Search Results for “EC” – Page 234 – media

Low-Cost CRISPR-Based Paper Strip Test to Improve Flu Diagnosis and Surveillance

Annually, less than 1% of people who contract the flu are tested, largely due to the need for skilled personnel and sophisticated equipment. Now, researchers have developed a low-cost paper strip test that could enable more individuals to determine the type of flu they have and receive appropriate treatment. This innovative test developed by researchers from the Broad Institute of MIT and Harvard (Cambridge, MA, USA) and Princeton University (Princeton, NJ, USA) employs CRISPR technology to differentiate between the primary seasonal flu types, influenza A and B, and the subtypes H1N1 and H3N2. It can also identify strains resistant to antiviral treatments and could potentially extend to detecting swine and avian flu strains, including H5N1, which currently affects cattle. This could enhance both outbreak response and clinical care by making accurate, affordable, and rapid testing accessible in doctors’ offices and laboratories across the world. The test is based on a ...
- Source: drugdu
- 121
- June 26, 2024
New Blood Test Enables Accurate Diagnosis of Dementia and Neurological Diseases

Frontotemporal dementia (FTD), amyotrophic lateral sclerosis (ALS), and progressive supranuclear palsy (PSP) represent a group of neurodegenerative diseases with symptoms that include dementia, behavioral changes, paralysis, muscle wasting, and movement impairments. These diseases are rare but have severe health impacts, and currently, there are no cures. Presently, conclusive diagnosis of the molecular pathology of these diseases during a patient’s lifetime is challenging because it typically requires examination of brain tissue. However, accurate diagnosis is essential for developing therapies and for patient stratification, which is necessary for testing targeted disease-modifying treatments. Now, researchers have demonstrated that the most common forms of FTD, as well as ALS and PSP, can be detected through blood tests, though these tests are not yet ready for routine clinical use. In the long term, they could significantly improve disease diagnosis and accelerate the development of new treatments. This research, led by the German Center for Neurodegenerative ...
- Source: drugdu
- 166
- June 26, 2024
FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Don Tracy, Associate Editor Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older. The FDA has approved Harmony Biosciences’ Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy. The FDA based the approval on results from a Phase III study conducted by Bioprojet, which evaluated the safety and efficacy of the treatment in patients over 6 years of age. Additionally, Wakix is the first non-scheduled treatment to be approved for EDS in pediatric patients.1 “Following the FDA’s decision to grant priority review, we are very pleased with the Agency’s timely review and approval of Wakix for pediatric narcolepsy patients with excessive daytime sleepiness,” said Jeffrey M. Dayno, MD, president, CEO, Harmony Biosciences, in a press release. “EDS is the primary symptom experienced ...
- Source: drugdu
- 98
- June 26, 2024
【EXPERT Q&A】Simaglutide API is exported to Thailand, which registration qualifications need to be met and the registration process for drug registration in Thailand (preparation manufacturers are local enterprises in Thailand)

Drugdu.com expert’s response: 1.Registration Qualification Requirements ①Pharmaceutical Business License: To export Semaglutide API to Thailand, it is first necessary to ensure that your enterprise possesses a Pharmaceutical Business License, which is the basic qualification for drug export. ②GMP Certification: GMP certification refers to the certification of a pharmaceutical production quality management system. For the export of Semaglutide API to Thailand, your enterprise must also obtain GMP certification to ensure the quality and safety of the product. ③Pharmaceutical Quality Management System Certification: In addition to the above two qualifications, pharmaceutical quality management system certification is also necessary. This will help guarantee the quality of product sales and service in the Thai market. ④Pharmaceutical Liability Insurance: To safeguard the rights and interests of consumers, your enterprise should also consider purchasing pharmaceutical liability insurance. 2.Thai Drug Registration Process (Assuming the Formulation Manufacturer is a Local Enterprise in Thailand) ①Submission of Registration Application: ...
- Source: drugdu
- 142
- June 26, 2024
Portable Device Analyzes White Blood Cell Activity to Monitor Cancer Patients’ Health

Chemotherapy and similar treatments aimed at eliminating cancer cells often adversely affect patients’ immune cells. Each year, this results in tens of thousands of cancer patients suffering from weakened immune systems, making them susceptible to potentially fatal infections. Physicians are tasked with balancing the dosage of chemotherapy—enough to kill cancer cells but not so much as to dangerously reduce the patient’s white blood cell count, leading to neutropenia. This condition not only impacts health but can also lead to social isolation between chemotherapy sessions. Traditionally, monitoring of white blood cells has been limited to blood tests. Now, a new at-home white blood cell monitor offers doctors the ability to remotely monitor their patients’ health more comprehensively. This device, which avoids blood draws, uses light to scan the skin at the top of the fingernail and employs artificial intelligence (AI) to identify critically low levels of white blood cells. Based on ...
- Source: drugdu
- 118
- June 25, 2024
AI-Powered Blood Test Predicts Parkinson’s Seven Years before Symptoms Appear

Parkinson’s disease is currently the fastest-growing neurodegenerative disorder worldwide, affecting nearly 10 million people globally. It is a progressive disease caused by the deterioration and death of nerve cells in a part of the brain known as the substantia nigra, which is essential for movement control. These nerve cells diminish or become damaged, losing their ability to produce a crucial chemical, dopamine, often due to the accumulation of a protein called alpha-synuclein. Presently, treatments for people with Parkinson’s, such as dopamine replacement therapy, are initiated after symptoms like tremors, slow movements, gait issues, and memory problems have already appeared. However, there is a consensus among researchers that early prediction and diagnosis could lead to discoveries of treatments capable of slowing or halting the progression of Parkinson’s by protecting dopamine-producing brain cells. Now, a simple blood test employing artificial intelligence (AI) can predict the onset of Parkinson’s up to seven years ...
- Source: drugdu
- 121
- June 25, 2024
Researchers reveal genetic makeup could identify treatment options for sepsis

Researchers from the Wellcome Sanger Institute, the University of Oxford and collaborators have revealed that genetic makeup could help determine the best treatment options for sepsis patients. Published in Cell Genomics, findings from the study could potentially lead to the development of targeted therapies to treat the condition. Responsible for 11 million deaths globally every year, sepsis is a serious condition in which the body responds improperly to an infection, causing the organs to work poorly. Depending on patients’ immune responses, which can be difficult to identify based on symptoms alone, treatment for sepsis can vary. Built on previous studies that identified different subgroups of patients with sepsis, researchers analysed data from the UK Genomic Advances in Sepsis study, involving 1,400 sepsis patients due to community-acquired pneumonia and faecal peritonitis, to investigate the impact of genetic variants that regulate expression quantitative trait locus (eQTLs), a type of gene expression. After ...
- Source: drugdu
- 84
- June 25, 2024
Researchers design genetic mole reversal therapy for rare skin condition

Researchers from the Francis Crick Institute, University College London (UCL) Great Ormond Street Institute for Child Health and Great Ormond Street Hospital for Children (GOSH) have created a new genetic therapy to alleviate debilitating moles in a rare skin condition. Published in the Journal of Investigate Dermatology, the treatment could help prevent affected children and adults from developing cancer. Covering up to 80% of children’s bodies at birth, congenital melanocytic naevus syndrome (CMN) is caused by progenitor-cell mutations during embryonic development that appear as large, painful or itchy moles, which can develop into severe melanoma. Funded by the National Institute for Health and Care Research (NIHR), the Caring Matters Now Charity, the Patient Support Group, LifeArc and the NIHR Great Ormond Street Hospital Biomedical Research Group Centre, researchers used a genetic therapy known as silencing RNA, which works to block the action of the mutation NRAS, which is mutated in ...
- Source: drugdu
- 78
- June 25, 2024
【EXPERT Q&A】What is the business process of exporting raw materials of Chinese companies to Indonesia to make medicines, health products and food raw materials?

Drugdu.com expert’s response: 1.Pre-preparation Stage ①Understanding Indonesian Market and Regulations: Firstly, Chinese companies need to understand Indonesia’s import regulations, regulatory requirements, and market demand for pharmaceuticals, healthcare products, and food ingredients, ensuring that exported products comply with Indonesian standards and regulations. ②Signing Trade Contracts: After clarifying market demand and regulatory requirements, Chinese companies should sign trade contracts with Indonesian importers or buyers, clarifying product specifications, quantity, price, delivery method, and other terms. 2.Export Declaration Stage ①Preparing Export Documents: Chinese companies need to prepare necessary export documents, including commercial invoices, packing lists, certificates of origin, export licenses (if required), etc. These documents must accurately reflect information such as product names, quantities, specifications, prices, etc. ②Export Declaration: Chinese companies submit export declaration forms and related documents to customs authorities for export declaration procedures. Customs authorities will review the information and documents to ensure they are complete and valid, and verify the ...
- Source: drugdu
- 139
- June 24, 2024
【EXPERT Q&A】How does the law regulate the production and sale of medical devices?

Drugdu.com expert’s response: In the production and sales of medical devices, countries have strict laws and regulations to regulate them. Taking China as an example, the Measures for the Supervision and Administration of Medical Device Production are formulated to strengthen the supervision and administration of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices. The measures clarify the laws, regulations, rules, mandatory standards and quality management specifications that should be observed in medical device production activities, and require medical device registrants and filers to be responsible for the safety and effectiveness of listed medical devices. At the same time, according to the different levels of medical device risks, China also implements classified management for medical device production, requiring enterprises engaged in different types of medical device production to obtain corresponding production licenses or make filings according to law. In addition, the country ...
- Source: drugdu
- 134
- June 21, 2024

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