- US gets rare earth reprieve from China, but not rollback Reuters
- China to Suspend Some Export Curbs as Trump Cuts Fentanyl Tariffs: Live News Bloomberg.com
- Is MP Materials’ Recent 292% Gain Justified After Strategic Supply Agreements? simplywall.st
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- Trump-Xi sign rare earths deal: What is it and why is it so important? The Indian Express
Category: 3. Business
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US gets rare earth reprieve from China, but not rollback – Reuters
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Clean Energy Trade and Emerging Markets: the Impact of Tariffs on the Energy Transition
Emerging economies are expanding deployment of clean energy while seeking to strengthen domestic manufacturing of key technologies. As they pursue those goals, some nations are plotting higher import tariffs to protect local firms – a move that sits uneasily with rising clean-tech imports and which could increase the cost of the energy transition.
The Clean Energy Trade and Emerging Markets report – produced by BloombergNEF and commissioned by Bloomberg Philanthropies – assesses how trade and industrial policy are reshaping flows of clean technology. It examines electric vehicles (EVs), batteries, solar products and wind turbines to help policymakers weigh the trade-offs between industrial strategy and decarbonization.
Industrial policy is enjoying a global revival. China sits at the center of clean-tech manufacturing – hosting at least 80% of capacity across major parts of the solar and battery supply chains – and it is against this backdrop that governments are seeking to strengthen their own industrial capacity.
Exports from China to Asia, Africa and Latin America are booming, with low-cost solar panels, batteries and EVs helping accelerate the energy transition in power generation, storage and transport. Clean-tech imports are reshaping markets – from record solar installations in Pakistan to an influx of EVs in Brazil.
Over 2022 to August 2025, China’s share of clean-tech exports to emerging economies rose from 23% to 31%. Low tariffs have supported that growth, but that openness is prompting concern among policymakers outside China seeking to build domestic industries. Several large developing countries are now considering higher import duties.
Rising trade barriers, however, present a delicate balancing act. BloombergNEF analysis finds that imposing higher tariffs could significantly increase the cost of achieving clean-power goals. Under an “extreme” scenario – where solar modules face 100% import duties and batteries 50% – the total cost of meeting the 2030 “tripling renewables” targets across eight regions would rise by at least $137 billion, or 16%. With higher financing costs and narrower margins, emerging markets are particularly sensitive to such cost increases.
Tariffs can help attract investment, diversify supply chains and build local value – but they also risk slowing clean-tech deployment, raising costs and delaying decarbonization. Striking the right balance between industrial ambition and low-cost clean technology will be one of the defining policy questions of the decade.
Download the report here.
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Fresenius Medical Care highlights real-world advances in hemodiafiltration and AI at ASN Kidney Week 2025
- Fresenius Medical Care researchers will present multiple abstracts that demonstrate proven, real-world benefits of hemodiafiltration (HDF), with one accepted as an oral presentation.
- Oral presentation highlights the association between HDF and reduced risk of cardiovascular and fluid-related hospitalization outcomes.
- Research shows how artificial intelligence is moving from theory into practice, supporting clinicians and patients in daily kidney disease care.
Bad Homburg (October 30, 2025) – Fresenius Medical Care AG (FME), the world’s leading provider of products and services for people with kidney diseases, will present new research showing how hemodiafiltration (HDF) is associated with improved outcomes for kidney patients and how innovations in artificial intelligence (AI) can support clinicians in daily care at the American Society of Nephrology (ASN) Kidney Week 2025, November 5-9 in Houston.“This research reflects Fresenius Medical Care’s commitment to patient-centered innovation, demonstrating how advanced therapies like hemodiafiltration can be tailored to improve outcomes in real-world settings,” said Frank Maddux, MD, Global Chief Medical Officer at Fresenius Medical Care. “By applying novel physical principles to kidney replacement therapy, we are leading the field in delivering transformative solutions that elevate the standard of care and advance precision medicine globally.”
FME’s Global Medical Office will present multiple abstracts across a range of critical topics in nephrology, underscoring the company’s commitment to advancing kidney care through innovation and evidence-based science.
Key presentations include:
- Hemodiafiltration is associated with reduced risk of cardiovascular and fluid-related hospitalization outcomes: Highlights how HDF may lower the risk of cardiovascular- and fluid-related hospitalizations.
- Implementation of Online High-Volume Hemodiafiltration in a Chronic Hemodialysis Center in the U.S.: Describes the first chronic dialysis unit to introduce high-volume HDF in the U.S.
- Preventing Falls in Patients on Dialysis Through Artificial Intelligence (AI)-Driven Risk Prediction: Showcases an AI model that predicts patients’ fall risk within a 31-day period.
- Supporting Clinician Adoption of Hemodiafiltration: A Real-Time Artificial Intelligence (AI) Chatbot with Verified Clinical Sources: Introduces a clinician-facing AI chatbot designed to educate and support clinicians implementing HDF.
- From Prompt to Plate: Can ChatGPT Plan a Safe and Clinically Appropriate Diet for Hemodialysis Patients?: Evaluates whether generative AI and large language models can provide safe, nutritionally accurate meal plans for dialysis patients.
“It excites us to see how our research and innovation can translate to everyday practice,” said Maddux. “By combining real-world evidence with innovative technologies, Fresenius Medical Care is helping shape the future of nephrology and set new standards for kidney care.”
In addition to scientific presentations, FME will participate in the following events during ASN Kidney Week:
- FME will host a breakfast symposium, “HighVolumeHDF: The Next Standard of Care for U.S. Patients – Evidence and Practical Use,” as part of the ASN Exhibitor Spotlight series (Thursday, November 6).
- ASN will present an educational symposium, “Hemodiafiltration: Considerations for Incorporation into Dialysis Care,” supported by an educational grant from Fresenius Medical Care (Friday, November 7).
- The Renal Research Institute (RRI), a subsidiary of Fresenius Medical Care, will host its annual symposium, “Reimagining Frontline Care: The Power of Research, AI, and Innovation,” highlighting real-world applications of AI and digital tools in kidney care (Tuesday, November 4).
FME leaders and researchers will also be available onsite at Booth #1815 to discuss research insights, clinical collaborations, and innovations in kidney care. Representatives from RRI will be available at Booth #1838.
To learn more about the company’s presence at ASN this year, please visit https://freseniusmedicalcare.com/en-us/asn-2025/.
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Study finds EVs quickly overcome their energy-intensive build to be cleaner than gas cars
DETROIT — Making electric vehicles and their batteries is a dirty process that uses a lot of energy. But a new study says that EVs quickly make up for that with less overall emissions through two years of use than a gas-powered vehicle.
The study also estimated that gas-powered vehicles cause at least twice as much environmental damage over their lifetimes as EVs, and said the benefits of EVs can be expected to increase in coming decades as clean sources of power, such as solar and wind, are brought onto the grid.
The work by researchers from Northern Arizona University and Duke University, published Wednesday in the journal PLOS Climate, offers insight into a transportation sector that makes up a big part of U.S. emissions. It also comes as some EV skeptics have raised concerns about whether the environmental impact of battery production, including mining, makes it worthwhile to switch to electric.
“While there is a bigger carbon footprint in the very short term because of the manufacturing process in creating the batteries for electric vehicles, very quickly you come out ahead in CO2 emissions by year three and then for all of the rest of the vehicle lifetime, you’re far ahead and so cumulatively much lower carbon footprint,” said Drew Shindell, an earth science professor at Duke University and study co-author.
The researchers evaluated several harmful air pollutants monitored by the Environmental Protection Agency, as well as emissions data, to compare the relative impact over time of EVs and internal combustion engines on air quality and climate change.
Their analysis said that EVs produce 30% higher carbon dioxide emissions than gasoline vehicles in their first two years. That can be attributed to the energy-intensive production and manufacturing processes involved in mining lithium for EV batteries.
They also sought to account for how the U.S. energy system might develop in coming years, assuming growth in clean energy. And they modeled four different scenarios for EV adoption, ranging from the lowest — a 31% share of vehicle sales — to the highest, 75% of sales, by 2050. (EV sales accounted for about 8% of new vehicle sales in the U.S. in 2024.)
The researchers said the average of those four models found that for each additional kilowatt hour of lithium-ion battery output, carbon dioxide emissions drop by an average of 220 kilograms (485 pounds) in 2030, and another 127 kilograms (280 pounds) in 2050.
The consistent decrease in CO2 emissions from EVs is “not only driven by the on-road vehicles, but also reduction that has been brought due to electricity production,” said lead author Pankaj Sadavarte, a postdoctoral researcher at Northern Arizona University.
Greg Keoleian, a University of Michigan professor of sustainable systems who wasn’t involved in the research, called it a “valuable study” that echoes other findings and “confirms the environmental and economic benefits” of EVs.
“Accelerating the adoption of battery electric vehicles is a key strategy for decarbonizing the transportation sector which will reduce future damages and costs of climate change,” he said.
Shindell, the Duke researcher, said the grid will evolve to have more solar and wind power.
“When you add a bunch of electric vehicles, nobody’s going to build new coal-fired power plants to run these things because coal is really expensive compared to renewables,” he said. “So the grid just overall becomes much cleaner in both the terms of carbon emissions for climate change, and for air pollution.”
Outside experts agreed — as long as the policy landscape supports it. That hasn’t been the case under President Donald Trump, who has worked to boost fossil fuels and restrain solar and wind power development.
“The great news is the rest of the world isn’t slowing down in terms of its embrace of this technology,” said Ellen Kennedy, principal for carbon-free transportation at RMI, a clean energy nonprofit. As for the U.S., she said, “I think it’s important to keep in mind states and local governments, there’s a lot that’s happening on those fronts.”
One thing the study didn’t address was recycling or disposal of batteries at the end of their life. Kennedy said battery recycling will improve, helping to address one of the environmental impacts of their production.
The study comes at a notable time given the challenges that EVs face in the U.S.
EVs have seen more interest in recent years as an alternative to gas-powered cars and trucks — particularly as they become more affordable and charging infrastructure becomes more available.
But growth has slowed amid shifting federal policy toward EVs and an industry step back from ambitious EV production promises.
Former President Joe Biden set a target for 50% of all new vehicle sales in the U.S. to be electric by 2030. But Trump reversed that policy, and Congress has terminated federal tax credits for an EV purchase. The administration has also targeted vehicle pollution rules that would encourage greater uptake of EVs in the U.S., and the president has attempted to halt a nationwide EV charging buildout.
“The study is important to show how really misguided the current administration’s policies are,” Shindell said. “If we want to protect us from climate change and from the very clear and local damage from poor air quality, this is a really clear way to do it: Incentivize the switch from internal combustion engines to EVs.”
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Alexa St. John is an Associated Press climate reporter. Follow her on X: @alexa_stjohn. Reach her at ast.john@ap.org.
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Read more of AP’s climate coverage.
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The Associated Press’ climate and environmental coverage receives financial support from multiple private foundations. AP is solely responsible for all content. Find AP’s standards for working with philanthropies, a list of supporters and funded coverage areas at AP.org.
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BBVA CIB reports record revenues of €4,832 million through September
Sustained growth in client activity, driven by sector specialization
Despite global uncertainty, BBVA CIB has reinforced its commitment to supporting the sustained growth of wholesale clients in 2025, thanks to a sector specialization model built on tailored solutions and a long-term strategic vision.
This approach is reflected in a 16% year-on-year increase in revenues from the corporate segment through September, with particularly strong performance in the energy (+23%), consumer & retail (+19%) and TMT (+16%) sectors. In the institutional segment, growth accelerated to 23% year-on-year, driven by strong performance in the public sector (60%) and among financial sponsors (+49%).
Business unit performance
Global Markets (GM) continued to deliver strong growth across all strategic areas, with currencies (FX) and equities playing a key role. Revenues reached €1,847 million through September, up 27% year-on-year. FX saw exceptional performance in Turkey and Mexico, driven by significantly higher trading volumes and the volatility stemming from geopolitical tensions. The equities business benefited from strong institutional activity in the U.S. and Asia, as well as the integration of BBVA Trader into the retail channels. The positive performance of the rates business was supported by activity in the U.S. and the financing business. Meanwhile, the credit business continued to perform solidly in the U.S., Europe and Mexico, underpinned by strong origination activity.
Global Transaction Banking (GTB) maintained strong momentum in the third quarter of 2025, with cumulative revenues reaching €1,841 million in the first nine months of the year, a 19% increase versus the same period in 2024. This performance reflects the consolidation of structured receivables solutions and notable progress in inventory, liquidity and supply chain management. Sustained growth was recorded in key markets, supported by higher transaction volumes across geographies and business units within the Group. These factors contributed to year-on-year improvements despite a more challenging environment marked by lower returns on interest rates and persistent geopolitical tensions. In this context, activity reached record levels in loans, deposits and guarantees, driving double-digit growth in both net interest income and fees. As a result, GTB’s efficiency ratio remained below industry standards, reflecting highly effective execution.
Investment Banking & Finance (IB&F) delivered an outstanding performance in the first nine months of the year, with results reaching €1,038 million, a 35% increase compared to the same period in 2024. This strong performance was mainly driven by corporate lending activity in the U.S., United Kingdom, Rest of Europe and Mexico, as well as structured trade finance in Spain and Rest of Europe. In addition, project finance continued to show strong momentum, particularly in the U.S. and Europe, with renewable energy and TMT projects as the main drivers of growth.
In a context marked by geopolitical uncertainty and market volatility, corporate finance activity remained resilient and dynamic, posting a significant increase in revenues over the nine-month period.
Cross-border business at BBVA CIB
Cross-border business continues to be one of the key growth drivers for BBVA CIB, strengthening market connectivity and supporting clients in their international expansion. So far this year, it already accounts for 43% of the division’s total revenues, following a strong momentum in recent months that has resulted in 17% growth. Mexico remains the most attractive market for clients, while the franchise continues to deepen its presence in the United States and United Kingdom, and relevant transactions are being closed in Brazil. This progress is underpinned by large structured financing deals and the development of innovative global trade finance solutions, particularly in prepayments and inventory finance.
Sustainability as a business driver
Between January and September 2025, BBVA CIB channelled approximately €49,700 million in sustainable finance, a 36% year-on-year increase. BBVA continues to promote the financing of clean technologies (cleantech) and renewable energy projects in the wholesale segment, as well as solutions such as sustainability-linked supply chain finance (confirming). Notably, financing for renewable energy projects reached €2,100 million through September.
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Virgin set to challenge Eurostar on Channel Tunnel route
Virgin Trains will be able to launch rail services through the Channel Tunnel after the UK’s rail regulator approved its application to share a depot with Eurostar.
The decision by the Office of Rail and Road (ORR) means Eurostar’s monopoly on passenger services is set to be broken for the first time since the tunnel opened in 1994.
Temple Mills railway storehouse in east London is the only depot in the UK able to accommodate the larger trains used in continental Europe and which is already linked to the cross-Channel line.
Virgin says it wants to start running services from 2030, but the ORR says several steps will need to be taken first.
The ORR had said the Temple Mills depot had enough space to either house an expanded Eurostar fleet or accommodate a rival company’s trains – but not both.
The regulator said a number of steps needed to be taken before new international services could run. Virgin needs to enter into a commercial agreement with Eurostar, will have to secure finance, access to track and stations, and have to get safety approvals from UK and EU authorities.
But the ORR said its decision unlocked plans for around £700m of investment and could create 400 new jobs, describing it as “a win for passengers, customer choice, and economic growth”.
Sir Richard Branson, founder of the Virgin Group, said: “The ORR’s decision is the right one for consumers – it’s time to end this 30-year monopoly and bring some Virgin magic to the cross-Channel route.”
Rail Minister Lord Hendy said he was “incredibly pleased” with the ORR’s decision and called it a “significant step forward”.
“Allowing Virgin Trains to share this vital facility will give passengers greater choice, better value and improve connectivity for millions, as well as drive innovation, lower fares and promote greener connections with Europe,” he said.
Martin Jones, deputy director of Access and International at the ORR, said: “While there is still some way to go before the first new services can run, we stand ready to work with Virgin Trains as their plans develop.”
Several firms had wanted to start operating services between London and mainland Europe, including Spanish start-up Evolyn, Richard Branson’s Virgin and a partnership between Gemini Trains and Uber.
The ORR only approved Virgin’s application on Thursday and rejected applications from Evolyn, Gemini and Trenitalia.
Virgin said it planned to launch rail services from London St Pancras to Europe from 2030.
This will include services to Paris Gare du Nord, Brussels-Midi and Amsterdam Centraal, with future plans to expand further across France, and into Germany and Switzerland.
The plans would mean Virgin Trains returning to the rails for the first time since 2019, when the company lost its contract to Avanti West Coast.
Virgin Trains had operated a service running from London Euston via Birmingham and Manchester to Scotland for 22 years before it was disqualified from bidding for the franchise.
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First UK phones to get satellite connectivity in signal blackspots announced
Zoe KleinmanTechnology editor
Getty ImagesVirgin Media O2 is set to become the first mobile network operator to offer UK customers automatic connectivity via satellite in places without phone signal.
O2 Satellite will be an optional service due to launch in the first half of 2026, following a partnership with Elon Musk’s satellite business Starlink to offer the service.
The firm has not yet revealed how much it will cost, but it will be an additional fee to pay each month.
Enabled smartphones will automatically switch to satellite coverage in parts of the UK where no terrestrial signal is available – such as rural areas – but those who sign up will not be able to make phone calls via satellite to begin with.
The service will only work with messaging, maps and location apps. O2 says this is because Starlink’s current satellites do not support calls, although the next generation of them will.
Calls made via WhatsApp, which uses data rather than phone signal, may work though. O2 intends to trial this before the service launches to the public.
The satellites will effectively act like “phone masts in the sky”, said Luke Pearce from analyst CCS Insight.
“In today’s world, connectivity is no longer optional,” he said.
“Whether it’s emergency SOS in life-saving situations or keeping a software-defined vehicle online, people now expect constant access.
“Satellite is the only technology that can truly close the coverage gap across mountains, oceans and rural areas.”
Satellite battle takes off
O2’s move comes several months after rival Vodafone carried out a successful live video call via satellite from a mountain in Wales where there was no other signal.
It claimed this was a UK-first, but it has not yet revealed any plans to roll out satellite-to-device services to customers.
Vodafone’s tech worked with the satellite firm AST, which currently has six satellites in orbit and aims to have up to 60 by the end of 2026.
Starlink, meanwhile, has more than 650 and has already launched similar services with phone networks in other countries including Australia, New Zealand, the US, Canada and Japan.
In the UK, Ofcom tweaked its regulations in September to enable satellite connectivity directly to smartphone devices.
Currently it is only possible to use it to text emergency services from newer iPhone and Android handsets.
But the use of low-earth orbit satellites for mobile communications has been criticised by astronomers, who say they pollute the night sky and make it more difficult to spot potential hazards such as asteroids.

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Siemens and Capgemini deepen partnership to empower industries for the next era of manufacturing
Siemens and Capgemini deepen partnership to empower industries for the next era of manufacturing – Capgemini
Siemens and Capgemini deepen partnership to empower industries for the next era of manufacturing – Capgemini
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U.S. FDA grants interchangeability designation to Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)
- The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025
- The interchangeability (IC) designations of STOBOCLO and OSENVELT were granted based not only on the comparative clinical data – including pharmacokinetics, efficacy, safety and an immunogenicity study in postmenopausal women with osteoporosis[1] – but also on analytical data demonstrating similarity of STOBOCLO and OSENVELT versus the reference product
- The IC designations enhance patient access and provider choice in the treatment of osteoporosis-related fracture as well as cancer-related bone loss
INCHEON, South Korea, Oct. 30, 2025 /PRNewswire/ — Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications.
The interchangeability (IC) designation is a regulatory designation granted by the FDA, which means STOBOCLO and OSENVELT may now be substituted at the pharmacy for the reference products without consulting the prescriber, subject to state laws.[2]
“Today’s IC designations reinforce confidence in STOBOCLO and OSENVELT among physicians and pharmacists, facilitating a more seamless switch from the reference products to our denosumab biosimilars,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “Building on our strong heritage in biosimilars, Celltrion remains committed to offering more affordable and much-needed treatment options to patients living with skeletal diseases, creating greater potential to deliver savings to patients and the U.S. healthcare system.”
The interchangeability designations of STOBOCLO and OSENVELT were based on the comprehensive evidence including the clinical results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of denosumab biosimilar to its reference product. [1]
STOBOCLO and OSENVELT were introduced in the U.S. market in July 2025. STOBOCLO is currently available in 60 mg/mL injection and OSENVELT is offered in 120 mg/1.7 mL (70 mg/mL) injection.
According to recent FDA draft guidance, biosimilar applicants can request an interchangeability designation using existing data from their Biologics License Application (BLA). Previously, the FDA granted this status only to biosimilars that submitted multiple switch studies meeting additional data criteria.
About STOBOCLO® (denosumab-bmwo) [3]
STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
INDICATIONS
STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:
- of postmenopausal women with osteoporosis at high risk for fracture
- to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer
IMPORTANT SAFETY INFORMATION
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities.
The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients
Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD.
STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab.
Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia.
Drug Products with Same Active Ingredient: Do not use with other denosumab products.
Hypersensitivity : If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO.
Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis.
Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO.
Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop.
Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur.
Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops.
Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes.
Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products.
Most common Adverse Reactions:
- In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis.
- Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache.
- Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
For more information, see Full Prescribing Information including Boxed Warning .
To learn more about the STOBOCLO REMs program please visit stoboclorems.com .
About OSENVELT® (denosumab-bmwo)[4]
OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
INDICATION
OSENVELT® (denosumab-bmwo) is indicated for:
- Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
IMPORTANT SAFETY INFORMATION
Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products.
Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly.
Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT.
Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake.
Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT.
Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose.
Most common Adverse Reactions:
- Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea.
- In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
- Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
For more information, see Full Prescribing Information .
About Celltrion , Inc.
Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.
About Celltrion USA
Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion’s FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (Ustekinumab-stba) STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo), OMLYCLO® (omalizumab-igec), and EYDENZELT® (aflibercept-boav) as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com. and stay updated with our latest news and events on our social media – LinkedIn
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.
These statements may be also identified by words such as “prepares”, “hopes to”, “upcoming”, “plans to”, “aims to”, “to be launched”, “is preparing”, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries’ management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company’s business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.
Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws.
Trademarks
STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, Inc.
PROLIA® and XGEVA® are registered trademarks of Amgen Inc.References
US-CT-P41-25-00008
For further information please contact:
Katie Gallagher
[email protected]
+1 617-657-1324SOURCE Celltrion
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