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Regulatory and Compliance Updates news
(page 17)
30 January 2026
Johnson & Johnson's AKEEGA® Gets CHMP Nod for mHSPC with BRCA1/2 Mutations
CHMP backs AKEEGA® for mHSPC with BRCA1/2 mutations, showing improved progression-free survival and manageable safety profile in Phase 3 AMPLITUDE study.
29 January 2026
Lilly Addresses AHA Concerns on 340B Program Changes
Lilly extends claims data collection to curb 340B program abuse, countering AHA's claims of illegality and burden, aiming for transparency and patient benefit.
28 January 2026
Sinopec to Lead Hydrogen Energy Standardization Committees Approved by National Energy Administration
Four committees will standardize hydrogen energy in areas like production, storage, and applications, aiming for international alignment and industry integration.
27 January 2026
Toray Develops Heat-Resistant Piezoelectric Polymer for Vibration Detection
The polymer withstands over 200°C, enhancing vibration detection in mobility, robotics, and aerospace. It's lead-free, fluorine-free, and suitable for complex shapes and large areas.
27 January 2026
BASF Unveils New Stoneville Cotton Varieties for 2026
Three new cotton varieties with advanced traits for herbicide and insect control are introduced, offering high yield potential and adaptability to various soil types.
26 January 2026
INEOS Introduces 70% Recycled Polymer for Cosmetics Packaging
New Recycl-IN grade offers 70% recycled content, maintaining quality and reducing carbon footprint for cosmetics packaging, with FDA and RecyClass certifications.
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26 January 2026
Future North Sea Energy System by European Network Operators
Europe's energy shift needs offshore wind and hydrogen integration in the North Sea for decarbonization, affordability, and supply security, requiring clear policies and infrastructure.
21 January 2026
Lhyfe Powers France's First Motorway Hydrogen Station for HGVs
The A4 motorway station offers 1 tonne/day hydrogen, certified RFNBO, for HGVs and light vehicles, enhancing low-carbon routes to Germany and Benelux.
20 January 2026
Axens Continues Consultation on Cathode Material Plant Project
Axens engages stakeholders in Valenciennes on its plant project, sharing updates and study results. Public meetings and consultations are planned for further input and transparency.
20 January 2026
Pakistani Farmers Sue RWE Over Climate Impact
Pakistani farmers claim damages for 2022 floods, alleging significant climate impact. RWE argues such lawsuits harm legal certainty and industrial stability in Germany.
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.
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.
9 January 2026
THOR completes global ISO 45001 target after Speyer accreditation
Expanded integrated management system now includes ISO 9001, 14001 and 50001. Management System and HSE teams credited; reinforces employee safety, environmental protection and product quality.
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.
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