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 ...
ICRA expects the revenues of its sample set of 25 Indian pharma companies (which account for ~60 per cent of the overall Indian pharma industry) to grow by 8-10 per cent in FY2025, post a YoY increase of 13-14 per cent in FY2024. Following the high base of FY2024, the revenue growth momentum from the US and Europe markets is expected to moderate to 8-10 per cent and 7-9 per cent, respectively, from the YoY expansion of 18-20 per cent and 16-18 per cent, respectively, estimated for FY2024. The domestic market is expected to see stable growth at 6-8 per cent, while the emerging markets may log in an 8-10 per cent rise in FY2025, against 16-18 per cent in FY2024. The revenue growth of the sample set companies in the US market in FY2024 has been supported by increased new product launches, product shortages in select therapeutic segments, and ...
WHO has launched a new network for coronaviruses, CoViNet, to facilitate and coordinate global expertise and capacities for early and accurate detection, monitoring and assessment of SARS-CoV-2, MERS-CoV and novel coronaviruses of public health importance. CoViNet expands on the WHO COVID-19 reference laboratory network established during the early days of the pandemic. Initially, the lab network was focused on SARS-CoV-2, the virus that causes COVID-19, but will now address a broader range of coronaviruses, including MERS-CoV and potential new coronaviruses. CoViNet is a network of global laboratories with expertise in human, animal and environmental coronavirus surveillance. The network currently includes 36 laboratories from 21 countries in all 6 WHO regions. Representatives of the laboratories met in Geneva on 26 – 27 March to finalize an action plan for 2024-2025 so that WHO Member States are better equipped for early detection, risk assessment, and response to coronavirus-related health challenges. The CoViNet ...
On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers. By SUZETTE GLASNER-EDWARDSThe recent series of settlements linked with claims against advertising and pharmaceutical manufacturing companies involved in the sales and marketing of opioid drugs are encouraging, demanding accountability for promoting highly addictive drugs such as OxyContin as non-addictive. These settlements, ranging from $350 to $465 million, provide a source of optimism for those living with opioid use disorders, especially given the inclusion of funding to support the treatment of such individuals. Yet questions about the potential future impact of these criminal and civil suit settlements on the opioid overdose epidemic remain. Coupled with the observation that opioid marketing practices have not shifted in the face of lawsuits in the past, under-recognition of addiction and overprescribing of medications with high addiction potential for ...
“If we don’t move toward accelerated approval, many patients will not be able to receive treatment in a timely manner. For many initial approvals of gene therapies, accelerated approval will become the standard process.” Peter Marks said at a seminar held by the Reagan-Udall Foundation in Washington last week . There are currently more than 10,000 rare diseases, but companies often struggle to bring treatments for these diseases to market due to small patient populations and financial constraints. Accelerated approval is a tool that can advance the development of innovative treatments and ensure that companies do not abandon promising treatments. Peter Marks said: “There are many gene therapies for rare diseases that are almost successful. The key question now is, how do we push them to the finish line smoothly?” For gene therapy for rare diseases, a balance between supervision and science is needed. How to supervise gene therapy more ...
For World Hearing Day, marked on 3 March, the World Health Organization (WHO) has released new technical guidance on hearing aid service delivery approaches for low- and middle-income settings. This document is designed to provide practical guidance to countries in developing hearing aid services in areas that lack human resources for assessing hearing, as well as fitting and maintaining hearing aids. The guidance, developed with support from the ATScale Global Partnership for Assistive Technology, is based on the principle of task sharing among specialists and trained non-specialists. It includes two approaches, one targeting adults and the other for children 5 years and over, and is accompanied by resources with tips for healthy ear care practices, use of hearing aids and how to support people living with hearing loss. “Over 400 million people with hearing loss could benefit from using hearing devices. However, less than 20% of these needs are fulfilled,” ...
Noncommunicable diseases (NCDs), such as cardiovascular disease, cancer, chronic respiratory disease and diabetes, are responsible for 75% of deaths worldwide. People affected by humanitarian emergencies are at increased risk of NCDs. It is estimated that strokes and heart attacks are up to 3 times more likely following a disaster. However, care and treatment for NCDs are often not included as a standard part of humanitarian emergency preparedness and response, which focus on the most immediate needs. To support integration of essential services for NCDs into emergency preparedness and humanitarian response, the World Health Organization (WHO), the Kingdom of Denmark, the Hashemite Kingdom of Jordan, the Republic of Kenya, and UNHCR, the UN Refugee Agency, are jointly convening a global high-level technical meeting on NCDs in humanitarian settings on 27-29 February in Copenhagen, Denmark. Humanitarian emergencies in recent years are becoming more complex and interconnected. Hunger and shortages of essential goods ...
The report includes five recommendations for the government to address these issues The Academy of Medical Sciences has published a new report that highlights evidence of declining health among children under five years in the UK and has called on policymakers to take urgent action. The new report highlights that children’s health has been overlooked in policy, the health service and research from pre-conception through pregnancy to the first five years of life. Written by several child health experts, the new report, Prioritising Early Childhood to Promote the Nation’s Health, Well-being and Prosperity, warns the UK government of major health issues including infant mortality, obesity and tooth decay and highlights the economic prosperity of children’s health, which is estimated to cost at least £16bn a year. According to the report, which involved perspectives from parents and carers, infant survival rates are worse than in 60% of similar countries and, between ...
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