Regulatory and Compliance Updates news (page 7)

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  10 November 2025

  Roche's Fenebrutinib Shows Promising Phase III Results for Multiple Sclerosis

  Fenebrutinib reduces relapses in RMS and slows disability in PPMS, showing potential as a high-efficacy oral treatment. Full data expected by 2026 for regulatory submission.
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  9 November 2025

  Merck's Enlicitide Decanoate Cuts LDL-C in HeFH Patients in Phase 3 Trial

  Enlicitide decanoate shows significant LDL-C reduction in HeFH patients, with a safety profile similar to placebo, in the CORALreef HeFH trial.
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  7 November 2025

  Novamont's Mater-Bi Mulch Film Certified as EU Inorganic Soil Improver

  Mater-Bi mulch film is biodegradable, doesn't release microplastics, and meets EU standards, aiding soil health and reducing agricultural plastic waste.
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  6 November 2025

  Boehringer Ingelheim's Apecotrep Reduces Proteinuria in Phase II Kidney Trial

  Apecotrep, a TRPC6 inhibitor, showed 40% proteinuria reduction in FSGS patients. Phase III trial recruiting; further Phase II trials planned for other kidney diseases.
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  6 November 2025

  Sasol Develops Methane Rich Gas Solution for South Africa's Post-2028 Gas Supply

  Sasol plans to supply Methane Rich Gas from 2028-2030 to bridge South Africa's gas supply gap, pending regulatory approval, while transitioning to LNG for long-term needs.
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  6 November 2025

  Johnson & Johnson's DARZALEX FASPRO®: First FDA-Approved Treatment for High-Risk Smoldering Multiple Myeloma

  DARZALEX FASPRO® reduces progression risk to active multiple myeloma by 51% in high-risk patients, marking a shift in treatment strategy.

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  6 November 2025

  Novo Nordisk's CagriSema Reduces Blood Pressure and Inflammation, Lowers Heart Disease Risk

  CagriSema shows potential in reducing blood pressure, inflammation, and heart disease risk, with ongoing trials to assess cardiovascular outcomes.
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  6 November 2025

  Novo Nordisk and U.S. Administration to Lower GLP-1 Costs and Expand Access

  Novo Nordisk to lower semaglutide prices in 2026, expand Medicare Part D coverage, and expects a slight negative impact on global sales growth.
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  6 November 2025

  Lilly and U.S. Government Expand Access to Obesity Drugs

  Medicare beneficiaries to access obesity drugs at $50/month. LillyDirect offers self-pay options. FDA approval pending.
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  6 November 2025

  Johnson & Johnson's CAPLYTA® Approved by FDA for Major Depressive Disorder Treatment

  FDA approves CAPLYTA® as adjunctive therapy for major depressive disorder, showing significant symptom improvement and safety in trials, with potential for remission.
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  6 November 2025

  Clariant and FUHUA Form Joint Venture for Flame Retardants

  The venture will produce halogen-free flame retardants in China, addressing regulatory needs. Clariant expands capacity with a CHF 100M investment and a new production line in Cangzhou.
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  6 November 2025

  Sasol Develops Methane Rich Gas Solution for South Africa's Post-2028 Gas Supply

  Sasol plans to supply Methane Rich Gas from 2028-2030 to bridge the gas supply gap, pending regulatory approval, while transitioning to LNG for long-term needs.
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  5 November 2025

  Hyundai Transys and BASF Develop Modular Seat with Elastollan TPU

  The new seat uses Elastollan TPU with SCF foaming for customizable, sustainable automotive interiors, offering recyclability, reduced VOCs, and energy efficiency.
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  5 November 2025

  Novo Nordisk's Wegovy® Helps Users Meet Health Targets, Reducing Obesity Risks

  Wegovy® users achieved BMI and waist targets, improving cardiovascular health and reducing obesity-related risks, as shown in the STEP UP trial.
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  5 November 2025

  EU Boosts Climate Goals Before COP30

  The EU commits to reducing GHG emissions by 66.25-72.5% by 2035 and 90% by 2040, aiming for climate neutrality by 2050, ahead of COP30.
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  5 November 2025

  Novo Nordisk Unveils New Oral Semaglutide Analyses at ObesityWeek 2025

  Oral semaglutide 25 mg shows improved blood sugar control, cardiovascular risk factors, and weight loss efficacy, comparable to injectable form, across various patient groups.
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  4 November 2025

  Securing Biogas Plant Connections to Gas Networks

  Propose regulations to ensure efficient, cost-effective biogas plant connections to gas networks, supporting climate goals and economic viability.
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  4 November 2025

  BASF Introduces Cavipor Clay Foam for Insulation Market

  Cavipor clay foam, now approved for floors and roofs, enhances energy efficiency and sustainability in building insulation, with easy application and recyclability.
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  4 November 2025

  Asahi Kasei's Nefecon Added to KDIGO Guidelines for IgA Nephropathy Treatment

  Nefecon's inclusion in KDIGO 2025 guidelines highlights its role in IgAN treatment, supporting Asahi Kasei's strategic growth in healthcare.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.