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Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer

By Don Tracy, Associate Editor IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer. Daiichi Sankyo and Merck have commenced the IDeate-Lung02 Phase III clinical trial, which aims to compare the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) vs. physician’s choice of chemotherapy in patients with relapsed small cell lung cancer (SCLC) following disease progression with only one prior line of platinum-based chemotherapy. According to both companies, the initiation of the trial was based on results from a subgroup analysis of the IDeate-PanTumor01 Phase I/II trial of ifinatamab deruxtecan, which was presented at the 2023 World Conference on Lung Cancer.1 “Patients living with small cell lung cancer face poor outcomes with currently available treatments,” said Mark Rutstein, MD, global head, oncology clinical development, Daiichi Sankyo, in a press release. “The IDeate-Lung02 trial is an important next step as we ...
- Source: drugdu
- 110
- August 3, 2024
【EXPERT Q&A】What are the FDA-approved Consensus Standards for medical devices?

Drugdu.com expert’s response: FDA-recognized consensus standards for medical devices are a set of standards recognized by the U.S. Food and Drug Administration (FDA). These standards are developed by standardization organizations such as ISO, IEC, ASTM, and others, aiming to ensure the safety, effectiveness, and quality of medical devices. These standards cover various aspects of medical devices, including design, manufacturing, testing, clinical evaluation, and risk management. Ⅰ.Source of Standards: Consensus standards are usually developed by professional standard organizations like the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC), and American Society for Testing and Materials (ASTM). These organizations, with the participation of a wide range of industry experts and stakeholders, create internationally recognized technical requirements and guidelines. Ⅱ.FDA Recognition: The FDA reviews and recognizes these standards, considering them to meet the FDA’s regulatory requirements. Recognized standards are listed in the FDA’s “Recognized Standards” list. Manufacturers can refer to these standards ...
- Source: drugdu
- 115
- August 2, 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
- 77
- August 2, 2024
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 80
- August 2, 2024
PharmaLab Japan

Organiser：Reed Exhibitions Time：July 9-11, 2025 address： 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: General Exhibition Area: Cell biology-related products, drug research-related products, various equipment, consumables, reagents, bioinformatics-related products, bioimaging equipment, software, databases, biological resources, biomaterials, biotech clusters, investment, industrial upgrading, etc. Regenerative Medicine Research Area: Cell culture, cell production products/services, regenerative medicine, cellular medicine, etc. Contract Services Area: Contract research and development (CRD), testing, analysis, contract expression, synthesis, refinement, clinical research CMO, CRO, SMO, technology transfer TLO, IP consulting, etc. Precision Processing Area: Precision/fine processing technologies, micro-chemical engineering (microTAS, Bio MEMS, biochips, biosensors), microchannels, microsystems, etc. About PharmaLab Japan： PharmaLab Japan is one of Asia’s leading exhibitions for pharmaceutical laboratories. With 250 highly anticipated conferences/seminars, it offers attendees the best platform to learn about life sciences. As a comprehensive biotechnology exhibition, it is widely recognized in the industry and brings together ...
- Source: drugdu
- 148
- 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
- 123
- 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
- 126
- August 1, 2024
Blood Test Predicts Alzheimer’s Disease with Over 90% Accuracy

Alzheimer’s disease impacts one in five women and one in ten men over their lifetimes, yet diagnostic tools are still often cumbersome and not widely accessible in primary care settings. Although specialized memory clinics frequently use advanced diagnostic methods like PET scans and cerebrospinal fluid tests, there is a significant need for simpler, quicker diagnostic tools that can be used in primary care. Now, a commercially available blood test for Alzheimer’s has demonstrated approximately 90% reliability in primary care settings, representing a major development for individuals seeking assistance for memory loss and suspected of having this neurological disease. Research on this innovative blood testing method, which evaluates levels of Plasma Phospho-Tau217, commenced in 2019 with studies showing that the blood test can detect Alzheimer ‘s-related changes even before symptoms appear and monitor the disease’s progression. Earlier this year, results indicated that this blood test is as reliable as, and ...
- Source: drugdu
- 143
- August 1, 2024
Groundbreaking Microarray Immunoassay Simultaneously Detect 30+ Allergens from Single Blood Sample

A revolutionary microarray immunoassay enables patients to receive results for multiple allergens using just a single blood sample, thereby minimizing the necessity for multiple tests and appointments. AliveDx’s (Eysins, Switzerland) groundbreaking microarray immunoassay is specifically designed to detect specific IgE antibodies directed against protein allergens in human serum and runs on the company’s proprietary MosaiQ platform. This multiplex immunoassay microarray is capable of detecting over 30 allergens, including those from both inhalants and foods and represents a significant leap in diagnostic capabilities by allowing simultaneous testing for various conditions. This method streamlines the diagnostic process, simplifies laboratory workflows, and reduces the manual labor typically associated with singleplex testing methods. Consequently, it saves significant time for both laboratories and clinicians, enhancing the ability to efficiently diagnose and exclude multiple conditions. For patients who are sensitized to multiple allergens, this technology offers a rapid, comprehensive diagnostic process and supports more targeted ...
- Source: drugdu
- 114
- August 1, 2024
MIT study reveals how specific cells in AD become vulnerable and resilient

The neurodegenerative condition is recognised as the most common form of dementia A study conducted by researchers at the Massachusetts Institute of Technology (MIT) has revealed how specific cells and circuits become vulnerable and resilient to cognitive decline in Alzheimer’s disease (AD), despite clear signs of disease pathology. Published in Nature, researchers measured gene expression differences using single-cell RNA profiling in more than 1.3 million cells of over 70 different cell types in six brain regions, including the prefrontal cortex, entorhinal cortex and hippocampus, from 48 tissues donated by the Religious Order Study and the Rush Memory and Aging Project at Rush University, 26 of whom had died with an AD diagnosis and 22 of whom had not. Currently the most common form of dementia, AD is a neurodegenerative condition that deteriorates the brain’s memory and thinking skills. Researchers found that one type of excitatory neuron in the hippocampus and four ...
- Source: https://ramaonhealthcare.com/mit-study-reveals-how-specific-cells-in-ad-become-vulnerable-and-resilient/
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- August 1, 2024

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