Search Results for “Clinical Trial” – Page 50 – media

Tirzepatide Shows Statistically Significant Improvements in Reducing Heart Failure Risk, Enhanced Symptoms

By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
- Source: drugdu
- 68
- August 5, 2024
Artificial Intelligence Test Determines Risk of Bowel Cancer Recurrence After Surgery

Bowel cancer, commonly referred to as colorectal cancer, can develop anywhere in the large bowel, including the colon and rectum. It ranks among the most prevalent cancers globally, with 1.9 million new cases recorded in 2020. The current protocols for determining the need for chemotherapy for patients with early-stage bowel cancer are not consistently reliable. As a result, some patients receive chemotherapy unnecessarily, while others who might benefit from it do not receive it and may face cancer recurrence. This decision is particularly challenging for stage II colon cancer, where the risk of recurrence post-surgery is generally lower. Now, a new artificial intelligence (AI) test can predict the risk of recurrence in bowel cancers, potentially helping patients avoid unnecessary chemotherapy. This test employs an AI algorithm to measure the concentration of immune cells known as CD3 in tumors at the early stages of bowel cancer. Previous studies have indicated that ...
- Source: drugdu
- 60
- August 5, 2024
NHS Scotland, AZ and Scottish universities partner for kidney health research

NHS Scotland, AstraZeneca (AZ) and the Universities of Glasgow and Dundee have entered into a partnership to accelerate research into treating chronic kidney disease (CKD). The collaboration aims to develop new medicines to slow down the progression of CKD, build infrastructure and enhance expertise in renal clinical trial delivery in Scotland to improve patient outcomes. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition caused by decreased kidney function, commonly caused by diabetes, hypertension and glomerulonephritis. By preventing the progression of CKD, patients will live longer, better lives, free from other consequences of the condition, including heart failure, cardiovascular disease and stroke, while also reducing pressure on the NHS. In addition to slowing the progression of CKD, NHS Scotland, AZ and the Universities of Glasgow and Dundee will work to reduce the risk of patients potentially needing dialysis, a procedure to remove waste products and excess fluid ...
- Source: drugdu
- 95
- August 3, 2024
NRx Receives Response From FDA Over Testing Use of Ketamine for Suicidal Depression in Adolescents

By Mike Hollan The company announced that it will conduct research based on guidance from the agency. NRx Pharmaceuticals announced that it has received a response from FDA over its proposed plan to study the impact of ketamine (NRX-100) as a treatment for suicidal depression in adolescents.1 Congress had previously stated that this is a requirement before NRx can filing a new drug application (NDA) for the use of ketamine to treat suicidal depression. According to NRx, it will work with Hope Therapeutics to conduct a clinical trial on ketamine’s use for this condition. The study will include participants aged 9-17, but it will not be required to include younger participants. The companies will also conduct studies involving animals to determine the safety of ketamine usage in adolescents. In a press release, NRx Pharmaceuticals chairman and HOPE Therapeutics co-CEO Prof. Jonathan Javitt said, “Youth suicide has reached crisis proportions in ...
- Source: drugdu
- 66
- August 2, 2024
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder

By Don Tracy, Associate Editor Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says. Image Credit: Adobe Stock Images/Mohammad Xte The FDA has approved Luye Pharma Group’s Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. According to the company, the treatment is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the United States. The product was granted a US patent in 2023, set to expire in 2039, and was approved as a new drug under the 505(b)(2) pathway.1 The approval is based on results from the company’s pivotal United States study of Erzofri.1 “The purpose of developing innovative formulations is to address unmet clinical needs, which includes covering aspects such as drug efficacy, compliance issues and side effects, among others. With a focus on ...
- Source: drugdu
- 105
- August 1, 2024
With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?

Guardant Health’s Shield, a liquid biopsy that screens for colorectal cancer by analyzing a patient blood sample, will compete against stool-based tests already established in the market. Shield could also face new competition from other liquid biopsy companies. By Frank Vinluan FDA approval of a Guardant Health blood test that screens for colorectal cancer makes it the first liquid biopsy approved for this type of cancer, clearing the way to make this test more accessible to more people. But commercialization will be a challenge as the new test is not expected to become the first or even second screening option for patients. The approval announced Monday for the test, named Shield, covers the screening of adults age 45 and older at average risk for colorectal cancer. Colorectal cancer is the third most common type of cancer in the U.S., excluding skin cancers, according to the American Cancer Society. For men and women combined, it’s ...
- Source: drugdu
- 96
- August 1, 2024
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

July 29, 2024 By Don Tracy, Associate Editor Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.1 “I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in ...
- Source: drugdu
- 75
- July 31, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
- 120
- July 30, 2024
Sanyou Bio Congratulates Eluminex Biosciences and Foreseen Biotechnology on Major Breakthroughs in Innovative Drug Project

SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
- Source: drugdu
- 52
- July 30, 2024
Talent Management Strategies for Post-Milestone Growth

By Tracy Duberman, PhD Insights from Takeda, Jazz, Nestlé Health Sciences, Humana, and other healthcare executives Milestones such as major acquisitions, FDA approvals for new therapies, or obtaining Series C funding are transformative events for pharmaceutical organizations. These triumphs come with nuanced challenges including how to integrate new teams while retaining core talent and how to sustain morale during rapid scaling. Pharma leaders managing talent post milestones need to focus on assessing future talent needs, implementing strategic talent acquisition, onboarding new hires to the company’s culture, leveraging internal talent mobility, prioritizing DE&I initiatives, recognizing employee performance, and focusing on employee well-being. Below are talent management strategies to consider for post-milestone growth. Projecting talent needs for future success: It is important to assess the impact of any large-scale change on both current and future talent and to have a data-informed approach to effectively manage talent during transformative phases. Understanding current talent ...
- Source: drugdu
- 74
- July 29, 2024

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