Renal cell carcinomas (RCCs) are notably diverse, encompassing over 20 distinct subtypes and generally categorized into clear cell and non-clear cell types; around 20% of all RCCs fall into the non-clear cell RCCs (non-ccRCC) category, with many subtypes being exceedingly rare and not extensively studied. Despite their varied molecular characteristics, non-ccRCCs are commonly treated with therapies designed for the more prevalent clear cell type, which impacts the effectiveness of the treatments. The differential diagnosis of non-ccRCC tumors poses significant challenges due to the overlapping morphological characteristics and the current biomarkers’ lack of specificity. A study has now uncovered new biomarkers in RCCs that could enhance the accuracy of diagnoses and potentially improve treatment strategies. This research utilized an integrative approach to examine comprehensive proteogenomic data from both cc and non-cc RCCs, advancing previous genomic-focused studies and deepening the understanding of the mechanisms driving renal cell carcinomas. These discoveries provide a ...
Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024 Oregon Therapeutics and Lantern Pharma have entered into a strategic artificial intelligence (AI)-driven collaboration to optimise the development of a protein disulfide isomerase (PDI) inhibitor drug candidate for a variety of novel and targeted cancer indications. XCE853 is being developed by Oregon in various indications, including drug-resistant ovarian and pancreatic cancer, certain haematological cancers and several paediatric cancers, including central nervous system cancers. Nearly 612,000 deaths are predicted to occur in the US in 2024 due to cancer and resistance to anticancer drugs will be responsible for 90% of those deaths. Under the terms of the agreement, Lantern will receive equal intellectual property (IP) co-ownership and drug development rights in newly discovered biomarkers, novel indications, and pharmacological use strategies for XCE853, while Oregon is entitled to financial benefits resulting from the licensing of the ...
The subtype accounts for 20% of all T-cell leukaemias, a rare form of blood cancer which produces too many abnormal T-cells OneChain Immunotherapeutics (OCI), a biotechnology company that specialises in developing CAR T cell therapies for oncological diseases, has announced that the CARxALL clinical trial has dosed its first cortical T-cell acute lymphoblastic leukaemia (coT-ALL) patient with OC-1, a CAR T therapy. Being conducted at Hospital Clínic and Hospital Sant Joan de Déu in Barcelona, the trial is open to both paediatric and adult patients worldwide. T-cell leukaemia is a rare form of blood cancer that occurs when the bone marrow produces too many abnormal T-cells, a type of white blood cell that protects the body from infections. The subtype, coT-ALL, accounts for 20% of T-cell leukaemias and is characterised by a poor prognosis in patients who do not respond to existing therapies. CAR T therapies are a form of ...
Johns Hopkins Medicine scientists have revealed a molecular pathway that lures cells down a path of genome duplication, a hallmark of cancer cells, which could potentially lead to new therapies and could stop the growth of cancers. Published in Science, the study reveals the consequences of molecules and enzymes triggering and regulating the process of making new cells out of the cells’ genetic material. Cells follow an orderly routine that begins with making a copy of their entire genome, followed by separating the genome copies and dividing the replicated DNA evenly into two “daughter” cells. When doing so, cells that are stressed can mistakenly run the risk of copying their genome again. Focusing on human cells that line breast ducts and lung tissue, scientists analysed thousands of images of single cells as they went through cell division and developed glowing biosensors to tag cyclin dependent kinases (CDKs), which play a ...
Chiesi Group and Gossamer Bio have announced a global collaboration and license agreement to develop and commercialise seralutinib to treat respiratory diseases. Chiesi will support Gossamer’s ongoing work for seralutinib in pulmonary arterial hypertension (PAH), as well as its development in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Predicted to affect up to 50,000 people in the US, PAH is a rare, progressive condition that causes high blood pressure in the lungs’ arteries. It is estimated that PH-ILD affects up to 100,000 patients in the US. Seralutinib is an inhaled inhibitor designed to be delivered via a dry powder inhaler for the potential treatment of pulmonary hypertension. As part of the deal, Chiesi will pay Gossamer $160m as a development reimbursement and the biopharmaceutical company will also be eligible to receive up to $146m in regulatory milestones and $180m in sales milestones. Under the terms of the agreement, Gossamer ...
Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
Chiatai Tianqing is conducting the “Randomized, controlled, double-blind, dual-simulation, multicenter Phase III clinical study to evaluate D1553 versus docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed previous standard therapy (D1553-III-01)” nationwide. Recently, the project has completed the enrollment and successful dosing of the first subject. Garsorasib is a novel targeted KRAS G12C mutation inhibitor, registered under the classification of chemical drug class 1, is the first self-developed KRAS G12C inhibitor in China that has entered the clinical trial stage, and is included in the breakthrough therapeutic varieties by the CDE. on December 29, 2023, the National Drug Administration (NMPA) has accepted Garsorasib’s New Drug Marketing Application 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 a KRAS ...
Recently, Tong Hua Dong Bao Pharmaceutical Company Limited (“Tong Hua Dong Bao” or the “Company”) signed a Commercialization License and MAH Cooperation Agreement (“Commercialization License and MAH Cooperation Agreement”) on the GLP-1 product simelglutide injection (“Simelglutide Injection”) with Beijing Quality Peptide Bio-pharmaceutical Technology Co. (hereinafter referred to as “QPBio”) entered into the Commercialization License and MAH Cooperation Agreement (hereinafter referred to as the “Agreement”) in relation to the GLP-1 product, Simeglutide Injection. Pursuant to the Agreement, the Company will obtain the exclusive commercialization rights and interests in Mainland China for ZT001 Simeglutide Injection (indication: blood glucose control in adults with type 2 diabetes mellitus) (the “Collaboration Product”), which is a clinical product under development by Plasmapeptide Biologics, as well as the right to co-develop the overseas market. The Cooperative Product has completed the Phase I clinical trial for the indication of type 2 diabetes mellitus in Mainland China and has ...
The Francis Crick Institute and Broken String Biosciences have announced a new collaboration to advance research in amyotrophic lateral sclerosis (ALS). The partnership aims to advance the understanding of genomic instability in the development of the neurodegenerative disease. Affecting an estimated 5,000 people in the UK, ALS is a rare and fatal neurological disorder that causes the brain and spinal cord nerve cells to progressively degenerate. The disorder gradually causes a loss of the ability to control voluntary movements and basic bodily functions. As part of the collaboration, the research project aims to develop novel applications for Broken String’s proprietary DNA break-mapping platform, INDUCE-seq, to leverage the technology to investigate the impact of genomic instability in the development of ALS. INDUCE-seq is a scalable platform technology that reveals the breaks induced by any nuclease-based genome editing system with high precision. It was created to address an unmet need for accurate ...
The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK The NHS has announced that it will be rolling out a new laser beam therapy this June to help prevent seizures in patients living with epilepsy. The new fibre optic laser therapy called laser interstitial thermal therapy (LITT) works to target the part of the brain that causes seizures without the need for invasive surgery. Affecting around 600,000 people in the UK, epilepsy is a chronic brain disease that causes seizures, which lead to involuntary movement. Around one in three people living with the condition are unable to control their seizures using anti-seizure drugs and may need invasive neurosurgery to remove the epilepsy-causing part of the brain. Being offered at King’s College Hospital NHS Foundation Trust and the Walton Centre in Liverpool, the treatment involves drilling a small hole to allow a 1.5mm-wide probe ...
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