SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
Scientists from Universidad Carlos III de Madrid (UC3M) and Johns Hopkins University (JHU), in the USA, have analyzed the growth of breast tumors from a biomechanical perspective and have created a computational model that simulates the invasion process of cancer cells, depending on the characteristics of the surrounding tissue and cell junctions, among other parameters. This type of model will help predict the evolution of a tumor in patients from its mechanical properties (stiffness, density, etc.) of the surrounding microenvironment, which can be determined through a biopsy or imaging techniques. The growth process of a solid tumor involves its expansion through the surrounding tissue, usually composed of a fibrillar matrix (for example, collagen). Its expansion depends on many factors such as the total number of tumor cells, their volume and stiffness, their access to nutrients, and the mechanical properties of the tissue in which they are developing. Supported by experimental ...
Singapore, March 19, 2024, WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has broken ground on its new 13.5-hectare CRDMO center in Tuas Biomedical Park, Singapore. The center will provide integrated biologics research, development and manufacturing services. WuXi Biologics announced a USD$1.4 billion (S$2 billion) investment in Singapore in 2022. The CRDMO center will be the first-of-its-kind in Singapore, offering end-to-end biologics research, development and manufacturing solutions upon completion. It will add 120,000L of manufacturing capacity to WuXi Biologics’ global network, and is expected to employ 1,500 staff. The site will be equipped with WuXi Biologics’ proprietary technical platforms, along with industry-leading technologies such as single-use technology to provide clients with time-and cost-efficient services. In line with WuXi Biologics’ Environmental, Social and Governance strategy, the site will implement sustainable concepts in the design and construction of the center, deploy ...
Don Tracy, Associate Editor In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment. Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1 “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press ...
The centre will deliver free training, outreach materials and programmes The University of Birmingham is set to lead UK-wide virtual reality (VR)-assisted training in medicines manufacturing to address critical skills demand in life sciences. Set to benefit future medicine and vaccine makers, the new RESILIENCE Centre for Excellence for UK Medicines Manufacturing Skills Centre aims to deliver free training, outreach materials and programmes. Supported by £4.5m of funding from Innovate UK and the Office for Life Sciences, the centre will be led by an academic consortium of UK universities, including University College London, Teesside University and Heriot-Watt University. The training centre aims to work with healthcare and pharmaceutical organisations to provide a single-entry point for training and career input, which includes a pipeline of continuing professional development courses. Hundreds of students across the UK are set to benefit from the training developed by the RESILIENCE Centre, including VR and mixed ...
Dive Brief Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition. The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics. The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients. Dive Insight Intuitive is preparing for competitive challenges from Medtronic and Johnson & Johnson, as well as a wave of startups hoping to vie for a piece of the growing market. The robot maker, which saw its procedure volumes increase by 21% in the fourth ...
On March 13, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd, and its subsidiary, Jinzhou Avanc Pharma Limited Liability Company (hereinafter referred to as Avanc Pharma), jointly developed the application for registration of Aripiprazole Oral Solution (trade name: Anxinqi®). The application for marketing registration of aripiprazole oral solution (trade name: Anxinqi®) jointly developed by Aohong Pharmaceutical Co. The drug is used for the treatment of schizophrenia in adolescents and adults aged 13 to 17 years old. Compared with other psychotropic drugs, it has the advantages of less side effects, significant efficacy, low relapse rate, etc. It is suitable for the long-term treatment of schizophrenia patients with a full course of disease, and it is the first-line anti-schizophrenia drug recommended by many domestic and foreign guidelines. Compared with oral solid preparation, oral solution has good fluidity, easy to take, precise and convenient dosage ...
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics. Traditionally, exosomes are isolated through ultrasound centrifugation, a process that requires eight hours or more, requires large sample volumes, and often harms the integrity of these delicate structures. Alternative methods also present challenges, including low purity and yield. Now, researchers have devised a diagnostic technique that employs sound waves to spin a single water droplet at speeds reaching 6,000 revolutions per minute, thereby facilitating the separation of tiny biological particles for exosome-based diagnostics. This novel approach involves a lightweight disk atop the spinning droplet and featuring etched channels that incorporate star-shaped nanoparticles designed for the label-free identification of exosomes. This method surpasses traditional techniques in efficiency, requiring less time and smaller sample volumes, and minimizes damage to the exosomes. It represents a significant ...
The neurodevelopmental condition affects up to four in 100 children A new study led by researchers at University College London (UCL) and other collaborators has revealed that adults who experienced amblyopia as children are more likely to experience serious diseases in adulthood. Published in eClinicalMedicine, the study was funded by the Medical Research Council, the National Institute of Health and Care Research (NIHR) and the Ulverscroft Foundation. Affecting up to four in 100 children, amblyopia, otherwise known as a ‘lazy eye,’ is a neurodevelopmental condition where the vision in one eye does not develop properly, caused by a breakdown in how the brain and eye work together. Carried out alongside seven other collaborators, including King’s College London, the NIHR Biomedical Research Centre and Great Ormond Street Hospital, researchers analysed more than 126,000 people aged 40 to 69 years from the UK Biobank cohort who had an ocular examination. Out of ...
Bacteria are outpacing scientific advancements, leading to a worrying increase in antibiotic resistance, a situation the World Health Organization has identified as an emerging global health crisis. The key to countering this trend lies in achieving quicker diagnostic results, comprehensive susceptibility testing across various sample types, and the ability to test against a broad range of commercially relevant antibiotics simultaneously. Now, a rapid antibiotic susceptibility testing (AST) system can provide targeted therapeutic results days faster than the current standard of care. Selux Diagnostics (Boston, MA, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary Positive Blood Culture (PBC) Separator. The addition of positive blood culture sample type expands the Selux Next Generation Phenotyping (NGP) System, making this the only FDA-cleared, single-platform technology to deliver rapid AST results for both positive blood culture and isolated colonies. The Selux PBC Separator streamlines the process for ...
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