Search Results for “aging” – Page 22 – media

FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 87
- August 23, 2024
New Microfluidics Method to Speed Up Blood Analyses

Researchers have developed a new method to accelerate and potentially scale up the process of separating particles in fluids, a technique that could prove useful for analyzing cancer cells from blood. This speedier and more precise method of elasto-inertial microfluidics was developed by a team led by researchers at KTH Royal Institute of Technology (Stockholm, Sweden) and involves controlling the movement of tiny particles in fluids by leveraging both the fluid’s elastic properties and the inertial forces arising from fluid movement. The microfluidic device features specially engineered channels that accommodate larger volumes of fluid rapidly, making it ideal for applications requiring quick, continuous particle separation. These channels efficiently sort and line up particles, essential for distinguishing different particle types. This high precision is achieved through the use of specially formulated fluids with high polymer concentrations, giving the fluid viscoelastic properties similar to egg whites that can both flow and rebound. ...
- Source: drugdu
- 85
- August 23, 2024
Asia Pharma Expo

Organiser：Nexzen Solutions Pvt. Ltd. Time： February 12th – 14th, 2025 address：Plot# 66, Block#C, Umme Kulsum Road, Bashundhara R/A, Dhaka-1229, Dhaka Exhibition hall：International Convention City, Bashundhara Dhaka Product range: Pharmaceutical Processing Machinery (Tablets/Capsules/Liquids/Injections/Ointments/Dry Syrups) Packaging Machinery & Equipment, Packaging Materials, API Consumables, Pharmaceutical Additives, Excipients, Finished Pharmaceutical Products, Formulation Laboratory Reagents Glassware and Equipment Analysis, R&D Equipment, Biotechnology Instruments, Environmental Control Equipment Service Utilities Products, Turnkey Solutions Contractors, Project Consultancy About Asia Pharma Expo : Asia Pharma Expo Dhaka is the largest, most influential, and the only internationally recognized exhibition for pharmaceutical ingredients and equipment in Bangladesh. Endorsed by the Bangladesh Pharmaceutical Industry Association, it serves as a vital platform for pharmaceutical information exchange in Bangladesh and its neighboring regions.
- Source: drugdu
- 223
- August 23, 2024
Rapid Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results

The World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there’s a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections. The WAVE system from Accelerate Diagnostics (Tucson, AZ, US) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic imaging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, ...
- Source: drugdu
- 86
- August 22, 2024
First-Of-Its-Kind AI-Enabled Smart Microscopy Platform to Accelerate Traditional Pathology Workflows

Pathology and tissue analysis are areas poised for transformative advancements. Drug developers and clinicians currently depend on long-established methods for crucial tasks such as diagnosing diseases, quantifying biomarkers, and predicting therapeutic responses. While there have been attempts to innovate by digitizing specimens and adding multiple markers to a single slide, there are still limitations, including the analysis of less than 1% of tissue samples and the inability to depict complex tissue architectures and cellular interactions that are only visible in three dimensions. 3D imaging technology captures significantly more data than traditional slide-based methods by digitizing whole biopsy specimens rather than just thin slices.Artificial intelligence (AI) and machine learning algorithms play a crucial role in quantifying relevant biomarkers and identifying areas for more detailed pathologist examination. Now, a pioneering 3D spatial biology platform can digitize entire tissue specimens quickly and non-destructively while providing AI-enabled quantitative analysis. This technology enhances the precision ...
- Source: drugdu
- 96
- August 21, 2024
Sound Pharmaceuticals plans to stick with WuXi amid BIOSECURE Act rumblings

Sound Pharmaceuticals wishes to maintain its relationship with the WuXi AppTec for manufacturing its lead Meniere’s disease drug SPI-1005, amidst increasing scrutiny on Chinese companies in the US, says CEO Jonathan Kil. In an exclusive interview with Pharmaceutical Technology Kil stated the company is “actively supporting WuXi”. The Biden administration set its sights on several Chinese firms with the introduction of the BIOSECURE Act, including WuXi AppTec. The BIOSECURE Act will withhold federal funding and contracts to companies should the biotech equipment or services used be sourced from ‘companies of concern’. These include several Chinese firms including WuXi. Under the Act, existing corporate ties will be permitted until 2032. According to Reuters, information stating the company transferred US intellectual property to Beijing without consent was shared with US senators driving this bill. Last month, Sound Pharmaceuticals completed a Phase III trial for its drug SPI-1005. Interim results from the study ...
- Source: drugdu
- 104
- August 21, 2024
CPhI South East Asia

Organiser：Informa Markets Time：July 16th – 18th, 2025 Address： 8, Jalan Dutamas 2, Kompleks Kerajaan, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Exhibition hall：Malaysia International Trade and Exhibition Centre Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-infectives, Penicillins, Aminoglycosides, Lincomycin, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Western Medicine Raw Materials Packaging Equipment: Pharmaceutical Machinery, Packaging Machinery, Packaging Materials, Pharmaceutical Production Equipment and Technology, Pharmaceutical Packaging Equipment, Pharmaceutical Packaging Materials, Pharmaceutical Production, Cleaning, Disinfection Equipment, and Laboratory Instrumentation Systems Pharmaceutical Products: Various Traditional Chinese Medicines, Western Medicines, New Drugs, APIs, Chemical Pharmaceuticals, Pharmaceutical Intermediates, Biopharmaceuticals, Traditional Medicines, Chinese Medicines, Herbal Medicines, Plant and Animal Extracts, Veterinary Drugs, Food Ingredients, and Additives, etc. About CPhI South East Asia： CPhI South East Asia is the most authoritative ...
- Source: drugdu
- 238
- August 21, 2024
【EXPERT Q&A】What is the export procedure of proprietary Chinese medicine?

Drugdu.com expert’s response: To successfully export proprietary Chinese medicines, the following processes are required: I. Preliminary Preparations Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market. Product Preparation: a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority. b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market. Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks. II. Preparation of Application Materials Basic Information of Medicines: Detailed information on the TCMs ...
- Source: drugdu
- 90
- August 20, 2024
Novel Test Identifies Patients at High Risk of Esophageal Cancers

Barrett’s esophagus is a precancerous condition where chronic acid reflux damages the esophageal lining, increasing the risk of progressing to esophageal cancer or high-grade dysplasia. Currently, about 90% of patients with Barrett’s esophagus undergo endoscopic surveillance every three to five years. However, this frequency may not be sufficient to catch some cancerous changes early. It’s estimated that up to 25% of patients progress to high-grade dysplasia or esophageal cancer before their next scheduled endoscopy, missing crucial early treatment opportunities. Common treatments include radiofrequency ablation or endoscopic resection to eliminate abnormal cells before they turn cancerous. Now, a novel test could significantly aid gastroenterologists in identifying which patients with Barrett’s esophagus are more likely to develop esophageal cancer, thus optimizing surveillance and management strategies. This innovative test, named Esopredict, is a PCR-based test that evaluates DNA methylation changes in the genes RUNX3, p16, HPP1, and FBN1 from biopsy samples. DNA methylation ...
- Source: drugdu
- 75
- August 20, 2024
FDA Grants Accelerated Approval to Gilead’s Livdelzi for the Treatment of Primary Biliary Cholangitis

By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
- Source: drugdu
- 107
- August 19, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.