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Regulatory and Compliance Updates news
(page 16)
16 December 2025
Equinor Challenges Økokrim Penalty
Equinor disputes a NOK 220M fine and NOK 500M confiscation claim for historical emissions, arguing it self-reported and addressed the issues. The case will proceed to court.
15 December 2025
Janssen's TECVAYLI® and DARZALEX FASPRO® Join FDA's Priority Voucher Program
TECVAYLI® and DARZALEX FASPRO® show significant survival benefits in multiple myeloma, gaining FDA Breakthrough Therapy Designation and Real-Time Oncology Review.
12 December 2025
Lilly's Inluriyo™ Shows Efficacy in ER+, HER2- Breast Cancer
Inluriyo™ improves survival in ER+, HER2- breast cancer, both alone and with abemaciclib, extending time to chemotherapy and showing durable benefits across patient groups.
12 December 2025
FDA Approves Johnson & Johnson's AKEEGA for BRCA2-Mutated Prostate Cancer
FDA approves AKEEGA for BRCA2-mutated prostate cancer, reducing disease progression by 54% and delaying symptoms by 59% in clinical trials.
12 December 2025
Merck's WINREVAIR™ Gains EU CHMP Support for Broader PAH Use
EU CHMP backs expanded WINREVAIR™ use for PAH, covering WHO FC II-IV. Decision by European Commission expected Q1 2026.
12 December 2025
Novo Nordisk: EMA Recommends Higher Wegovy® Dose for 20.7% Weight Loss
EMA backs Wegovy® 7.2 mg for obesity, showing 20.7% weight loss in trials, preserving muscle, and reducing cardiovascular risks. Approval pending in EU, US, UK, and more.
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12 December 2025
Ercros Achieves Top ESG Rating from Lighthouse
Ercros scores 87/100 in Lighthouse's ESG Rating 2025, excelling in social and governance pillars, with improvements in environmental management and supplier assessments.
11 December 2025
Roche Secures CE Mark for Broadest Automated Mass Spectrometry IVD Menu
Roche's automated mass spectrometry platform now offers 39 tests, enhancing lab efficiency and supporting faster, precise diagnoses, including antibiotic monitoring.
10 December 2025
OMV Petrom Advances Romania's Energy Security
Neptun Deep progresses for 2027 gas. Anaconda-1 drilling follows. Onshore exploration continues. Production licenses extended 15 years.
10 December 2025
Holcim Earns CDP "A" Rankings for Climate and Water Leadership
Holcim's climate and water efforts earn CDP "A" rankings, validating its sustainability strategy and progress towards net-zero and nature-positive goals.
9 December 2025
Futerro Submits Permit Applications for Port-Jérôme-sur-Seine Biorefinery
Futerro's biorefinery in Normandy aims to produce bio-based plastics, with support from local authorities, targeting production by early 2029.
9 December 2025
Borouge and Borealis Introduce Recleo: Cost-Effective Recycled Solutions
Recleo offers a global portfolio of recycled polyolefins, enhancing sustainability and compliance with evolving regulations, while ensuring quality and reliability for diverse applications.
9 December 2025
Lilly's Jaypirca Improves Progression-Free Survival in Treatment-Naïve CLL/SLL
Jaypirca reduced disease progression risk by 80% in CLL/SLL patients, showing promising safety and efficacy in a Phase 3 trial, with fewer adverse events compared to chemoimmunotherapy.
9 December 2025
Roche's Gazyva Approved by EU for Lupus Nephritis
Gazyva, combined with MMF, shows superior results in treating lupus nephritis, potentially delaying end-stage kidney disease, based on phase II and III studies.
9 December 2025
Roche Introduces CE-Marked PCR Test for Accurate Vaginitis Diagnosis
The new PCR test improves vaginitis diagnosis by detecting bacteria and yeast, using a single swab for faster, accurate results, enhancing healthcare efficiency.
9 December 2025
Borealis and Borouge Introduce Recleo: Cost-Effective Recycled Polyolefins
Recleo offers a global portfolio of recycled polyolefins, enhancing sustainability and meeting regulatory targets with consistent quality and reliable supply.
8 December 2025
Boehringer Ingelheim's JASCAYD® Approved in China for Progressive Pulmonary Fibrosis
JASCAYD® (nerandomilast) gains approval in China for progressive pulmonary fibrosis, offering a new treatment option after five years, based on successful Phase III trials.
8 December 2025
Roche's Columvi Combo Shows Sustained Survival Benefit in Phase III Study
Columvi with GemOx doubles survival in R/R DLBCL patients, approved in 50+ countries, offering a non-transplant treatment option.
8 December 2025
TotalEnergies and NEO NEXT Merge to Form UK's Largest Independent Oil and Gas Producer
TotalEnergies holds 47.5% in NEO NEXT+, enhancing synergies and cash flow with a diverse asset portfolio, producing over 250,000 barrels daily by 2026. Completion expected in H1 2026.
8 December 2025
Evonik Releases EPDs for Building Protection Products
EPDs for PROTECTOSIL® products offer transparency on environmental impact, aiding construction decisions and aligning with future regulatory requirements.
7 December 2025
Genmab's Phase 3 Trial Shows EPKINLY + R2 Benefits in Relapsed Follicular Lymphoma
EPKINLY + R2 reduces disease progression risk by 79% in relapsed follicular lymphoma, with a 95% response rate. FDA-approved, it offers a new second-line treatment option.
6 December 2025
Protagonist and Takeda: Rusfertide's Long-Term Efficacy in Polycythemia Vera
Rusfertide shows sustained hematocrit control and reduced phlebotomy need in polycythemia vera over 52 weeks, with a consistent safety profile.
5 December 2025
Sumisho Realty Management Receives Business Improvement Order
SRM received a business improvement order for compliance issues. Measures are underway to prevent recurrence and strengthen internal controls. Impact on financial results is expected to be limited.
4 December 2025
Merck's EXZOLT CATTLE-CA1 Conditionally Approved by FDA for Screwworm and Tick Control
EXZOLT CATTLE-CA1, a new isoxazoline pour-on, is conditionally approved for screwworm and cattle fever tick control, with a 98-day meat withdrawal period. Available by prescription in 2026.
3 December 2025
FDA Expands Approval for Lilly's Jaypirca in CLL/SLL Treatment
FDA approves Jaypirca for CLL/SLL patients previously treated with covalent BTK inhibitors, offering a new treatment option with proven efficacy and safety.
3 December 2025
Umicore: Slight Increase in Blood Lead Levels Near Hoboken Site
Average blood lead levels near the site rose but stayed within norms. Participation in tests decreased. Umicore continues environmental efforts and encourages more children to join studies.
2 December 2025
Johnson & Johnson's IMAAVY® (nipocalimab) Approved by European Commission for Generalised Myasthenia Gravis
IMAAVY® (nipocalimab) gains EU approval for gMG, showing sustained disease control in adults and adolescents, with consistent safety and tolerability.
2 December 2025
Roche's Point-of-Care Test for Bordetella Infections Gains FDA and CE Approval
The test delivers PCR-accurate results in 15 minutes, differentiating Bordetella species, aiding rapid diagnosis and treatment, crucial for vulnerable groups.
1 December 2025
TotalEnergies and Chevron Expand Offshore Collaboration
TotalEnergies sells 40% of Nigerian exploration licenses to Chevron, enhancing their joint offshore ventures. Completion awaits regulatory approval.
1 December 2025
Uniper Sells Datteln 4 Power Plant to ResInvest Group
Datteln 4, a modern coal plant, was sold as part of EU-mandated structural remedies. It provides electricity, traction power, and district heating in the northern Ruhr area.
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