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Regulatory and Compliance Updates news
(page 19)
6 December 2025
Protagonist and Takeda: Rusfertide's Long-Term Efficacy in Polycythemia Vera
Rusfertide shows sustained hematocrit control and reduced phlebotomy need in polycythemia vera over 52 weeks, with a consistent safety profile.
5 December 2025
Sumisho Realty Management Receives Business Improvement Order
SRM received a business improvement order for compliance issues. Measures are underway to prevent recurrence and strengthen internal controls. Impact on financial results is expected to be limited.
4 December 2025
Merck's EXZOLT CATTLE-CA1 Conditionally Approved by FDA for Screwworm and Tick Control
EXZOLT CATTLE-CA1, a new isoxazoline pour-on, is conditionally approved for screwworm and cattle fever tick control, with a 98-day meat withdrawal period. Available by prescription in 2026.
3 December 2025
FDA Expands Approval for Lilly's Jaypirca in CLL/SLL Treatment
FDA approves Jaypirca for CLL/SLL patients previously treated with covalent BTK inhibitors, offering a new treatment option with proven efficacy and safety.
3 December 2025
Umicore: Slight Increase in Blood Lead Levels Near Hoboken Site
Average blood lead levels near the site rose but stayed within norms. Participation in tests decreased. Umicore continues environmental efforts and encourages more children to join studies.
2 December 2025
Johnson & Johnson's IMAAVY® (nipocalimab) Approved by European Commission for Generalised Myasthenia Gravis
IMAAVY® (nipocalimab) gains EU approval for gMG, showing sustained disease control in adults and adolescents, with consistent safety and tolerability.
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2 December 2025
Roche's Point-of-Care Test for Bordetella Infections Gains FDA and CE Approval
The test delivers PCR-accurate results in 15 minutes, differentiating Bordetella species, aiding rapid diagnosis and treatment, crucial for vulnerable groups.
1 December 2025
TotalEnergies and Chevron Expand Offshore Collaboration
TotalEnergies sells 40% of Nigerian exploration licenses to Chevron, enhancing their joint offshore ventures. Completion awaits regulatory approval.
1 December 2025
Uniper Sells Datteln 4 Power Plant to ResInvest Group
Datteln 4, a modern coal plant, was sold as part of EU-mandated structural remedies. It provides electricity, traction power, and district heating in the northern Ruhr area.
28 November 2025
Asahi Kasei's Oita Plant Earns EcoVadis Platinum for Sustainability
The Oita Plant received its second EcoVadis Platinum Medal for top 1% sustainability, excelling in Environment and Labor & Human Rights.
28 November 2025
MAIRE Challenges EuroChem's Unlawful Actions in UK Court Dispute
MAIRE seeks over €700M in damages, citing EuroChem's contract breaches and contempt of UK court orders, while EuroChem turns to Russian courts, defying arbitration agreements.
26 November 2025
Toray Unveils New Bonding Material for Ultra-Thin Semiconductor Wafers
New bonding material enables thinner semiconductor wafers, enhancing AI, NAND, and power semiconductor performance while reducing environmental impact. Mass production set for 2028.
26 November 2025
Novo Nordisk Seeks FDA Approval for Higher Dose of Wegovy 7.2 mg
FDA to review semaglutide 7.2 mg for obesity under expedited program. Phase 3 trial shows 20.7% weight loss. Approval offers new weight management option.
26 November 2025
RWE and Apollo Secure Long-Term Funding for German Grid Expansion
RWE and Apollo form a JV for Amprion's grid expansion, with Apollo investing €3.2 billion. RWE retains control and will reinvest over the next decade.
25 November 2025
Eni Expands Stake in Nigerian Deepwater Block OML 118
Eni's subsidiary NAE acquires an additional 2.5% in OML 118, raising its share to 15%, aligning with its strategy to enhance its upstream portfolio in Nigeria.
21 November 2025
Merck's KEYTRUDA and Padcev Approved by FDA for Bladder Cancer Treatment
FDA approves first PD-1 inhibitor plus ADC regimens for cisplatin-ineligible muscle-invasive bladder cancer, based on KEYNOTE-905 trial results showing significant EFS improvement.
21 November 2025
ORLEN Joins TNFD for Enhanced ESG Transparency
ORLEN adopts TNFD framework to integrate nature-related impacts into ESG reporting, enhancing biodiversity protection and aligning with global best practices.
20 November 2025
MOL and Slovnaft Seek EC Intervention on Janaf's Pipeline Practices
Janaf's unexpected demands on crude oil deliveries raise supply security concerns, potentially breaching contracts and affecting EU fuel supply.
20 November 2025
Nobian's Salt Mining in Heiligerlee Extended to 2035
Dutch ministry approves salt mining extension in Heiligerlee until 2035, ensuring supply for chemical production. Additional studies on cavern closure and soil subsidence required.
20 November 2025
Boehringer Ingelheim's Avian Flu Vaccines Receive EU CVMP Approval
EU CVMP endorses VAXXITEK® and VAXXINACT® vaccines for H5 avian flu, enhancing outbreak preparedness and supporting safe trade with DIVA technology.
20 November 2025
DOMO Chemicals Achieves EcoVadis Platinum Rating with Improved Score
DOMO improved its EcoVadis score by 33 points, excelling in environment, labor, ethics, and procurement, reflecting its commitment to sustainable practices and responsible business.
20 November 2025
EnWG Draft Changes Essential for Biomethane Expansion
The EnWG draft risks undermining biomethane's role in Germany's energy transition, threatening production, infrastructure, and investment security.
19 November 2025
Terumo Aortic Launches Fenestrated TREO® IDE Study in US
The study evaluates endovascular repair of aortic aneurysms using the Fenestrated TREO® System, enrolling 210 patients across 45 US sites, with a 5-year follow-up.
19 November 2025
TotalEnergies Boosts Stake in Nigeria's OPL257
TotalEnergies acquires 50% of OPL257 from Conoil, increasing its stake to 90%. Conoil gains 40% in OML136. The deal supports Egina South field development. Completion awaits approvals.
19 November 2025
Merck's KEYTRUDA® Subcutaneous Form Approved by European Commission
KEYTRUDA SC, a subcutaneous immune checkpoint inhibitor, is approved in Europe for faster administration across all adult indications.
19 November 2025
Merck Reports Positive Phase 3 Trial Results for HIV-1 Treatment DOR/ISL
DOR/ISL shows non-inferiority to BIC/FTC/TAF in HIV-1 treatment-naïve adults, meeting efficacy and safety goals. Detailed findings to be presented at a future scientific congress.
19 November 2025
BASF Expands Biomass-Balanced Methanol Certification with ISCC EU
BASF's methanol now meets four sustainability certifications, aiding chemical and biofuel sectors in reducing fossil use and achieving sustainability goals.
19 November 2025
Roche's Lunsumio SC Approved in EU for Relapsed Follicular Lymphoma
Lunsumio SC offers quick administration for relapsed follicular lymphoma, reducing treatment time to one minute with proven efficacy and safety.
18 November 2025
Genmab's EPKINLY Combination Approved by FDA for Relapsed Follicular Lymphoma
EPKINLY + R² shows superior progression-free survival and response rates in Phase 3 trial for relapsed follicular lymphoma, with a consistent safety profile.
18 November 2025
EU Imposes Safeguard Measures on Ferroalloy Imports; Impact on Elkem
The EU enacts tariff rate quotas on ferroalloy imports, effective Nov 2025 for three years, excluding silicon metal. Elkem anticipates sales shifts and potential price increases.
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