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From moonshots to megawatts: Fusion's Cold War moment

From moonshots to megawatts: Fusion's Cold War moment

The Hill6 days ago

When Neil Armstrong stepped onto the lunar surface in 1969, he declared it a 'giant leap for mankind.' This iconic moment, captured on grainy television screens worldwide, was not merely a triumph of human ingenuity but the result of intense geopolitical competition between the U.S. and the Soviet Union.
The rivalry, fueled by the existential anxieties of the Cold War, paradoxically propelled humanity forward. Today, we stand on the threshold of another transformative milestone — achieving practical nuclear fusion. And once again, competition, particularly among the U.S., China and Europe, may prove critical.
Idealists often advocate global cooperation, envisioning pooled resources and collective progress. However, historical realities suggest that competitive pressure often yields faster, more substantial results. The sluggish progress of ITER, the International Thermonuclear Experimental Reactor, a collaboration of 35 nations including the U.S., China, Russia and several European countries, illustrates the inherent inefficiencies in sprawling multinational cooperation.
Initially proposed in 1985, ITER's schedule has repeatedly slipped, with first plasma now anticipated no sooner than 2034. Development setbacks, bureaucratic inertia, conflicting national interests, inconsistent funding, and prolonged negotiations have significantly hindered progress.
Contrast ITER's delays with the rapid advances of private and national fusion efforts. In the U.S., ventures such as Commonwealth Fusion Systems, driven by academic ingenuity and substantial private investments, have reached critical milestones. Commonwealth recently demonstrated a groundbreaking high-temperature superconducting magnet, a crucial advancement toward viable fusion energy. Today, more than 50 private startups globally have attracted more than $8 billion in investment, all racing to be the first to commercialize fusion.
China, too, has aggressively advanced its fusion ambitions. Chinese researchers working on the Experimental Advanced Superconducting Tokamak, popularly known as the 'artificial sun,' recently maintained plasma at over 120 million degrees Celsius for more than 400 seconds, a remarkable achievement that brings fusion significantly closer to practical application. These achievements make clear that when the stakes are high, competitive dynamics accelerate progress in ways international collaborations often cannot.
Europe, often perceived as a collaborative partner in ITER, is now asserting itself as a formidable competitor in the fusion arena. The European Union has long supported fusion research through such initiatives as EUROfusion, which coordinates research across numerous European laboratories. Facilities such as the Joint European Torus in the UK and the Wendelstein 7-X stellarator in Germany have achieved significant milestones, demonstrating Europe's commitment to advancing fusion technology.
Moreover, European startups such as Marvel Fusion in Germany have attracted substantial investments to develop innovative fusion approaches, signaling a shift towards a more competitive stance in the global fusion race.
The historical parallels are instructive. The Cold War-era space race between the U.S. and the Soviet Union resulted in unprecedented technological achievements. Beyond landing astronauts on the moon, this competition spurred developments in microelectronics, telecommunications, materials science and computing. The intense desire to outperform a geopolitical rival drove nations to push technological limits, delivering widespread benefits continuously.
Could NASA have achieved the moon landing sooner had it been obligated to negotiate every decision with multiple international partners? The answer is unequivocally no. Multilateral consensus-building, however well-intentioned, tends to slow decision-making and dilute ambition.
This lesson applies directly to the fusion race. With the accelerating impacts of climate change and global energy demands expected to rise by nearly 50 percent by 2050, fusion energy's promise — clean, abundant, and nearly limitless energy — is urgently needed. Fusion has the potential to decarbonize global energy grids, diminish geopolitical tensions over fossil fuels, and provide stable energy to developing nations.
Of course, competition is not without critics. Some argue it leads to duplication, secrecy, or geopolitical tension. Yet history and current fusion progress show competition can sharpen focus, streamline resources, and accelerate timelines where cooperation might stall.
Indeed, competition among the U.S., China and Europe is about more than mere technological superiority; it shapes geopolitical alliances, influences global economic dynamics, and may redefine leadership in the 21st century. Just as the U.S. emerged from the space race as a global technological and economic powerhouse, the victor in fusion development will likely dictate future standards for global energy and technology governance.
Fusion technology inherently offers widespread humanitarian benefits. Even if initial successes are regionally concentrated, these breakthroughs will inevitably diffuse globally due to their immense economic and environmental advantages. Like space-derived innovations such as satellite technology and computing, fusion's benefits will become universally accessible.
Climate negotiations at COP28 underscore the difficulties inherent in international cooperation. Achieving even minimal consensus on reducing fossil fuel production (The 'transition away from fossil fuels' agreement) was politically contentious and largely ineffective, delivering superficial agreements that catered more to geopolitical power dynamics than to any meaningful climate solutions. Such bureaucratic delays and diluted outcomes illustrate why humanity cannot afford to rely solely on multilateral cooperation.
Ultimately, the fusion race is not merely a geopolitical contest; it is a vital competition for human survival and global prosperity. While competition may not always be harmonious or efficient, neither was the space race. Yet, the space race advanced humanity dramatically. Allowing the fusion race to unfold unhindered may again deliver swift, transformative solutions at a time when humanity urgently needs them. Our planet and our future depend on embracing this competitive drive.
Oded Gour-Lavie is CEO and co-founder of nT-Tao, a compact fusion power company based in Israel.

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European Commission Approves ADCETRIS ® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD
European Commission Approves ADCETRIS ® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD

Business Wire

time2 hours ago

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European Commission Approves ADCETRIS ® (brentuximab vedotin) for the Treatment of Adult Patients with Newly Diagnosed Stage IIb/III/IV Hodgkin Lymphoma in Combination with ECADD

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADCETRIS ® (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (ECADD) – a chemotherapy regimen – in adult patients with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025. The approval for this ADCETRIS-based combination regimen, known as BrECADD, in frontline Hodgkin lymphoma is based on the results of the randomized Phase 3 HD21 trial. The study met its co-primary safety and efficacy endpoints, with BrECADD demonstrating significantly superior safety as assessed by treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS) in comparison to escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone (eBEACOPP), a standard of care treatment in Europe 1. 'Today's approval represents a significant advancement for patients with Hodgkin lymphoma in the European Union,' said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. "This approval reinforces the role of ADCETRIS as a backbone in the treatment of specific lymphomas, offering healthcare professionals greater flexibility to tailor treatment plans according to individual patient needs. We're proud to contribute another impactful option for those diagnosed with this challenging disease.' ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in the European Union (EU) in six distinct indications. This decision marks the second approval for an ADCETRIS-based combination regimen for frontline Hodgkin lymphoma, broadening the spectrum of available treatments for patients who historically have had limited options. 'With BrECADD, patients now have a treatment option that not only offers greater curative potential 2* but also significantly reduces treatment-related morbidity compared to eBEACOPP,' said Peter Borchmann, MD, PhD, University Hospital of Cologne, Germany, and trial chairman of the HD21 study. 'This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients.' About the HD21 Trial The HD21 study is a Phase 3, multi-country, prospective, open-label, randomized, multicenter trial conducted by the German Hodgkin Study Group (GHSG) with a PET-response adapted designed to assess the feasibility, efficacy, safety and tolerability of BrECADD, a novel, rationally designed, CD30-intensified frontline regimen for patients with advanced Hodgkin lymphoma. Enrolled patients with newly diagnosed, Stage IIb with large mediastinal mass and/or extranodal lesions, Stage III or IV Hodgkin lymphoma were randomized to receive two cycles of either escalated BEACOPP or BrECADD, respectively, followed by interim PET staging. A decision is then made if patients received a further two or four cycles of escalated BEACOPP or BrECADD. The HD21 trial aims to evaluate a new treatment regimen to minimize side effects, while maintaining similar responses to treatment. The study has co-primary endpoints: safety is assessed by treatment-related morbidity (TRMB) (superiority), a novel endpoint focused on clinically relevant, acute toxicities of primary chemotherapy, and efficacy is assessed by PFS (non-inferiority). Secondary endpoints are tumor response (complete response [CR] rate), overall survival (OS), infertility rate at one year, second malignancies, frequency of adverse events, therapy adherence and quality of life. About ADCETRIS® (brentuximab vedotin) ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Pfizer's proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells. ADCETRIS injection for intravenous infusion has received FDA approval for eight indications: Adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vinblastine, and dacarbazine (2018) Pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide (2022) Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation (2015) Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates (2011) Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (2018) Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen (2011) Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) after prior systemic therapy (2017) Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product (2025) Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019. ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP, (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (7) for the treatment of adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD). ADCETRIS has received marketing authorization by regulatory authorities in 80 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See Important Safety Information below. ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies. Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. ADCETRIS (brentuximab vedotin) Important Safety Information (European Union) Please refer to Summary of Product Characteristics (SmPC) before prescribing. Contraindications ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. Combined use of bleomycin and ADCETRIS causes pulmonary toxicity. Special Warnings and Precautions Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in PML and death can occur in ADCETRIS-treated patients. PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal. Patients should be closely monitored for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. ADCETRIS should be held for any suspected case of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established. ADCETRIS dosing should be permanently discontinued if a diagnosis of PML is confirmed. The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms). Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. ADCETRIS should be held for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed. Pulmonary Toxicity: Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients should be treated appropriately. Consider holding ADCETRIS dosing during evaluation and until symptomatic improvement. Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections. Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered. If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. Premedication may include paracetamol, an antihistamine and a corticosteroid. IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin. Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome. These patients should be monitored closely and managed according to best medical practice. Management of TLS may include aggressive hydration, monitoring of renal function, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care. Peripheral neuropathy (PN): ADCETRIS may cause peripheral neuropathy, both sensory and motor. ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases. In clinical trials, the majority of patients had resolution or improvement of their symptoms. Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require a delay and a dose reduction of ADCETRIS or discontinuation of treatment. Hematological toxicities: Grade 3 or Grade 4 anaemia, thrombocytopenia, and prolonged (≥ 1 week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose. Febrile neutropenia: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10 9 /L, fever ≥ 38.5 0 C; ref CTCAE v3) has been reported with treatment with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops. In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. When ADCETRIS is administered in combination with AVD or CHP, primary prophylaxis with G-CSF, beginning with the first dose, is recommended for all adult patients regardless of age. In combination therapy with AVD or CHP, advanced age was a risk factor for febrile neutropenia. Severe cutaneous adverse reactions (SCARs): Cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ADCETRIS. Fatal outcomes have been reported for SJS and TEN. If SJS, TEN or DRESS occur, ADCETRIS should be discontinued, and appropriate medical therapy should be administered. Gastrointestinal (GI) Complications: GI complications including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, some with fatal outcomes, have been reported in patients treated with ADCETRIS. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately. Hepatotoxicity: Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS. Patients experiencing hepatotoxicity may require a delay, change in dose or discontinuation of ADCETRIS. Hyperglycemia: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus. However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored. Anti-diabetic treatment should be administered as appropriate. Infusion site extravasation: Extravasation during intravenous infusion has occurred. Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration. Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations. CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Nevertheless, ADCETRIS should be used with caution in other CD30+ CTCL patients after careful consideration of the potential benefit-risk on an individual basis. Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Polysorbate content in excipients: This medicinal product contains 2 mg of polysorbate 80 per vial, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Interactions Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers) Co‑administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P‑gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin. Therefore, co‑administration of brentuximab vedotin with strong CYP3A4 and P‑gp inhibitors may increase the incidence of neutropenia. If neutropenia develops, refer to Tables 1 and 2 for dosing recommendations for neutropenia. Co‑administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin. Though PK data are limited, co‑administration of rifampicin appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. Co‑administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes. Etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD regimen) The pharmacokinetics of ADC and MMAE have not been characterized in the setting of BrECADD. Exposures of brentuximab vedotin and concurrent chemotherapy are not expected to be affected in the BrECADD regimen. Fertility, pregnancy and lactation Women of childbearing potential: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. Pregnancy: There are no data from the use of ADCETRIS in pregnant women. Studies in animals have shown reproductive toxicity. ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the fetus. Breast-feeding: There is no data as to whether brentuximab vedotin or its metabolites are excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman. Fertility: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility. MMAE has been shown to have anagenic properties. Therefore, men being treated with this medicine are advised to have sperm samples frozen and stored before treatment. Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose. Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness). Undesirable Effects Monotherapy: The most frequent adverse reactions (≥10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤1%. Adverse events led to treatment discontinuation in 24% of patients. Combination Therapy: In the studies of ADCETRIS as combination therapy in 662 patients with previously untreated advanced HL and 223 patients with previously untreated CD30+ PTCL, the most common adverse reactions (≥ 10%) were: infections, neutropenia, peripheral sensory neuropathy, nausea, constipation, vomiting, diarrhea, fatigue, pyrexia, alopecia, anemia, weight decreased, stomatitis, febrile neutropenia, abdominal pain, decreased appetite, insomnia, bone pain, rash, cough, dyspnea, arthralgia, myalgia, back pain, peripheral motor neuropathy, upper respiratory tract infection, and dizziness. In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients. Adverse events led to treatment discontinuation in 10% of patients. Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, and peripheral neuropathy. Combination Therapy (BrECADD regimen): In the HD21 study, 747 patients received BrECADD, and 741 patients received eBEACOPP. The safety profile of ADCETRIS in patients receiving BrECADD remained consistent with other combination therapy (AVD/CHP). Serious adverse reactions occurred in 39.4% patients receiving BrECADD treatment, and 36.4% in patients who received eBEACOPP. The most common serious adverse reactions in patients who received BrECADD (> 3%) were febrile neutropenia (19.3%), pyrexia (3.9%), and neutropenia (3.2%). Serious cardiac adverse reactions occurred in 2.7% of patients receiving BrECADD and 1.1% of patients receiving eBEACOPP. The most common serious cardiac adverse reaction in patients who received BrECADD (>0.5%) was tachycardia (0.9%). Serious adverse events led to treatment discontinuation in 2% of patients in both BrECADD and eBEACOPP arms. The most common serious adverse events that led to discontinuation in the BrECADD arm were febrile neutropenia (0.3%) and cardiac failure (0.3%). ADCETRIS ® (brentuximab vedotin) for injection U.S. Important Safety Information BOXED WARNING PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML, and death can occur in ADCETRIS-treated patients. CONTRAINDICATION Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation). WARNINGS AND PRECAUTIONS Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS. Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid. Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL. Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses. Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections. Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures. Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment. Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment. Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS. PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed. Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement. Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy. Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately. Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated. Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise male patients with female partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS. ADVERSE REACTIONS The most common adverse reactions (≥20%) in adult patients are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash. The most common laboratory abnormalities (≥20%) in adult patients are decreased neutrophils, increased creatinine, decreased hemoglobin, decreased lymphocytes, increased glucose, increased ALT, and increased AST. The most common Grade ≥3 adverse reactions (≥5%) in combination with AVEPC in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection. DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions. USE IN SPECIAL POPULATIONS Lactation: Breastfeeding is not recommended during ADCETRIS treatment. Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Important Notice For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could', 'anticipates', 'estimates', 'projects' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Footnotes: *While late relapse is rare, PFS status after 5 years does not guarantee cure. Patients should be monitored and encouraged to report any return of symptoms as appropriate. References: Borchmann P, Ferdinandus J, Schneider G, et al. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial [published correction appears in Lancet. 2024 Nov 30;404(10468):2164. doi: 10.1016/S0140-6736(24)02571-6.]. Lancet. 2024;404(10450):341-352. Bröckelmann PJ, Goergen H, Kohnhorst C, von Tresckow B, Moccia A, Markova J, Meissner J, Kerkhoff A, Ludwig WD, Fuchs M, Borchmann P, Engert A. Late Relapse of Classical Hodgkin Lymphoma: An Analysis of the German Hodgkin Study Group HD7 to HD12 Trials. J Clin Oncol. 2017 May 1;35(13):1444-1450. doi: 10.1200/JCO.2016.71.3289. Epub 2017 Feb 27. PMID: 28240973.

H Company Launches Next-Generation Autonomous AI Agents for Enterprise and Consumer Markets
H Company Launches Next-Generation Autonomous AI Agents for Enterprise and Consumer Markets

Business Wire

time3 hours ago

  • Business Wire

H Company Launches Next-Generation Autonomous AI Agents for Enterprise and Consumer Markets

PARIS--(BUSINESS WIRE)-- H Company, a leading European AI Research and Product company backed by $220 million from tier-one investors, today announced the public launch of its autonomous AI agent platform featuring three specialized agents built to carry out complex digital tasks with human-in-the-loop. 'We are witnessing the transition from conversational AI to execution intelligence,' said Charles Kantor, Co-founder and Chairman of H Company. Share The launch includes: Runner H™, an orchestration platform for multi-step task completion, Surfer H™, a web-native agent for browser-based automation, Tester H™, an enterprise solution for automated software testing. The company simultaneously open-sourced Holo-1, its proprietary visual-language model, in partnership with Hugging Face, Nvidia (NIM soon available) and AWS (Amazon). Transforming AI from Assistants to Executors H Company's current product selection supports its aim of making trusted, action-oriented AI agents available to organizations of all sizes. H Company's agents, which are built on proprietary multimodal models, bridge the gap by combining planning and vision capabilities to deliver measurable business outcomes. 'We are witnessing the transition from conversational AI to execution intelligence,' said Charles Kantor, Co-founder and Chairman of H Company. 'Entering the era, where agents don't just assist—they complete entire workflows autonomously, delivering the productivity gains enterprises have been seeking from AI investments." Runner H Runner H serves as H Company's flagship orchestration platform, delivering "intelligence in motion" by enabling users to accomplish complex, multi-step objectives through a single natural language prompt and is now available to the public. Runner H dynamically coordinates specialized sub-agents and integrates with existing enterprise applications (including MCPs and agnostic interactions proprietary and additional agents), supporting seamless workflows across web browsers, document systems, and business applications while maintaining cost-effectiveness at scale. Surfer H Surfer H operates as a web-native automation agent, navigating browser environments with human-like precision while delivering cost-effective automation solutions. Unlike API-dependent solutions, Surfer H interacts directly with web interfaces, enabling deployment across any website without custom integrations or compatibility requirements, creating a powerful, general-purpose, cost-effective web automation system. Tester H Tester H addresses enterprise software testing challenges by converting natural language test scenarios into executable automated testing protocols. The platform supports both web and mobile applications, enabling teams to scale quality assurance processes without expanding technical testing resources. Proven Performance Metrics Benchmark testing demonstrates H Company's agents deliver superior cost-performance ratios and optimal value propositions compared to existing market solutions: Surfer H achieved 92.2% task completion accuracy on the WebVoyager benchmark at just $0.13 per task, establishing the strongest tradeoff between accuracy and cost. Performance exceeds that of major technology providers while reducing operational costs by up to 10 times, setting the Pareto frontier for performance-per-dollar. Holo-1 visual-language model achieves 76.2% UI localization accuracy with affordable inference costs, leading performance among models under 7B parameters (the highest small-size model overall). Open Source Strategy Accelerates Market Adoption H Company's release of Holo-1 under Apache 2.0 licensing enables developers and enterprises to build production-ready custom automation solutions using visual AI capabilities. The model delivers commercial-grade accuracy for UI understanding and interaction. The open-source initiative includes the WebClick dataset, featuring 1,639 real-world UI interaction scenarios designed to advance industry-wide development of visual AI applications. Market Availability and Enterprise Adoption Runner H is immediately available for public access, in waves, while Tester H targets enterprise customers requiring automated software testing capabilities. The platform's browser-based agent, Surfer H, ensures compatibility with existing enterprise privacy requirements, addressing key concerns for large-scale organizational deployment. About H Company H Company is a next-generation AI research and product company pioneering the future of autonomous, agentic AI. Founded to build intelligence that acts—not just reacts—H Company is creating the foundational infrastructure for autonomous AI systems that drive real-world outcomes across industries. With $220 million in funding, H Company is backed by leading global investors including Accel, Eric Schmidt and Yuri Milner. To learn more, visit

Misophonia Has Genetic Links to Depression And Anxiety, Study Finds
Misophonia Has Genetic Links to Depression And Anxiety, Study Finds

Yahoo

time3 hours ago

  • Yahoo

Misophonia Has Genetic Links to Depression And Anxiety, Study Finds

Most of us can relate to feeling uncomfortable when someone scrapes their nails down a chalkboard. For those suffering the condition misophonia, sounds like slurping, snoring, breathing, and chewing and draw an equally stressful response. A study published in 2023 by researchers in the Netherlands suggests the condition shares genes with mood disorders such as anxiety, depression, and PTSD. University of Amsterdam psychiatrist Dirk Smit and colleagues analyzed the genetic data from the Psychiatric Genomics Consortium, UK Biobank, and 23andMe databases and found people who self-identified as having misophonia were more likely to have genes associated with psychiatric disorders, as well as tinnitus. Watch the clip below for a summary on their findings. Patients with tinnitus – a persistent, shrill ringing in the ears – are also more likely to have psychological symptoms of depression and anxiety. "There was also an overlap with PTSD genetics," Smit told Eric W. Dolan at PsyPost. "This means that genes that give a sensitivity to PTSD also increase the likelihood for misophonia, and that could point to a shared neurobiological system that affects both. And that could suggest that treatment techniques used for PTSD could also be used for misophonia." This doesn't mean misophonia and these other conditions necessarily have shared mechanisms, only that some of the genetic risk factors may be similar. Previous research found people who experience misophonia are more likely to internalize their distress. Smit and team's research, published in 2023, also backed this up, showing strong links with personality traits such as worry, guilt, loneliness, and neuroticism. Responses to a triggering sound can range from irritation and anger to distress that interferes with everyday life. "It has been argued… that misophonia is based on the feelings of guilt about the evoked irritation and anger rather than behavioral expressions of anger itself that causes the distress," write Smit and team. People with autism spectrum disorder ( ASD) were less likely to experience misophonia. This was unexpected as those with ASD have a decreased tolerance to sounds. "Our results suggest that misophonia and ASD are relatively independent disorders with regard to genomic variation," the researchers write in their paper. "It raises the possibility that other forms of misophonia exist, one that is mostly driven by conditioning of anger or other negative emotionality to specific trigger sounds moderated by personality traits." Smit and colleagues caution their data was mostly European so the same links may not show up in different populations. What's more, misophonia was not medically diagnosed in their data samples, only self-reported which may also skew the results. But their study also provides clues for where further research could focus to find the biological mechanism behind misophonia. A 2023 survey suggests misophonia is more prevalent than previously thought, making studies like this one invaluable for understanding how our perception of the world links with our mind's ability to cope within it. This research was published in Frontiers in Neuroscience. An earlier version of this article was published in October 2024. Experimental Drug Helped Cancer Patients Live 40% Longer in Clinical Trial Leprosy Was Lurking in The Americas Long Before Colonization, Study Finds Does Retinol Reverse Signs of Aging? Here's The Science.

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