Search Results for “EC” – Page 35 – media

KCL study reveals particles in cows’ milk effective for oral delivery of RNA drugs

In a new study, researchers from King’s College London (KCL) have revealed that tiny particles present in cows’ milk could offer a new and effective method for the oral delivery of ribonucleic acid (RNA) drugs. Published in the Journal of Nanobiotechnology, the tiny particles known as extracellular vesicles (EV) could help protect and deliver RNA drugs following oral administration. RNA therapies are a powerful class of drugs based on nucleic acids that offer a way to target previously untreatable diseases on a molecular level. Despite successful administration via injection, there has been no successful way to deliver them orally, as the drugs are destroyed by the harsh conditions of the gut. Researchers extracted EVs from cows’ milk and loaded them with RNA molecules to treat inflammatory bowel disease (IBD). EVs are nanoscale transporters that carry biological molecules in a protective coat throughout the body, controlling and regulating the access of ...
- Source: drugdu
- 102
- May 1, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 121
- April 30, 2024
Fosun Pharma’s Self-developed Artemisinin Medicines Inject New Impetus to Malaria Prevention and Treatment in Africa

SHANGHAI, April 26, 2024 /PRNewswire/ — World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China’s scientific research efforts have become a ticket for China’s innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in ...
- Source: drugdu
- 70
- April 30, 2024
New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier

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 ...
- Source: drugdu
- 110
- April 29, 2024
【EXPERT Q&A】What is the specific process of ce certification for medical devices?

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 ...
- Source: drugdu
- 124
- April 29, 2024
Judge approves settlement of more than $500M from Philips recall

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 ...
- Source: drugdu
- 83
- April 28, 2024
How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?

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 ...
- Source: drugdu
- 75
- April 28, 2024
FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females

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 ...
- Source: drugdu
- 98
- April 28, 2024
Chiatai Tianqing Enrolls Subjects in Phase III Clinical Study of D-1553 Tablets for the Treatment of KRAS G12C Mutation-Positive Non-Small Cell Lung Cancer

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 ...
- Source: drugdu
- 73
- April 28, 2024
GLP-1/GIP Dual-Target Receptor Agonist (THDBH120 for Injection) Clinical Trial Approval for Weight Loss Indication Declaration

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 ...
- Source: drugdu
- 93
- April 26, 2024

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