Search Results for “cancer” – Page 73 – media

FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

By Don Tracy, Associate Editor Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Blood cell red 3d background vein flow platelet wave cancer medicine artery abstract. Red cell hemoglobin blood donate anemia isolated plasma leukemia donor vascular system anatomy hemophilia vessels. Image Credit: Adobe Stock Images/Five Million StocksThe FDA has granted priority to review to Novartis’ Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP). According to the company, the designation was based on promising results from the Phase III ASC4FIRST trial, in which Scemblix showed superior major molecular response (MMR) rates compared to current standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, and bosutinib.1 “We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to ...
- Source: drugdu
- 64
- August 2, 2024
Avzivi® (BAT1706) receives marketing approval from European Commission

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 74
- August 1, 2024
New gut microbiome atlas could offer better treatment for digestive disorders

The new Human Gut Microbiome Atlas could help treat conditions including IBS and AMR Researchers from King’s College London (KCL) have developed a new gut microbiome atlas in collaboration with MetaGenoPolis and the Science for Life Laboratory to help better understand how microorganisms in the gut impact disease. Published in Genome Research, the Human Gut Microbiome Atlas, which identifies gut bacteria in people with 23 separate diseases across 19 countries, could lead to more effective treatments for conditions such as inflammatory bowel disease (IBS). The human gut microbiome provides an individual profile of bacteria and other microorganisms that live in the gut, which helps perform key bodily functions, including digestion. However, fragmented data existing on the genetic makeup of individual microbes in the gut has prevented large-scale comparative studies and doctors from tailoring treatment to work with the specific microbiome of patients. After performing a survey of genetic data from ...
- Source: drugdu
- 65
- July 31, 2024
GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
- Source: drugdu
- 100
- July 31, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
- 120
- July 30, 2024
Sanyou Bio Congratulates Eluminex Biosciences and Foreseen Biotechnology on Major Breakthroughs in Innovative Drug Project

SHANGHAI, July 26, 2024 /PRNewswire/ — On July 15, Eluminex Biosciences announced that their tri-specific fusion antibody drug, EB-105, has administered its first dose to a diabetic macular edema patient in the United States. This clinical trial, known as LOTUS, is an open-label, multicenter, single-dose, dose-escalation clinical trial via intravitreal injection, currently being conducted in four hospitals across the United States. On July 22, 2024, Foreseen Biotechnology announced the exclusive global licensing of their ADC targeted drug, FS001, to Ipsen Pharma SAS of France. Ipsen will have exclusive rights to develop, manufacture, and commercialize FS001 worldwide. The total licensing fee, including upfront payments, milestone payments, and sales royalties, amounts to US$1.03 billion. Eluminex Biosciences’s preclinical studies have shown that EB-105 can effectively inhibit signal transduction pathways such as VEGF-A/VEGFR-2, Ang-2/Tie-2, and IL-6/IL-6R. In addition to targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), EB-105 also inhibits intracellular inflammation-related signal ...
- Source: drugdu
- 52
- July 30, 2024
AstraZeneca grows oncology portfolio with Pinetree’s EGFR degrader

AstraZeneca has signed a licensing agreement with Pinetree Therapeutics for a preclinical epidermal growth factor receptor (EGFR) degrader candidate, potentially worth more than $545m. AstraZeneca will pay $45m upfront for global developmental and commercialisation rights for the pan-EGFR degrader, and Pinetree will also be in line to receive up to $500m in milestone-based payments along with tiered royalties on sales. “[The] pan-EGFR degrader was developed from AbReptor, our proprietary multispecific antibody platform and has demonstrated promising preclinical anti-tumour activity in drug-resistant and tyrosine kinase inhibitor (TKI)-resistant tumours, as well as enhanced activity when used in combination with current EGFR inhibitors,” said Dr Hojuhn Song, founder and CEO of Pinetree. Targeted protein degraders, often called molecular glues, have been a growing area of interest in recent years. Most of these therapies are developed in oncology. According to GlobalData’s drug database, over 200 therapies in development have been classified as molecular glue ...
- Source: drugdu
- 89
- July 26, 2024
BioAtla receives FDA fast track designation for ozuriftamab vedotin

BioAtla has received a fast track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) ozuriftamab vedotin (BA3021) to treat a certain type of head and neck cancer. Ozuriftamab vedotin is a conditionally and reversibly active ADC targeted against ROR2, a receptor tyrosine kinase present in many solid tumours. ROR2 is a non-canonical wnt5A signalling receptor, the overexpression of which is associated with poor prognosis and resistance to standard therapies. This fast track designation concerns the use of ozuriftamab vedotin in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) for whom the disease has progressed despite platinum-based chemotherapy and anti-PD-1/PD-L1 antibody treatment. The ADC is the subject of an ongoing multi-centre, open label Phase II trial (NCT05271604) investigating the therapy’s efficacy and safety for this indication. Though a full readout is still pending, interim data from ...
- Source: drugdu
- 75
- July 26, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 83
- July 26, 2024
Protein Signatures in Blood Can Predict Risk of Developing More Than 60 Diseases

Measuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements from a small blood sample to predict a variety of diseases. In the research, published in Nature Medicine, which was carried out as part of an international partnership involving Queen Mary University of London (London, UK), the investigators used data from the UK Biobank Pharma Proteomics Project (UKB-PPP). This project represents the largest proteomic study to date, analyzing around 3,000 plasma proteins from over 40,000 randomly selected UK Biobank participants. These protein measurements are linked to detailed electronic health records. The researchers applied sophisticated analytical techniques to identify a specific ‘signature’ of 5 to 20 key proteins for predicting each disease. They discovered that these protein ‘signatures’ can predict the onset of 67 different diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neuron ...
- Source: drugdu
- 76
- July 25, 2024

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