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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
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- 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
- 149
- 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
- 128
- 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
- 144
- 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
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- 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
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/
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- August 1, 2024
Fosun PharmaceuPharmacopeia as an Official Control Product

On July 23, 2024, Guilin Nanopharm received a letter from the United States Pharmacopeial Convention (hereinafter referred to as USP) “Donation Recognition Program Team”, which mentioned that the artesunate control product donated by Guilin Nanopharm has been listed as an official control product by USP. Artesunate is the original anti-malarial drug developed by Guilin Pharmaceuticals for the secondary research and development of artemisinin. It solved the problem of water solubility of artemisinin and obtained the certificate of Class I New Drug No. X-01 issued by the Ministry of Health of China in 1987. The control of Artesunate was calibrated by Guilin Southern Pharmaceuticals and USP official laboratories respectively, and the content determination results were identical, both were 99.8%. The data of infrared, mass spectrometry, nuclear magnetic resonance (NMR), related substances, moisture and other assays showed complete match. The inclusion of this control as an official control by USP ...
- Source: drugdu
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- August 1, 2024
Avzivi® (BAT1706) receives marketing approval from European Commission

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 92
- August 1, 2024

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