Alexion, AstraZeneca Rare Disease has received approval from the US Food and Drug Administration (FDA) for Voydeya (danicopan) as an add-on therapy to treat extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH). A first-in-class, oral Factor D inhibitor, Voydeya has been developed for patients who continue to suffer from EVH despite treatment with C5 inhibitors such as Ultomiris (ravulizumab) or Soliris (eculizumab). The FDA’s decision is grounded in the positive outcomes of the ALPHA Phase III trial, which demonstrated that Voydeya met its primary endpoint of haemoglobin change from baseline to week 12, alongside all key secondary endpoints. The drug was generally well-tolerated with no new safety concerns. As part of the ALPHA double-blind, placebo-controlled, multiple-dose trial, patients were enrolled and randomised to receive Voydeya or placebo apart from their ongoing Soliris or Ultomiris therapy over 12 weeks. It aimed to assess the superiority of Voydeya as an ...
Mike Hollan The study used technology developed by a variety of companies, including RYLTI. AI digital twins are here. A group of researchers presented the first study to use digital twins created using AI. According to a press release,1 the group consisted of researchers from Genzeva, LumeGene, RYLTI, Brigham & Women’s Hospital of Harvard University, and QIAGEN Digital Insights worked together to bring the digital creations into a study on the molecular mechanisms of endometrial-related disorders. Dr. William G. Kearns, co-founder, CEO, and chief scientific officer at Genzeva and LumaGene, led the study. In a press release, he said, “This landmark study demonstrated a way to combine omics and a digital twin ecosystem to understand the molecular mechanism of disease better. By incorporating Genzeva’s multiomics platform, QIAGEN’s Digital Insight, and RYLTI’s pioneering biomimetic AI platform for genomic analyses we uncovered hidden dark data with insights that may never have been ...
In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
Researchers at Kennedy Krieger Institute and Johns Hopkins Medicine have developed a new, accessible approach to analyze a patient’s walking ability and stances more effectively. Following numerous tests, they determined that a simple video recorded on a personal pocket device, such as a smartphone or tablet, can be used to measure gait at a clinical, high-quality level. Experts say current state-of-the-art approaches to gait analysis are often expensive and inaccessible due to time constraints and extensive efforts required for assessments. However, there is a significant need for this analysis in patients experiencing conditions such as traumatic brain injury, physical injury, or disorders. Through freely available software they created, walking abilities can now be assessed more conveniently, enhancing the comprehensiveness of rehabilitation. Dr. Ryan Roemmich, a research scientist at the Kennedy Krieger Institute, assistant professor of physical medicine and rehabilitation at the Johns Hopkins University School of Medicine, and co-principal investigator ...
On March 25th, Daxing District Government, AstraZeneca, Minhai Biological and other companies signed a strategic cooperation memorandum in Daxing, Beijing, to jointly explore the mode of cooperation in the field of vaccines, and help China’s vaccine innovation products to cooperate and develop at home and abroad. Daxing District’s life and health industry ecosystem has been continuously improved, creating a favorable business environment that attracts foreign investment and strengthens the confidence of global outstanding enterprises in long-term development in Beijing. The strategic cooperation between AstraZeneca and Minhai Biotechnology will further expand the circle of friends and influence of Daxing District’s world-class vaccine industry cluster, and will become a substantive measure for Daxing District to implement the “Action Plan for Attracting and Utilizing Foreign Investments with Greater Efforts by Solidly Pushing Forward the Opening Up of the Country to the Outside World at a High Level”. This time in Beijing Daxing to ...
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 ...
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 ...
Kidney failure poses a significant threat to life if not adequately treated, yet precise diagnosis often eludes patients, leaving them uncertain about the best treatment approach. Now, a groundbreaking advancement by scientists has led to the discovery of a new technique for examining genomic data that could offer an accurate diagnosis for those suffering from unexplained kidney failure. Researchers from Newcastle University (Newcastle upon Tyne, UK) used data from the Genomics England 100,000 Genomes Project to establish a diagnosis for patients facing unexplained kidney failure. They discovered that certain segments of these patients’ genomes were absent, as a result of which their conditions went undiagnosed with standard genetic analysis techniques. The researchers have now identified this missing gene and found the mutations within it, allowing them to classify this as NPHP1-related -related kidney failure. For their study, the team reviewed the genetic sequencing data of 959 individuals with advanced kidney ...
Recently, Chiatai Tianqing received the Certificate of Drug Registration approved and issued by the State Drug Administration (NMPA), in which the company’s product Iopromide Injection in the field of medical imaging was approved to be listed and deemed to have passed the consistency evaluation as the second domestic one. Iopromide injection is a diagnostic drug, which can be used for intravascular and intracorporeal imaging, and is currently widely used in clinical applications and has great potential. Iopromide is a tri-iodinated non-ionic water-soluble X-ray contrast agent with high iodine content and good contrast effect, which is used for computed tomography (CT) enhancement, arteriography and venography, arterial/venous digital subtraction angiography (DSA), cardiovascular angiography, venous urography, endoscopic retrograde cholangiopancreatography (ERCP), arthrocentesis, and other body cavity examinations. Iopromide has the advantages of stable nature, easy to use, lower toxic side effects than ionic iodine contrast agent, good systemic tolerance, etc., and has become a ...
On March 25, CSPC Pharmaceutical Group (1093.HK) announced that the semaglutide injection developed by the group has been approved by the National Medical Products Administration of the People’s Republic of China to conduct the clinical trial in China for weight management indication in overweight or obese adult patients on the basis of calorie diet reduction and increased physical activity. It is also the second indication for this product to be approved for clinical trials after blood sugar control in adults with type 2 diabetes. Semaglutide injection is currently the most significant product in the field of weight loss and is still growing rapidly with broad market prospects. The raw materials used in this product are completely prepared through chemical synthesis, using advanced synthesis, purification and characterization technologies. The raw materials prepared are of higher purity, avoiding host proteins and other immunogenic substances introduced during the biological fermentation process, and ensuring ...
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