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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
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- 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
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- 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
AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
- Source: https://www.pharmaceutical-technology.com/news/abbvie-looks-to-add-an-eighth-indication-for-jak-inhibitor-rinvoq/
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- July 17, 2024
Delix plans further trials with neuroplastogen after positive Phase I data

Delix Therapeutics is planning to initiate two studies to evaluate patients with major depression investigating its lead neuroplastogen candidate, DLX-001, Delix CMO Dr. Aaron Koenig told Pharmaceutical Technology. Upon the completion of an ongoing Phase I study, the Bedford, Massachusetts-based biotech will take the small molecule into two planned trials—a Phase Ib study and a Phase II study, Koenig said. DLX-001 is a neuroplastogen designed to promote neuroplasticity without giving rise to the deleterious attributes of first- and second-generation psychedelics. “With many psychoactive drugs, you’re talking about the concentrations that you’re able to maintain, continuously engaging the receptor for some period of time. We think that this [DLX-001] has a Cmax-driven effect, meaning that it’s about flipping the switch on the receptor so that downstream effects can then occur,” said Koenig. In May, the company released Phase I data, which demonstrated that treatment with DLX-001 does not produce any psychedelic ...
- Source: https://www.pharmaceutical-technology.com/news/delix-plans-further-trials-with-neuroplastogen-after-positive-phase-i-data/?cf-view
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- July 17, 2024
Innovate UK grants £4m to four companies to evaluate biomarkers for dementia

The progressive neurodegenerative disease affects more than 55 million people globally Innovate UK has awarded £4m through its Contracts for Innovation to four UK companies for research into dementia diagnosis. As part of the Bio-Hermes-002 study led by the US-based Global Alzheimer’s Platform Foundation (GAP) in partnership with Novo Nordisk, the organisations will evaluate blood-based and digital innovative biomarkers for the neurological condition. Affecting more than 55 million people globally, which is expected to triple by 2050, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The study aims to explore whether these biomarkers can predict the extent of tau and amyloid brain pathology and potentially provide more efficient and less invasive alternatives to the current gold standard for dementia diagnoses: positron emission tomography brain imaging. The project will involve 1,000 participants who are cognitively normal, have mild cognitive impairment or ...
- Source: https://www.ukri.org/news/uk-and-us-join-forces-to-tackle-dementia-with-innovative-biomarkers/
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- July 17, 2024
UK Researchers developing new tetanus test to identify global immunity gaps

The serious, rare condition is responsible for up to 7% of all neonatal deaths globally Researchers from the University of Birmingham are developing a new blood-free test to help identify children across the Global South missing immunity to tetanus and other essential vaccines. Supported by £1.1m of funding by the Medical Research Council, the low-cost, non-invasive saliva lateral flow test can potentially reveal whether a person has protection against tetanus within just 15 minutes. Estimated to be responsible for up to 293,000 deaths worldwide every year, according to the European Centre for Disease Prevention and Control, tetanus is a serious disease of the nervous system caused by a toxin-producing bacterium, Clostridium tetani, and is responsible for up to 7% of all neonatal deaths globally. Newborn tetanus is a rare condition that occurs in infants most often within the first ten days of life, resulting from an infection in the umbilical ...
- Source: https://pharmatimes.com/news/uk-researchers-developing-blood-free-tetanus-test-to-identify-global-immunity-gaps/
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- July 17, 2024
Multiplex PCR Test Detects Common Viral and Bacterial Causes of Respiratory or Sore Throat Infections in 15 Minutes

The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs. bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801818/multiplex-pcr-test-detects-common-viral-and-bacterial-causes-of-respiratory-or-sore-throat-infections-in-15-minutes.html
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- July 17, 2024
Smartphone-Controlled Microfluidic Device Enables Rapid Influenza Detection

The influenza virus represents a significant public health concern, annually causing epidemics with high morbidity and mortality rates. The virus is known for its high mutation rate and the existence of multiple subtypes, which require varied clinical approaches. Consequently, there is a critical need for an accurate, rapid, and portable method to differentiate between influenza virus subtypes to manage virus transmission and inform clinical treatment decisions. Researchers have now developed a spatial encoding of a centrifugal microfluidic disc-integrated smartphone-controlled (SEDphone) platform for detecting influenza virus subtypes. In a study, researchers from the Hefei Institutes of Physical Science of the Chinese Academy of Sciences (Anhui, China) developed a novel approach that combines Loop-mediated Isothermal Amplification (LAMP) with CRISPR/Cas12a technologies for rapid and accurate detection of various influenza viruses. This method amplifies target sequences using LAMP and detects them through CRISPR/Cas12a-mediated trans-cleavage activity, thus cleaving reporter probes and emitting fluorescent signals. ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801817/smartphone-controlled-microfluidic-device-enables-rapid-influenza-detection.html
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- July 17, 2024

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