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Regulatory and Compliance Updates news
(page 9)
20 January 2026
Avantium Achieves Triple ISO Certification
Avantium's FDCA plant in Delfzijl earns ISO 14001, 45001, and 9001 certifications, affirming its commitment to environmental, safety, and quality standards.
20 January 2026
Borealis Invests EUR 49M in Burghausen for Circular Polypropylene Expansion
Investment boosts production of Borstar® Nextension PP, enhancing purity, processability, and recyclability, supporting circular design and compliance with EU packaging regulations.
19 January 2026
MOL Group to Acquire Majority Stake in Serbian NIS
MOL to gain control of Serbia's sole refinery, enhancing its Central and Southeastern European market presence. Transaction awaits regulatory approvals, aims for completion by March 2026.
19 January 2026
MOL Acquires Majority Stake in Serbian NIS
MOL to gain control of Serbia's sole refinery, enhancing its Central and Southeastern European market presence. Transaction awaits regulatory approvals, with completion aimed by March 2026.
19 January 2026
Rompetrol Energy's Petromidia Cogeneration Plant Now Operational
The Petromidia cogeneration plant is operational, enhancing energy infrastructure, reducing costs, and supplying electricity and steam to the refinery and National Energy System.
19 January 2026
AGC Biologics Gains U.S. and EU Approval for Waskyra™ Gene Therapy
Waskyra™ gene therapy for Wiskott-Aldrich syndrome approved, offering a new treatment using patient cells, reducing donor dependency and rejection risk.
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16 January 2026
Sasol Addresses Sulphurous Odour Reports in Johannesburg
Secunda Operations are stable with emissions within limits. No source identified for Johannesburg odour. Monitoring and community engagement continue.
16 January 2026
Genmab Reports Phase 3 Trial Results for Epcoritamab in Relapsed/Refractory DLBCL
Epcoritamab shows improved progression-free survival in Phase 3 trial for R/R DLBCL. Safety profile consistent. Further analysis and regulatory discussions planned.
16 January 2026
Johnson & Johnson's CAPLYTA® Shows Promise for Remission in Major Depressive Disorder
CAPLYTA® nearly doubles remission rates in major depressive disorder when used with antidepressants, showing sustained benefits over six months in clinical studies.
16 January 2026
Boliden Seeks EU Strategic Project Status for Nautanen
Boliden aims to develop Nautanen copper deposit as a sustainable mine, enhancing EU's green transition. Production may start in the early 2030s, pending permits and feasibility studies.
14 January 2026
Johnson & Johnson's TECVAYLI® Shows Improved Survival in Multiple Myeloma Patients
TECVAYLI® monotherapy reduces disease progression and death risk in multiple myeloma patients refractory to anti-CD38 and lenalidomide, showing superior survival benefits.
13 January 2026
WuXi Biologics Gains UK MHRA GMP Certification for Ophthalmic Biologic Manufacturing
Two WuXi facilities in Wuxi passed UK MHRA inspection with no critical findings, confirming their global GMP compliance and robust quality systems.
8 January 2026
SkyNRG Advances Project Wigeon with Key Environmental Approvals
Project Wigeon secures environmental approvals, moving to engineering phase. Facility to produce SAF from RNG, reducing emissions and boosting local economy by 2030.
6 January 2026
Johnson & Johnson Seeks EMA Approval for TECVAYLI and DARZALEX Combo in Relapsed Multiple Myeloma
The EMA application is based on Phase 3 data showing improved survival in relapsed multiple myeloma with TECVAYLI and DARZALEX, with similar adverse event rates to standard care.
5 January 2026
WuXi Biologics Earns ISO 20400 for Sustainable Procurement
Achieving ISO 20400, the company integrates sustainability in procurement, enhances supply chain resilience, and commits to net-zero goals with recognized ESG efforts.
5 January 2026
Takeda and Protagonist Submit NDA for Rusfertide in Polycythemia Vera Treatment
Rusfertide shows promise in controlling hematocrit and reducing phlebotomy in PV patients, meeting key endpoints in Phase 3 VERIFY study.
31 December 2025
Novo Nordisk Wins Semaglutide Patent Case in China
China's Supreme Court upholds the semaglutide patent, boosting confidence in foreign medical innovation and supporting sustainable development in China.
24 December 2025
Elkem Reports Fatality After Explosion at Saint-Fons Workshop
An explosion at a Saint-Fons site resulted in one death and three injuries. Operations are halted, and investigations are underway. Psychological support is provided to affected employees.
23 December 2025
Worley Rosenberg Wins EPC Contract for ConocoPhillips Project
EPC contract covers modifications at Ekofisk Complex. FEED completed; EPC starts Jan 2026, ends autumn 2028. Part of Albuskjell, Vest Ekofisk, Tommeliten Gamma redevelopment. Regulatory approval pending.
22 December 2025
FDA Approves Novo Nordisk's Oral Wegovy for Adult Weight Loss
FDA approves Wegovy pill, the first oral GLP-1 for weight loss, showing ~17% loss in trials. Available January at $149/month, it also reduces cardiovascular risks in adults with obesity.
22 December 2025
Novo Nordisk: FDA Approves Wegovy® Oral Pill for Weight Management
Wegovy® pill, an oral GLP-1, shows 16.6% weight loss in trials. Launch expected in the US by January 2026. Approval based on OASIS and SELECT trials.
22 December 2025
EC Approves Johnson & Johnson's TREMFYA® for Treating Plaque Psoriasis in Children
TREMFYA® gains EC approval for treating moderate to severe plaque psoriasis in children, marking the first IL-23 inhibitor for pediatric use.
22 December 2025
Roche's Lunsumio VELO Approved by FDA for Subcutaneous Use in Follicular Lymphoma
Lunsumio VELO cuts treatment time to one minute for relapsed follicular lymphoma, offering outpatient care with a manageable safety profile.
19 December 2025
WuXi Biologics Earns CDP "A" Ratings for Climate and Water
Recognized for environmental leadership, achieving net-zero by 2050, and reducing water use by 30% by 2025. Collaborates with suppliers for sustainable practices.
18 December 2025
FDA Approves Boehringer Ingelheim's JASCAYD for Progressive Pulmonary Fibrosis
JASCAYD, a PDE4B inhibitor, slows lung function decline in progressive pulmonary fibrosis, offering a new treatment option based on Phase III trial results.
18 December 2025
Johnson & Johnson's TRUFILL n-BCA Approved by FDA for Chronic Subdural Hematoma Treatment
FDA approves TRUFILL n-BCA for MMA embolization in chronic subdural hematoma, offering a minimally invasive alternative to surgery with proven safety and effectiveness.
18 December 2025
Lilly's Orforglipron Maintains Weight Loss in Phase 3 Trial
Orforglipron met primary and key secondary endpoints for weight maintenance at 52 weeks post-weight loss on Wegovy. FDA submission for obesity treatment is underway.
18 December 2025
Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment
CagriSema, combining cagrilintide and semaglutide, shows 23% weight loss in trials. If approved, it offers a new obesity treatment option.
18 December 2025
Novo Nordisk Seeks FDA Approval for CagriSema, a Weekly Obesity Treatment
CagriSema, a weekly injectable combining GLP-1 and amylin analogues, shows promising weight loss results in trials and awaits FDA review for obesity management.
18 December 2025
Takeda's Zasocitinib Phase 3 Trials Show Promise for Plaque Psoriasis Treatment
Zasocitinib met all primary and secondary endpoints in Phase 3 trials, showing potential for clear skin in plaque psoriasis with a consistent safety profile.
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