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FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors

Don Tracy, Associate Editor Action marks the first FDA-approved blood screening test for malaria. Roche announced that the FDA has officially approved the Cobas Malaria test, focused on inspecting blood donors for malaria, aiming to enhance the safety of blood supply. The test, which screens blood samples for five species of Plasmodium parasites, is the first of its kind approved for this purpose and aims to reduce the risk of malaria transmission through transfusions. Roche stated that it expects the test to be available in the United States at some point during the second quarter of this year.1 “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood,” said Matt Sause, CEO, Roche Diagnostics, in a press release. “The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for ...
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- March 29, 2024
Novo Nordisk Acquires Cardior Pharmaceuticals for $1.112B in Effort to Bolster Cardiovascular Disease Pipeline

Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
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- March 29, 2024
Blood Analysis Predicts Sepsis and Organ Failure in Children

Sepsis poses a grave risk in which a severe immune reaction to infection leads to organ damage. Identifying sepsis in children is complex since the symptoms mirror those of many pediatric illnesses. Presently, if sepsis is suspected, medical practitioners administer antibiotics, increase fluids, and intensify monitoring for the child, leading to some receiving unneeded treatments. Now, a new technique developed by researchers can predict the likelihood of a child developing sepsis and succumbing to organ failure. The research by investigators at the University of Queensland (Brisbane, Australia) involved more than 900 critically ill children in the emergency departments and intensive care units across four hospitals. Blood samples collected during the acute stage of their infection were examined for gene activation or suppression. This analysis allowed the researchers to identify gene expression patterns that could predict the child’s risk of organ failure within the next 24 hours, as well as whether ...
- Source: drugdu
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- March 29, 2024
Simple Skin Biopsy Test Detects Parkinson’s and Related Neurodegenerative Diseases

Parkinson’s disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), are progressive neurodegenerative diseases that, despite having some similar symptoms like tremors and cognitive issues, vary in their outcomes and do not benefit from identical treatments. A common feature among them is the accumulation of an abnormal protein in nerve fibers within the skin, known as phosphorylated α-synuclein (P-SYN). Now, neurologists have developed a simple skin biopsy test that can detect this abnormal form of alpha-synuclein with high positivity rates in individuals with such disorders. In the study, neurologists at Beth Israel Deaconess Medical Center (BIDMC, Boston, MA, USA) enrolled 428 people, ages 40-99 years who were either diagnosed with one of the synucleinopathies based on clinical evaluations confirmed by specialists or were healthy volunteers ...
- Source: drugdu
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- March 29, 2024
Mabwell reaches the Oversea Market of South Asia and Africa

Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa. 9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness. About 9MW0813 9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion ...
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- March 29, 2024
a global network for coronaviruses

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 ...
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- March 29, 2024
Ruike Biologicals and Rongsheng Biologicals Sign Strategic Cooperation Agreement on New Adjuvant Vaccine Project

On March 25th, Jiangsu Ruike Biotechnology Co., Ltd (hereinafter referred to as “Ruike Biotechnology”, stock code: 02179.HK) and Shanghai Rongsheng Biopharmaceutical Co. (hereinafter referred to as “Rongsheng Biopharmaceuticals”) in Shanghai. At the meeting, both parties signed a strategic cooperation agreement on the new adjuvant vaccine project and discussed the details of the project. Adjuvant is an important component in the development of vaccines, and new adjuvants have become the key to the success of innovative vaccine research and development. According to the terms of the agreement, the two parties will jointly carry out the development of new adjuvant vaccines, with Ruike Biologicals providing new adjuvants independently developed based on the new adjuvant technology platform, and Rongsheng Biologicals providing viral antigens independently designed by Rongsheng Biologicals. The project will improve the immunogenicity of existing Rongsheng Bio’s vaccines under development by empowering them with novel adjuvants for the purpose of optimizing immunization ...
- Source: drugdu
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- March 29, 2024
Beijing Municipal Party Secretary Yin Li Met with Novartis Global CEO Wansheim

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 ...
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- March 29, 2024
LifeArc provides £750,000 fund for clinical trial to treat neuroferritinopathy

The progressive and incurable brain disorder currently affects approximately 100 patients worldwide LifeArc has announced that it has funded a pivotal clinical trial at the University of Cambridge for £750,000 to re-purpose a UK-licensed medicine to treat the ultra-rare genetic disease neuroferritinopathy. The recently launched DefINe trial aims to stop the progression of the disease with an existing drug known as Ferriprox (deferiprone), manufactured by Chiesi Global Rare Diseases. Affecting approximately 100 patients worldwide, neuroferritinopathy is a progressive and incurable brain disorder caused by changes in a gene that produces the ferritin light chain protein. This change can lead to a build-up of iron in the brain, which can cause severe symptoms such as loss of speech and swallowing. With currently no effective treatments available to treat the condition, the new randomised, placebo-controlled trial aims to reduce the iron accumulation in the brain using Ferriprox, an affordable oral tablet licensed ...
- Source: drugdu
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- March 29, 2024
PhaSER Biomedical and the Sanders TDI partner for clinical drug discovery research

PhaSER will provide 8HUM mouse models for the TDI to accelerate a pipeline of novel therapeutic targets PhaSER Biomedical has announced its long-term partnership with the Sanders Tri-Institutional Therapeutic Discovery Institute (TDI) to advance the institute’s pre-clinical drug discovery research. Based in the US, the TDI comprises the Memorial Sloan Kettering Cancer Center, Rockefeller University and Weill Cornell Medicine. The TDI, first formed in 2013, aims to provide academic investigators with access to industrial-scale tools and techniques, to more effectively accelerate drug discovery and bring new cures to patients with the greatest medical need. As part of the ten-year agreement, PhaSER will provide 8HUM mouse models for TDI to use to accelerate and improve drug discovery on a pipeline of novel targets in a variety of therapeutic areas. PhaSER’s 8HUM unique mouse models aim to transform the ways drugs are metabolised in humans and use multiple applications in drug discovery ...
- Source: drugdu
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- March 29, 2024

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