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Regulatory and Compliance Updates news
(page 23)
29 September 2025
Novo Nordisk Submits BLA for Hemophilia A Treatment Mim8 to FDA
Mim8, a bispecific antibody for hemophilia A, offers flexible dosing and is under FDA review. It aims to improve clotting and reduce bleeding episodes.
29 September 2025
UPM Partners with Versowood to Enhance Wood Sourcing in Finland
UPM secures pulpwood and sawmill by-products from Versowood, selling its Korkeakoski sawmill in return. The deal awaits regulatory approval by 2025.
29 September 2025
Dow, Zermatt, Nature’s Variety: Recyclable Pet Food Pouch with Advanced Recycled Content
New pet food pouch uses recyclable, food-contact compliant recycled plastic, aligning with EU 2030 targets and consumer demand for sustainable packaging.
26 September 2025
Eni Challenges AGCM's Biofuel Cartel Allegations
Eni disputes AGCM's decision, citing misrepresentation of facts and market logic, and plans to defend its case in court, highlighting potential harm to its reputation and Italian energy investments.
25 September 2025
ARLANXEO's Baypren® CR Plant Achieves ISCC PLUS Certification
The Dormagen plant's ISCC PLUS certification supports sustainable synthetic rubber production, reducing carbon footprint and ensuring responsible sourcing and compliance.
24 September 2025
Toray Achieves UL Certification for Torelina™ A660HV PPS Resin with RTI 200°C and CTI 600V
Torelina™ A660HV meets new UL standards, enhancing applications in power semiconductors and renewable energy with high voltage and temperature resistance.
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24 September 2025
Trinseo's ALTUGLAS™ R-LIFE™ VML-H CR50 Achieves UL Yellow Card Certification
ALTUGLAS™ R-LIFE™ VML-H CR50, a PMMA with 50% recycled content, meets UL standards for flammability and thermal performance, ensuring suitability for demanding applications.
24 September 2025
Worley Consulting: Tech Rollout Key to Net Zero in Aviation
Feedstock is sufficient for SAF; the challenge is accelerating technology deployment and diversifying production pathways to achieve net zero in aviation.
23 September 2025
Dow Introduces Non-Fluoropolymer Processing Aid for Film Packaging
DOWSIL™ 5-1050 PPA enhances film processing, reduces melt fracture, and complies with EU and US food safety regulations.
22 September 2025
ExxonMobil Expands Guyana Offshore Capacity with Seventh Project
ExxonMobil's Hammerhead project in Guyana will produce 150,000 barrels/day by 2029, boosting local jobs and investments. Total committed funds for seven projects exceed $60 billion.
22 September 2025
Evonik Introduces MaxiPure® Polysorbate 80 for Injectable Drugs
MaxiPure® Polysorbate 80 offers ultra-high purity for injectable drugs, enhancing protein stability and solubilization, while ensuring regulatory compliance and formulation reliability.
22 September 2025
Aramis: SDE++ Subsidy Scheme Update
The SDE++ scheme funds CO2 reduction projects. The 2025 round opens on 7 October with €8 billion available. Now includes CO2 storage outside the Netherlands.
22 September 2025
Lhyfe Becomes Europe's Largest RFNBO Hydrogen Producer
Lhyfe's four sites in France and Germany are now RFNBO certified, ensuring 100% renewable hydrogen production and compliance with EU environmental standards.
19 September 2025
Roche's Lunsumio Subcutaneous Formulation Recommended for EU Approval
Lunsumio SC offers faster administration and high response rates for relapsed follicular lymphoma, with low cytokine release syndrome risk, pending EU approval.
19 September 2025
FDA Approves Merck's Subcutaneous KEYTRUDA QLEX for Solid Tumors
KEYTRUDA QLEX, a subcutaneous immune checkpoint inhibitor, offers comparable efficacy to IV KEYTRUDA in treating metastatic NSCLC, with administration possible in one minute by healthcare providers.
19 September 2025
Sasol Seeks Clarity on Highveld Air Quality Regulations
Sasol seeks a court ruling on emission targets in the Highveld Air Quality Plan, aiming for legal clarity while maintaining commitment to air quality goals.
19 September 2025
Merck's ENFLONSIA™ Recommended by EU CHMP for RSV Prevention in Infants
ENFLONSIA™ awaits EU approval for infant RSV prevention, offering a single-dose option for all weights. Backed by Phase 2b/3 and Phase 3 trials, decision expected by year-end.
19 September 2025
Merck Gains EU CHMP Support for KEYTRUDA SC and New Head and Neck Cancer Use
CHMP backs KEYTRUDA SC for all EU adult indications and a new use in LA-HNSCC. Awaiting European Commission's final decision.
19 September 2025
Uniper Sells Datteln 4 Power Plant to ResInvest Group
The sale of Datteln 4, a modern coal plant, is part of EU state aid conditions. Regulatory approvals are pending. Purchase price undisclosed.
18 September 2025
Aptar Pharma's Unidose System Delivers First FDA-Approved Intranasal Diuretic Enbumyst
Enbumyst™, an intranasal diuretic, offers a faster, self-administered alternative for edema treatment, using Aptar's Unidose System for effective nasal drug delivery.
18 September 2025
MOL Group Converts Plastic Waste into High-Value Products at Tiszaújváros Site
MOL's pilot test in Hungary converts plastic waste into polyethylene and polypropylene, advancing its circular economy strategy with ISCC PLUS certification.
18 September 2025
BENEO Gains Thai FDA Approval for Prebiotic Claim
Thai FDA approves chicory root fibre Orafti® Inulin for prebiotic claims, aligning with rising consumer interest in digestive health.
17 September 2025
WuXi Biologics Gains GMP Certification for Three Facilities from Turkey's TITCK
Three WuXi facilities passed TITCK's inspection, reinforcing their global quality standards and expanding into the Turkish market.
17 September 2025
Novo Nordisk's Oral Semaglutide Achieves 16.6% Weight Loss in Obesity Study
Oral semaglutide 25 mg shows significant weight loss and improved physical activity in a 64-week trial, with mild to moderate side effects, pending FDA approval.
17 September 2025
EU Allocates €100m in ETS Allowances for Airlines' Sustainable Fuel Purchase
In 2024, 1.3 million ETS allowances will support airlines using sustainable fuels, covering price differences and promoting EU climate goals.
17 September 2025
BASF Unveils Keropur Additive Series for TOP TIER+ Standard
Keropur AP 225-20 meets TOP TIER+ and EPA standards, available before 2027. Enhances engine protection, fuel economy, and emissions. Deliveries start 2026.
17 September 2025
UPM Adhesive Materials Earns RecyClass Recognition for HDPE and PET Label Recycling
RecyClass approves RW85C adhesive for HDPE and PET recycling, enhancing recyclability and supporting circular economy goals.
16 September 2025
POLYVANTIS Unveils New Label Films at Labelexpo 2025
New PMMA and PC films offer UV protection, anti-counterfeiting, and compliance with safety standards, addressing industry challenges in labeling.
16 September 2025
PPG Introduces Non-Methanol Coating for Ophthalmic Lenses
New coating replaces methanol, meets regulations, maintains durability, and enhances safety for lens makers. Compatible with existing systems, supports sustainability goals.
16 September 2025
Iberdrola Achieves Europrivacy Certification for Digital Contracting
Iberdrola gains Europrivacy certification, ensuring top data protection standards in digital contracting across EU and EEA, reinforcing its commitment to privacy and ethical digital strategy.
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