Search Results for “EC” – Page 69 – media

Arcutis’ Zoryve bags 2nd FDA nod, this time as a foam to treat ‘the great neglected disease in dermatology’

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. Late Friday, Arcutis’ roflumilast—now approved in both cream and foam form under the brand name Zoryve—passed muster with U.S. regulators to treat seborrheic dermatitis in patients ages 9 and older. Arcutis has previously estimated there are more than 10 million people in the U.S. with seborrheic dermatitis, which causes red patches on the skin covered with large, flaking scales and a persistent itch. The disease most often affects parts of the body with oil-producing glands, such as the scalp, face, upper chest and back. Back in July 2022, roflumilast’s cream formulation won the company’s first approval in plaque psoriasis. In both its forms, roflumilast targets phosphodiesterase-4 (PDE4), an intracellular enzyme that boosts production of pro-inflammatory mediators and decreases production of ...
- Source: drugdu
- 85
- December 19, 2023
WHO officially recognizes noma as a neglected tropical disease

In a pivotal move towards addressing one of the world’s most underrecognized health challenges, the World Health Organization (WHO) today announced the inclusion of noma (cancrum oris or gangrenous stomatitis) in its official list of neglected tropical diseases (NTDs). This decision, which was recommended by the 17th meeting of the Strategic and Technical Advisory Group for Neglected Tropical Diseases (STAG-NTD), underscores WHO’s commitment to expanding health services to the world’s most vulnerable populations. Noma, a severe gangrenous disease of the mouth and face, primarily affects malnourished young children (between the ages of 2 and 6 years) in regions of extreme poverty. It starts as an inflammation of the gums, which, if not treated early, spreads quickly to destroy facial tissues and bones. It frequently leads to death, with survivors suffering severe disfigurement. Accurate estimation of the number of noma cases is challenging due to the rapid progression of the disease ...
- Source: drugdu
- 84
- December 19, 2023
BAT1308 (anti-PD-1 monoclonal antibody) injection combined with platinum-containing chemotherapy for endometrial cancer approved in Phase II/III clinical

On December 15, 2023, BIO-THERA Bio-Pharmaceutical Co., Ltd. announced that it had received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approved the application for a Phase II/III clinical trial of the investigational drug BAT1308 injection in combination with platinum-containing chemotherapy for the first-line treatment of advanced or recurrent mismatch-modification-repaired protein-deficient (dMMR) endometrial cancer. BAT1308 is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA, which belongs to IgG4κ subtype and is expressed by Chinese hamster ovary cells.PD-1 is mainly expressed by activated T-lymphocytes, and is an inhibitory immune checkpoint.PD-L1 and PD-L2 are the two ligands of PD-1, and when PD-L1 or PD-L2 bind to PD-1, it can inhibit immune activation of T-cells through the downstream signaling pathway to inhibit immune activation of T cells. It has been found that a variety of tumor cells can express PD-L1 and PD-L2 and bind to PD-1 ...
- Source: drugdu
- 81
- December 19, 2023
Next-Generation Colorectal Cancer Screening Test Enables Earlier Disease Detection

Colorectal cancer (CRC) stands as the second leading cause of cancer-related deaths in the U.S. and is particularly prevalent in men under 50. Notably, there’s been a shift in CRC affecting younger individuals, with 20% of cases in 2019 occurring in people 54 and younger, a rise from 11% in 1995. Additionally, there has been an increase in advanced disease incidence, particularly in individuals under 65. A significant number of CRC cases and deaths can be prevented through regular screening, surveillance, and quality treatment. Now, a new technology offers convenient at-home test collection with the highest sensitivity available for non-invasive CRC screening. Geneoscopy Inc. (St. Louis, MO, USA) has developed a multi-target stool RNA (mt-sRNA) biomarker panel for detecting precancerous lesions and colorectal cancer. RNA, a dynamic molecule crucial for protein synthesis, adapts to disease conditions and regulates numerous genes in cellular processes. Changes in RNA pathways are linked to ...
- Source: drugdu
- 114
- December 18, 2023
“Magnetic Wave Knife” technology is here! Fosun Pharma and Insightec to establish a joint venture in China

On December 13, 2023, Fosun Pharma announced that its medical device subsidiary has signed a cooperation agreement with Insightec on December 12, to establish a joint venture in China, Fosun Insightec Medical Technology Company Limited* (hereinafter referred to as “Fosun Insightec”). Fosun Insightec will focus on the commercialization, clinical application and research of the Magnetic Resonance Guided Focused Ultrasound (MRFU) Brain Therapy System (i.e. Magnetic Wave Knife Brain Therapy System) in China, which will help Parkinson’s Disease patients and patients with idiopathic tremor to regain a high quality of life. In addition, Fosun Meditech plans to establish strategic partnerships with a number of medical centers in China to further explore the potential application of the Magnetic Wave Knife in neurological diseases and benefit a wider range of patients. Mr. Liu Yi, Senior Vice President of Fosun Pharma and Chairman and CEO of the Medical Device Division, said that he is ...
- Source: drugdu
- 167
- December 17, 2023
Fosun Pharma’s Global Multicenter Phase III Clinical Program for New Anti-malarial Drugs Receives USD 3.3 Million Investment from GHIT Fund Jointly Enhancing Global Accessibility of Anti-malarial Drugs

(Shanghai, China, December 14, 2023) Japan’s Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen) in a global multicenter Phase III clinical trial project in Africa and Southeast Asia for a new anti-malarial drug, artemether benfluorex amodiaquine triple combination formulation, led by Fosun Pharmaceuticals (“the project “) invests approximately US$3.3 million (approximately JPY500 million1 ) to advance the development and launch of this new drug. The Project will be jointly conducted by Fosun Pharma, Marubeni Corporation of Japan, the Mahidol-Oxford Research Center for Tropical Medicine in Thailand, a division of the University of Oxford (“MORU”), and the Medicines for Malaria Foundation (“MMV”), and this is the first time that the GHIT Fund has invested in a research project led by a According to GHIT, the drug candidate could address the widespread Plasmodium artemisinin partial resistance (ART-R) problem in the ...
- Source: drugdu
- 99
- December 17, 2023
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
- 100
- 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
- 98
- 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
- 84
- 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
- 121
- December 16, 2023

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