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Regulatory and Compliance Updates news
(page 21)
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.
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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.
15 September 2025
ORLEN Expands SAF Fuel Availability in Baltic Markets
SAF is now available in Vilnius, Riga, and Tallinn, reducing emissions and supporting EU regulations. ORLEN plans further expansion and domestic production to enhance sustainability.
15 September 2025
Novo Nordisk's Oral Semaglutide Approved in EU for Cardiovascular Benefits
EMA approves Rybelsus® label update for cardiovascular benefits in type 2 diabetes. SOUL trial shows reduced hospitalizations and consistent benefits across BMI and weight.
15 September 2025
BASF's European Performance Materials Sites Achieve REDcert² Certification
BASF's certified sites offer sustainable plastics via mass balance, reducing fossil feedstock with renewable and recycled materials.
12 September 2025
Clean Food Group's CLEAN Oil™ 25 Gains Cosmetics Approval for Sustainable Beauty
CLEAN Oil™ 25, a sustainable cosmetic ingredient, receives approval in key markets, marking a milestone in biotech innovation and sustainable beauty product development.
11 September 2025
Trinseo's ALTUGLAS™ R-Life Achieves ISO 14021 Validation
ALTUGLAS™ R-Life uses 100% recycled MMA monomer, reducing virgin material use. Certified by DNV, it meets ISO 14021 standards for accurate environmental claims.
11 September 2025
Palatinose™ Enhances Gut Hormones for Metabolic Health: Study by BENEO
Palatinose™ boosts GLP-1 and PYY, improving glycaemic response and metabolic stability in adults with metabolic syndrome, especially with timed intake.
11 September 2025
Merck's CAPVAXIVE Shows Positive Immune Response in At-Risk Youth
CAPVAXIVE outperforms PPSV23 in immune response for at-risk children, with comparable safety, covering more serotypes. Results to be shared with global regulators.
11 September 2025
Iberdrola to Acquire 84% of Neoenergia in Brazil for €1.88 Billion
Iberdrola buys PREVI's 30.29% stake in Neoenergia, boosting its share to 84%. The deal awaits regulatory approval. Neoenergia serves 40M Brazilians and leads in infrastructure investment.
10 September 2025
ANDRITZ to Build Sewage Sludge Incineration Plant for RBB in Germany
The plant will enhance sewage sludge treatment, recover phosphorus, and boost energy efficiency, serving over 70 municipalities in line with German regulations. Completion is set for November 2028.
10 September 2025
BASF Launches GLYSANTIN ELECTRIFIED Coolants for EV Safety
New coolants meet China's 2025 standards, reduce battery risks, and enhance EV safety. Production starts in Shanghai, focusing on local market needs.
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