PharmaFocus Today – Page 70 – media

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
- 80
- July 17, 2024
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia

By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 84
- July 17, 2024
Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
- Source: https://medcitynews.com/author/fvinluan/
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- July 17, 2024
Cohort Study Compares Weight Loss Effects of Tirzepatide vs. Semaglutide

By Don Tracy, Associate Editor JAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults. Tirzepatide and semaglutide are both GLP-1 agonists that have demonstrated the ability to offer significant weight reduction in patients with obesity, with or without type 2 diabetes (T2D). There are currently no real-world data comparing the effectiveness of the two in treating overweight or obese populations. In a cohort study recently published in JAMA Internal Medicine, researchers set out to provide a head-to-head comparison of these medications in a real-world clinical setting, focusing on weight loss outcomes and gastrointestinal adverse events (AEs). The study included 18,386 patients who were new users of tirzepatide or semaglutide with overweight or obesity, regardless of T2D status. Additionally, patients were selected based on their electronic health records data and propensity-score matched to ensure comparability. ...
- Source: drugdu
- 107
- July 16, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 96
- July 16, 2024
Metagenomic Next-Generation Sequencing Identifies Pathogens Causing CNS Infections

Metagenomic next-generation sequencing (mNGS) is a shotgun sequencing method where all the nucleic acid (DNA and RNA) in a clinical sample is sequenced at a very high depth, 10-20 million sequences per sample. This technique is applicable to various clinical samples, including cerebrospinal fluid, plasma, respiratory secretions, urine, stool, or tissue. A single mNGS test can detect sequences from all pathogens—viruses, bacteria, fungi, and parasites—thereby aiding in identifying the potential cause of a patient’s infection. Now, data from a new study underscores the effectiveness and diagnostic capabilities of mNGS in diagnosing infectious diseases such as meningitis, encephalitis, and myelitis in both adults and children. mNGS technology, originally developed at the University of California, San Francisco (UCSF, San Francisco, CA, USA) and exclusively licensed to Delve Bio (Boston, MA, USA), has been hailed as the future of infectious disease diagnostics, enabling physicians to avoid frustrating cycles of testing for patients battling ...
- Source: drugdu
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- July 16, 2024
New Blood Test Aims to Improve Management of Multiple Sclerosis

Multiple Sclerosis (MS) is an autoimmune, inflammatory, and neurodegenerative condition where axonal loss leads to irreversible neurological damage and disability. Currently, approximately 2.8 million people globally are affected by MS, though this figure is likely underestimated due to underdiagnosis in underserved and remote areas lacking adequate neurological care and imaging facilities. While no cure exists for MS, available treatments aim to reduce the frequency of relapses, which are linked to nerve cell damage and the progression of the disease. There is a critical need for an accessible, affordable, and accurate blood test that can detect early signs of neuronal injury and disease activity. The neurofilament light chain (NfL) protein has been identified as a key biomarker for nerve cell damage. Now, a new blood test that measures levels of NfL could facilitate earlier detection of MS-related neuronal injury and improve disease management. Siemens Healthineers (Forchheim, Germany), in collaboration with Novartis ...
- Source: drugdu
- 86
- July 16, 2024
Researchers awarded £1.5m for national dementia inequalities network

The ESRC EquaDem Network Plus aims to improve disparities in diagnosis and care Dementia researchers from the University of Liverpool have been awarded £1.5m to establish the first-ever national network for dementia inequalities in diagnosis and care. The new network is just one of four dementia networks that have benefited from £5.5m funding from the Alzheimer’s Society, the Economic and Social Research Council (ESRC) and the National Institute for Health and Care Research (NIHR). Affecting more than 944,000 people in the UK, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. For those living with the condition, as well as their unpaid carers, many inequalities can often be faced when accessing care and obtaining an assessment and diagnosis. The University of Liverpool’s Institute of Population Health’s senior research fellow, Dr Clarissa Giebel, will lead the network in collaboration with Dame Louise ...
- Source: drugdu
- 100
- July 16, 2024
New policy review reveals ten cancer challenges facing new UK government

Macmillan Cancer Support estimates that cancer affects over three million people in the UK A new policy review produced by cancer doctors and experts from across the UK, including King’s College London (KCL), has revealed the ten biggest cancer challenges facing the new UK government. Published in the Lancet Oncology, the review highlights the time-critical issues impacting the delivery of cancer care services by the NHS, which should be urgently addressed via a comprehensive national cancer control plan. It is estimated that there are more than three million people living in the UK with cancer, according to Macmillan Cancer Support, with breast cancer being the most prevalent, accounting for more than 55,000 people. The authors said that the NHS in the UK is behind other countries and, if not prioritised, could add additional strain to the healthcare system, widen social inequality and weaken economic recovery. The review highlighted several ongoing ...
- Source: drugdu
- 70
- July 16, 2024
MSD closes $1.3bn EyeBio acquisition, plans pivotal trial for lead asset

Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
- Source: drugdu
- 57
- July 16, 2024

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