According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
Drugdu.com expert’s response: The specific process of CE certification for medical devices typically includes the following steps: 1.Preparation of Application: Manufacturers first need to prepare comprehensive application materials, including technical documentation, product specifications, quality management system documents, etc. 2.Selection of Certification Body: Choose an appropriate certification body for CE certification, ensuring that it is accredited and recognized. 3.Evaluation and Testing: The certification body will conduct evaluation and testing of the product to ensure compliance with the relevant European Union Medical Device Directives. 4.Compilation of Technical Documentation: Manufacturers need to compile complete technical documentation, including product descriptions, design files, test reports, etc. 5.Conducting Audit: The certification body will audit the manufacturer’s technical documentation to ensure its completeness and compliance with requirements. 6.Issuance of Certificate: If the product passes the audit and meets the requirements, the certification body will issue a CE certification certificate, confirming that the product complies with relevant standards ...
Dive Brief District Judge Joy Flowers Conti approved a settlement on Thursday that will provide more than $500 million to people who purchased, leased or rented recalled Philips devices. Philips must put at least $467.5 million into a settlement fund for users who bought a recalled device and for devices returned to the company. The company must also set aside $34 million into a payer settlement fund. Flowers is a judge for the U.S. District Court for the Western District of Pennsylvania. The agreement does not include personal injury and medical monitoring claims, which the plaintiffs’ attorneys are pursuing separately. Dive Insight The settlement is related to Philips’ ongoing recall of sleep apnea devices and ventilators. Philips started recalling the devices in June 2021 because foam used to soundproof the machines could break down and be inhaled by patients, posing potential health risks. The majority of the funds will go ...
Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry. By Katie Adams on April 25, 2024 Walgreens announced this week that it is expanding its specialty pharmacy offerings to include cell and gene therapy services. The move could allow Walgreens to play a bigger role in a growing market — research shows that specialty medications now account for more than half of the country’s prescription drug spend, despite making up a small percentage of total prescriptions. With the announcement, the pharmacy giant introduced a newly integrated business unit called Walgreens Specialty Pharmacy. The unit encompasses most of Walgreens’ assets in the specialty pharmacy space, including specialty pharmacy subsidiary ...
Don Tracy, Associate Editor Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA announced that it has approved Pivya (pivmecillinam), for the treatment of uncomplicated urinary tract infections (UTIs) in adult females. According to the agency, the approval supports a communal health issue, with close to half of all women experiencing at least one UTI in their lifetime. Before reaching approval, Pivya, which is now available, was given Priority Review and Qualified Infectious Disease Product designations. As part of its support against UTIs, Pivya was designed to fight specific bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The FDA based their approval on positive results from three different clinical trials comparing various Pivya dosing regimens to placebo, a different oral antibacterial drug, and ibuprofen. In all three trials, Pivya demonstrated a higher level of effectiveness in treating UTIs ...
Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a randomized, controlled, double-blind, dual-simulation, multi-center, Phase III clinical study to evaluate D1553 versus docetaxel in the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed prior standard therapy (D1553-III-01). “. Now recruiting nationwide. Trial Drug Profile D-1553 tablets are a novel targeted KRAS G12C mutation inhibitor, registered and classified as a chemical drug class 1. On December 29, 2023, China’s National Drug Administration (NMPA) has accepted the New Drug Marketing Application for D-1553 Tablets for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of KRAS G12C mutation confirmed by testing. In August 2023, Chiatai Tianqing entered into a license and collaboration agreement with Yifang Bio to obtain the exclusive license rights for the ...
Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
Shanghai, China, April 23, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). Currently, no product targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial ...
Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually A trial led by researchers at Queen Mary University London, in partnership with two research institutes in Zambia and Zimbabwe, has identified the mechanisms that contribute to the long-term impacts of severe acute malnutrition (SAM) and HIV infection in children. Funded through the Medical Research Council’s (MRC) Global Challenges Research Fund, the study published in Nature Communications aims to identify a treatment to promote the healing of intestinal damage caused by SAM. Affecting around 17 million children every year, predominantly in Africa, SAM and malnutrition are responsible for almost half of all child deaths globally and cause damage to the enteropathy, the small intestine, by reducing its ability to absorb nutrients. The new phase 2 trial, involving 125 children who had been hospitalised due to complications from arising SAM, evaluated four ...
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