Category: 3. Business

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.

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.

 

 

What’s going on here?

The US dollar took a step back this week, with mounting confidence that the Federal Reserve is about to cut interest rates—boosting the euro, yen, and other major currencies just as global central banks gear up for a flurry of meetings.

What does this mean?

Traders now see a 90% chance the Fed will trim rates at its next meeting, according to LSEG, with at least two more cuts expected this year. The dollar index edged down 0.2% to 98.906, while the euro and yen strengthened. Softer US job numbers added fuel to the idea that the dollar’s gotten ahead of itself. There’s also chatter about a potential Fed leadership shake-up, with Kevin Hassett rumored as a possible replacement for Jerome Powell—which could mean even looser policy. Meanwhile, central banks from Tokyo to Frankfurt are lining up rate decisions, and shifting paths could spark big moves across currency markets in the days ahead.

Why should I care?

For markets: Interest rates call the shots.

The Fed’s expected shift is already rippling through financial markets. A softer dollar is driving investors to size up opportunities in currencies like the euro and yen. Small moves—like a modest 0.1% euro gain and steady yen at 155.15—reflect a wait-and-see mood, but a potential rate hike from the Bank of Japan could strengthen the yen and upend carry trades. That could force investors to redraw strategies as well as rebalance global portfolios.

The bigger picture: Global central banks face a turning point.

A packed run of central bank meetings—from Australia and Canada to Japan and Europe—underscores a shift in policy momentum. With core US inflation inching higher and speculation swirling about Fed leadership, investors face a world where currency and asset values could swing sharply. That means risk assets, from stocks to crypto, may see more volatility as diverging rate plans reset global market dynamics.

Over the past year, AI in legal departments has shifted from theory to practice. Organizations are maturing past the informal exploration stage and are now actively creating strategies for the implementation of AI solutions to drive efficiency. This evolution was the focus of “AI Unleashed: The Journey, One Year Later,” a key session at the ELM Amplify 2025 user conference, which provided a real-world look at progress, challenges, and strategies for successful AI adoption.

Insights from industry leaders at Marsh McLennan and DHL revealed that successful AI implementation in legal departments is not about chasing the latest technology. Instead, it requires a focused strategy, clear governance, and a deep understanding of organizational needs. Why is a focused strategy so important for AI in legal departments? A focused strategy ensures that AI projects are not isolated experiments, but integral components of the department’s long-term vision. It helps prioritize high-impact problems and aligns AI initiatives with core business goals for maximum organizational benefit.

What is the best strategy for AI adoption in legal departments?

The best strategy for adopting AI in legal departments is to focus on the quality of use cases, not the quantity. Success for legal departments often comes from the smaller, more focused use cases. Tiffani Huynh of DHL shared that her team initially pursued a long list of initiatives but soon realized the need for a more focused strategy. The key was creating a plan that directly tied AI projects to the legal department’s long-term vision.

Similarly, Chris Terry of Marsh McLennan stressed the importance of making progress. understanding core departmental needs. By concentrating on high-impact areas, their team avoids distractions from vendors and scattered internal requests. Both panelists agreed that impactful AI projects have to consider what solutions will be the most effective, future-proof, and have the most longevity. This requires developing a clear plan, avoiding distractions, and prioritizing initiatives with the greatest organizational benefit.

How are legal departments using AI today?

Over the past year, leading legal departments have made tangible progress, moving from pilot programs to live, value-adding AI in legal solutions. Their experiences show how a dedicated strategy translates into measurable advancements in efficiency and capability.

The team at Marsh McLennan has successfully established a robust AI governance process, a critical foundation for any organization. They leveraged AI in existing external solutions to drive adoption through practical applications, including:

• Translations
• Pre-execution contract comparisons and redlining
• M&A due diligence and routine legal administrative work, using an in-house ChatGPT-based platform

DHL has gone live with several key solutions that leverage AI. Notable applications include:

• An EEOC position statement generator
• Contract extraction and drafting
• A strategic shift from an in-house tool to Copilot, enhanced with legal-specific prompt training
• A legal operations career architect agent
• Pilots focused on document review and contract creation and analysis

An audience poll at the conference revealed that Copilot was the most-cited AI tool, highlighting the widespread adoption of foundational AI across the industry.

What are the main hurdles to implementing AI in legal?

The primary hurdles to implementing AI in legal departments are internal barriers related to governance, resource constraints, and organizational change. An audience poll confirmed that “approval,” “governance,” and “risk management” are the top factors slowing AI adoption.

Chris Terry noted that large organizations naturally struggle to adapt to rapid change, a challenge made worse by the need to protect sensitive data when using AI tools. Multi-layered approval processes, along with newly created internal AI committees, can create dramatic slowdowns that may leave key stakeholders disengaged or render the technology outdated prior to implementation. To push through these obstacles, Tiffani Huynh urges legal operations professionals to focus on internal marketing and consistent internal storytelling.

Furthermore, AI initiatives often require support from other departments like IT and finance, whose resources are already stretched thin. Both panelists emphasized the need to involve these stakeholders early in roadmap discussions to ensure alignment and secure necessary support.

Change management also remains a universal challenge. How can legal teams overcome resistance to AI adoption? Doing so requires both top-down support from leadership and a bottom-up effort to address team members’ concerns. Empowering internal AI advocates to demonstrate value and providing clear communication can help drive adoption and build trust.

How can legal teams make progress on their AI journey?

The session provided a clear message: successful AI in legal implementation is a marathon, not a sprint. Based on the expert panel’s insights, here are three actionable takeaways to guide your AI journey:

1. Don’t chase “shiny objects.” Start by developing a strategic plan that aligns with your department’s core objectives. Focus on solving problems that will provide the broadest and most significant impact.
2. Acknowledge internal barriers. Proactively engage with stakeholders in IT, finance, and other key departments. Build a strong business case and a clear governance framework to smooth the path for approval and implementation.
3. Start with mindset, then move to metrics. First, encourage adoption and gather qualitative feedback. Use small, early wins to build momentum and justify further investment before focusing on demonstrating a hard return on investment.