Glidewell Welcomes Dr. Bushra Imam as Director of Education and Integration
Accomplished digital dentistry expert aims to optimize full-arch implant workflows for both the lab and clinicians.
IRVINE, CA / ACCESS Newswire / May 30, 2025 / Glidewell is proud to further its commitment to helping clinicians excel in full-arch implant solutions with the addition of Dr. Bushra Imam to the Glidewell Implant Department.Dr. Bushra Imam
Dr. Imam is a general practitioner who brings nearly 15 years of experience in the full-arch implant and digital dentistry field. Her legacy is rooted in helping dentists find synergy between the surgical and restorative phases of implant dentistry, specifically focusing on patient-centric techniques and a minimally invasive treatment approach. Dr. Imam has become an authority in her field, collaborating and lecturing with leading clinicians, as well as working with top companies in the industry.
'I'm excited to spearhead a renewal of the Glidewell Implant Department while serving as Director of Education and Integration,' said Dr. Imam. 'The capabilities of Glidewell's lab make it one of the easiest to work with for dental restorations of any kind, and we will continue to improve based on doctor feedback.'
Dr. Imam joined Glidewell in January 2025 with a mission to expand and refine the lab's support for both digital and analog workflows. Under her leadership, Glidewell now supports a wide range of full-arch workflows, including photogrammetry, Shining 3D intraoral photogrammetry, OPTISPLINT® verification jigs, and Inclusive® Full-Arch Scan Bodies. A fully integrated comprehensive workflow - from same-day provisional delivery on the day of surgery to final prosthesis - will soon be available, complete with stackable surgical guides that enhance precision and predictability.
'Glidewell has long been a trusted provider of full-arch implant solutions,' said Dzevad Ceranic, executive vice president of lab operations at Glidewell. 'With Dr. Imam's expertise, we're doubling down on innovation to help clinicians achieve outstanding surgical and restorative outcomes.'
These advancements reinforce Glidewell's mission to empower dentists with the tools and support needed to deliver world-class care. For more information, visit glidewell.com.
All third-party trademarks are property of their respective owners.
Contact InformationEldon Thompson Sr. Director of Marketing
SOURCE: Glidewell
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26 minutes ago
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U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer
NUBEQA® is the first and only androgen receptor inhibitor (ARi) approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC) with or without chemotherapy. Approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated NUBEQA plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 46% compared to placebo plus ADT. These results were consistent with the established safety profile of NUBEQA. WHIPPANY, N.J., June 03, 2025--(BUSINESS WIRE)--Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001).1 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial was designed to assess the efficacy and safety of NUBEQA plus ADT in patients with mCSPC.1 A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (N=446) or placebo (N=223) twice daily in addition to ADT.1 NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2 "Clinical data from the ARANOTE trial supporting this new regimen showed that NUBEQA plus ADT demonstrated powerful efficacy in men with mCSPC," said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM) and principal investigator of the ARANOTE trial. "Today's approval further expands physicians' options for using NUBEQA with and without docetaxel in this setting, providing a potential new choice for patients." Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 in the U.S., and about 375,000 men died from the disease worldwide.4,5 Prostate cancer diagnoses are projected to increase to 2.9 million worldwide by 2040.6 "This approval, which is supported by strong clinical data, reaffirms NUBEQA as an important therapy for men with prostate cancer and underscores our commitment to delivering meaningful outcomes for patients and their families," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "We thank the scientists, doctors, patients and their families who made it possible to provide this new treatment option for metastatic castration-sensitive prostate cancer." Results from the Phase III ARANOTE trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology.1 Results of the radiographic progression-free survival (rPFS) analysis were consistent across prespecified subgroups, including a 40% risk reduction (HR 0.60, 95% CI: 0.44-0.80) with NUBEQA plus ADT in patients with high-volume mCSPC and a 70% risk reduction (HR 0.30, 95% CI: 0.15-0.60) in patients with low-volume disease.1 The results were consistent with the established safety profile of NUBEQA. Rates of serious adverse events were similar between the treatment arms (24% for NUBEQA plus ADT compared to 24% for placebo plus ADT).1,2 Discontinuation due to treatment-emergent adverse events (TEAEs) was 6% for patients treated with NUBEQA plus ADT compared to 9% in patients receiving placebo plus ADT.1,2 About the ARANOTE Trial7 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial study assessed the efficacy and safety of NUBEQA plus ADT in patients with mCSPC. A total of 669 patients were randomized to receive 600 mg of NUBEQA twice daily or matching placebo in addition to ADT. The primary endpoint was rPFS, measured as time from randomization to date of first documented radiographic progressive disease or death due to any cause, whichever occurs first. About NUBEQA® (darolutamide)2 NUBEQA® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic castration-sensitive prostate cancer (mCSPC) Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%). In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%). In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%). Drug Interactions Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed. Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information. About Metastatic Castration-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 men in the U.S., and nearly 375,000 men died from the disease worldwide.4,5 At the time of diagnosis, most men have localized prostate cancer, in which their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this castration-sensitive, or hormone-sensitive, disease. Approximately 10% of men will already present with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), when first diagnosed.8,9,10 Men with mCSPC will start their treatment with hormone therapy, such as ADT, an androgen receptor inhibitor (ARi) plus ADT, or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer (CRPC), which is associated with limited survival.11,12 About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 BayerBAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This 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. References Saad F, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the Phase III ARANOTE trial. J Clin Onc. 2024;42(36):4271-4281. NUBEQA® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; June 2025. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed June 2025. Prostate Cancer: Statistics. Accessed June 2025. American Cancer Society. Cancer Facts & Figures 2024. Accessed June 2025. James ND, et al. The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet. 2024;403:1683-1722. NCT04736199. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Accessed June 2025. Piombino C, et al. De novo metastatic prostate cancer: are we moving toward a personalized treatment? Cancers (Basel). 2023;15(20):4945. Helgstrand JT, et al. Trends in incidence and 5-year mortality in men with newly diagnosed, metastatic prostate cancer - A population-based analysis of 2 national cohorts. Cancer. 2018;124(14):2931-2938. Buzzoni C, et al. Metastatic prostate cancer incidence and prostate-specific antigen testing: new insights from the European Randomized Study of Screening for Prostate Cancer. Eur Urol. 2015;68:885-890. Siegel DA, et al. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020;69:1473-1480. Hahn AW, et al. Metastatic castration sensitive prostate cancer: optimizing patient selection and treatment. Am Soc Clin Oncol Educ Book. 2018;23;38:363-371. View source version on Contacts Media: Polina Miklush, Tel +1 862.431.8817Email: Error 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
Business Wire
28 minutes ago
- Business Wire
U.S. FDA Approves NUBEQA ® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor (ARi) NUBEQA ® (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), which is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which demonstrated a significant reduction of 46% in the risk of radiographic progression or death (rPFS) for those treated with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT (hazard ratio [HR] 0.54; 95% CI 0.41-0.71; p<0.0001). 1 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial was designed to assess the efficacy and safety of NUBEQA plus ADT in patients with mCSPC. 1 A total of 669 patients were randomized 2:1 to receive either 600 mg of NUBEQA (N=446) or placebo (N=223) twice daily in addition to ADT. 1 NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). 2 'Clinical data from the ARANOTE trial supporting this new regimen showed that NUBEQA plus ADT demonstrated powerful efficacy in men with mCSPC,' said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM) and principal investigator of the ARANOTE trial. 'Today's approval further expands physicians' options for using NUBEQA with and without docetaxel in this setting, providing a potential new choice for patients.' Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. 3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 in the U.S., and about 375,000 men died from the disease worldwide. 4,5 Prostate cancer diagnoses are projected to increase to 2.9 million worldwide by 2040. 6 'This approval, which is supported by strong clinical data, reaffirms NUBEQA as an important therapy for men with prostate cancer and underscores our commitment to delivering meaningful outcomes for patients and their families,' said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. 'We thank the scientists, doctors, patients and their families who made it possible to provide this new treatment option for metastatic castration-sensitive prostate cancer.' Results from the Phase III ARANOTE trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncolog y. 1 Results of the radiographic progression-free survival (rPFS) analysis were consistent across prespecified subgroups, including a 40% risk reduction (HR 0.60, 95% CI: 0.44-0.80) with NUBEQA plus ADT in patients with high-volume mCSPC and a 70% risk reduction (HR 0.30, 95% CI: 0.15-0.60) in patients with low-volume disease. 1 The results were consistent with the established safety profile of NUBEQA. Rates of serious adverse events were similar between the treatment arms (24% for NUBEQA plus ADT compared to 24% for placebo plus ADT). 1,2 Discontinuation due to treatment-emergent adverse events (TEAEs) was 6% for patients treated with NUBEQA plus ADT compared to 9% in patients receiving placebo plus ADT. 1,2 About the ARANOTE Trial 7 The randomized, double-blind, placebo-controlled Phase III ARANOTE trial study assessed the efficacy and safety of NUBEQA plus ADT in patients with mCSPC. A total of 669 patients were randomized to receive 600 mg of NUBEQA twice daily or matching placebo in addition to ADT. The primary endpoint was rPFS, measured as time from randomization to date of first documented radiographic progressive disease or death due to any cause, whichever occurs first. About NUBEQA ® (darolutamide) 2 NUBEQA ® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic castration-sensitive prostate cancer (mCSPC) Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo. In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – Seizure occurred in patients receiving NUBEQA. In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%). In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%). In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%). Drug Interactions Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed. Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and C max of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information. About Metastatic Castration-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. 3 In 2020, an estimated 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 men in the U.S., and nearly 375,000 men died from the disease worldwide. 4,5 At the time of diagnosis, most men have localized prostate cancer, in which their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this castration-sensitive, or hormone-sensitive, disease. Approximately 10% of men will already present with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), when first diagnosed. 8,9,10 Men with mCSPC will start their treatment with hormone therapy, such as ADT, an androgen receptor inhibitor (ARi) plus ADT, or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer (CRPC), which is associated with limited survival. 11,12 About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This 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. References Saad F, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the Phase III ARANOTE trial. J Clin Onc. 2024;42(36):4271-4281. NUBEQA ® (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; June 2025. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Accessed June 2025. Prostate Cancer: Statistics. Accessed June 2025. American Cancer Society. Cancer Facts & Figures 2024. Accessed June 2025. James ND, et al. The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet. 2024;403:1683-1722. NCT04736199. Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE). Accessed June 2025. Piombino C, et al. De novo metastatic prostate cancer: are we moving toward a personalized treatment? Cancers (Basel). 2023;15(20):4945. Helgstrand JT, et al. Trends in incidence and 5-year mortality in men with newly diagnosed, metastatic prostate cancer - A population-based analysis of 2 national cohorts. Cancer. 2018;124(14):2931-2938. Buzzoni C, et al. Metastatic prostate cancer incidence and prostate-specific antigen testing: new insights from the European Randomized Study of Screening for Prostate Cancer. Eur Urol. 2015;68:885-890. Siegel DA, et al. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020;69:1473-1480. Hahn AW, et al. Metastatic castration sensitive prostate cancer: optimizing patient selection and treatment. Am Soc Clin Oncol Educ Book. 2018;23;38:363-371.
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Telix Manufacturing Solutions (TMS) Established in Yokohama, Japan
MELBOURNE, Australia and KYOTO, Japan, June 4, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that it has established Telix Manufacturing Solutions (TMS) in Yokohama, Japan. Telix's first cyclotron facility in the Asia Pacific region represents a significant milestone in the Company's global manufacturing strategy. TMS Yokohama will serve as a hub for commercial and clinical supply, and future research and development in the region. It expands Telix's global production network which includes in-house and partner facilities. Originally opened in 2018, the site comprises a cyclotron and multiple production hot cells and was designed and built by JFE Engineering Corporation (JFE) as the Contract Manufacturing Organization (CMO) for TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) in Japan and China, including for the ZIRCON-CP study[2]. Taking over the lease and operational management of this facility will provide greater control over existing clinical supply with the possibility to expand production to other Telix investigational and future commercial products in the region, including Illuccix® (TLX591-CDx, 68Ga-PSMA-11) and Pixclara®1 (TLX101-CDx, 18F-floretyrosine) for Greater Tokyo, and TLX591 (177Lu rosopatamab tetraxetan) for the Asia Pacific region. Further, the Company plans to install Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology, which it believes will facilitate standardized, high-efficiency and cost-effective production of commercially important medical isotopes. Darren Patti, Group Chief Operating Officer, Telix said, "We are pleased to announce Telix's first cyclotron facility in the Asia Pacific region, strategically located in Japan — the world's second-largest nuclear medicine market. TMS Yokohama enhances our capacity to meet growing demand in the region and supports our mission to provide patients with access to advanced diagnostic and therapeutic radiopharmaceuticals." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[1], by the Australian Therapeutic Goods Administration (TGA)[2], by Health Canada[3], by the Brazilian Health Regulatory Agency (ANVISA)[4], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[5], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[6] and in multiple countries within the European Economic Area (EEA)[7] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[8]. TLX250-CDx, TLX101-CDx and TLX591 have not received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: [1] Telix ASX disclosure 20 December 2021. [2] Telix ASX disclosure 2 November 2021. [3] Telix ASX disclosure 14 October 2022. [4] Telix ASX disclosure 18 March 2025. [5] Telix ASX disclosure 13 February 2025. [6] Telix media release 29 April 2025. [7] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. [8] Telix ASX disclosure 17 January 2025. Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. View original content to download multimedia: SOURCE Telix Pharmaceuticals Limited Sign in to access your portfolio
