the health of a patient, each therapeutic area has its own data-gathering tools. Think glucose monitors in diabetes and heart monitors for cardiovascular disease. But in mental health, a clinician relies on what a patient says. Self-reporting is incomplete and lacks objectivity, says George Eleftheriou, CEO and co-founder of Feel Therapeutics. Feel is trying to bring more complete and objective data collection to the field of mental health. The San Francisco-based startup does it with wearable technology that continuously collects data and provides recommendations. “One of the things we hear is how poor storytellers people are and [how they] cannot truly depict what happened over the past ...
- Source: drugdu
- 132
- April 16, 2024
Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer

Don Tracy, Associate Editor Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis. Novartis and Arvinas announced that they have agreed to terms on a collaboration to develop and commercialize ARV-766, Arvinas’ advanced Protac androgen receptor degrader designed for prostate cancer treatment. Per terms of the deal, Novartis will focus on worldwide clinical development, commercialization, and will obtain all associated rights for ARV-766 and the AR-V7 program. In turn, Arvinas will receive an upfront payment of $150 million, with the ability to receive up to $1.01 billion based on developmental, regulatory, and commercial milestones, plus royalties on sales of ARV-766. Completion of the deal depends on when regulatory approvals are met, which requires acquiescence with the Hart-Scott-Rodino Act.1 “We are thrilled to partner with an organization that shares our dedication to delivering transformative medicines to patients with significant unmet need,” said John Houston, PhD, ...
- Source: drugdu
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- April 16, 2024

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