Latest news with #gadolinium
Yahoo
19-06-2025
- Business
- Yahoo
Bayer Files for Approval of gadoquatrane in the U.S.
FDA submission seeks approval for investigational gadolinium-based contrast agent (GBCA) gadoquatrane for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions for adults and pediatric patients including term neonates Submitted dose corresponds to a 60 percent reduction in gadolinium compared to macrocyclic GBCAs dosed at 0.1 mmol gadolinium per kilogram of body weight Not intended for media outside of the US WHIPPANY, N.J., June 17, 2025--(BUSINESS WIRE)--Bayer today announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates. The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60 percent reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. The submission of gadoquatrane to the US FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The first results from the Phase III QUANTI CNS study were presented at the European Congress of Radiology (ECR) in February of this year and further results are planned to be presented at upcoming scientific meetings. Nearly 40 million MRI scans are performed each year in the United States. "There is a rising need for medical imaging, among others driven by the increasing incidence of chronic diseases such as cancer and cardiovascular diseases," said Dr. Konstanze Diefenbach, Head of Radiology Research & Development, Bayer. "As a leader in radiology, we are committed to advancing innovation in this field, including options to reduce the gadolinium dose. Patients can benefit from a dose reduction, especially patients with chronic conditions who require multiple contrast-enhanced MRI examinations during their lifetime. This is in line with guidance from health authorities and guidelines from scientific bodies which recommend using the lowest dose required to obtain the needed clinical information." Bayer recently announced the submission of gadoquatrane to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, marking the first application for marketing authorization for the investigational contrast agent. Further regulatory applications to health authorities worldwide are planned for the coming months. About the Phase III development program QUANTIThe pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg body weight, which represents a 60 percent lower gadolinium dose compared to macrocyclic contrast agents dosed at 0.1 mmol Gd/kg body weight. QUANTI consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies – QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) – as well as the QUANTI Pediatric study. In total, 808 patients in 15 countries participated in the program. The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane in children is similar to that in adults. The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed. About gadoquatraneGadoquatrane is Bayer's investigational extracellular macrocyclic contrast agent in clinical development for contrast enhancement in MRI. This low dose gadolinium-based contrast agent features a distinct tetrameric structure with high stability and high relaxivity. About MRIWith an estimated 65 million procedures performed annually worldwide, contrast-enhanced MRI plays a key role in the healthcare continuum. MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. About Radiology at BayerBuilding on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer's comprehensive offerings also include informatics solutions and a medical imaging platform with digital and artificial intelligence (AI) powered applications. In 2024, Bayer's radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI. About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. View source version on Contacts Contact for media inquiries: Victoria Vigener, phone +49 151 23438911 Email: Contact for US media inquiries: Jennifer May, phone, 412-656-8192 Email: Find more information at Error al recuperar los datos Inicia sesión para acceder a tu cartera de valores Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos Error al recuperar los datos
Daily Tribune
07-04-2025
- Business
- Daily Tribune
China vows to stay 'safe and promising land' for foreign investment
A top Chinese official has vowed to protect US firms and pledged his country will remain a "promising land" for foreign investment, Beijing said Monday, after it slapped 34 percent tariffs on US imports. China retaliated last week against levies at the same level announced by US President Donald Trump on what he called "liberation day". It also imposed export controls on seven rare earth elements, including gadolinium -- commonly used in magnetic resonance imaging -- and yttrium, which is used in consumer electronics. Vice commerce minister Ling Ji told a panel of US company representatives on Sunday that the tariffs "firmly protect the legitimate rights and interests of enterprises, including American companies", his ministry said. Those levies -- which come into effect on Thursday -- "are aimed at bringing the United States back onto the right track of the multilateral trade system", he told the representatives, including of GE Healthcare and Medtronic. Also present was a representative of electric vehicle giant Tesla, run by close Trump advisor and tech billionaire Elon Musk, who has extensive business interests in China. "The root cause of the tariff issue lies in the United States," Ling said. He urged the firms to "take pragmatic actions to jointly maintain the stability of global supply chains and promote mutual cooperation and win-win outcomes". The United States exported $144.6 billion in goods to China in 2024, much less than the $439.7 billion it imported, Commerce Department data shows. Among its exports, key sectors include electrical and electronic equipment and various fuels, alongside oilseed and grains. Trading floors were overcome by a wave of selling on Monday, in response to the showdown. The selling in Asia was across the board, with no sector unharmed -- tech firms, car makers, banks, casinos and energy firms all felt the pain as investors abandoned riskier assets. Among the biggest losers, Chinese e-commerce titans Alibaba tanked more than 14 percent and rival shed 13 percent, while Japanese tech investment giant SoftBank dived more than 10 percent and Sony gave up 9.6 percent.
Yahoo
07-04-2025
- Business
- Yahoo
China vows to stay 'safe and promising land' for foreign investment
A top Chinese official has vowed to protect US firms and pledged his country will remain a "promising land" for foreign investment, Beijing said Monday, after it slapped 34 percent tariffs on US imports. China retaliated last week against levies at the same level announced by US President Donald Trump on what he called "liberation day". It also imposed export controls on seven rare earth elements, including gadolinium -- commonly used in magnetic resonance imaging -- and yttrium, which is used in consumer electronics. Vice commerce minister Ling Ji told a panel of US company representatives on Sunday that the tariffs "firmly protect the legitimate rights and interests of enterprises, including American companies", his ministry said. Those levies -- which come into effect on Thursday -- "are aimed at bringing the United States back onto the right track of the multilateral trade system", he told the representatives, including of GE Healthcare and Medtronic. Also present was a representative of electric vehicle giant Tesla, run by close Trump advisor and tech billionaire Elon Musk, who has extensive business interests in China. "The root cause of the tariff issue lies in the United States," Ling said. He urged the firms to "take pragmatic actions to jointly maintain the stability of global supply chains and promote mutual cooperation and win-win outcomes". The United States exported $144.6 billion in goods to China in 2024, much less than the $439.7 billion it imported, Commerce Department data shows. Among its exports, key sectors include electrical and electronic equipment and various fuels, alongside oilseed and grains. Trading floors were overcome by a wave of selling on Monday, in response to the showdown. The selling in Asia was across the board, with no sector unharmed -- tech firms, car makers, banks, casinos and energy firms all felt the pain as investors abandoned riskier assets. Among the biggest losers, Chinese e-commerce titans Alibaba tanked more than 14 percent and rival shed 13 percent, while Japanese tech investment giant SoftBank dived more than 10 percent and Sony gave up 9.6 percent. ll-oho/je/dhw
Dubai Eye
05-04-2025
- Business
- Dubai Eye
China to impose tariffs of 34% on all US goods
China has announced a slew of additional tariffs and restrictions against US goods as a countermeasure to sweeping tariffs imposed by US President Donald Trump. The Finance Ministry said it would impose additional tariffs of 34 per cent on all US goods from April 10. Beijing also announced controls on exports of medium and heavy rare-earths, including samarium, gadolinium, terbium, dysprosium, lutetium, scandium and yttrium to the United States, effective April 4. "The purpose of the Chinese government's implementation of export controls on relevant items in accordance with the law is to better safeguard national security and interests, and to fulfill international obligations such as non-proliferation," the Commerce Ministry said in a statement. It also added 11 entities to the "unreliable entity" list, which allows Beijing to take punitive actions against foreign entities.
Egypt Independent
04-04-2025
- Business
- Egypt Independent
China retaliates against Trump's trade war
China said on Friday it will impose reciprocal 34% tariffs on all imports from the United States from April 10, making good on a promise to strike back after US President Donald Trump escalated a global trade war. On Wednesday, Trump unveiled an additional 34% tariffs on all Chinese goods imported into the US, in a move poised to cause a major reset of relations and worsen trade tension between the world's two largest economies. 'This practice of the US is not in line with international trade rules, seriously undermines China's legitimate rights and interests, and is a typical unilateral bullying practice,' China's State Council Tariff Commission said in a statement announcing its retaliatory tariffs. Since returning to power in January, Trump had already levied two tranches of 10% additional duties on all Chinese imports, which the White House said was necessary to stem the flow of illicit fentanyl from the country to the US. That means Chinese goods arriving in the US would be effectively subject to 54% tariffs. China's retaliation against the latest round of US tariffs are more sweeping than its earlier reciprocal actions. Beijing had responded to those previous levies swiftly, but moderately, imposing retaliatory tariffs on targeted US imports including agricultural products and fuel, while taking action against certain American firms and ramping up export controls. The 54% tariffs are higher than what many analysts had expected and could fundamentally reshape relations, and roughly half a trillion dollars in trade, between the two economies after decades of interdependence. As part of the retaliatory measures announced Friday, when hundreds of millions of people in China celebrated a major public holiday, the country also added 11 American companies to its 'unreliable entity list,' including drone manufacturers, and put export controls on 16 American companies to prohibit the export of Chinese dual-use items. The Commerce Ministry announced anti-dumping investigations into imported medical CT X-ray tubes originating from the United States and India. In addition, Beijing also unveiled export controls on seven types of rare-earth minerals to the US, including samarium, gadolinium and terbium. The challenges are multifold for businesses with supply chains rooted in China, which are now left scrambling as they face not only the unexpectedly high US levies on Chinese imports, but also on other Asian countries due to Trump's broad-based tariffs. The tariffs also come at a challenging time for China's own slowing economy, with officials in recent weeks ramping up efforts to spur weak domestic consumption as they braced for the widening trade war. US stock futures plunged Friday after China announced it would retaliate. Dow futures fell 1,000 points, or 2.3%. The broader S&P 500 was set to open 2.4% lower and the tech-heavy Nasdaq Composite was on pace to start the day 2.7% lower. European and UK stocks were down more than 3% Friday, on pace for their worst performance in years. Markets have been on edge for days: On Thursday, the Dow fell more than 1,600 points, or nearly 4%. The S&P 500 fell nearly 5% and the Nasdaq plunged nearly 6%. Each major US index recorded its worst performance in about five years, since the pandemic. This is a developing story and will be updated.
