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Blood-Based Machine Learning Assay Noninvasively Detects Ovarian Cancer

Ovarian cancer is one of the most common causes of cancer deaths among women and has a five-year survival rate of around 50%. The disease is particularly lethal because it often doesn’t cause symptoms in its early stages. The absence of effective screening tools and the disease’s asymptomatic nature contribute to its diagnoses during the later stages when treatment options are less effective. A cost-effective, accessible detection method could revolutionize the clinical approach to ovarian cancer screening and potentially save lives. Although liquid biopsy technologies, which analyze blood for tumor-derived DNA, have been explored for noninvasive cancer detection, their utility in ovarian cancer has been limited. Now, a retrospective study presented at AACR 2024 has demonstrated that a blood-based machine learning assay, which combines cell-free DNA (cfDNA) fragment patterns with levels of the proteins CA125 and HE4, can effectively distinguish patients with ovarian cancer from healthy controls or patients with ...
- Source: drugdu
- 124
- April 13, 2024
PureTech Startup Gets $100M to Try For Success Where Sage & Others Fall Short in Depression

Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health.Even when depression drugs address known and validated targets, their commercial potential can be constrained by dosing or safety limitations. Seaport Therapeutics’ drugs use a novel delivery approach to overcome those limitations. The startup launched on Tuesday, backed by $100 million in financing. Boston-based Seaport was formed by PureTech Health, a company that creates startups, typically around a platform technology. One notable example is neuropsychiatric drugs developer Karuna Therapeutics, which grew and eventually spun out of PureTech as a publicly traded company with a lead drug taking a novel approach to schizophrenia. Bristol Myers Squibb last year struck a $14 billion deal to acquire Karuna, whose schizophrenia drug is currently under FDA review. Former Karuna CEO Steven ...
- Source: drugdu
- 142
- April 12, 2024
Philips restricted from selling respiratory machines in DOJ consent decree

Dive Brief The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices. The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a ...
- Source: drugdu
- 77
- April 12, 2024
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models

Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels for hypothyroidism patients. However, the high cost of mass spectrometers, often reaching several hundred thousand dollars, restricts them to labs that require the transportation of blood samples for analysis, thereby complicating chronic disease management. Now, researchers have taken a big step towards building inexpensive hardware that could make mass spectrometry local. The team has used 3D printing to create a low-cost ionizer, a vital component of the mass spectrometer, that can deliver twice as good a performance as its high-end counterparts. The device developed at MIT (Cambridge, MA, USA) spans just a few centimeters and is designed for mass production, enabling its integration into mass spectrometers through robotic assembly method. This also makes it more economical than traditional ionizers which often ...
- Source: drugdu
- 140
- April 12, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 84
- April 11, 2024
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 127
- April 10, 2024
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections

Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West Nile, and Zika viruses are the four most significant arboviruses of concern, all being transmitted by mosquito bites. In 2023 alone, dengue virus accounted for over five million cases and 5,000 deaths worldwide. Traditionally, assessing the risk of arboviruses in blood donors has relied on single-pathogen tests, dual-pathogen tests, or donor history questionnaires, with those having traveled to or lived in areas endemic for arboviruses being temporarily deferred. Now, an in vitro nucleic acid test that can detect all four types of arboviruses can help minimize the risk of blood transfusion-transmitted infections. The new Procleix ArboPlex Assay from Grifols (Barcelona, Spain;) is an automated nucleic acid test (NAT) specifically validated for screening blood donors to detect chikungunya, dengue, West Nile and Zika viruses. The ...
- Source: drugdu
- 91
- April 10, 2024
FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy

Davy James Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy. The FDA has approved Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) to treat adults with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy that included an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.1 The regulatory action expands the indication for Abecma to earlier lines of treatment in patients whose disease relapsed or became refractory following administration of the three primary treatment classes following two prior lines of therapy. “Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the ...
- Source: drugdu
- 81
- April 9, 2024
AstraZeneca reports positive Phase III results for Imfinzi in small cell lung cancer

Though a recent Phase III trial failed to achieve its primary endpoint with Imfinzi (durvalumab) in a specific subset of non-small cell lung cancer (NSCLC), AstraZeneca has announced that another Phase III study evaluating the checkpoint inhibitor has demonstrated a survival benefit in patients with limited-state small cell lung cancer (LS-SCLC). As per the 5 April press release, Imfinzi monotherapy demonstrated statistically and clinically meaningful improvements across the study’s primary endpoints of overall survival (OS) and progression-free survival (PFS). Additionally, the safety profile of the Imfinzi remained consistent with previous findings. The randomised, double-blind, placebo-controlled Phase III ADRIATIC study (NCT03703297) is actively evaluating Imfinzi as both a monotherapy and as a combination therapy with AstraZeneca’s Imjudo (tremelimumab) for the treatment of patients with LS-SCLC who have not progressed following concurrent chemoradiotherapy (cCRT). The study enrolled a total of 730 patients who were randomly assigned to receive placebo or 1500mg Imfinzi, ...
- Source: drugdu
- 151
- April 9, 2024
Study reveals new aptamer targeting tool can detect early signs of motor neurone disease

Researchers from the University of Edinburgh and the University of Aberdeen have revealed that an aptamer (biological molecules) tool can successfully detect early signs of motor neurone disease (MND). Published in Acta Neuropathologica, the aptamer was collaboratively developed by scientists at the University of Edinburgh, the Instituto Italiano di Tecnologia, King’s College London and the Centre for Genomic Regulation in Spain. Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. The new method works to detect MND by targeting the protein association with the disease in brain tissue before the onset of symptoms. It uses small biological molecules to bind to protein clumps that accumulate in the brains of people living with MND. Funded by Target ALS, researchers from Edinburgh and Aberdeen discovered that the ...
- Source: drugdu
- 143
- April 9, 2024

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