Latest news with #Bayer
News.com.au
3 hours ago
- Business
- News.com.au
Liverpool bank on 'world-class' Wirtz after record deal
The golden boy of German football is set to become the new prince of the Premier League after Florian Wirtz joined Liverpool from Bayer Leverkusen for a club-record fee. Fresh from winning a 20th English top-flight title, Arne Slot's Reds have broken the bank to land a rising star already labelled as one of the world's best by former Reds midfielder and Wirtz's former coach Xabi Alonso. British media reported on Friday that the Premier League champions had agreed a deal worth up to £116 million ($157 million) to secure the services of the attacking midfielder. German reports claim the fee is even higher, starting at 130 million euros (£111 million, $149 million) with add-ons taking it to 150 million euros. Wirtz's abundant potential as a teenager sparked a row between his hometown club Cologne and Leverkusen five years ago when Leverkusen, who are backed by pharmaceutical giants Bayer, swooped to sign him at 17. Cologne argued that a gentleman's agreement not to poach youth team players had been violated, but Leverkusen said Wirtz was a first-team signing and within months he had made his Bundesliga debut. His rise was interrupted by a cruciate knee ligament injury in March 2022 that forced him to miss the next 10 months. By the time he returned, Alonso had been installed as Leverkusen boss and together they would spearhead the club's greatest days. Leverkusen ended Bayern Munich's dominance of the Bundesliga in stunning fashion, romping to the title and the German Cup without losing a single match in the 2023/24 season. Wirtz netted his first career hat-trick on the day the title was sealed against Werder Bremen, on his way to being crowned Bundesliga player of the year. "Flo is one of the top players in the world, he's world class," said Real Madrid coach Alonso, who compared his protege to Lionel Messi in terms of his understanding of the game. "Why is Messi so good? Because he knows how and when to play simple passes. Messi says: 'You're in a better position? Here, there you have the ball'," added Alonso, a hero of Liverpool's 2005 Champions League triumph. "It's not always about making the most brilliant move, but the best and smartest. Florian can do that. That's why he's so good." - 'Perfect for me' - Both star player and coach committed to staying with the Leverkusen project for another 12 months, but defeat in the Europa League final to Atalanta to round off the 2023/24 campaign was a sign of things to come. Bayern restored their grip on the German game last season but could not convince Wirtz to follow the lead of many others in joining from their Bundesliga rivals. Instead, he made it clear his preference was a move to the Premier League champions and the chance to add his name to Liverpool's cast of legends. "I'm really excited to have a new adventure in front of me. This was also a big point of my thoughts: that I want to have something completely new, to go out of the Bundesliga and to join the Premier League," said Wirtz. "I spoke also with some players who played there and they told me that it's perfect for me and every pitch is perfect, you can enjoy every game. I'm really looking forward to playing my first game." Despite 57 goals and 65 assists in 197 games for Leverkusen, Wirtz will begin life at Anfield in the shadow of Mohamed Salah. But the Reds are banking on Wirtz's creativity to help maintain the 32-year-old's prolific goalscoring numbers and ease the burden of carrying the Liverpool attack. The club's previous record signing, £85 million recruit Darwin Nunez, has failed to deliver and could be sold to help recoup some of their major outlay on new faces. Liverpool will hope Wirtz can handle the pressure of his price tag and the physicality of the Premier League to ensure there is no second season slump under Slot.
News24
4 hours ago
- Business
- News24
Liverpool bank on ‘world-class' Wirtz after record deal
The golden boy of German football is set to become the new prince of the Premier League after Florian Wirtz joined Liverpool from Bayer Leverkusen for a club-record fee. Fresh from winning a 20th English top-flight title, Arne Slot's Reds have broken the bank to land a rising star already labelled as one of the world's best by former Reds midfielder and Wirtz's former coach Xabi Alonso. British media reported on Friday that the Premier League champions had agreed a deal worth up to £116 million ($157 million) to secure the services of the attacking midfielder. German reports claim the fee is even higher, starting at 130 million euros (£111 million, $149 million) and increasing with add-ons to 150 million euros. Wirtz's abundant potential as a teenager sparked a row between his hometown club Cologne and Leverkusen five years ago when Leverkusen, who are backed by pharmaceutical giants Bayer, swooped to sign him at 17. Cologne argued that a gentleman's agreement not to poach youth team players had been violated, but Leverkusen said Wirtz was a first-team signing, and within months, he had made his Bundesliga debut. His rise was interrupted by a cruciate knee ligament injury in March 2022 that forced him to miss the next 10 months. By the time he returned, Alonso had been installed as Leverkusen boss, and together, they would spearhead the club's greatest days. Leverkusen ended Bayern Munich's dominance of the Bundesliga in stunning fashion, romping to the title and the German Cup without losing a single match in the 2023/24 season. Officially a Red ✍️ — Liverpool FC (@LFC) June 20, 2025 Wirtz netted his first career hat-trick on the day the title was sealed against Werder Bremen, on his way to being crowned Bundesliga player of the year. 'Flo is one of the top players in the world; he's world-class,' said Real Madrid coach Alonso, who compared his protege to Lionel Messi in terms of his understanding of the game. 'Why is Messi so good? Because he knows how and when to play simple passes. Messi says: 'You're in a better position? Here, there you have the ball',' added Alonso, a hero of Liverpool's 2005 Champions League triumph. 'It's not always about making the most brilliant move, but the best and smartest. Florian can do that. That's why he's so good.' Both star player and coach committed to staying with the Leverkusen project for another 12 months, but defeat in the Europa League final to Atalanta to round off the 2023/24 campaign was a sign of things to come. Bayern restored their grip on the German game last season but could not convince Wirtz to follow the lead of many others in joining from their Bundesliga rivals. Instead, he made it clear that his preference was to move to the Premier League champions and to have the chance to add his name to Liverpool's cast of legends. 'I'm really excited to have a new adventure in front of me. This was also a big point of my thoughts: that I want to have something completely new, to go out of the Bundesliga and to join the Premier League,' said Wirtz. 'I spoke also with some players who played there and they told me that it's perfect for me and every pitch is perfect, you can enjoy every game. I'm really looking forward to playing my first game.' Despite 57 goals and 65 assists in 197 games for Leverkusen, Wirtz will begin life at Anfield in the shadow of Mohamed Salah. But the Reds are banking on Wirtz's creativity to help maintain the 32-year-old's prolific goalscoring numbers and ease the burden of carrying the Liverpool attack. The club's previous record signing, £85 million recruit Darwin Nunez, has failed to deliver and could be sold to help recoup some of their major outlay on new faces. Liverpool will hope Wirtz can handle the pressure of his price tag and the physicality of the Premier League to ensure there is no second season slump under Slot.
Yahoo
7 hours ago
- Business
- Yahoo
CHMP recommends third indication for darolutamide for patients with advanced prostate cancer
ORION CORPORATION PRESS RELEASE 20 JUNE 2025 at 13.30 EEST CHMP recommends third indication for darolutamide for patients with advanced prostate cancer CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union. Positive opinion is based on results from the pivotal Phase III ARANOTE trial. Pending approval, this broadened indication would give doctors the option to use darolutamide plus ADT, with or without chemotherapy (docetaxel), offering greater flexibility to tailor treatment plans to meet mHSPC patients' needs. Orion's collaboration partner Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The CHMP recommendation is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC. A final decision on marketing authorisation from the European Commission is anticipated in the coming months. The U.S. Food and Drug Administration (FDA) recently approved darolutamide in combination with ADT for mHSPC in June 2025, making it the first and only in the US and FDA-approved ARi for the treatment of patients with mHSPC, in combination with ADT, with or without chemotherapy. Darolutamide, under the brand name Nubeqa®, is approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. Darolutamide is developed jointly by Orion and Bayer. Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide.1 In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths. 2 Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.3 About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of adverse events in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT. About darolutamide Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and the growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide's low potential for blood-brain barrier penetration. Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were roughly similar to the respective comparator arm. Darolutamide is a treatment option for doctors and patients, considering its tolerability and low risk of drug interaction. A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy. About metastatic hormone-sensitive prostate cancer At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.4,5,6 For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an androgen receptor inhibitor (ARi). Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. References Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed: June 2025. Ferlay J et al. 2024. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available at: Accessed June 2025.. James ND et al. Lancet 2024; 403: 1683–722. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890. Publisher:Orion CorporationCommunicationsOrionintie 1A, FI-02200 Espoo, Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
a day ago
- 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
The Star
3 days ago
- Business
- The Star
Global companies bullish on Chinese market's prospects
Foreign companies, especially those in Europe, are showing growing confidence in China's market potential, as the country's latest economic data underscores a steady recovery in consumption and industrial activity, reaffirming China's appeal as an engine of global growth. World business leaders expressed strong optimism about growth prospects in China, pointing to its vast consumer market, robust investment options in manufacturing and rising innovation capacity as key drivers of new development opportunities for multinational corporations based in Europe and beyond. They reaffirmed their long-term commitment to the Chinese market with plans to further expand investment in the world's second-largest economy, saying that China's steady economic momentum signals long-term potential and broader space for future growth. "China's vast and robust consumer market offers multinational corporations many opportunities, fueled by diversified demand drivers and significant growth potential," said James Zhou, chief commercial officer of Louis Dreyfus Co, a global agribusiness group based in the Netherlands. Roy Jakobs, CEO of Dutch multinational health technology company Royal Philips, also noted signs of stabilization in the Chinese economy, supported by the recovery in consumer activity. "We see consumer confidence and consumer spending rising, which is really encouraging," he said. According to data from the National Bureau of Statistics, China's retail sales grew 6.4 percent year-on-year in May, compared with a 5.1 percent rise in April, making it the fastest pace of growth since late 2023. Despite global uncertainties and rising geopolitical tensions, Jakobs said that Philips remains optimistic about China's prospects, betting on opportunities arising from the country's aging population, continued healthcare reform and rapidly advancing digital ecosystem to drive sustainable business growth. "In the mid- to long-term, we have a very strong outlook on China. We believe China will still be an important driver of global GDP," he said, adding that his company will strengthen its innovation hubs and establish a new one in Beijing. Malu Nachreiner, head of the Region Asia for the Crop Science Division of Bayer, said the Germany-based life sciences enterprise sees promising long-term growth prospects in the Chinese economy. China's steady economic growth indicates great potential for development, thereby providing foreign companies such as Bayer a broader scope for growth in the Chinese market, she said. In early 2025, Bayer launched a new supply center in Hangzhou, Zhejiang province, with an investment of 40 million euros ($46 million). "We are committed to continuing our investments, as we look forward to the opportunities that will arise as the market further opens up," Nachreiner added. French industrial software company Dassault Systemes also reaffirmed its strong commitment to the Chinese market. The company "benefits from China's high-quality development, with the demand driven by digital transformation presenting new opportunities for future business growth", said Zhang Ying, managing director of Dassault Systemes Greater China. Dassault Systemes has established innovation centers in seven cities, including Chongqing, Changchun in Jilin province, and Qingdao in Shandong province, while three more centers are currently under construction. As 2025 marks the company's 20th anniversary in China, "we will further expand our investment", Zhang said. Francisco Veloso, dean of INSEAD business school, said he believes China is poised for long-term growth, led by innovation and entrepreneurship, despite macroeconomic headwinds and rising global uncertainties. - China Daily/ANN
