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BioAtla receives FDA fast track designation for ozuriftamab vedotin

BioAtla has received a fast track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) to treat a certain type of head and neck cancer. Ozuriftamab vedotin is a conditionally and reversibly active ADC targeted against ROR2, a receptor tyrosine kinase present in many solid tumours. ROR2 is a non-canonical wnt5A signalling receptor, the overexpression of which is associated with poor prognosis and resistance to standard therapies. This fast track designation concerns the use of ozuriftamab vedotin in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) for whom the disease has progressed despite platinum-based chemotherapy and anti-PD-1/PD-L1 antibody treatment. The ADC is the subject of an ongoing multi-centre, open label Phase II trial (NCT05271604) investigating the therapy’s efficacy and safety for this indication. Though a full readout is still pending, interim data from ...
- Source: drugdu
- 83
- July 26, 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
- 87
- July 26, 2024
AI Model Identifies Breast Tumor Stages Likely To Progress to Invasive Cancer

Ductal carcinoma in situ (DCIS) is a non-invasive type of tumor that can sometimes progress to a more lethal form of breast cancer and represents about 25% of all breast cancer cases. Between 30% and 50% of DCIS patients may develop an invasive stage of cancer, yet identifying which tumors will progress is still a challenge due to unknown biomarkers. Current diagnostic practices include multiplexed staining or single-cell RNA sequencing to determine DCIS stages in tissue samples, but these methods are costly and not widely used. This has led to potential overtreatment of patients with DCIS. Now, a new artificial intelligence (AI) model can distinguish different stages of DCIS from inexpensive and readily available breast tissue images. The model developed by an interdisciplinary team of researchers from MIT (Cambridge, MA, USA) and ETH Zurich (Zurich, Switzerland) was trained and tested using one of the largest datasets of its kind ...
- Source: https://www.labmedica.com/pathology/articles/294801919/ai-model-identifies-breast-tumor-stages-likely-to-progress-to-invasive-cancer.html
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- July 26, 2024
Handheld Device Puts Power of Lab-Based Diagnostic Testing in the Palm of Your Hand

Many common tests for infectious diseases work by detecting either antigens related to the virus or antibodies created in response to the infection. These tests, which now include widely used COVID-19 rapid antigen tests, offer the advantages of speed and broad availability. However, polymerase chain reaction (PCR) tests still surpass these in terms of accuracy, reaching nearly 100%. PCR tests, considered the gold standard in infectious disease diagnostics, excel because they detect a pathogen’s genetic material like RNA directly. This capability increases specificity, reducing the likelihood of false positives. PCR can also amplify minimal amounts of genetic material, allowing it to detect infections at very low levels. Yet, PCR requires specialized skills and expensive equipment, which limits its availability, particularly in low-resource settings. Researchers at the University of Connecticut (Storrs, CT, USA) have now developed a platform technology that incorporates PCR-like capabilities within a handheld device, as detailed in ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801920/handheld-device-puts-power-of-lab-based-diagnostic-testing-in-the-palm-of-your-hand.html
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- July 26, 2024
【EXPERT Q&A】What qualifications do foreign trade enterprises need to agent drug export?

Drugdu.com expert’s response: The qualifications required for foreign trade enterprises to act as agents for pharmaceutical exports primarily encompass the following aspects: I. Basic Qualifications 1.Foreign Trade Management Right: Foreign trade companies must possess general foreign trade import and export management rights, which serve as the fundamental prerequisite for acting as agents for pharmaceutical exports. This right permits the company to engage in or act as an agent for the import and export of various goods and technologies, except for those commodities and technologies whose import and export are restricted or prohibited by the state. 2.Registration: Foreign trade companies need to register with relevant government departments. For instance, they must register with the Ministry of Foreign Trade and Economic Cooperation to obtain import and export qualifications and with the Entry-Exit Inspection and Quarantine Bureau to acquire a quarantine registration code. These registrations are crucial steps to ensure compliance with regulations ...
- Source: drugdu
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- July 26, 2024
Pharmapack

Organiser： Informa Exhibitions Group Time：January 22-23, 2025 address：1, place de la Porte de Versailles, 75015 Paris, France Exhibition hall：Paris Expo Porte de Versailles Product range: Ⅰ. Design and innovation of drug delivery systems, raw materials (aluminum, cardboard, plastic, and glass) Ⅱ. Transformers, packaging machinery, production equipment, automation and assembly line systems, product and packaging design services, parts and components for thermoforming packaging Ⅲ. Aerosols, ampoules, sprays, blisters, medical devices, pharmaceutical packaging, vials, unit doses Ⅳ. Labels and markings, medical pumps, medical bags, syringes, pen injectors, reconstitution systems, tubes, and more Ⅴ. Pharmaceutical subcontractors, printing and labeling, instruction manuals, brochures, sterilization technologies and services, control, tracking and anti-counterfeiting, transportation materials and services About Pharmapack： Pharmapack, the Pharmaceutical Packaging Exhibition in Paris, France, is the largest and most authoritative pharmaceutical packaging exhibition in the country. It brings together global leading industry designers, pharmaceutical manufacturers, drug packaging, and delivery system suppliers. It ...
- Source: drugdu
- 120
- July 26, 2024
Portable PCR Platform to Detect Multiple Pathogenic Bacteria Targets and Antibiotic Susceptibility at POC

Gonorrhea, the second most reported bacterial sexually transmitted infection (STI), affected approximately 82 million people globally in 2020. The incidence is higher in low and middle-income countries where the burden of drug resistance is most pronounced. Gonorrhea can lead to severe health complications such as pelvic inflammatory disease, chronic pelvic pain, and infertility. Since not all patients show symptoms, the true burden of the disease is likely much greater than reported cases suggest. To combat this, rapid and advanced diagnostics are crucial for detecting drug-resistant bacterial infections early and guiding effective treatment. Now, a portable PCR platform with high multiplexing capabilities is being developed to identify multiple pathogenic bacterial targets and their antibiotic susceptibility, thus aiding in point-of-care treatment decisions. Prompt Diagnostics (Baltimore, MD, USA) has been awarded USD 1 million by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X, Boston, MA, USA) to further the development of its portable PCR ...
- Source: drugdu
- 108
- July 25, 2024
Protein Signatures in Blood Can Predict Risk of Developing More Than 60 Diseases

Measuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements from a small blood sample to predict a variety of diseases. In the research, published in Nature Medicine, which was carried out as part of an international partnership involving Queen Mary University of London (London, UK), the investigators used data from the UK Biobank Pharma Proteomics Project (UKB-PPP). This project represents the largest proteomic study to date, analyzing around 3,000 plasma proteins from over 40,000 randomly selected UK Biobank participants. These protein measurements are linked to detailed electronic health records. The researchers applied sophisticated analytical techniques to identify a specific ‘signature’ of 5 to 20 key proteins for predicting each disease. They discovered that these protein ‘signatures’ can predict the onset of 67 different diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neuron ...
- Source: drugdu
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- July 25, 2024
FDA Approves Merz Aesthetics’ Xeomin for Simultaneous Treatment of Upper Facial Lines

By Don Tracy, Associate Editor The new approval expands Xeomin’s indications to include horizontal forehead lines and lateral canthal lines.The FDA has approved Merz Aesthetics’ Xeomin (incobotulinumtoxinA) as the first and only neurotoxin in the United States indicated for the simultaneous treatment of upper facial lines, including forehead lines, frown lines, and crow’s feet. According to the company, to improve the appearance of moderate to severe upper facial lines, the recommended dose is 20 units for glabellar frown lines, 20 units for horizontal forehead lines, and 24 units for the crow’s feet for a total of 64 units. Xeomin was initially approved by the FDA in 2011 for temporary improvement in the appearance of moderate to severe glabellar lines and frown lines.1 “Xeomin is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines),” said Samantha Kerr, PhD, ...
- Source: drugdu
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- July 25, 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
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- July 25, 2024

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