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Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree. According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace. “When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA plays an important role in protecting consumers, ...
- Source: drugdu
- 111
- December 16, 2023
St. Jude decks out more celebs in t-shirts for seasonal donation drive

St. Jude Children’s Research Hospital has brought together another busload of celebrities, artists and influencers for its annual #ThisShirtSavesLives campaign, decking them out in a new-look t-shirt in a push to persuade people to make monthly donations to its cause. The campaign, which began in 2017, has a simple premise. Famous people wear a t-shirt displaying the text “this shirt saves lives.” The only way to get an official version of the t-shirt is to donate $19 a month, or $228 once, to St. Jude. That proposition seems to have found plenty of takers, with the hospital reporting that it has distributed nearly 1 million shirts so far. St. Jude has redesigned the t-shirt for the latest campaign, replacing the large text used in years gone by with five repeating lines of smaller text. The shirt represents the first redesign in the history of the campaign, with previous years using ...
- Source: drugdu
- 109
- December 16, 2023
US WorldMeds’ Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. This week, the U.S. FDA approved US WorldMeds’ (USWM) Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior multiagent, multimodality treatment, USWM said in a press release. Between 700 and 800 cases of neuroblastoma are diagnosed in the U.S. each year, according to the American Cancer Society. Ninety percent of diagnoses occur before a patient is 5 years old and more than 50% of neuroblastoma cases are classified as high-risk. Approximately half of children with high-risk neuroblastoma don’t live more than five years past their diagnosis, USWM added. Avoiding relapse is ...
- Source: drugdu
- 97
- December 16, 2023
Study Highlights Need for Pharma Industry to Address Stigmatization of Acne

Don Tracy, Associate Editor JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas. Currently, little is known about the magnitude of stigmatizing attitudes toward individuals with acne. In a recent study published by the JAMA Network, researchers aimed to explore the degree of stigma toward individuals with acne and whether these attitudes vary based on characteristics of the individuals with acne or of the survey participants. In order to find an efficient answer, the authors employed a cross-sectional internet survey using digitally enhanced portraits to assess stigmatizing attitudes, recruiting a total of 1357 respondents in the US, with a focus on acne-related attitudes. To perform the survey, the authors provided four stock portraits of adults who varied in sex and skin tone and who were digitally enhanced to have acne, with one of 12 ...
- Source: drugdu
- 106
- December 16, 2023
Atropos Health, Seqster Team Up to Reduce Disparities in Clinical Trials

Atropos Health and Seqster joined forces to address historical diversity and inclusion challenges in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. By KATIE ADAMS Two healthcare data companies joined forces on Thursday to address historical diversity and inclusion challenges in clinical trials. Atropos Health, a Palo Alto-based company that delivers clinical data to physicians at the point of care, formed a strategic partnership with Seqster, a San Diego-based company that aggregates patient data from various sources. Together, they plan to remove barriers that perpetuate the lack of diversity in clinical trials. The partnership seeks to enable the swift creation of turnkey patient registries that generate real world evidence from existing registries in under 48 hours. These registries encompass real time updates to medical records, patient reported outcomes and tools for querying ...
- Source: drugdu
- 97
- December 16, 2023
Next-Gen Esophageal DNA Test Offers Enhanced Assay Performance and Lower Costs

Chronic heartburn may indicate Barrett’s Esophagus (BE), a precancerous condition where the esophagus lining is damaged due to digestive fluids. Although BE itself doesn’t manifest symptoms, it significantly increases the risk of developing esophageal adenocarcinoma (EAC), a dangerous cancer. Many individuals with BE are unaware of their condition and consequently, their elevated cancer risk. Timely identification of BE and precancerous cells is crucial for effective monitoring and intervention, preventing the progression to fatal esophageal cancer. Now, an advanced test for detecting esophageal precancer has demonstrated improved assay efficiency and cost-effectiveness in comprehensive validation studies. Lucid Diagnostics (New York, NY, USA) has launched EsoGuard 2.0, its next-generation EsoGuard Esophageal DNA test. The EsoGuard test begins with extracting DNA from esophageal cells gathered using the EsoCheck Cell Collection Device. This DNA undergoes bisulfite conversion, tagging unmethylated sites. It then focuses on two genes, VIM and CCNA1, identifying 31 methylation sites linked to ...
- Source: drugdu
- 93
- December 16, 2023
Blood Tests Used to Hunt for Cancer DNA May Help Detect Cancers Faster

For a long time, visible signs of tumor growth on scans were the benchmark for initiating cancer treatment. However, the emergence of precision oncology tools, including circulating tumor DNA sequencing, is changing this approach. These advancements allow for earlier cancer detection and adaptation of treatment strategies to combat mutations that cause resistance to current therapies. They also offer the potential for less toxic alternatives to chemotherapy. New research led by a clinical scientist at UC Davis Health (Sacramento, CA, USA) highlights the benefits of using blood tests to search for cancer DNA. This method can speed up cancer detection and inform the use of targeted treatments. Cancer DNA circulating in a patient’s blood can be identified from a simple blood draw. This DNA is then sequenced to determine its genetic structure, helping to classify the cancer based on the findings in the blood sample. Unlike traditional tissue biopsies, which are ...
- Source: drugdu
- 95
- December 16, 2023
Nuzyra ® has been on the market for two years and both dosage forms have been included in medical insurance

On December 13, 2023, the National Health Insurance Bureau and the Ministry of Human Resources and Social Security announced the “National Drug List for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2023)”, and the oral dosage form of Nuzyra ® (omadacycline mesylate), exclusively promoted by HanHui Pharma (a wholly owned subsidiary of HaiZheng Pharmaceuticals) in mainland China and the product of Zaidin Pharmaceuticals, has successfully been included in the 2023 edition of the National Health Insurance The oral dosage form of Nuzyra ® (omadacycline mesylate), a product of Zaidin Pharmaceuticals, has been successfully included in the 2023 edition of the National Health Insurance Drug Catalog, which will be formally implemented on January 1, 2024 Mr. Shen Xinghu, Secretary of the Party Committee and Chairman of the Board of Directors of Haizheng Pharmaceutical, said: Haizheng Pharmaceutical is committed to building HANHUI into an industry-leading pharmaceutical enterprise integrating research, production ...
- Source: drugdu
- 92
- December 16, 2023
First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Ipilimumab Biosimilar HLX13

Shanghai, China, Dec 13th, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject was dosed for a phase 1 clinical trial of the company’s independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) in China. Immune checkpoint inhibitors are playing a crucial part in immunotherapy, which has emerged in recent years as a novel approach to combating tumour cells with distinct advantages and enormous promise [1]. In addition to PD-1/L1 and LAG-3, CTLA-4 is also an inhibitory immune checkpoint which expressed on regulatory T cells and activated T cells and has a higher affinity to B7 molecules compared with CD28, thus can competitively bind to B7 molecules to inhibit the proliferation and activation of T cells [2]. Anti-CTLA-4 fully human monoclonal antibody (mAb) can block the inhibitory effects of CTLA-4 on the co-stimulation signal necessary to T cell activation and can increase the number ...
- Source: drugdu
- 141
- December 16, 2023
New Sample Preparation Solutions Simplify and Automate Respiratory Diagnostic Testing

Clinical laboratories performing respiratory testing are required to generate results of the highest quality results. Now, an automated nucleic acid purification instrument along with kits for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens has been designed to fulfill the requirements of these laboratories. Thermo Fisher Scientific Inc. (Waltham, MA; USA) has launched the high-throughput, versatile KingFisher Apex Dx system that allows scientists’ labs to recover quality nucleic acids for sensitive downstream applications with maximum consistency, reproducibility, and reliability. The system has been designed to be a part of modular sample preparation for real-time PCR analysis workflow, providing precise results, accurate data management, and robust security features that meet cybersecurity and diagnostic regulatory standards. Additionally, Thermo Fisher has launched the MagMAX Dx Viral/Pathogen NA Isolation kit which offers advanced formulation to ensure reproducible results and is automation-compatible with the KingFisher Apex Dx. These products together ...
- Source: drugdu
- 119
- December 15, 2023

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