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Regulatory and Compliance Updates news
(page 15)
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.
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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.
15 February 2026
Genentech's Gazyva Shows Positive Phase III Results in Primary Membranous Nephropathy
Phase III study shows Gazyva achieves significant remission in primary membranous nephropathy, with safety profile consistent and no new signals. Data to be shared with health authorities.
13 February 2026
EMA Recommends Withdrawal of Levamisole Medicines
Levamisole's risks, including leukoencephalopathy, outweigh benefits for treating parasitic infections. EMA advises EU market withdrawal due to safety concerns.
12 February 2026
European Industry Leaders Urge Action for Competitiveness and Sustainability
EU industry leaders stress urgent reforms to prevent job losses and closures, advocating for regulatory changes and investment to balance green goals with competitiveness.
12 February 2026
Stahl Achieves Early GIO Compliance for Food-Packaging Coatings
Stahl's food-packaging coatings meet GIO standards early, enhancing sustainability and offering customers regulatory-ready solutions for future compliance.
11 February 2026
Merck's KEYTRUDA and KEYTRUDA QLEX Approved for PD-L1+ Platinum-Resistant Ovarian Cancer
FDA approves KEYTRUDA regimens for platinum-resistant ovarian cancer, showing reduced disease progression and death risk in trials.
11 February 2026
ORLEN Acquires 25% Stake in Afrodite Gas Discovery
ORLEN acquires 25% of PL293 in the North Sea, targeting 1.9 bcm of gas. The project tests new production methods and aligns with ORLEN's strategy for Norwegian gas development by 2030.
10 February 2026
ArcelorMittal to build €1.3bn electric arc furnace in Dunkirk
Scheduled for 2029, it will cut CO2 intensity threefold, receive 50% support via Energy Efficiency Certificates and relies on EU TRQ/CBAM changes plus a long-term EDF power deal.
10 February 2026
FDA Grants Priority Review to Takeda's Oveporexton for Narcolepsy Type 1
Oveporexton, an orexin agonist, aims to treat narcolepsy type 1 by restoring orexin signaling. FDA's decision expected in Q3. Current treatments insufficient for many patients.
9 February 2026
CNF's Stance on UK SAF Mandate
The SAF Mandate should exclude crop-based fuels to ensure policy integrity, investor confidence, and focus on scalable, sustainable fuel pathways for long-term emissions reduction.
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