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Regulatory and Compliance Updates news
(page 18)
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.
17 December 2025
Aptar's Bidose System Delivers FDA-Approved CARDAMYST Nasal Spray for PSVT
CARDAMYST, a self-administered nasal spray for PSVT, offers reliable, easy-to-use treatment with Aptar's protective dual-container system, enhancing drug delivery solutions.
17 December 2025
Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Approval for Faster NSCLC Treatment
FDA approves RYBREVANT FASPRO™ for EGFR-mutated NSCLC, offering faster, subcutaneous administration with fewer side effects compared to IV delivery.
17 December 2025
Merck's KEYTRUDA and Padcev Enhance Survival in Cisplatin-Eligible MIBC Patients
KEYTRUDA and Padcev improve survival and response rates in MIBC patients, showing promise as perioperative treatment with consistent safety profiles.
17 December 2025
Commission Enhances Carbon Border Adjustment Mechanism
The EU expands CBAM to more products, introduces anti-circumvention measures, and launches a fund to support EU producers against carbon leakage.
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16 December 2025
EU Proposes Measures to Boost Health Sector Innovation and Resilience
The EU introduces a Biotech Act, Safe Hearts Plan, and medical device reforms to enhance biotech, tackle cardiovascular diseases, and streamline regulations for innovation and patient safety.
16 December 2025
PPG Secures REDCert² Certification for Sustainable Materials at European Sites
PPG's Amsterdam and Søborg sites achieve REDCert², ensuring sustainable raw material use and supporting customers' environmental goals with high-performance products.
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
VTTI and Höegh Evi advance permitting for Zeeland Energy Terminal
Draft scope memorandum published and public participation opened for a floating LNG terminal in Vlissingen‑Oost; operational target Q3 2029.
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.
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.
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