Search Results for “FDA” – Page 93 – media

Study finds 3D-printed blood vessels could improve heart bypass outcomes

Coronary heart disease is the most common form of heart and circulatory disease Researchers from the University of Edinburgh, in collaboration with Heriot-Watt University, have revealed that artificial blood vessels printed using novel 3D printing technology could transform the treatment of cardiovascular diseases (CVD). The findings published in Advanced Materials Technologies demonstrate that artificial blood vessels could improve outcomes for heart bypass patients. CVD affects around seven million people in the UK and is a significant cause of disability and death. Heart bypass surgery is a procedure used to treat coronary heart disease, the most common form of heart and circulatory disease that affects around 2.3 million people in the UK. It occurs when coronary arteries become narrowed by a build-up of fatty material within their walls. Researchers led by the University of Edinburgh’s School of Engineering used a rotating spindle integrated into a 3D printer to print tubular grafts made from ...
- Source: https://pharmatimes.com/news/study-finds-3d-printed-blood-vessels-could-improve-heart-bypass-outcomes/
- 109
- August 1, 2024
AST System Delivers Actionable Results for Gram-Negative Bacteria Directly from Positive Blood Cultures

Annually, sepsis claims the lives of 11 million people globally, with 1.3 million of these deaths linked to antibiotic-resistant bacteria. For clinicians, the ability to quickly and accurately interpret antimicrobial susceptibility testing (AST) results is essential to save lives and tailor treatment strategies effectively. Rapid AST not only improves patient outcomes but also reduces the global antimicrobial resistance (AMR) burden by supporting the execution of effective Antimicrobial Stewardship (AMS) programs. Predicting AMR in patients with gram-negative infections is often a more complex and time-consuming process. Early diagnosis and timely treatment are crucial in enhancing outcomes for sepsis patients. Studies have shown that each hour’s delay in administering antibiotics significantly increases the likelihood of hospital mortality, even if antibiotics are given within the first six hours. Now, a novel AST system delivers actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours, enabling same-day treatment ...
- Source: drugdu
- 88
- July 31, 2024
Silicon Chip Based Blood Test Rapidly Diagnoses Patients with Hypothyroidism

Hypothyroidism impacts about 10% of the U.S. population, making the Thyroid Stimulating Hormone (TSH) test the most frequently conducted immunoassay in the United States. Traditional testing often involves significant time commitments for patients, including visits to labs and waiting 2 to 5 days for results. Now, a new TSH immunoassay performed on a silicon chip delivers results in approximately 30 minutes. Genalyte (San Diego, CA, USA) has received U.S. Food and Drug Administration (FDA) approval for its groundbreaking immunoassay, the first of its kind to be cleared for use on a silicon chip-based device. The Maverick Diagnostic System (MDS) incorporates silicon chip-based photonic ring resonator technology, enabling the execution of multiple rapid tests simultaneously from a small sample of whole blood or serum. This system is also connected to the cloud, facilitating the retrieval of assay protocols and enabling clinical oversight. Genalyte’s innovation effectively minimizes the traditional bulky lab machinery ...
- Source: drugdu
- 91
- July 31, 2024
CHMP backs Boehringer’s Spevigo for preventing rare psoriasis flare-ups

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new indication of Boehringer Ingelheim’s Spevigo (spesolimab) injection for the prevention of generalised pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age. Spevigo originally received a European Commission approval for the infusion in December 2022, for the treatment of GPP flares in adults as a monotherapy. However, this approval would offer younger patients the chance to use Spevigo to prevent flare-ups. Spevigo attaches to the interleukin-36 receptor (IL-36), which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP. GPP is a rare, severe type of psoriasis where patients suffer from widespread pustules on red skin, often accompanied by systemic symptoms like fever and fatigue. It is distinct from other forms of psoriasis, as it can become life-threatening due to complications ...
- Source: drugdu
- 82
- July 31, 2024
Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer

By Don Tracy, Associate Editor FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) has found that AstraZeneca’s Imfinzi (durvalumab) achieved the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) in the Phase III AEGEAN trial. However, AstraZeneca noted that although the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, its potential should not be overlooked. Results of the trial were published in The New England Journal of Medicine. “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, ...
- Source: drugdu
- 67
- 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
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 108
- July 27, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 83
- July 26, 2024
Vivacelle Bio Launches Phase III Clinical Trial for VBI-S to Treat Hypovolemic Septic Shock

By Don Tracy, Associate Editor The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors. Vivacelle Bio has launched a Phase III clinical trial for its leading therapeutic candidate, VBI-S, designed to treat hypovolemic septic shock. According to the company, the trial will be conducted across seven major septic shock treatment centers in the United States, which include some of the biggest septic shock treatment centers in the country. Investigators seek to compare VBI-S and standard of care (SOC) to SOC alone in a 1:1 ratio. “Initiation of our Phase III trial is a significant achievement for our team following years of dedicated work developing our phospholipid nanoparticle technology platform,” said Harven DeShield, PhD, JD, MSc, CEO, Vivacelle, in a press release. “Based on our excellent Phase II results, and the positive interaction with ...
- Source: drugdu
- 90
- July 25, 2024
Telix raises $398m to advance kidney and brain cancer radiotherapies

Not long after pulling a last-minute plug on a $232m initial public offering (IPO) on Nasdaq, Telix Pharmaceuticals has raised $398m (A$600m) via the issue of convertible bonds. The bonds, which are convertible into ordinary shares, will yield a 2% – 2.75% interest, the radiopharmaceutical specialist said in a 23 July press release. The maturity date is set for five years from now, at the end of July 2029. Australia-based Telix said it intends to list the convertible bonds on the Official List of Singapore Exchange Securities Trading Limited (SGX-ST). While Telix had been planning on going public on Nasdaq earlier this year, the company U-turned on the IPO citing market conditions at the time. Telix had been on course to raise $232m in the listing, though the company maintained that the decision was not “predicated on the need to raise capital”. Instead, the convertible bonds bring low-cost financing to ...
- Source: drugdu
- 62
- July 25, 2024

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