Author: admin

  • Science journal retracts study on safety of Monsanto’s Roundup: ‘serious ethical concerns’ | US news

    Science journal retracts study on safety of Monsanto’s Roundup: ‘serious ethical concerns’ | US news

    The journal Regulatory Toxicology and Pharmacology has formally retracted a sweeping scientific paper published in 2000 that became a key defense for Monsanto’s claim that Roundup herbicide and its active ingredient glyphosate don’t cause cancer.

    Martin van den Berg, the journal’s editor in chief, said in a note accompanying the retraction that he had taken the step because of “serious ethical concerns regarding the independence and accountability of the authors of this article and the academic integrity of the carcinogenicity studies presented”.

    The paper, titled Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans, concluded that Monsanto’s glyphosate-based weed killers posed no health risks to humans – no cancer risks, no reproductive risks, no adverse effects on development of endocrine systems in people or animals.

    Regulators around the world have cited the paper as evidence of the safety of glyphosate herbicides, including the Environmental Protection Agency (EPA) in this assessment.

    The listed authors of the paper were three scientists who did not work for Monsanto – Gary Williams, Robert Kroes and Ian Munro, and was held up by the company as a defense against conflicting scientific evidence linking Roundup to cancer. The fact that it was authored by scientists from outside the company, from seemingly independent researchers, gave it added validity.

    But over the last decade, internal company documents, that came to light in litigation brought by plaintiffs in the US suffering from cancer, revealed Monsanto’s influence on the paper. The documents included an email from a company official discussing the research paper and praising the “hard work” of several Monsanto scientists as part of a strategy Monsanto called “Freedom to Operate” (FTO).

    The corporate files showed how company officials celebrated when the paper was published.

    In one email following the April 2000 publication of the Williams paper, Lisa Drake, then Monsanto government affairs official, described the toll the work of developing “independent” research papers took on multiple Monsanto employees.

    “The publication by independent experts of the most exhaustive and detailed scientific assessment ever written on glyphosate … was due to the perseverance, hard work and dedication of the following group of folks,” Drake wrote. She then listed seven Monsanto employees. The group was applauded for “their hard work over three years of data collection, writing, review and relationship building with the papers’ authors”.

    Drake further emphasized why the Williams paper was so significant for Monsanto’s business plans: “This human health publication on Roundup herbicide and its companion publication on ecotox and environmental fate will be undoubtedly be [sic] regarded as ‘the’ reference on Roundup and glyphosate safety,” she wrote in the email dated 25 May 2000.

    “Our plan is now to utilize it both in the defense of Roundup and Roundup Ready crops worldwide and in our ability to competitively differentiate ourselves from generics.”

    In a separate email, a company executive asked if Roundup logo polo shirts could be given to eight people who worked on the research papers as a “token of appreciation for a job well done”.

    Monsanto’s Hugh Grant, who at that time was a senior executive on his way toward being named CEO and chairman, added his own praise, writing in an email: “This is very good work, well done to the team, please keep me in the loop as you build the PR info to go with it.”

    In 2015, William Heydens, a Monsanto scientist, suggested that he and colleagues “ghost-write” another scientific paper. Monsanto could pay outside scientists to “edit & sign their names” to the work that he and others would do, Heydens wrote in an email. “Recall that is how we handled Williams Kroes and Munro 2000.”

    The emails were spotlighted in jury trials in which plaintiffs suffering from cancer won billions of dollars in damages from Monsanto, which was bought by Bayer AG in 2018.

    Gary Williams, one of the authors of the now retracted 2000 research paper, could not immediately be reached for comment. In 2017, Williams’s former employer New York Medical School said it found “no evidence” that a faculty member violated the school’s prohibition against authoring a paper ghostwritten by employees of Monsanto. The two other authors of the paper, Robert Kroes and Ian Munro, are deceased.

    In explaining the decision to retract the 25-year-old research paper, Van den Berg wrote: “Concerns were raised regarding the authorship of this paper, validity of the research findings in the context of misrepresentation of the contributions by the authors and the study sponsor and potential conflicts of interest of the authors.”

    He noted that the paper’s conclusions regarding the carcinogenicity of glyphosate were solely based on unpublished studies from Monsanto, ignoring other outside, published research.

    Van den Berg did not respond to a request for comment.

    When asked about the retraction, Bayer said in a statement that Monsanto’s involvement was adequately noted in the acknowledgments section of the paper in question, including a statement that referred to “key personnel at Monsanto who provided scientific support”. The company said the vast majority of thousands of published studies on glyphosate had no Monsanto involvement.

    “The consensus among regulatory bodies worldwide that have conducted their own independent assessments based on the weight of evidence is that glyphosate can be used safely as directed and is not carcinogenic,” the company said.

    An EPA spokesperson said that the agency was aware of the retraction but “has never relied on this specific article in developing any of its regulatory conclusions on glyphosate”.

    The spokesperson said the EPA has “extensively studied glyphosate, reviewing more than 6,000 studies across all disciplines, including human and environmental health, in developing its regulatory conclusions”.

    The updated human health risk assessment the agency is currently conducting for glyphosate is “using gold standard science”, the spokesman said. That assessment should be released for public comment in 2026 and will not rely on the retracted article.

    “The retraction of this study is a long time coming,” said Brent Wisner, one of the lead lawyers in the Roundup litigation and a key player in getting the internal documents revealed to the public.

    Wisner said the Williams, Kroes and Munro study was the “quintessential example of how companies like Monsanto could fundamentally undermine the peer-review process through ghostwriting, cherrypicking unpublished studies, and biased interpretations”.

    “This garbage ghostwritten study finally got the fate it deserved,” Wisner said. “Hopefully, journals will now be more vigilant in protecting the impartiality of science on which so many people depend.”

    News of the retraction of the study came in the same week the Trump administration urged the US supreme court to take up Bayer’s bid to curtail thousands of lawsuits claiming Roundup causes cancer.

    In a brief filed at the court, the solicitor general, D John Sauer, said the company was correct that the federal law governing pesticides pre-empts lawsuits that make failure-to-warn claims over the products under state law.

    Plaintiffs have said they developed non-Hodgkin’s lymphoma and other forms of cancer due to using Roundup and other glyphosate-based herbicides sold by the company, either at home or on the job.

    This story is co-published with the New Lede, a journalism project of the Environmental Working Group.

    Continue Reading

  • Abu Dhabi Grand Prix | Why the Yas Marina Circuit makes for a great F1 season finale

    Abu Dhabi Grand Prix | Why the Yas Marina Circuit makes for a great F1 season finale

    Every season since 2014 – and from 2009-10 – the chequered flag waving at the Yas Marina Circuit has signalled the end of another epic season of F1 racing. As the sun dips below the horizon, floodlights bring one of the most spectacular…

    Continue Reading

  • Sindh providing best, free health services to people: Bilawal – RADIO PAKISTAN

    1. Sindh providing best, free health services to people: Bilawal  RADIO PAKISTAN
    2. Bilawal opens two SIUT units at hospital’s new building  Dawn
    3. Bilawal claims improvement in Sindh’s health sector after 18th amendment  The Nation (Pakistan )
    4. SIUT…

    Continue Reading

  • Charles Leclerc says brother’s FP1 appearance the ‘only positive’ from Friday in Abu Dhabi

    Charles Leclerc says brother’s FP1 appearance the ‘only positive’ from Friday in Abu Dhabi

    Charles Leclerc hailed his younger brother Arthur’s Free Practice 1 appearance at the Abu Dhabi Grand Prix as a “very special moment”, with the Monegasque suggesting that it was the “only positive” from Friday after another tough outing…

    Continue Reading

  • Deepika Padukone Is 'Incredibly Proud' Of Ranveer Singh As She Reviews Dhurandhar, Calls It 'Worth Every Minute' – thedailyjagran.com

    1. Deepika Padukone Is ‘Incredibly Proud’ Of Ranveer Singh As She Reviews Dhurandhar, Calls It ‘Worth Every Minute’  thedailyjagran.com
    2. Dhurandhar Movie Review: Ranveer Singh Infiltrates Pakistan & Extends Uri Promise ‘Ghus Ke Maarenge’, Dear…

    Continue Reading

  • Jordi Savall and the Berliner Philharmoniker ride a wave of elation — review

    Jordi Savall and the Berliner Philharmoniker ride a wave of elation — review

    Unlock the Editor’s Digest for free

    Dawn was breaking when the musicians stumbled out of the church after an all-night recording session with Jordi Savall….

    Continue Reading

  • AI credit concerns playing out differently in investment grade and high yield, Goldman says – Reuters

    1. AI credit concerns playing out differently in investment grade and high yield, Goldman says  Reuters
    2. Wall Street races to protect itself from AI bubble  Rolling Out
    3. Barclays exec says top five tech firms could need $100 billion in funding next year  WKZO
    4. The AI Industry’s Tangled Finances  The Dispatch
    5. Taking a position: AI debt frenzy gives birth to new CDS markets  IFR Asia

    Continue Reading

  • Max Whitlock details plans for return, desire to expand skill repertoire

    Max Whitlock details plans for return, desire to expand skill repertoire

    A week after double Olympic artistic gymnastics champion Max Whitlock announced his return to training and dreams of a fifth Olympic Games appearance at LA28, the 32-year-old has detailed his comeback plans in an exclusive interview with…

    Continue Reading

  • FDA Okays CAR T-Cell Therapy for Marginal Zone Lymphoma – Medscape

    1. FDA Okays CAR T-Cell Therapy for Marginal Zone Lymphoma  Medscape
    2. Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)  Bristol Myers Squibb
    3. Bristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi  European Pharmaceutical Review
    4. FDA Approves Liso-Cel in Pretreated R/R Marginal Zone Lymphoma  Oncology Nursing News
    5. FDA Approves CAR-T Therapy for Marginal Zone Lymphoma  Oncology News Central

    Continue Reading

  • Sobi to Showcase Scientific advances and Commitment to Haematology at ASH 2025

    Sobi to Showcase Scientific advances and Commitment to Haematology at ASH 2025

    Sobi® (STO: SOBI), today announced its participation at the 65th American Society of Hematology (ASH) Annual Meeting, taking place on 6 – 9 December in Orlando, Florida. At this year’s meeting, Sobi will showcase its commitment to advancing care in haematology with 19 scientific abstracts, including two oral presentations. These feature the most recent clinical data and insights from completed and ongoing studies across Sobi’s innovative portfolio including data from efanesoctocog alfa, pegcetacoplan, avatrombopag, emapalumab, and pacritinib. These presentations underscore Sobi’s mission to deliver life-changing therapies for patients with rare and severe blood disorders.

     

    “We will present evidence at ASH from a post hoc analysis demonstrating that pacritinib reduces or stabilises spleen size, improves haematologic parameters, and lessens myelofibrosis symptoms in patients with highrisk disease. These findings matter because they address key drivers of morbidity which affect daytoday functioning and quality of life. The ASH meeting also offers an opportunity to discuss the latest research on emapalumab, efanesoctocog alfa, pegcetacoplan, avatrombopag, as well as loncastuximab tesirine,” said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi.

     

     

    Summary of full Sobi data to be presented at ASH 2025:

    Efanesoctocog alfa

    Clinical outcomes up to four years of once-weekly Efanesoctocog Alfa Prophylaxis in previously treated adults, adolescents, and children with severe Haemophilia A: Interim analysis of the Phase 3 XTEND-ed long-term extension study.

     

     

     

     

    Oral Presentation

    Session Name: 322. Haemophilia A and B: Clinical and epidemiological: Innovations shaping the future of Haemophilia care

    Date: 7 December 2025

    Time: 12:00 PM – 1:30 PM ET

    Presentation Time: 1:00 PM – 1:15 PM ET

    Room: OCCC – W304EFGH

    Publication Number: 539

    Understanding unmet needs for people with Haemophilia A receiving factor and non-factor treatments.

     

     

     

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 2679

    Real-world experience of Efanesoctocog Alfa in Haemophilia A patients in the US: A retrospective analysis.

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 1286

    Patient characteristics, treatment patterns, and bleeding in people with Haemophilia A without inhibitors initiating Efanesoctocog alfa in the US: An administrative claims analysis.

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 1290

    Quality of life and functional improvements with Efanesoctocog alfa in patients with moderate to severe Haemophilia A: A real-world survey.

    Poster Presentation

    Session name: Poster Session III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 4846

    Pegcetacoplan

    Consistent benefits of Pegcetacoplan treatment in PNH patients with and without a history of Aplastic Anaemia in real world: Analysis of the ongoing COMPLETE Phase 4 observational study.

     

     

    Poster Presentation

    Session Name: 101. Red Cells and Erythropoiesis, Excluding Iron: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Early results from the ongoing Pegcetacoplan Silo of the International Paroxysmal Nocturnal Haemoglobinuria Interest Group Registry.

    Poster Presentation

    Session Name: 508. Bone Marrow Failure: Acquired: Poster II

    Date: 7 December 2025

    Time: 6:00:00 PM – 6:00:00 PM ET

    Location: OCCC – West Halls B3-B4

    Real-world clinical characteristics and treatment outcomes in PNH patients prescribed Pegcetacoplan: Insights of complement inhibitor-experienced and -naïve patients across Europe, the United States and Canada.

     

     

    Poster Presentation

    Session Name: 508. Bone Marrow Failure: Acquired: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Pegcetacoplan – Publication Only Abstracts

    Real-world effectiveness of Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria: A systematic review of clinical and patient-reported outcomes.

     

    Publication only – published online on 3 November 2025, at 9:00 AM ET

    Low risk for Meningococcal and encapsulated bacteria infections with systemically administered Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria and C3 Glomerulopathies.

     

    Overview of treatment advances with complement Inhibitors in patients with Paroxysmal Nocturnal Haemoglobinuria.

     

    Optimising PNH treatment with the complement inhibitor Pegcetacoplan: A case report.

    User experience with Pegcetacoplan on-body Injector in patients with Paroxysmal Nocturnal Hemoglobinuria.

    Avatrombopag

    Real-world treatment patterns and outcomes among patients with immune thrombocytopenia (ITP) who switched treatment from Eltrombopag or Romiplostim to Avatrombopag in the United States: Results from the real-AVA 3.5 study.

     

    Poster Presentation

    Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Real-world safety and efficacy of Avatrombopag in adults with Immune Thrombocytopenia: A systematic review and meta-analysis.

    Global Abstract

    Session Name: 311. Disorders of platelet number or function: Clinical and epidemiological: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Patient-reported outcomes of Avatrombopag for Chronic Immune Thrombocytopenia: Interim analysis of the Phase 4 ADOPT Study.

     

     

     

     

    Poster Presentation

    Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Emapalumab

    Use of Emapalumab is associated with rapid and sustained benefits in pHLH subgroups, including CNS involvement and previously untreated patients: Pooled analysis of prospective trials NI-0501-04, NI-050105 and NI-050109.

     

    Poster Presentation

    Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Emapalumab induces rapid, durable responses and reliable bridging to curative HSCT in patients with primary HLH: Pooled analysis of prospective trials NI-0501-04, NI-0501-05 and NI-0501-09.

     

     

    Poster Presentation

    Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Pacritinib

    Real-world treatment patterns and outcomes in patients with myelofibrosis who presented with thrombocytopenia and anaemia at initiation of Pacritinib treatment.

     

     

     

     

    Oral Presentation

    Session Name: 908. Outcomes Research: Myeloid

    Malignancies: Real-World Experiences

    Session date: 7 December 2025

    Session time: 4:30 PM – 6:00 PM ET

    Presentation time: 5:30 PM – 5:45 PM

    Room: OCCC – W414CD

    Pacritinib in patients with high-risk myelofibrosis: Outcomes from post-hoc analyses of two Phase 3 studies.

     

     

     

     

    Poster Presentation

    Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Real-world treatment patterns and clinical outcomes in patients with Myelofibrosis treated with Pacritinib (PAC): Results from the MY-PAC Study.

     

     

    Poster Presentation

    Session Name: 908. Outcomes research: Myeloid Malignancies: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    PROSPERA (ABNL-MARRO 002): A randomised Phase 2 study of Pacritinib vs. Hydroxyurea in patients with Advanced Proliferative Chronic Myelomonocytic Leukaemia (CMML)

     

     

     

    Poster Presentation

    Session Name: 637. Myelodysplastic Syndromes: Clinical and epidemiological: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Treatment patterns and outcomes in patients with myelofibrosis treated with Pacritinib following a switch from Ruxolitinib: The MY-PAC Study.

     

     

    Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Incidence, prevalence, and clinical outcomes of Myelofibrosis with and without Cytopenia in the United States.

     

     

     

     

    About ALTUVOCT ® (efanesoctocog alfa)

    ALTUVOCT® (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (HA). ALTUVOCT can be used for all age groups and any disease severity.

     

    About the Sobi and Sanofi Collaboration
    Sobi and Sanofi collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

     

    About Aspaveli®/Empaveli® (pegcetacoplan)
    Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b inhibitor designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the US, European Union, and other countries globally, and for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States. It is under regulatory review for C3G and primary IC-MPGN in the European Union and other countries globally.

     

    About the Sobi and Apellis Collaboration

    Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialisation. Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

     

    About Doptelet® (avatrombopag)

    Doptelet (avatrombopag) is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo an invasive procedure. Doptelet is also approved for the treatment of chronic ITP in pediatric patients.

     

    About Gamifant® (emapalumab-lzsg)
    Gamifant is an anti-IFNγ antibody that binds free and receptor-bound IFNγ, which when secreted in an uncontrolled manner can cause hyperinflammation. Gamifant is indicated for intravenous infusion over one hour and is FDA approved for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) in Still’s disease.

     

    About Vonjo® (pacritinib)
    Vonjo (pacritinib) is a kinase inhibitor indicated in the United States for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Vonjo is also being investigated for other rare hematologic conditions, including VEXAS syndrome.

     

    Sobi®

    Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

     

     

    Contacts

    For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

     

     

    Continue Reading