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Regulatory and Compliance Updates news
(page 7)
29 April 2026
LANXESS and Fuelcare partner on European fuel biocide distribution
EU-approved fuel biocides (Kathon FP 1.5, Preventol D2/FuelClear M15) to protect stored fuels—prevent microbial growth, sludge and corrosion; includes dosing tech and expanded service hubs.
29 April 2026
UPM Q1 2026: Strong start led by decarbonization solutions
Q1 sales €2,505m; comparable EBIT €274m (-5%); operating cash flow €89m; net debt €2,962m. Energy and biofuels strong. H1 comparable EBIT guidance €325–525m.
29 April 2026
Neste Q1 2026 Interim Report
Strong Q1: comparable EBITDA EUR 861m; cash flow before financing EUR 286m; renewable margin USD 856/t; oil refining margin USD 23.0/bbl; leverage 31.7%; volumes hit by maintenance
28 April 2026
Plastic Ingenuity adopts PureCycle PureFive recycled PP for coffee lids
Coffee lids now use 25-100% recycled polypropylene from a dissolution process; material retains virgin-like performance, has FDA food-contact clearance and GreenCircle certification.
28 April 2026
GSK: FDA grants priority review and Breakthrough Therapy for bepirovirsen
Phase III B-Well trials showed significantly higher functional cure rates and acceptable safety in chronic hepatitis B; drug is an antisense oligonucleotide; PDUFA date 26 Oct 2026
28 April 2026
UPM joint venture with Sappi enters EU Phase II merger review
EC opened Phase II on 28 Apr 2026. The proposed graphic-paper JV needs approvals in other jurisdictions; parties are cooperating and say the deal strengthens European supply resilience.
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28 April 2026
REMONDIS: Closing the Textile Loop
Joint initiatives improve textile collection, sorting and recycling; mechanical and chemical recycling needed for mixed fibres. EPR funding and eco-modulation to fund infrastructure and boost reuse.
28 April 2026
Borealis awarded EcoVadis Gold 2026
EcoVadis score rose to 84/100 (from 80); improvements in environment, labour & human rights and ethics; sustainable procurement maintained; max score for policy implementation.
28 April 2026
Boehringer Ingelheim’s survodutide achieves 16.6% weight loss in Phase III obesity trial
Trial met co-primary endpoints; 85.1% achieved ≥5% weight loss vs 38.8% placebo; weight loss mainly fat with reduced waist circumference; GI events were mild–moderate; MASH trials ongoing
27 April 2026
GSK efimosfermin granted FDA Breakthrough and EMA PRIME for MASH
Phase II data: once-monthly long-acting FGF21 candidate improved fibrosis and disease resolution in F2/F3, well tolerated; phase III underway and F4 trials planned; condition drives liver transplants
27 April 2026
Johnson & Johnson’s IMAAVY granted FDA Priority Review for wAIHA
FDA granted Priority Review to nipocalimab sBLA for warm autoimmune hemolytic anemia after Phase 2/3 ENERGY showed durable hemoglobin responses and fatigue improvement; review ~6 months.
27 April 2026
Johnson & Johnson: FDA approves CAPLYTA sNDA to reduce schizophrenia relapse risk
FDA approved sNDA for CAPLYTA (lumateperone) to prevent relapse in schizophrenia. Phase 3 randomized‑withdrawal: 63% lower relapse risk (HR 0.37); 84% relapse‑free at 6 months; safety consistent.
27 April 2026
Lilly to acquire Ajax Therapeutics for AJ1‑11095, a first‑in‑class Type II JAK2 inhibitor
Lead program in Phase 1; POC data due late 2026. Designed to deliver deeper, more durable responses than current Type I JAK2 therapies. Deal may pay up to $2.3B, subject to closing.
27 April 2026
Dow and RDM Group launch Multiboard CirculaRR — food-contact packaging from 100% recycled fibre and recycled PE
Plastic-coated paper packaging made from recycled cartonboard and ISCC PLUS-certified recycled PE. Food-contact compliant, designed for mixed-paper recycling; suitable for frozen and dry pet food
24 April 2026
BASF launches ELASTOSPRAY BMB biomass‑balance isocyanate for North American SPF market
Drop-in biomass-balance isocyanate for SPF systems requires no reformulation, offers 21-29% lower product carbon footprints, REDcert2-verified, supports EPDs and local renewable-energy production
24 April 2026
Mitsui Chemicals, Idemitsu Kosan and Sumitomo Chemical cleared by JFTC for Sumitomo’s PP and LLDPE integration into Prime Polymer
MOU (Sept 2025) and definitive agreement (Dec 2025) formalize PP/LLDPE business integration; overseas antitrust reviews are ongoing and the deal will close after their clearance.
24 April 2026
Chugai Q1 FY2026 Results
Core rev ¥321.7B (+11.5%), core OP ¥163.3B (+17.1%), core net ¥118.6B (+19.6%). Launched Elevidys (DMD JP); Lunsumio+Polivy approved for LBCL. R&D: NXT007 switch, Enspryng (MOGAD), Foundayo US approval.
24 April 2026
EMA recommends Redemplo for adults with familial chylomicronaemia syndrome (FCS)
siRNA blocking APOC3 cut triglycerides 80% vs 17% in trial; lowered acute pancreatitis rates; given subcutaneously every 3 months; common AEs: hyperglycaemia, headache, nausea.
24 April 2026
Kemira Q1 2026: Revenue and Profitability Down; Performance Actions Accelerated
Q1 revenue and margins fell due to weak demand, pricing and FX; volumes stable. Operative EBITDA down; operating cash flow improved. Outlook unchanged; cost and pricing measures accelerated.
23 April 2026
Novo Nordisk: Oral semaglutide lowers HbA1c in adolescents with type 2 diabetes
PIONEER TEENS phase 3a: first oral GLP‑1 RA trial in 10–17‑year-olds with type 2 diabetes (n=132). 52‑week, placebo‑controlled; safety matched adult trials; regulatory filings planned H2.
23 April 2026
Brenntag launches BYPHAR biopharma brand
BYPHAR offers three-tier raw materials (Explore/Enhance/Excel) with GMP/regulatory-ready documentation; co-branded suppliers and global supply, supporting development to commercial manufacturing.
23 April 2026
WuXi Biologics secures South Korea MFDS GMP certification for commercial bispecific antibody production
Three facilities won South Korea MFDS GMP approval, enabling end-to-end commercial manufacture of a bispecific antibody for biliary tract cancer; inspection found no major deficiencies.
22 April 2026
Linde on Ethisphere's 2026 World's Most Ethical Companies list
Included on Ethisphere's 2026 World's Most Ethical Companies list for the sixth consecutive year after a rigorous assessment of governance, compliance, ethics culture and environmental/social impact.
22 April 2026
Axens CAM factory wins Net Zero label and C3IV approval
MACARON CAM plant chosen among 150 major strategic projects; recognized as strategic for EU battery supply chains, will seek permits with public inquiry in summer 2026, FID mid‑2027, production 2030.
22 April 2026
Fred. Olsen Seawind to acquire Vattenfall’s stake in Muir Mhòr floating wind farm
JV partner will take 100% ownership via share sale, subject to regulatory and Crown Estate Scotland approval. Development proceeds; offshore consent pending. Up to 1 GW, operation early 2030s.
21 April 2026
Roche’s fenebrutinib halves RMS relapse rate to ~1 per 17 years
FENhance 1/2: the BTK inhibitor cut MRI lesion activity vs teriflunomide and showed trends to less disability; PPMS trial non‑inferior to ocrelizumab. Safety: similar LFTs; more deaths.
21 April 2026
FDA approves Merck’s IDVYNSO (doravirine/islatravir)
Once-daily, tenofovir-free two-drug regimen approved for virologically suppressed adults; Phase 3 non-inferior to BIC/FTC/TAF. Contraindicated with strong CYP3A inducers or 3TC/FTC; skin reactions.
21 April 2026
Roche's ENSPRYNG cuts MOGAD relapse risk by 68%
Phase III METEOROID met primary endpoint in MOGAD: treatment cut relapses vs placebo, reduced MRI lesions and rescue therapy use, showed consistent safety; data to be filed with regulators
21 April 2026
EBA annual event: Europe shifts to industrial-scale battery execution
Panelists stressed transition from project launches to industrial ramp-up, needing coordinated policy, finance and market measures, new funding tools, and scalable tech to secure competitiveness
21 April 2026
Genentech Enspryng cuts MOGAD relapse risk 68% in Phase III
METEOROID met its primary endpoint: drug delayed first relapse vs placebo, with early response (~8w), lower relapse rate, fewer MRI lesions and rescue tx; safety consistent; filings planned
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