Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
Dive Brief Philips has recalled several models of Sense XL Torso coils due to the risk of the devices heating up during MRI scans and burning patients. Philips updated the instructions for six models of Sense XL Torso coils used with 1.5T and 3.0T MRI scanners, according to a recall notice posted Monday by the Food and Drug Administration. The recall does not require products to be removed from facilities or where devices are sold. Twelve reported injuries have been associated with the recall, the FDA said. No deaths were reported. Dive Insight Philips’ latest recall is yet another safety problem for the company, which has spent more than three years managing a recall of over 15 million respiratory devices. The company has had recent issues with imaging machines. In November, Philips recalled certain MRI scanners because of the risk of machines exploding. The FDA said at the time that ...
The Pharmaceutical Research and Manufacturers of America (PhRMA) China Office announced that Mr. Leo Lee, President and Managing Director of Novartis China, has joined the PhRMA China Executive Liaison Group. Mr. Lee, a long-time veteran of the biopharmaceutical industry who has held senior management positions in a number of multinational corporations and has extensive experience in strategy development and implementation, business development and operational management, joins PhRMA’s China Executive Liaison Group and expresses its confidence that Mr. Lee will bring invaluable experience to the group, as well as its appreciation to the member companies for their continued support of PhRMA. Novartis is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA). About the PhRMA China Executive Liaison Group The China Executive Liaison Group (CELG) consists of the China General Managers of PhRMA member companies. As an important bridge between PhRMA China Office and member companies in China, the ...
In a significant advancement for endometriosis diagnosis, Serac Healthcare, in collaboration with the University of Oxford, has presented new data showcasing the effectiveness of 99mTc-maraciclatide in imaging the earliest stage of the disease. The DETECT study’s findings, presented by Dr. Tatjana Gibbons at the European Endometriosis Congress, reveal the agent’s potential as a non-invasive diagnostic tool. The study involved imaging the first ten patients with suspected endometriosis using a SPECT-CT camera, followed by laparoscopic surgery to confirm the presence and location of endometriotic lesions. The imaging results aligned with surgical and histological reports, suggesting that 99mTc-maraciclatide could accurately identify superficial peritoneal endometriosis, which accounts for approximately 80% of all diagnoses and is typically only detectable through surgery. David Hail, CEO of Serac Healthcare, expressed optimism about the findings: “The promising initial findings have been further confirmed by more patients in this study indicating the very exciting possibility that maraciclatide has ...
invoX Pharma Limited has presented updated findings from its phase 1 study of FS222, showcasing significant anti-tumour activity in patients with advanced solid tumours. The data, revealed at the 2024 American Society of Clinical Oncology Annual Meeting, highlights FS222’s potential as a ground-breaking treatment option. FS222, a CD137/PD-L1 bispecific antibody, is part of invoX’s innovative product pipeline. The phase 1 trial involved 100 subjects and aimed to establish the drug’s safety and maximum tolerated dose. The study also assessed FS222’s anti-tumour activity, pharmacokinetics, and pharmacodynamics. The treatment, administered every four weeks, led to increased T cell proliferation and CD8+ T cell infiltration within tumours. While treatment-related adverse events were dose-dependent, they remained manageable and reversible. Dr Elena Garralda, Director of Early Drug Development at Vall d’Hebron University Hospital, commented on the drug’s potential: “While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response ...
Mike Hollan Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges. Alvana Maliqi, Associate director of value and access strategy Alvana Maliqi served as lead author on Cencora’s latest research initiatives focused on pre-approval information exchange (PIE). She spoke with Pharmaceutical Executive about the research and how the industry can utilize this information more efficiently. Pharma Executive: What does the passage of the PIE legislation allow biopharma companies to do? Alvana Maliqi: The Consolidated Appropriations Act, 20231 (or pre-approval information exchange [PIE] legislation”) was signed into law in 2022, providing a safe harbor for pharmaceutical companies to proactively engage in PIE with payers about new products and/or new indications. Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...
The process of biopsy is important for confirming the presence of cancer. In the conventional histopathology technique, tissue is excised, sliced, stained, mounted on slides, and examined under a microscope to identify cancerous markers. This lengthy procedure often results in patients waiting weeks or months for their results, causing treatment delays and heightened anxiety. Now, a breakthrough digital medical imaging system promises to transform cancer detection by offering instantaneous results, facilitating timely and effective treatment across all cancer types. The Photon Absorption Remote Sensing (PARS) system, an innovative, built-from-scratch technology developed by researchers at the University of Waterloo (Ontario, Canada), marks a radical departure from traditional cancer detection methods, promising diagnoses within minutes and enabling rapid surgical intervention. The system utilizes lasers to irradiate tissue samples, producing a comprehensive, high-resolution data set. This data is then processed by an artificial intelligence (AI) system that converts it into a conventional histopathology ...
Alzheimer’s disease (AD) is a neurodegenerative condition that causes the brain to deteriorate over time, marked by the buildup of certain harmful proteins that eventually lead to a decline in brain function and cell death. These changes can happen long before any symptoms show up. Scientists have found certain proteins in the cerebrospinal fluid that are good indicators of AD. One of the most promising markers for early and more precise detection of AD in the blood is phosphorylated tau at position 217 (pTau217). It’s seen as a game-changer for diagnosing AD sooner, categorizing patients for research studies, and improving how patients are cared for and treated. Now, an innovative and novel blood test can be used in the screening, diagnosis, and monitoring of AD based on the circulating level of this promising biomarker pTau217. ALZpath Dx (Carlsbad, CA, USA) has developed a robust and scalable plasma-based ultra-sensitive assay, branded ...
Our teenaged son never misses an opportunity to tease me when I do something he deems old-fashioned. “Hey Mom and Dad,” he’ll ask, “what was it like back in the 1900’s?” While our son’s question is rhetorical, it did get us thinking about how much has changed in our field of study: medicine. At the start of the 1900s, the practice of medicine was based on a “symptom model” where care was sought when patients felt poorly and would see a doctor who would try to make them feel better. Addressing symptoms is important, but in the 21st century, many major medical problems do not present symptoms before they cause trouble. No one has ever said, “I feel I may have a stroke soon,” or “I think I may break a hip.” So, what about age itself? Is aging symptomatic? Is aging a disease? Can aging be fixed? In cardiology, ...
At RSNA 2023, AI startup Hoppr announced that it teamed up with AWS to launch a new foundation model. The product, named Grace, is a B2B model designed to help application developers build better AI solutions for the medical imaging field — and to build them more quickly. By KATIE ADAMS AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago. The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio. Chicago-based Hoppr, which was founded in 2019, ...
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