Search Results for “EC” – Page 33 – media

Cipla and Glenmark initiate recall of certain products in the US

Cipla and Glenmark Pharmaceuticals are recalling specific products from the US market due to distinct manufacturing issues, the latest Enforcement Report issued by the US Food and Drug Administration (USFDA) noted. The recalls involve inhalation solutions and extended-release capsules used for treating respiratory conditions and high blood pressure, respectively. New Jersey-based subsidiary of Cipla, Cipla USA is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. This product is manufactured at Indore SEZ plant of the company in India. It is prescribed for controlling the symptoms of lung diseases such as chronic bronchitis, asthma, and emphysema. The recall of the affected inhalation solution lot is claimed to be due to complaints of “short fill”. The US regulator detailed that the affected lot was recalled after reports of less fill volume in respules and the presence of a few drops of liquid in the intact pouch. Simultaneously, Glenmark Pharmaceuticals, ...
- Source: drugdu
- 124
- May 8, 2024
Henlius Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA

Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6%. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease ...
- Source: drugdu
- 70
- May 8, 2024
Study finds mechanical changes in tumour tissue offer new insights for cancer research

Bladder cancer, including papillary tumours, is the ninth most common cancer type worldwide Researchers from ETH Zurich and University Hospital Basel have revealed new insights for cancer research when focusing on mechanical changes in tumour tissue after investigating the early stages of bladder cancer. Researchers aimed to understand what governs the direction in which bladder tumours grow and whether it plays a role in malignant and benign formations. Currently the ninth most common cancer type worldwide, bladder cancer occurs when cells in the bladder start to grow without control. Papillary tumours, long, slender benign or malignant tumours that grow from tissue that lines the inside of the organ, are usually easy to treat, while muscle-invasive bladder cancer, which spreads into the thick muscle of the bladder wall, requires surgical removal of the bladder. Similar to bronchioles in the lungs, researchers wondered whether molecular mechanisms could be responsible for creating the ...
- Source: drugdu
- 103
- May 6, 2024
BigHat Biosciences partners with Janssen Biotech

Strategic collaboration to leverage BigHat’s AI/ML (Artificial Intelligence / Machine Learning) guided Milliner platform to design high-quality next-generation protein therapeutics BigHat Biosciences, a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform announced a collaboration with Janssen Biotech Inc., a Johnson & Johnson company. This strategic collaboration combines the drug discovery, clinical development and data science expertise from Johnson & Johnson with BigHat’s Milliner platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high-quality antibodies for multiple Neuroscience therapeutic targets. The agreement was facilitated by Johnson & Johnson Innovation. BigHat’s antibody design platform, Milliner, integrates a synthetic biology-based high-speed wet lab with machine learning technologies into a full-stack antibody discovery and engineering platform, to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins ...
- Source: drugdu
- 105
- May 5, 2024
Exploring molecular landscapes of cancer in Hispanic/Latin American patients

A new editorial paper was published in Oncoscience (Volume 11) on April 22, 2024, entitled, “Exploring oncogenic driver molecular alterations in Hispanic/Latin American cancer patients: A call for enhanced molecular understanding.” In this new editorial, researcher Rafael Parra-Medina from Fundación Universitaria de Ciencias de la Salud and Instituto Nacional de Cancerología begins by discussing Latin America’s (LA) population -; a heterogeneous mix of Amerindian, African, and Caucasian ancestries with different proportions in different regions. Countries such as Argentina, Brazil, Colombia, Costa Rica, Uruguay, and Venezuela have a higher proportion of Caucasian while regions in Mexico, Perú, and Bolivia have a higher proportion of Amerindian ancestries. Although the overall incidence of cancer in Latin American countries is generally lower compared to high-income nations, the mortality rate is notably higher. “This disparity can be attributed to several factors, including smoking habits, diet quality, levels of physical activity, access to healthcare services, and ...
- Source: drugdu
- 99
- May 5, 2024
PharmaLink partners with Recall Results on safety of drugs

PharmaLink has partnered with Recall Results on an accurate and responsive process for drug recalls, withdrawals and market actions in the pharmaceutical industry. The collaboration combines PharmaLink’s pharmaceutical returns processing expertise with Recall Results’ knowledge and advanced technologies for managing complex recalls.It will focus on the development of integrated systems to streamline the process of recalls, supporting recalls of any class to the patient level. It aims to cut down the time to identify and respond to potentially harmful pharma products in the market.With a focus on patient safety and compliance, the two companies are set to establish new standards in recall management. PharmaLink CEO Thierry Beckers stated: “Through this partnership, PharmaLink offers comprehensive services for the notification, product retrieval, processing, storage and disposal of recalled products from the healthcare supply chain.“We could not be more excited about the launch of this strategic partnership and the solutions it brings to ...
- Source: drugdu
- 121
- May 5, 2024
Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing

Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages, which impact their ability to deliver timely test results and maintain satisfactory patient care. Now, an innovative robotic blood drawing device for the medical laboratory market could help ease staff workload and provide a more consistent patient experience. Developed by Vitestro (Utrecht, The Netherlands), this innovative blood-drawing device is designed to perform safe and accurate blood draws. It utilizes artificial intelligence (AI) for ultrasound-guided 3D reconstruction and ensures submillimeter precision in needle insertion. This high level of accuracy and consistency in blood collection is achieved through a combination of AI, advanced imaging technologies, and robotics. By automating blood draws, Vitestro’s device not only reduces the physical demand on staff but also enhances the satisfaction of both patients and healthcare providers. The ...
- Source: https://www.labmedica.com/pathology/articles/294801059/robotic-blood-drawing-device-to-revolutionize-sample-collection-for-diagnostic-testing.html
- 147
- May 4, 2024
Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
- Source: https://medcitynews.com/author/fvinluan/
- 88
- May 4, 2024
Cardinal receives FDA warning letter over unapproved syringes

Dive Brief Cardinal Health marketed convenience kits that include piston syringes not authorized by the Food and Drug Administration, the agency said in an April 24 warning letter. The agency found the violations during an inspection of Cardinal’s facility in Waukegan, Illinois. Cardinal distributed syringes made by Jiangsu Shenli Medical Production with “substantially different technological characteristics” than those cleared by the FDA, according to the letter. Cardinal has come under scrutiny after the company recalled some of its disposable syringes last year because their dimensions had changed, making them incompatible with certain infusion pumps. The FDA has also taken steps to block plastic syringes made by Jiangsu Shenli from being imported. Dive Insight The warning letter focuses on Cardinal’s Monoject luer-lock tip syringes, which are intended to inject fluids into the body or withdraw fluids, and Monoject enteral feeding syringes, which deliver fluid, food or medications to ...
- Source: https://www.medtechdive.com/news/cardinal-warning-letter-unapproved-syringes/714934/
- 91
- May 4, 2024
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases

GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name underscores Roche’s dedication to ongoing enhancement across its entire product line, encompassing everything from raw materials and manufacturing to quality control. The cobas eplex system has been redesigned with new features that enhance usability, reliability, and serviceability. Notable improvements include onboard quality control tracking and monitoring, eSignature capabilities, onboard epidemiology reports, email alerts, and customizable comments to support clinical decisions. Additionally, GenMark has refined its cartridge manufacturing processes, ensuring an adequate supply and enhanced validity. The system offers tests for infectious diseases, focusing on panels for respiratory and bloodstream infections, which can progress to sepsis, and the company is developing panels for gastrointestinal infections, meningitis, and encephalitis. The cobas eplex system integrates the entire order-to-report process to maximize the ...
- Source: https://www.labmedica.com/microbiology/articles/294801045/enhanced-rapid-syndromic-molecular-diagnostic-solution-detects-broad-range-of-infectious-diseases.html
- 91
- May 4, 2024

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