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Regulatory and Compliance Updates news
(page 15)
25 February 2026
Merck Presents Phase 3 Trial Results for HIV-1 Treatment DOR/ISL at CROI 2026
DOR/ISL shows non-inferiority and similar safety to BIC/FTC/TAF in HIV-1 treatment-naïve adults and maintains suppression in those switching from other therapies.
25 February 2026
MOL and Janaf Agree on Adria Pipeline Capacity Tests
Long-term tests will assess Adria pipeline capacity. MOL seeks clarity on Russian oil shipments and criticizes Janaf's pricing. Two competitive routes are vital for regional supply security.
25 February 2026
Regulation Essential for OCCS Investment in Maritime Decarbonization
A DNV report highlights the need for clear regulations to advance OCCS technology, crucial for maritime decarbonization, with pilot projects showing technical feasibility and economic potential.
25 February 2026
Clariant Gains EU Approval for Rice Bran Wax in Food-Contact Plastics
EU approval allows rice bran wax additives in PET, PLA, and PVC for food-contact, offering a sustainable alternative to montan wax with lower carbon footprint and supply chain benefits.
24 February 2026
Johnson & Johnson Seeks FDA Approval for IMAAVY® to Treat wAIHA
IMAAVY® targets wAIHA by blocking FcRn, reducing IgG. Phase 2/3 study shows improved hemoglobin and fatigue.
24 February 2026
Rompetrol Rafinare Schedules Turnaround for Petromidia and Vega Refineries
Petromidia and Vega refineries will halt operations for a 20-day scheduled maintenance, focusing on inspections, equipment cleaning, and component replacements to ensure safety and efficiency.
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23 February 2026
Johnson & Johnson's RYBREVANT® Approved for New Dosing Options in EGFR-Mutated Lung Cancer
European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.
23 February 2026
Novo Nordisk: CagriSema Shows 23% Weight Loss in Trial, Misses Primary Endpoint
CagriSema achieved 23% weight loss in 84 weeks but didn't match tirzepatide. Further trials will explore higher doses. Safe profile with mild gastrointestinal effects.
21 February 2026
Johnson & Johnson's TREMFYA® Shows Sustained Remission in Ulcerative Colitis Over 3 Years
TREMFYA® maintains clinical, endoscopic, and histologic outcomes in ulcerative colitis through 140 weeks, with high patient retention and no new safety concerns.
20 February 2026
Chugai Launches Japan's First Regenerative Treatment for Duchenne Muscular Dystrophy
ELEVIDYS, a one-time therapy for DMD, targets ambulatory patients aged 3-7. Safety measures and post-marketing studies are in place following reports of liver failure cases.
20 February 2026
Roche's Giredestrant NDA Accepted by FDA for Advanced Breast Cancer
FDA accepts giredestrant NDA based on phase III data showing reduced disease progression risk in ER-positive breast cancer. Decision expected by December 18, 2026.
19 February 2026
Zenyaku's Rituxan Approved for Autoimmune Hemolytic Anemia Treatment
Rituxan gains approval for treating autoimmune hemolytic anemia, targeting B cells to reduce autoantibodies. Effective for warm AIHA, CAD, and PCH, offering an alternative to steroids.
19 February 2026
Genentech's Venclexta and Acalabrutinib Combo Approved by FDA for Untreated CLL
FDA approves all-oral, fixed-duration regimen for CLL, reducing treatment time. AMPLIFY study shows 35% lower risk of progression or death compared to chemoimmunotherapy.
19 February 2026
BASF Introduces Circalo for Low Carbon Ethanol Production
Circalo connects farmers and ethanol producers to reduce carbon intensity, aligning with Section 45Z, using xarvio tools for data verification and compliance.
19 February 2026
Trinseo's Rho Plant Achieves ISO 9001 Certification
The Rho facility's ISO 9001:2015 certification highlights its quality management and ability to produce high-quality recycled monomers. Other Trinseo sites also hold this certification.
19 February 2026
Merck Reports Positive Phase 3 Trial Results for ENFLONSIA in High-Risk Infants and Children
ENFLONSIA shows consistent safety and efficacy in high-risk infants over two RSV seasons, supporting expanded use for children under 2.
19 February 2026
AGC Biologics Gains Anvisa GMP Certification for Seattle Facility
The Seattle site can now supply biopharmaceuticals to Brazil, enhancing AGC's global supply capabilities and expanding regulatory approvals to over 11 countries.
18 February 2026
AFC Energy permitted to export and sell low‑carbon hydrogen from Dunsfold pilot
UK Environment Agency revision allows export and sale of ISO 14687 grade D hydrogen from the Dunsfold ammonia cracker; pilot yields up to 300 kg/day.
18 February 2026
AFC Energy permitted to export and sell low‑carbon hydrogen from Dunsfold pilot plant
Environment Agency approved export/sale of low‑carbon ISO 14687 D hydrogen from Dunsfold pilot (up to 300kg/day); JV with ICL advancing Hy‑5 rollout and permitting for larger sites.
18 February 2026
AFC Energy Gains Approval to Export and Sell Low Carbon Hydrogen from Ammonia Cracking Plant
The UK Environment Agency's permit revision allows hydrogen production training at Dunsfold and supports future deployments with Industrial Chemicals Group Ltd.
18 February 2026
Toray's Ehime and Nagoya Plants Achieve ISCC PLUS Certification for Engineering Plastics
Two plants gain ISCC PLUS certification, enabling use of biomass and recycled materials in PBT and LCP resins, supporting carbon footprint reduction.
18 February 2026
Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Breakthrough Status for Advanced Head and Neck Cancer
FDA grants Breakthrough Therapy Designation to RYBREVANT FASPRO™ for HPV-unrelated head and neck cancer after platinum-based chemotherapy and PD-1/PD-L1 inhibitor.
18 February 2026
PureCycle and TOPPAN Partner for Sustainable Recycled Packaging Solutions
They developed a snack bar wrapper with 30% recycled content, targeting thermoforming applications to meet regulatory demands without compromising safety or performance.
18 February 2026
VolagHy Releases EIA Program for Kuopio Site
The EIA program for the Kuopio site outlines environmental, social, and land-use assessments, moving the project into the formal evaluation phase with stakeholder engagement.
17 February 2026
Vattenfall Divests French Sales Business to Alterna énergie
Vattenfall transfers its French electricity and gas sales business, ensuring seamless service continuity. Alterna énergie will integrate all employees and maintain existing contracts.
17 February 2026
Novo Nordisk: EU Approves Higher Wegovy® Dose for Obesity, 21% Average Weight Loss
The EU approved a 7.2 mg Wegovy® dose for obesity. In studies, participants lost 21% body weight on average. Common side effects: nausea, diarrhea, vomiting, and dysaesthesia.
17 February 2026
FDA Approves Johnson & Johnson's Monthly EGFR Therapy RYBREVANT FASPRO
FDA approves monthly dosing for RYBREVANT FASPRO, maintaining efficacy and reducing administration time and reactions compared to bi-weekly and IV schedules for EGFR-mutated NSCLC treatment.
17 February 2026
Stahl Wins 2025 adiFORMULATOR Award from adidas
Stahl's commitment to safer formulations and ZDHC compliance earns recognition, highlighting its role in advancing sustainable practices in the chemical industry.
17 February 2026
Neste and World Fuel Services Expand SAF Availability at 100+ European Airports
The five-year agreement supports regulatory compliance and boosts SAF supply, leveraging World Fuel's network and Neste's production capabilities.
16 February 2026
Roche Reports Positive Phase III Results for Gazyva in Membranous Nephropathy
Phase III study shows Gazyva achieves higher remission rates in membranous nephropathy, with safety consistent and no new signals. Data to be shared with health authorities.
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