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FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension

Davy James Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies. The FDA has approved Idorsia Ltd’s Tryvio (aprocitentan) to reduce hypertension in combination with other antihypertensive drugs in adults whose blood pressure is not adequately controlled by other therapies. Tryvio is an endothelin receptor antagonist that interferes with the binding of endothelin (ET)-1 to ETA and ETB receptors.1 “Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies. This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events,” Jean-Paul Clozel, MD, CEO of Idorsia said in a press release. “In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a ...
- Source: drugdu
- 107
- March 22, 2024
Startup Lands $150M for Delicate Dance Between Cancer Cells & Immune Cells

Clasp Therapeutics’ novel T cell engagers could offer advantages over others in this class of cancer immunotherapies. The startup is based on the research of Johns Hopkins University scientist Bert Vogelstein. By FRANK VINLUANCancer immunotherapy comes in several forms, and one area of growing research interest is a type of drug called a T cell engager. These drugs bind to a cancer cell and a T cell simultaneously, bringing both of them together to spark a therapeutic effect. Robert Ross, CEO of Clasp Therapeutics, likens T cell engagers to the chaperone at a middle school dance who grabs a boy and a girl in each hand, getting them to dance together. But in cancer drugs, just as in school dances, sometimes the pairing just isn’t right. The wrong pairing in cancer happens when a drug that’s targeted to a tumor also hits healthy cells, causing toxic effects. Clasp is developing ...
- Source: drugdu
- 101
- March 22, 2024
Henlius’ Trastuzumab Approved in Brazil, a Semi-Exclusive License Area, in Latin America

Recently, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), independently developed and manufactured by Henlius, has been approved to be marketed in Brazil for the treatment of HER2-positive breast cancer and gastric cancer. To date, the product has been approved for marketing in more than 40 countries and regions worldwide. Following the commercialization of HANQUYOU in Argentina, the approval of HANQUYOU in Brazil, the largest economy and the most populous country in Latin America, has become another anchor point for Henlius’ continuous global commercial expansion. Latin America and the Caribbean comprises 33 countries and regions with a total population of close to 660 million as of 2022 and a per capita GDP of close to $10,000 per capita [1]. In Latin America, breast and gastric cancers are the most and fifth most prevalent malignancies, respectively. The total number of new cases of breast and gastric cancer in the region in 2022 ...
- Source: drugdu
- 110
- March 22, 2024
WuXi Biologics Breaks Ground on CRDMO Center in Singapore

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 ...
- Source: drugdu
- 190
- March 22, 2024
Researchers suggest treatments for rare diseases could reduce burden of kidney disease

Rare kidney diseases are a group of conditions which account for over 5% of people living with chronic kidney disease A new study led by University College London (UCL) and the UK Kidney Association has suggested that treatments for rare diseases could significantly reduce the burden of kidney disease for patients and the NHS. Published in The Lancet in alignment with World Kidney Day (14 March 2024), the study draws on the largest kidney disease dataset ever created, the UK’s National Registry of Rare Kidney Disease (RaDaR). Affecting over seven million adults, according to Kidney Research UK, chronic kidney disease (CKD) is characterised by the gradual loss of kidney function over a period of months to years. Rare kidney diseases such as cystinosis and Fabry disease are a group of conditions that affect less than one in 2,000 people, accounting for over 5% of people with CKD. Researchers charted the ...
- Source: drugdu
- 84
- March 22, 2024
New study reveals neurological conditions as leading cause of ill health worldwide

In 2021, neurological conditions, including Alzheimer’s disease, affected approximately 3.4 billion people globally In a new study funded by the Bill & Melinda Gates Foundation, results published in the Lancet Neurology have determined that neurological conditions are currently the leading cause of ill health worldwide. Results showed that the biggest contributors to neurological health loss globally were stroke, neonatal encephalopathy, migraine, Alzheimer’s disease and other dementias, and diabetic neuropathy. Affecting 3.4 billion people globally in 2021, neurological conditions are any conditions that affect the brain, spinal cord and nerves, which can affect anyone at any age. The study revealed that the number of people globally living with or dying from neurological conditions has drastically risen in the past three decades, partially due to ageing societies. Worldwide, the analysis suggests that the total amount of disability, illness and premature death caused by neurological conditions increased by 18% between 1990 and 2021. ...
- Source: drugdu
- 135
- March 22, 2024
Everest Medicines Announces Singapore Health Sciences Authority Approves NEFEGAN® for the Treatment of Primary IgA Nephropathy in Adult Patients

Shanghai, China – March. 20, 2024 — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health Sciences Authority (HSA) has approved NEFEGAN® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. NEFEGAN®, known in other Everest territories as Nefecon®, was the first ever treatment for IgAN fully approved by the U.S. Food and Drug Administration, and Singapore marks the third region in Everest territories that received New Drug Application (NDA) approval after Macao and mainland China. “The NDA approval in Singapore marks an important event for IgAN patients in the region as we continue to expand patient access to Nefecon® throughout Asia, an area of high IgAN disease prevalence,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Following approval of ...
- Source: drugdu
- 99
- March 22, 2024
Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run. During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said: “The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.” The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by ...
- Source: drugdu
- 120
- March 22, 2024
Blood Test Identifies Individuals at Highest Risk of Dying From Heart Failure

Heart failure is a serious condition where the heart is unable to pump blood effectively throughout the body, leading to frequent hospital stays and a decline in quality of life. A protein known as neuropeptide Y (NPY) is produced by nerves in the heart under severe stress. NPY can cause dangerous heart rhythms and narrow the heart’s smallest blood vessels, forcing the heart to work harder and narrowing the arteries that supply blood to the heart. Now, a new study has found that measuring NPY levels could predict the progression of heart failure, paving the way for a blood test to assist in managing heart failure treatment within the next five years. The collaborative study by researchers at the University of Oxford (Oxford, UK) and University of Glasgow (Scotland, UK) found that patients with the highest NPY levels had a 50% greater chance of dying from heart complications within three ...
- Source: drugdu
- 101
- March 21, 2024
Improved Microneedle Technology Speeds Up Extraction of Sample Interstitial Fluid for Disease Diagnosis

Interstitial fluid has many similarities with blood, and its secrets are still being uncovered. A microneedle offers a minimally invasive method to sample this fluid directly under the skin. This tool allows for real-time and continuous monitoring of biomarkers circulating in the body. Despite their small size, just two to three times the width of a human hair and around a millimeter in length, microneedles can make a significant difference in early infection diagnosis and personal health monitoring. Now, researchers have developed improved microneedle technology that enhances the extraction of interstitial fluid by collecting more sample quantities in less time. Sandia National Laboratories (Albuquerque, NM, USA) is leading the way in microneedle research through collaboration with different partners to enhance this technology. Sandia has achieved a breakthrough in interstitial extraction, moving from using multiple needle arrays to a single microneedle technique that collects enough fluid for analysis in just about ...
- Source: drugdu
- 91
- March 21, 2024

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