Search Results for “cancer” – Page 76 – media

EMA validates Philogen and Sun Pharma’s MAA for melanoma

The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by ...
- Source: drugdu
- 106
- July 8, 2024
GSK buys COVID, influenza vaccines from retrenching CureVac

British drugmaker GSK on Wednesday, July 4 2024, bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline. According to the statement, GSK, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu. It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac said it would cut about 30 per cent of its jobs as it focuses on mRNA-based cancer therapies and other earlier-stage projects. It added GSK’s cash payment extends funding, which would have run out at the end of next year, into 2028. Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases. Wednesday’s agreement reflects GSK CEO Emma Walmsley’s focus on ...
- Source: drugdu
- 96
- July 6, 2024
Submission of Nidlegy marketing authorisation application validated by EMA

Philogen and Sun Pharmaceutical Industries (“Sun Pharma”) announces that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorisation Application (MAA) for Nidlegy , which was finalised on June 3 2024. “The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, chief executive officer and chief scientific officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need.” Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. The data of the Phase III Nidlegy trial are expected to be published in a peer-reviewed scientific journal in 2024. https://sunpharma.com/wp-content/uploads/2024/07/Press-Release-Validation-of-Nidlegy%E2%84%A2-Marketing-Authorization-Application-Submission-by-EMA.pdf
- Source: drugdu
- 91
- July 6, 2024
GSK Pays CureVac €400M to Pick Up Clinical-Stage mRNA Vaccines for Infectious Diseases

GSK is taking over development of an avian influenza vaccine candidate as a bird flu outbreak continues in U.S. dairy cows. Meanwhile, CureVac is restructuring and returning its attention to cancer vaccines, which was the initial focus of the mRNA company. By Frank VinluanGSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced two vaccine candidates into clinical testing, and now GSK is taking over both, one of them in development for an infectious disease target that’s particularly hot right now. Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing, and a Covid-19 vaccine in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights ...
- Source: drugdu
- 89
- July 5, 2024
Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC

Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
- Source: drugdu
- 71
- July 4, 2024
University of Liverpool launches new biotech spin-out company Galytx

The University of Liverpool has announced the launch of a new biotech spin-out company, Galytx, to develop novel therapeutic drugs to treat cancer and fibrotic diseases. The new company will focus on developing small molecular therapeutic drugs against a highly clinically molecular target, galectin-3, a carbohydrate-binding protein that has a close association with the pathogenesis, progression and morbidity of multiple fatal diseases, including cancer, fibrosis and inflammation. Professor Lu-Gang Yu, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, has been leading research at the University of Liverpool and has recently identified several non-carbohydrate, wholly synthetic small molecular compounds as potent galectin-3 inhibitors that have shown huge potential to be developed as galectin-3-targeted novel therapeutic drugs for the treatment of fatal diseases. Yu said: “Galectin-3 is increasingly recognised as a multi-functional, multi-mode promoter in cancer as well as in fibrosis-associated organ failures such as hearts, lungs and kidneys” and ...
- Source: drugdu
- 82
- July 3, 2024
Magnolia Medical Announces New Platform to Reduce Misdiagnosis of Sepsis

By Mike Hollan The platform utilizes standards set forth in a recently published document from the CDC. After years of collaborating with hospitals, Magnolia Medical has launched a new digital platform designed to prevent sepsis misdiagnosis.1 The platform, Magnolia Analytics, was designed with the CDC’s recently published Blood Culture Contamination guidelines in mind. The main addition to the guidelines is a new step utilizing initial specimen diversion devices, which Magnolia specializes in. CDC notes that reducing sepsis misdiagnosis is important as it can play a key role in reducing the amount of needlessly prescribed antibiotics, which can then further play a role in reducing instances of antibiotic resistance. In a press release, Magnolia Medical co-founder and CEO Greg Bullington said, “In response to our customer’s clear unmet needs, we developed Magnolia Analytics as a custom, exclusive solution to support our hospitals in achieving and sustaining their blood culture contamination rates ...
- Source: drugdu
- 72
- July 3, 2024
Eating baby carrots three times a week raises skin carotenoid levels in young adults

A new study found that eating a snack of baby carrots just three times a week significantly increased skin carotenoids in young adults. Levels of these phytonutrients were boosted even more when this healthy snack was combined with a multivitamin containing the carotenoid beta carotene. Carotenoids, which are responsible for the bright red, orange and yellow colors of many fruits and vegetables, can be measured in the skin to gauge fruit and vegetable consumption since diet is the only source of these pigments. Higher levels of skin carotenoids are associated with increased antioxidant protection and a lower risk of chronic diseases such as heart disease and certain cancers. This marker also reflects improved skin health and immune function. Mary Harper Simmons, Master of Science in Nutrition student at Samford University, said, “Previous studies have demonstrated that skin carotenoid levels can be increased by consuming three times the recommended serving of ...
- Source: drugdu
- 75
- July 2, 2024
The Lancet sub-journal publishes clinical phase 1b/2 results of the next-generation CD20 antibody MIL62 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma

Recently, eClinical Medicine, a sub-journal of The Lancet, published the results of a phase 1b/2 study of recombinant humanized monoclonal antibody MIL62 injection in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma, led by Prof. Yuankai Shi of Cancer Hospital, Chinese Academy of Medical Sciences. The study was designed to evaluate the efficacy and safety of MIL62 in combination with lenalidomide in the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common pathological subtypes of non-Hodgkin’s lymphoma (NHL) and are inert lymphomas. In China, FL accounts for about 8% of B-cell NHL, while MZL accounts for about 12%. Early progression in patients with inert lymphoma is directly related to poor prognosis, with approximately 20% of patients experiencing disease recurrence or progression within 24 months of diagnosis (POD24). These patients typically have a poor prognosis, ...
- Source: drugdu
- 103
- June 29, 2024
Customizable AI Tool Helps Pathologists Identify Diseased Cells

Pathologists are tasked with examining body fluids or tissues to diagnose diseases, a process that involves distinguishing rare disease-indicating cells from thousands of normal cells under a microscope. This skill requires extensive training. Artificial intelligence (AI) can assist by learning to differentiate between healthy and diseased cells from digital pathology images. However, traditional AI tools, once trained, lack flexibility. They are designed for specific tasks, such as identifying cancer cells in one organ but not another, and might not align perfectly with a pathologist’s specific needs in different scenarios. Now, a collaborative team of computer scientists and physicians has developed a new AI tool that not only identifies diseased cells but also adapts to a pathologist’s requirements. Developed at Stanford Medicine (Stanford, CA, USA), the tool, named nuclei.io, functions like a human assistant that evolves with feedback. Starting with the basic function of recognizing different cell types by their nuclei, ...
- Source: drugdu
- 93
- June 28, 2024

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