PharmaFocus Today – Page 120 – media

Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status

Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. By Frank Vinluan High placebo responses common in tests of neuropsychiatric drugs makes any clinical trial in major depressive disorder risky. Intra-Cellular Therapies now has data showing its drug met key goals of a pivotal clinical trial, beating a placebo in this indication. The results build the case for expanding the product’s label, which could push its sales into blockbuster territory. According to the preliminary results reported Tuesday, the drug, lumateperone, led to statistically significant and clinically meaningful reductions in scores measured on a widely used rating scale for assessing depression episodes, which was the main clnical trial goal. The drug also met a key secondary ...
- Source: drugdu
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- April 18, 2024
Deep Learning Powered AI Algorithms Improve Skin Cancer Diagnostic Accuracy

Artificial intelligence (AI) algorithms are increasingly being utilized in various clinical settings, such as dermatology. These algorithms are developed by training a computer with hundreds of thousands or millions of images of various skin conditions, each labeled with details like the diagnosis and patient outcomes. Through a process known as deep learning, the computer learns to identify patterns in the images that are indicative of specific skin diseases, including cancers. Once sufficiently trained, the algorithm can suggest potential diagnoses based on new images of a patient’s skin. However, these algorithms do not operate in isolation; they are used under the supervision of clinicians who evaluate the patient, make their own diagnostic assessments, and decide whether to follow the algorithm’s recommendations. Now, a new study led by researchers at Stanford Medicine (Stanford, CA, USA) has found that AI algorithms, which utilize deep learning, can enhance the accuracy of diagnosing skin cancers. ...
- Source: drugdu
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- April 18, 2024
Blood-Based Test Detects and Monitors Aggressive Small Cell Lung Cancer

Small cell lung cancer (SCLC) is a highly aggressive type of cancer known for its ability to metastasize. The behavior of tumors is largely governed by which genes are turned on, or transcribed, irrespective of whether mutations are present. Researchers have identified various signature patterns of gene activation in SCLC, and these subtypes dictate how the cancer responds to treatments and its specific vulnerabilities. There is a significant need for blood-based tests that can determine SCLC subtypes, track disease progression, recognize transformations into other types of lung cancer, and identify potential treatment targets, especially when standard biopsies are not feasible. Scientists have now made progress towards a liquid biopsy capable of distinguishing between multiple SCLC subtypes from blood samples. New research at Fred Hutch Cancer Center (Seattle, WA, USA) has revealed that big-picture patterns of DNA packaging, gene activation, and mutations may provide the information required to develop a blood-based ...
- Source: drugdu
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- April 18, 2024
Bio-Rad and Oncocyte partner to develop and commercialise transplant monitoring products

Bio-Rad Laboratories and Oncocyte Corporation have partnered to develop and commercialise solid tissue transplant monitoring products for researchers and laboratories to “advance science and save lives”. The collaboration will utilise Bio-Rad’s Droplet Digital Polymerase Chain Reaction (ddPCR) technology. Solid organ transplantation is a medical procedure to treat end-stage organ failure of the kidneys, liver, pancreas, heart and lung. Currently the most commonly transplanted organ worldwide, kidney transplantation was performed more than 42,800 times in 2022, according to the United Network for Organ Sharing. Under the terms of the agreement, Bio-Rad has agreed to participate in a private placement of Oncocyte’s equity and has secured exclusive commercial rights in certain markets to commercialise the precision diagnostics company’s assay for transplant monitoring research using the QX600 ddPCR system. When organs are transplanted, cell-free DNA, otherwise known as donor-derived cell-free DNA (dd-cfDNA), a sensitive biomarker for organ health that requires a simple blood ...
- Source: drugdu
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- April 18, 2024
UCL study reveals carbon beads could help reduce progression of liver disease

Liver cirrhosis, caused by long-term liver damage, is estimated to affect around 100 million people worldwide Researchers from University College London (UCL) have invented and tested innovative carbon beads that could help restore a healthy gut microbiome as well as reduce the progression of liver disease. The study, published in Gut and funded via the EU’s Horizon 2020 research and innovation programme, demonstrated that the CARBALIVE beads had a positive impact on gut health, liver, kidney and brain function in animal models. Estimated to affect around 100 million people worldwide, liver cirrhosis is caused by long-term liver damage, including alcohol, liver infections such as hepatitis B or C and obesity. In collaboration with Yaqrit, a UCL spinout, UCL researchers developed small oral carbon beads with a microscopic physical structure to absorb both large and small molecules in the gut. The “carbon beads… are swallowed and passed through the body unaltered” ...
- Source: drugdu
- 114
- April 18, 2024
Jardiance and Ofev propel Boehringer’s human pharma sales

Boehringer Ingelheim reported robust sales in 2023, with a 10.3% increase in human pharma sales that was strongly driven by Jardiance (empagliflozin) and Ofev (nintedanib). The German company announced that it had reached €20.8bn ($22.1bn) in human pharma sales in 2023, also achieving a 14.2% boost in research and development (R&D) investments that reached €5.8bn. Boehringer’s R&D investments accounted for 22.5% of net sales, as per a 16 April press release. In the press release, Michael Schmelmer, a member of Boehringer’s board of managing directors with responsibility for finance and group functions, said, “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients’ lives.” Last year, Jardiance propelled the company’s growth with a 31% sales jump, ...
- Source: drugdu
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- April 18, 2024
Kind Pharmaceuticals Announces Settlement

HANGZHOU, China, April 17, 2024 /PRNewswire/ — Today, Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC (“Kind Pharmaceuticals”), together with its Chief Executive Officer Dr. Dong Liu and Chief Scientific Officer Dr. Shaojiang Deng, announced a resolution of their recent dispute with FibroGen, Inc. regarding Kind Pharmaceuticals’ hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI) technology. The parties have agreed to withdraw all pending legal proceedings between them regarding this HIF-PHI technology, without payment by either party. HIF-PHIs are a class of compounds that can be used to treat anemia. Kind Pharmaceuticals’ HIF-PHI drug candidate, AND017, is currently being studied in a clinical trial for the treatment of anemia in chronic kidney disease (CKD) patients. As a result of the settlement, Kind Pharmaceuticals remains free to develop AND017 and other HIF-PHIs in its pipeline. Dr. Liu, Chief Executive Officer of Kind, commented: “Kind is pleased that these disputes have been fully ...
- Source: drugdu
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- April 18, 2024
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
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- April 17, 2024
Unique Metabolic Signature Could Enable Sepsis Diagnosis within One Hour of Blood Collection

Sepsis is a life-threatening condition triggered by an extreme response of the body to an infection. It requires immediate medical intervention to prevent potential death or lasting damage. Delay in diagnosing patients with sepsis or septic shock is linked with heightened mortality and morbidity, emphasizing the critical need for prompt diagnosis to improve survival rates. Now, new research findings promise faster diagnosis and better outcomes for sepsis and septic shock patients. In the study led by Murdoch University (Perth, Australia), researchers successfully used blood plasma metabolic phenotyping to accurately diagnose sepsis or septic shock within an hour of collecting blood samples. This method marks a significant improvement over traditional pathogen culturing techniques, which may take days to yield results. According to the researchers, metabolic signatures were the key to the breakthrough. The study involved the analysis of blood plasma samples collected from 152 patients admitted to the Intensive Care Unit ...
- Source: drugdu
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- April 17, 2024
DeepScribe Brings Ambient AI to AWS Marketplace

Mike Hollan Users will be able to access DeepScribe’s documentation platform through AWS. DeepScribe announced that its ambient AI clinical documentation software is available as a purchasing option on Amazon’s AWS Marketplace.1 This includes the entirety of Deepscribe’s platform, including Customization Studio, Clinical Moments, and Real-Time. Healthcare organizations will have the ability to deploy ambient AI that integrates directly with their HER. In a press release, DeepScribe co-founder and COO said, “Our inclusion in the AWS Marketplace is made possible by our work with AWS as well as the integrity of our enterprise-ready AI clinical documentation solution. The increased accessibility will enable enterprise healthcare organizations to consolidate their cloud spend and more easily deploy DeepScribe to address the critical issue of clinician burnout as it automates clinical documentation, improves efficiency, and allows greater focus on delivering patient care.” In the same press release, Deepscribe’s co-founder and CEO Akilesh Bapu said, ...
- Source: drugdu
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- April 17, 2024

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