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Johns Hopkins researchers find minimal regret after gender affirming surgery

In a Viewpoint article published Dec. 27, 2023, in JAMA Surgery, three Johns Hopkins researchers urge the medical community to dismiss a widely held, but scientifically unsupported belief that many people who are transgender and gender diverse (TGD), and undergo gender affirming surgery (GAS), later regret their decision to undergo such procedures. The researchers are: Harry Barbee, Ph.D., assistant professor and interdisciplinary social scientist at the Johns Hopkins Bloomberg School of Public Health; Bashar Hassan, M.D., a postdoctoral research fellow in plastic and reconstructive surgery at the Johns Hopkins Center for Transgender and Gender Expansive Health (CTH) and the University of Maryland Medical Center’s R Adams Cowley Shock Trauma Center; Fan Liang, M.D., medical director at the CTH and assistant professor of plastic and reconstructive surgery at the Johns Hopkins University School of Medicine In their article, the three report findings from a retrospective look at the limited amount of ...
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- December 30, 2023
Original and patented consumables are given priority to be included in medical insurance

The era of medical insurance access management has arrived, the catalog of consumables has been dynamically adjusted, and many places have clearly supported the entry of new technologies and new consumables into medical insurance. 1. Original, patented and centralized purchasing consumables will be included in the medical insurance catalog with priority Recently, the Shaanxi Provincial Medical Insurance Bureau issued the “Notice of the Shaanxi Provincial Medical Insurance Bureau on Further Improving the Payment Management of Medical Insurance Medical Consumables” (hereinafter referred to as the “Notice”). It is clarified that the implementation of the access management of the medical insurance medical consumables catalog will be promoted and the province’s unified catalog of medical insurance medical consumables will be steadily formulated. According to the “Notice”, the payment management of medical insurance medical consumables must follow four principles: first, ensuring basics, second, encouraging innovation, third, being fair and open, and fourth, dynamic adjustment. ...
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- 114
- December 30, 2023
Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024

BY SEAN WHOOLEY The Farapulse PFA system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX)+ announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system. The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024. AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib. Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue. Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in ...
- Source: drugdu
- 188
- December 30, 2023
Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

SHANGHAI, Dec. 26, 2023 /PRNewswire/ — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA). On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria. Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year. Preclinical studies on its mechanism show that JMKX003801 can overcome carbapenem resistance with very broad antibacterial spectrum. On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema. There are about 120 million patients of chronic kidney disease (CKD) in ...
- Source: drugdu
- 103
- December 30, 2023
FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states. By FRANK VINLUAN An old drug with a wide range of uses now has a new FDA alert that could spare patients from some severe reactions. The FDA communication covers promethazine hydrochloride, a medicine approved for managing allergic reactions, motion sickness, and post-operative nausea and vomiting. It’s also used as a sedative or as an adjunct to analgesics. While promethazine is available in oral formulations, the FDA alert issued Wednesday covers versions administered either as a deep intramuscular injection or as a slow intravenous injection. The agency now says it recommends administration by deep intramuscular injection to reduce the risk of severe chemical irritation and damage to tissues. If promethazine must be dosed intravenously, the FDA ...
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- December 30, 2023
Innovative Drug FXI Inhibitor SHR-2004 Injection Phase I Healthy Human Study Results Shine at ASH

Recently, the 65th American Society of Hematology Annual Meeting (ASH) was held in San Diego, USA. As one of the largest and most comprehensive international conferences covering both malignant and non-malignant hematology, ASH attracts over 25,000 hematologists from more than 100 countries each year, sharing cutting-edge advances and breakthrough clinical data in hematology. At this conference, the independently developed (Factor XI) FXI inhibitor SHR-2004 injection by Hengrui Pharmaceuticals was presented as a poster. The research results are encouraging, supporting further clinical exploration in the prevention or treatment of venous thromboembolic diseases. Research Background SHR-2004 injection is a humanized monoclonal antibody that selectively binds to coagulation factors FXI and FXIa, inhibiting the activation of FXI by FXIIa and thereby blocking the cascade reaction process of the endogenous coagulation pathway, exerting an anticoagulant effect. Preclinical studies have shown that SHR-2004 prolongs activated partial thromboplastin time (APTT) and inhibits FXI activity. This study ...
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- December 30, 2023
AMP Publishes Best Practice Guidance for Slice Testing Approach in Diagnostics

As the discovery of genes linked to a variety of inherited conditions accelerates, clinical labs are finding it increasingly challenging to keep up with multiple assays dedicated to specific disease-related gene panels. To streamline this process, labs are adopting a ‘slice testing’ approach that employs a comprehensive capture backbone to analyze data pertinent to a specific gene set. Like conventional disease-focused panels, slice testing sequences a wide array of genes but narrows down the analysis to a pre-selected group of pertinent genes. This method combines the benefits of high-quality gene panels with the wider scope and adaptability of exome sequencing. The Association for Molecular Pathology (AMP, Rockville, MD, USA) has released a detailed report that explores the unique aspects of employing a slice testing strategy for diagnostic purposes. This includes the intricacies of gene selection, analytical performance, coverage, quality, and data interpretation. The report consolidates expert consensus recommendations and findings ...
- Source: drugdu
- 137
- December 29, 2023
AI Accurately Predicts Cancer Outcomes from Tissue Samples

Patient tissue samples are commonly examined on slides by pathologists, a process integral to diagnosis. This traditional method, while effective, is notably time-intensive and subject to variability in interpretations among different pathologists. Moreover, some subtle details in pathology images might escape human observation but could hold critical insights into a patient’s health status. Over recent years, several artificial intelligence (AI) models have been developed to undertake certain tasks typically performed by pathologists, such as classifying cell types or gauging cellular interactions based on proximity. Nevertheless, these models have not fully captured the more intricate aspects of tissue image analysis that pathologists conduct, including recognizing complex cell spatial arrangements and filtering out irrelevant image ‘noise’ that could distort interpretations. Addressing this gap, researchers have now introduced an innovative AI model that is capable of examining the spatial organization of cells within tissue samples, offering precise predictions about cancer patient outcomes and ...
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- 140
- December 29, 2023
Key Leadership Lessons for Biotech Executives from a Hospital Administrator

While it may appear that hospital administrators and biotech CEOs have quite dissimilar jobs because they face different challenges daily, this article attempts to conveys the value of some of the underlying principles that one can develop in the field of hospital administration, that may have some value in other healthcare fields and in other executive positions. By PETE O’HEERON When one thinks of the dynamic biotech landscape, with many early-stage firms delving into therapies for diverse maladies, such as cancer or heart disease, to any of a number of rare diseases, the executive leadership image that arises is certainly quite different than one might imagine for a healthcare executive, such as a hospital administrator. While patient health might be an end goal for both, the milieu within which they operate is seemingly quite distinct. It is certainly not typical for individuals to transition between these two realms, and yet, ...
- Source: drugdu
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- December 29, 2023
Cytokinetics Heart Drug’s Trial Data Look Competitive With BMS Med Camzyos

Cytokinetics drug aficamten met the main goal of a pivotal test in obstructive hypertrophic cardiomyopathy. If approved, the daily pill would compete against a Bristol Myers Squibb drug projected to become a blockbuster seller. By FRANK VINLUAN An experimental Cytokinetics drug has Phase 3 data showing it improved the ability of the heart to work during exercise. In addition to meeting this main goal of its pivotal test in a rare cardiovascular disease, the results look competitive with a Bristol Myers Squibb product already on the market. The Cytokinetics drug, aficamten, is a potential treatment for obstructive hypertrophic cardiomyopathy (oHCM), a condition that leads to thickening of heart muscle that makes it harder for the organ to pump blood. Patients experience fatigue and shortness of breath. The condition can progress to heart failure. Cytokinetics reported preliminary Phase 3 results on Wednesday showing that after 24 weeks, treatment with its once-daily ...
- Source: drugdu
- 152
- December 29, 2023

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