Search Results for “AI” – Page 10 – media

ARS Pharmaceuticals’ anaphylaxis nasal spray gains FDA approval

The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals‘ neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I). The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg. Previously, only injectable epinephrine was available for such patients. Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention. Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure. The approval of neffy is supported by data from four clinical studies involving 175 healthy adults. These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections. The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products. In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart ...
- Source: drugdu
- 79
- August 13, 2024
KCL and UCL scientists develop accurate AI brain imaging model for research

Researchers from King’s College London have developed a new artificial intelligence (AI) brain imaging model in collaboration with University College London (UCL) which is realistic and accurate enough to use in medical research. Published in Nature Medicine Intelligence, the three-dimensional, synthetic images of the human brain could help support research to predict, diagnose and treat brain diseases including dementia, stroke and multiple sclerosis. According to Brain Research UK, there are an estimated 11 million people in the UK who are living with a neurological condition. Among the most common are Alzheimer’s disease, epilepsy and stroke. In collaboration with the London Medical Imaging and AI Centre for Value-Based Healthcare and NVIDIA data scientists and engineers, researchers trained the AI model in weeks as opposed to months using the NVIDIA Cambridge-1 supercomputer. The model is able to produce 3D, high-resolution images that have all the characteristics of real human brains, including correct ...
- Source: drugdu
- 80
- August 13, 2024
First Patient Dosed of Phase 2 Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein in Combination with Serplulimab Plus HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
- Source: drugdu
- 119
- August 12, 2024
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank VinluanA Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize its ...
- Source: drugdu
- 89
- August 10, 2024
DCGI waives off local trials for drugs approved in well-regulated markets

The CDSCO, with approval from the Central government, has notified a list of countries under rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to conditions, consider the waiver of local clinical trials for several drugs if already approved in well-regulated markets. The countries on the list include the US, UK, Japan, Australia, Canada and the European Union. The categories of new drugs specified are: • Orphan drugs for rare diseases • Gene and cellular therapy products • New drugs used in pandemic situation • New drugs used for specific defence purpose • New drugs having significant therapeutic advance over the current standard care The move is expected to accelerate access to innovative therapies within the country. Lauding the decision, Anil Matai, Director General, OPPI, says that this move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating ...
- Source: drugdu
- 53
- August 10, 2024
3D Pathology with AI to Enhance Prognosis Accuracy for Barrett’s Esophagus Patients

Barrett’s esophagus is a condition where the lining of the esophagus changes due to chronic gastroesophageal reflux. Individuals with Barrett’s esophagus are at a slightly increased risk of developing esophageal cancer and require regular surveillance endoscopies. During these procedures, gastroenterologists collect numerous biopsies from the affected tissues. These samples are then cut into thin sections and placed on glass slides for examination under a microscope by pathologists. However, the tissue sections that pathologists view represent only about 1% or less of the actual biopsies and provide just a two-dimensional view, which can be misleading. Researchers are now conducting clinical studies of archived tissues from patients with the condition to develop computational 3D pathology methods for Barrett’s esophagus risk stratification. The research team at UW College of Engineering (Seattle, WA, USA) had previously invented 3D pathology methods to assess prostate cancer risk and shifted their focus on gastrointestinal applications of their ...
- Source: drugdu
- 64
- August 10, 2024
Kerendia Demonstrates Significant Efficacy Treating Heart Failure with Left Ventricular Ejection Fraction of 40% or More

By Don Tracy, Associate Editor The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events. Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1 “We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and ...
- Source: drugdu
- 62
- August 8, 2024
Big Servier Acquisition Pays Off as FDA Approves Drug for Two Types of Rare Brain Cancer

The FDA approved Servier Pharmaceuticals’ Voranigo as a treatment for two types of low-grade gliomas. The drug, which is projected to become a blockbuster product, comes from Servier’s $1.8 billion acquisition of Agios Pharmaceuticals’ oncology business. By Frank Vinluan A Servier Pharmaceuticals drug designed to penetrate the brain to hit its targets is now FDA approved for treating two rare types of brain cancer. The FDA approval announced Tuesday covers the treatment of adults and adolescents 12 and older who have Grade 2 astrocytoma or oligodendroglioma. The drug, vorasidenib, may be prescribed after surgery, as long as the cancers have mutations to the IDH1 or IDH2 enzymes the once-daily pill is designed to inhibit. The FDA said this regulatory decision marks the agency’s first for a systemic therapy for these cancers driven by either the IDH1 or IDH2 mutations. France-based Servier, which has its U.S. headquarters in Boston, will commercialize ...
- Source: drugdu
- 74
- August 8, 2024
Researchers reveal brain parasites could be used to treat cognitive disorders

Researchers from the University of Glasgow, in collaboration with Tel Aviv University, along with international researchers, have revealed that brain parasites could be used to deliver drugs to the brain to treat cognitive disorders. In the study published in Nature Microbiology, researchers explored whether the common brain parasite Toxoplasma gondii could be used to deliver treatment across the blood-brain barrier, a major complication for the treatment of many neurological conditions. According to a study published in the Lancet Neurology in March and funded by the Bill & Melinda Gates Foundation, neurological conditions are considered the leading cause of ill health worldwide, with stroke, neonatal encephalopathy, migraine, Alzheimer’s disease (AD) and other dementias, and diabetic neuropathy being the biggest global contributors. Researchers engineered Toxoplasma gondii parasites to deliver the MeCP2 protein, a therapeutic protein that has been dubbed a promising target for Rett syndrome, a debilitating neurological disorder caused by mutations in ...
- Source: drugdu
- 61
- August 8, 2024
New AI Protocol Instantaneously Detects Cancer Genomic Biomarkers Directly from Tumor Biopsy Slides

The late 90s marked the beginning of the era of precision oncology, yet recent studies in the U.S. indicate that most cancer patients are not receiving FDA-approved precision therapies. Factors such as high costs, extensive tissue requirements, and lengthy processing times have hampered the broader adoption of precision oncology, often leading to treatments that are not only suboptimal but potentially harmful. A significant barrier is the lack of testing; many cancer patients endure critical delays waiting for standard genomic tests following an initial tumor diagnosis, which can be life-threatening. Now, a groundbreaking advancement has been made with the development of a new generation of artificial intelligence (AI) tools that enable the rapid and cost-effective detection of clinically actionable genomic alterations directly from tumor biopsy slides. This innovation could cut weeks and save thousands of dollars in clinical oncology treatment workflows for diseases like breast and ovarian cancers. The new AI ...
- Source: drugdu
- 87
- August 7, 2024

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