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Regulatory and Compliance Updates news
(page 21)
3 November 2025
Clariant Wins Petrobras Best Suppliers Award for Chemicals
Clariant excels in quality, ESHA, delivery, and contract management, scoring 5.7/6 on Petrobras's Supplier Performance Index, enhancing its reliability and performance.
3 November 2025
Takeda's Dengue Vaccine Proven Effective for 7 Years
QDENGA shows long-term safety and efficacy, reducing dengue cases and hospitalizations. Approved in 41 countries, it remains effective across all virus serotypes with no new safety issues.
3 November 2025
Uniper Sells Uniper Wärme GmbH to Steag Iqony Group
The sale fulfills EU conditions for Uniper's stabilization package. Uniper Wärme serves 14,400 customers with a 750 km district heating network using CHP and eco-friendly heat sources.
3 November 2025
Roche's Gazyva Shows Significant Disease Reduction in Lupus Study
Phase III study shows Gazyva meets primary and secondary endpoints in SLE, potentially setting a new care standard by targeting B cells and reducing organ damage risk.
31 October 2025
Johnson & Johnson Seeks FDA Approval for STELARA in Pediatric Ulcerative Colitis
sBLA submitted for STELARA to treat pediatric ulcerative colitis, backed by Phase 3 UNIFI Jr trial data, aiming to expand treatment options for children.
31 October 2025
Iberdrola Acquires PREVI's 30.29% Stake in Neoenergia
Iberdrola now controls 84% of Neoenergia, investing €1.92 billion. Neoenergia leads Brazil's distribution with 40M customers and 3,800 MW renewable capacity.
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30 October 2025
LANXESS Launches Sustainable Additive for Extreme Pressure
Additin RC 2515 now uses over 80% sustainable materials, reducing PCF by 34%. It excels in extreme pressure applications and is ISCC PLUS-certified.
30 October 2025
EIB Provides €90 Million for TVO's Olkiluoto Nuclear Plant Upgrades
The EIB funds upgrades to enhance safety and reliability of Olkiluoto's nuclear units, supporting Finland's energy independence and EU climate goals.
30 October 2025
BASF and ETH Zurich: Recycling Automotive Waste into High-Value Feedstock
Recycling automotive shredder residue with biomass reduces emissions, offers new feedstocks, and requires supportive policies for mixed waste gasification.
29 October 2025
Johnson & Johnson to Conduct Study Comparing IMAAVY™ and Alternative FcRn Blocker for gMG
The EPIC study will compare IMAAVY™ to efgartigimod in gMG patients, including a treatment-switch arm. Vibrance-MG data shows sustained IgG reduction and disease control in pediatric patients.
29 October 2025
Merck and Eisai Update on LEAP-012 Trial for Hepatocellular Carcinoma
The LEAP-012 trial showed no overall survival benefit for the treatment, but progression-free survival improved. The study is closed, and further data analysis is ongoing.
29 October 2025
Merck's KEYTRUDA Approved in EU for Treating Resectable LA-HNSCC
KEYTRUDA gains EU approval as the first anti-PD-1 therapy for resectable LA-HNSCC with PD-L1 expression, based on KEYNOTE-689 results.
28 October 2025
Merck and Eisai's WELIREG and LENVIMA Improve PFS in Advanced Renal Cell Carcinoma Trial
The trial showed significant PFS and ORR improvements with WELIREG and LENVIMA in advanced RCC patients post anti-PD-1/L1 therapy, with consistent safety profiles.
28 October 2025
Roche's Gazyva Shows Positive Phase III Results in Pediatric Nephrotic Syndrome
Gazyva achieved sustained remission in young nephrotic syndrome patients, reducing steroid use. No new safety issues. Data to be shared with health authorities.
27 October 2025
Dow's Freeport MDI Facility Achieves ISCC PLUS Certification
The Freeport facility now offers bio-circular isocyanates with ISCC PLUS certification, enhancing sustainability and supply chain transparency for various industries.
27 October 2025
Merck's WINREVAIR Approved by FDA for Expanded PAH Treatment
WINREVAIR, now approved for PAH, improves exercise capacity, reduces clinical worsening risks, and shows significant efficacy in the ZENITH trial. Monitor hemoglobin and platelets during treatment.
27 October 2025
Johnson & Johnson's Icotrokinra Shows Therapeutic Benefit and Safety in Ulcerative Colitis
Icotrokinra shows sustained clinical benefits and safety in ulcerative colitis, with Phase 3 trials underway for broader applications.
27 October 2025
Johnson & Johnson's TREMFYA® Shows Two-Year Remission in Crohn's Disease
TREMFYA® maintains remission in Crohn's disease over 96 weeks, with consistent safety and efficacy in both subcutaneous and intravenous regimens.
24 October 2025
Johnson & Johnson: Nipocalimab Reduces Sjögren’s Disease Activity and Severity
Nipocalimab shows promise in reducing Sjögren’s disease symptoms and autoantibodies, with a favorable safety profile and ongoing Phase 3 trials.
23 October 2025
Merck's KEYTRUDA and KEYTRUDA QLEX Get FDA Priority Review for Bladder Cancer Treatment
FDA grants priority review for KEYTRUDA combinations with Padcev, showing improved survival in muscle-invasive bladder cancer patients ineligible for cisplatin-based chemotherapy.
23 October 2025
INEOS Alerts Europe on Risk to Medicine Supply
European BDO production is threatened by cheap imports from China, risking jobs and medicine supply chains. Urgent EU action is needed to block unfair competition and protect local industry.
22 October 2025
Boehringer Ingelheim's JASCAYD® Approved in China for IPF Treatment
Nerandomilast, approved in China for IPF, showed significant lung function improvement in Phase III trials. It offers favorable tolerability and is also FDA-approved in the U.S.
22 October 2025
EU Report Highlights Growth in Sustainable Aviation Fuel
EASA's report shows increased SAF production in the EU, with biofuels dominating. A 2030 target of 6% SAF blending is on track, but synthetic fuels are still developing.
21 October 2025
Borealis and Promix: Recyclable Packaging for PPWR Compliance
Developed recyclable packaging with Borcycle™ M and Promix Microcell Technology, meeting EU's 2030 PPWR targets for recyclability and recycled content in non-food applications.
20 October 2025
Roche's Gazyva Approved by FDA for Lupus Nephritis Treatment
FDA approves Gazyva for lupus nephritis, showing superior results in trials, offering a new treatment option to prevent kidney disease progression.
19 October 2025
Raludotatug Deruxtecan Shows 50.5% Response in Platinum-Resistant Ovarian Cancer, Reports Daiichi Sankyo and Merck
Raludotatug deruxtecan achieved a 50.5% response rate in phase 2 for platinum-resistant ovarian cancer, with a 5.6 mg/kg dose selected for phase 3.
18 October 2025
Genmab Reports Positive Phase 1/2 Trial Results for Rina-S in Advanced Endometrial Cancer
Rina-S shows 50% response rate in advanced endometrial cancer trial; FDA grants Breakthrough Therapy Designation.
18 October 2025
Merck's KEYTRUDA Plus Chemotherapy Reduces Disease Progression Risk in Platinum-Resistant Ovarian Cancer
KEYTRUDA with chemotherapy shows significant survival benefits in platinum-resistant ovarian cancer, leading to FDA priority review for expanded use.
17 October 2025
Roche Unveils Phase III Data for Vamikibart in Uveitic Macular Edema
Vamikibart shows promise in treating UME, with significant vision improvements in trials, offering a non-steroid alternative with fewer side effects.
17 October 2025
FDA Approves Novo Nordisk's Oral Semaglutide for CV Risk Reduction in High-Risk Type 2 Diabetes Adults
Oral semaglutide reduces major cardiovascular events in high-risk type 2 diabetes patients, showing a 14% risk reduction over 4 years, with consistent safety profile.
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