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First-Of-Its-Kind AI-Enabled Smart Microscopy Platform to Accelerate Traditional Pathology Workflows

Pathology and tissue analysis are areas poised for transformative advancements. Drug developers and clinicians currently depend on long-established methods for crucial tasks such as diagnosing diseases, quantifying biomarkers, and predicting therapeutic responses. While there have been attempts to innovate by digitizing specimens and adding multiple markers to a single slide, there are still limitations, including the analysis of less than 1% of tissue samples and the inability to depict complex tissue architectures and cellular interactions that are only visible in three dimensions. 3D imaging technology captures significantly more data than traditional slide-based methods by digitizing whole biopsy specimens rather than just thin slices.Artificial intelligence (AI) and machine learning algorithms play a crucial role in quantifying relevant biomarkers and identifying areas for more detailed pathologist examination. Now, a pioneering 3D spatial biology platform can digitize entire tissue specimens quickly and non-destructively while providing AI-enabled quantitative analysis. This technology enhances the precision ...
- Source: drugdu
- 97
- August 21, 2024
Novel Nanoparticles Found in Blood Pave Way for Less Invasive Cancer Diagnosis

Extracellular vesicles (EVs) and exosomes, tiny nanoparticles about 1,000 times smaller than a human hair, are secreted by all cells into biofluids like blood and urine. These particles are known to transport genetic material safely through the body. Researchers have now discovered a new class of RNAs within EVs that could transform the diagnosis and treatment of cancer and other diseases. This team found that these RNAs change in the presence of cancer, indicating their potential as biomarkers for diseases like prostate cancer or as therapeutic targets. The research group at the Icahn School of Medicine at Mount Sinai (New York, NY, USA) has dubbed these RNAs “EV-UGRs” (Extracellular Vesicles-Associated Unannotated Genomic Regions), following their identification in the blood and urine of patients with prostate cancer. UGRs, often described as the genome’s “dark matter,” play a key role in gene regulation and protein synthesis. The team previously discovered that EVs ...
- Source: drugdu
- 107
- August 21, 2024
FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease

By Don Tracy, Associate Editor Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.The FDA has approved Incyte Sundax Pharmaceuticals’ Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) in patients who have not responded to at least two previous lines of systemic therapy. According to both companies, Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. The approval was based on promising results from the AGAVE-201 study.1 “With the approval of Niktimvo, patients with chronic GVHD whose disease has progressed after prior therapies, now have a new treatment option with a novel mechanism of action to help address the serious and devastating complications associated with this disease,” said Hervé Hoppenot, CEO, Incyte, in a press release. “Niktimvo is Incyte’s second approved treatment for ...
- Source: drugdu
- 88
- August 21, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 72
- August 21, 2024
South African president calls on WHO for better mpox response

Amidst the global health emergency declared for mpox, the South African president has called for a greater emphasis on an equitable distribution of healthcare interventions. The World Health Organization (WHO), “must be different and correct the unfair treatment from the previous one [public health emergency] declared in 2022, where vaccines and therapeutics were developed and made available primarily to Western countries, with little support extended to Africa,” said Cyril Ramaphosa, the president of South Africa in a 17 August statement on the recent mpox outbreak in Africa. Ramaphosa called on the WHO to collaborate more closely with the Africa Centers for Disease Control and Prevention (Africa CDC) to allow wider access to vaccines, while countries in the African Union (AU) to increase domestic resource allocation. The AU is a continental union consisting of 55 African member states. Thus far, the AU has granted $10.4m in emergency funds to support Africa ...
- Source: drugdu
- 82
- August 21, 2024
Sound Pharmaceuticals plans to stick with WuXi amid BIOSECURE Act rumblings

Sound Pharmaceuticals wishes to maintain its relationship with the WuXi AppTec for manufacturing its lead Meniere’s disease drug SPI-1005, amidst increasing scrutiny on Chinese companies in the US, says CEO Jonathan Kil. In an exclusive interview with Pharmaceutical Technology Kil stated the company is “actively supporting WuXi”. The Biden administration set its sights on several Chinese firms with the introduction of the BIOSECURE Act, including WuXi AppTec. The BIOSECURE Act will withhold federal funding and contracts to companies should the biotech equipment or services used be sourced from ‘companies of concern’. These include several Chinese firms including WuXi. Under the Act, existing corporate ties will be permitted until 2032. According to Reuters, information stating the company transferred US intellectual property to Beijing without consent was shared with US senators driving this bill. Last month, Sound Pharmaceuticals completed a Phase III trial for its drug SPI-1005. Interim results from the study ...
- Source: drugdu
- 105
- August 21, 2024
New research reveals AI bowel cancer test can help patients avoid chemotherapy

A study led by researchers at the University of Leeds has revealed that a new artificial intelligence (AI) test to determine the risk of recurring bowel cancers could help patients avoid chemotherapy. The findings published in the Journal of Clinical Oncology Production could help doctors when deciding whether a patient needs chemotherapy following bowel cancer surgery. Found anywhere in the large bowel, bowel cancer is one of the most common cancers in the world, with 1.9 million cases diagnosed in 2020. In the UK alone, bowel cancer is the fourth most common cancer, affecting over 250,000 people. Researchers aimed to establish whether the number of CD3 cells within tumours could be used to predict the risk of a tumour coming back after surgery. In previous studies, bowel and rectal tumours with higher numbers of CD3 immune cells, which attack the cancer and help the body tackle the disease, have been ...
- Source: drugdu
- 64
- August 21, 2024
Researchers map interactions of 144 active substances to identify drug benefits

Researchers from the Technical University of Munich (TUM) have successfully mapped the interactions of over 100 active substances with around 8,000 proteins to help identify previously unknown benefits of existing drugs. Published in Nature Biotechnology, researchers yielded more than one million dose-responsive curves, which demonstrated the mechanism behind the effects of active substances over the course of treatment. Precision medicine is designed to optimise efficiency or therapeutic benefit for particular groups of patients using genetic or molecular profiling to provide patients with the most individualised treatment possible. To do this, a precise understanding of what is happening at the cellular level is required. Researchers treated cells with various doses of 144 active substances, most of which are already being used in cancer treatment or are in the clinical approval stage. Once extracted, the team analysed proteins using mass spectrometry before studying the cell reactions using the data. In cancer, depending ...
- Source: drugdu
- 72
- August 21, 2024
CPhI South East Asia

Organiser：Informa Markets Time：July 16th – 18th, 2025 Address： 8, Jalan Dutamas 2, Kompleks Kerajaan, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Exhibition hall：Malaysia International Trade and Exhibition Centre Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-infectives, Penicillins, Aminoglycosides, Lincomycin, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Western Medicine Raw Materials Packaging Equipment: Pharmaceutical Machinery, Packaging Machinery, Packaging Materials, Pharmaceutical Production Equipment and Technology, Pharmaceutical Packaging Equipment, Pharmaceutical Packaging Materials, Pharmaceutical Production, Cleaning, Disinfection Equipment, and Laboratory Instrumentation Systems Pharmaceutical Products: Various Traditional Chinese Medicines, Western Medicines, New Drugs, APIs, Chemical Pharmaceuticals, Pharmaceutical Intermediates, Biopharmaceuticals, Traditional Medicines, Chinese Medicines, Herbal Medicines, Plant and Animal Extracts, Veterinary Drugs, Food Ingredients, and Additives, etc. About CPhI South East Asia： CPhI South East Asia is the most authoritative ...
- Source: drugdu
- 239
- August 21, 2024
【EXPERT Q&A】What is the export procedure of proprietary Chinese medicine?

Drugdu.com expert’s response: To successfully export proprietary Chinese medicines, the following processes are required: I. Preliminary Preparations Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market. Product Preparation: a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority. b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market. Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks. II. Preparation of Application Materials Basic Information of Medicines: Detailed information on the TCMs ...
- Source: drugdu
- 92
- August 20, 2024

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