Refine by
Safety Data Articles & Analysis
24 articles found
In recent years, the fight against cancer has seen significant advances, particularly with the emergence of targeted therapy. Among the most promising strategies in this domain is the development of radioactive drug conjugates(RDCs). These innovative therapeutic agents combine the targeting capabilities of antibodies with the cytotoxic effects of radioactive isotopes, providing a powerful ...
The scientific realm behind the development and evaluation of therapeutic drugs, pesticides, industrial and environmental chemicals profoundly relies on a field of research called Pharmacokinetic/Toxicokinetic (PK/TK) studies. These investigations provide substantial information on how an organism affects a substance, delineating vital zones of absorption, distribution, metabolism, and excretion. ...
Antibody-drug conjugates (ADCs) are a new class of drugs that combine the advantages of both antibodies and small molecule toxins. Compared with traditional cytotoxins, ADCs have the advantages of strong targeting, less toxic side effects, etc. They can accurately target tumor cells, reduce side effects, and improve the therapeutic effect.ADC drugs are mainly composed of monoclonal antibodies, ...
Methods of measuring FeNO Fractional exhaled nitric oxide (FeNO) measurement plays a crucial role in the diagnosis and management of airway inflammation. FeNO testing is recommended by the National Institute for Health and Care Excellence (NICE) to help diagnose asthma1, with the NObreath® device one of three devices recommended by NICE1. In 2005 the American Thoracic Society (ATS) and the ...
In recent years, there has been a growing trend of using video technology in surgical procedures to enhance precision, communication, and training. While the benefits of video in surgery are many, there are also concerns regarding the legal risks that may arise from its use. Medical professionals fear that video footage of a surgery could potentially be used against them in legal proceedings, ...
Mental health is a critical concern for all companies. One in five individuals will experience a mental health problem during their lives, according to the World Health Organization. For many people, the workplace is where mental health problems first begin and/or become exacerbated. ...
Why Do You Need One? A medical battery pack is an essential part of any medical device. It provides power to the device when no other power source is available. This kinf of battery pack can be used on a number of devices, including portable defibrillators, heart monitors and other life-saving devices. There are many different types of medical battery pack manufacturing on the market today. ...
Unlike the development of most small or large molecules, which typically measures only one part or the metabolite for pharmacokinetic analysis, multiple parts of ADCs need to be measured to characterize their PK properties. Therefore, a thorough understanding of the clinical pharmacology of ADCs is critical for selecting a safe and effective dose for patients. Biological Analysis of ADC In order ...
Currently, ADC has played a significant role in the treatment of some malignant tumors, such as trastuzumab in the treatment of breast cancer, but its application in the treatment of prostate cancer (PCa) progress slowly. In recent years, ADC has made rapid progress in the treatment of metastatic castration-resistant prostate cancer (mCRPC). STEAP1, TROP2, PSMA, CD46, and B7-H3 are currently ...
As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
AFM13 is a first-in-class tetravalent, bispecific NK cell engager that binds to CD30 on tumor cells and CD16A on NK cells. By engaging CD16-positive NK cells, AFM13 leads to NK cell-mediated killing of tumor cells.1 Pembrolizumab (Keytruda®) is approved in patients with R/R classical Hodgkin lymphoma as monotherapy. AFM13 showed single agent clinical activity with solid safety profile in a ...
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
Background: Disruption of the microbiome is key to the pathogenesis of recurrent Clostridioides difficile infection (CDI). Place bo-control led trials assessing microbiome therapeutics have demonstrated efficacy in recurrent CDI; hov/ever, long-term safety and efficacy data from rigorously conducted studies of microbiome therapies, including cumulative efficacy in those who received a second dose ...
Imagine you’ve just been diagnosed with cancer and you’re enrolled in a clinical trial for a promising new drug. You notice that after chemotherapy you struggle with occasional fatigue. Yet, whenever you visit your doctor every couple of weeks, you feel fine. This is not only a frustrating experience for patients, but it can also compromise the safety data in a clinical trial. The ...
ByAiCure
A healthy vagina is home to a diversity of microbes that work in tandem to keep an acidic environment in check. But this balance of flora can be easily disrupted, or shift throughout the menstrual cycle. This is where probiotics might come in, to help replenish the good bacteria, and curb the bad. Probiotics and the vaginal microbiome The billions of bacteria, fungi, viruses, and other microbes ...
ByJuno Bio
Follow-up data from the landmark SPRINT study of the effect of high blood pressure on cardiovascular disease have confirmed that aggressive blood pressure management — lowering systolic blood pressure to less than 120 mm Hg — dramatically reduces the risk of heart disease, stroke, and death from these diseases, as well as death from all causes, compared to lowering ...
Childhood vaccinations provide immunity to children against serious infectious diseases before they are exposed to them to prevent illness. Many childhood diseases, such as smallpox and polio, have been almost completely eradicated as a result of widespread, standardized childhood vaccination programs. Some vaccinations, such as those for highly contagious diseases including measles, mumps, ...
ENB Therapeutics reports preliminary data from the ongoing Phase 1/2 trial assessing the safety and efficacy of lead product ENB-003 in combination with pembrolizumab. Safety data are encouraging with no significant drug related safety events from the first 3 dosing cohorts. Best overall responses from the first 6 patients include 2 disease stabilizations and 1 confirmed partial response. The ...
Ancora Heart Inc., a Santa Clara, Calif.-based company looking to help those with heart failure, is heralding results from an interim analysis of patients treated in a U.S. early feasibility study evaluating the safety of the investigational Accucinch ventricular repair system. The multicenter, nonrandomized, prospective study is assessing the system in patients with symptomatic heart failure ...
Interim study results from systolic heart failure patients treated with percutaneous therapy designed to improve left ventricular function presented at TCT 2019 Santa Clara, Calif.–September 25, 2019–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced results from an interim analysis of heart failure patients treated in the CorCinch FMR ...