PharmaFocus Today – Page 222 – media

Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing

Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that. Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory ...
- Source: drugdu
- 163
- February 7, 2024
Cell Sorter Chip Technology to Pave Way for Immune Profiling at POC

Monitoring the response of the immune system of cancer patients during disease and treatment is important for achieving favorable outcomes. To do this, labs utilize flow cytometry to perform immune profiling, which involves identifying and quantifying a patient’s immune cells at a specific time. This information is vital for determining the most effective treatment for a cancer patient. Continuing this profiling during treatment helps clinicians understand how well the treatment is working. Despite the promise of immune profiling in guiding therapy being a burgeoning area in cancer research and treatment, it hasn’t been widely adopted in clinical practice due to the high cost, large size, and complexity of flow cytometry equipment. These machines are confined to specialized labs, and transporting blood samples to these facilities is time-consuming and requires special conditions to keep the cells viable, making routine monitoring of cancer patients challenging. Now, a novel cell sorter chip technology ...
- Source: drugdu
- 129
- February 7, 2024
Valneva sells Ixchiq priority voucher for $103m to fuel R&D

Valneva has sold its US Food and Drug Administration (FDA) priority review voucher for €95m ($103m) to an undisclosed party. The French company received the priority review voucher when its chikungunya vaccine, Ixchiq, got FDA approval in November 2023.Valneva plans to use the funds from the voucher sale to advance its research and development (R&D) efforts, as per a 5 February press release. The voucher sale price is in line with the company’s previous projections of gaining €90m-€110m with such a sale. One of the projects that the company plans to use its proceeds for is the Lyme disease vaccine, VLA15. Valneva is co-developing the vaccine in partnership with Pfizer. VLA15 is an experimental multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. The vaccine is being evaluated in a placebo-controlled Phase III trial (NCT05477524). The trial suffered a delay when both companies paused patient ...
- Source: drugdu
- 125
- February 7, 2024
Contentious Medicare price negotiations underway as US drug prices rise

The US’ HHS has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively. In the announcement accompanying the offers, CMS administrator Chiquita ...
- Source: drugdu
- 139
- February 7, 2024
Moderate kimchi intake linked to lower obesity rates, study shows

In a recent study published in the journal BMJ Open, researchers explored the relationship between kimchi consumption and obesity in South Korea. Obesity is associated with nutritional, environmental, and lifestyle factors and is a significant risk factor for diabetes, chronic kidney disease, cardiovascular disease, and hyperlipidemia. Obesity prevalence in South Korea has increased steadily over the years. Meanwhile, the prevalence of abdominal obesity has also increased over time. Increased obesity prevalence is associated with higher medical expenditure; thus, obesity prevention remains a public health priority. In Korea, kimchi is a traditional side dish low in calories but rich in vitamins, dietary fiber, polyphenols, and lactic acid bacteria. There are concerns about kimchi as one of the major contributors to sodium intake. A 2019-20 survey revealed that daily sodium intake from kimchi was 500 mg (15% of total sodium intake). Studies have shown associations between increased sodium intake and a greater ...
- Source: drugdu
- 116
- February 6, 2024
COVID-19 recovery disparities uncovered among racial and ethnic groups

In a recent study published in Frontiers in Public Health, researchers from the United States of America (US) investigated the racial and ethnic variation in symptoms, activity level, health status, and missed work. They assessed this via follow-ups post-initial infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although the symptoms were equally prevalent among the groups, they found that three and six months post-infection, Hispanic participants reported poorer health and reduced activity compared to non-Hispanic participants. Further, racial minority participants reported more negative impacts on health status, activity, and absence from work as compared to the White population. Background The coronavirus disease 2019 (COVID-19) pandemic highlighted disparities, wherein ethnic and racial minoritized populations were observed to face greater infection risks due to the essential nature of their work, limited remote work options, and challenges in practicing social distancing. The infected individuals faced barriers to care, including underinsurance and lack ...
- Source: drugdu
- 190
- February 6, 2024
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace

Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment. San Diego–based Neuralace says this marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for PDN. The company says its Axon Therapy could offer “new hope” to millions with the condition. Axon Therapy uses mPNS to deliver a quick, painless and non-invasive treatment in sessions lasting just 13.5 minutes, according to Neuralace. Each session utilizes magnetic pulses to provide relief for a potential improvement in pain management. Neuralace said a recent trial of 71 patients demonstrated efficiency, plus significant improvements in subject outcomes. The company believes its therapy represents a paradigm shift in PDN treatment. Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. The company says FDA clearance paves the way for broader access to innovative pain ...
- Source: drugdu
- 137
- February 6, 2024
FDA clears stereotactic guidance system from ClearPoint Neuro

ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with using a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction. ClearPoint Neuro’s ClearPointer works with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation. SmartFrame OR can be used with or without available bone screw fiducials. ClearPoint Neuro plans to begin a limited market release of the system in the first half of 2024. It earmarked the second ...
- Source: drugdu
- 123
- February 6, 2024
Hengrui ADC Innovative Drug SHR-A1811 HER2 Positive Gastric Cancer Indication Proposed to be Included in Breakthrough Therapy Variety

This study was led by Professor Jin Li of Dongfang Hospital, Tongji University, with the participation of a total of 17 centers across China. Previously, four other indications of SHR-A1811 have been included in the list of breakthrough therapeutic varieties by the Drug Evaluation Center of the State Drug Administration, and the indications are: recurrent or metastatic breast cancer with low expression of HER2, HER2-positive recurrent or metastatic breast cancer, HER2-mutated advanced non-small-cell lung cancer that has failed previous platinum-containing chemotherapy, and advanced non-small-cell lung cancer that has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan, and has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan. irinotecan treatment failure, and HER2-positive colorectal cancer. In 2020, gastric cancer ranks 5th in global cancer incidence and 4th in mortality. HER2-positive gastric cancer is a unique disease subtype that requires different treatment strategies from HER2-negative gastric cancer. The global HER2-positive rate of gastric ...
- Source: drugdu
- 140
- February 6, 2024
默沙东PD-1抑制剂可瑞达®联合化疗在华获批治疗局部晚期或转移性胆道癌新适应证

中国上海，2024年2月4日——默沙东宣布，其PD-1抑制剂帕博利珠单抗（商品名：可瑞达®）已获得中国国家药品监督管理局（NMPA）批准联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）患者的一线治疗。此次新适应证的获批是基于全球III期临床试验KEYNOTE-966的数据。默沙东全球高级副总裁兼中国总裁田安娜表示：“我们很高兴看到，在健康中国2030战略全面实施的带动下，创新药物审评审批进程持续提速，尤其在临床急需的新药方面可及性大幅提升，近年来，胆道恶性肿瘤发病率呈上升趋势，且晚期患者治疗选择有限。作为肿瘤治疗领域领导者，我们将致力于覆盖更多发病率及死亡率高、总体生存率低、治疗难度大的恶性肿瘤，并以更快速度为癌症患者带来更多创新治疗选择。” 胆道恶性肿瘤是一种起源于胆管上皮细胞的恶性肿瘤，具有早期诊断困难，根治性切除率低，复发率高等特点。胆道癌主要包括胆囊癌和肝内外胆管癌。其中，肝内胆管癌是仅次于肝细胞癌的第二大原发性肝癌，约占原发性肝癌的10%~15%。网址：https://mp.weixin.qq.com/s/FJ4prENGNtAl-LmO9s70dw
- Source: drugdu
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- February 6, 2024

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