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Regulatory and Compliance Updates news
(page 10)
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.
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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
21 April 2026
Siemens expands Industrial Edge for enhanced data and AI integration
Industrial Edge: AI Suite & WinCC Unified GA. Management adds IEC62443 security and air‑gap. Information Hub gets bidirectional sync and ARM support. New machine‑vision and rugged HW partners.
21 April 2026
LANXESS at IFAT 2026: Filtration for PFAS, Phosphorus, Micropollutants and UPW
IFAT showcase: ion‑exchange resins and adsorbents for regenerable phosphorus removal (Bayoxide E IN 20), PFAS and fluoride (MDS/TP resins), micropollutants (VP OC), and the LewaPlus design tool.
21 April 2026
LKAB advances Luleå critical‑minerals demonstration plant
Installation underway at demo facility; building complete, commissioning autumn. Malmberget pilot tests the chain. Tech will extract phosphorus and 17 REEs from iron‑ore residues; permits ongoing.
21 April 2026
FDA accepts Roche sBLA for Gazyva/Gazyvaro in systemic lupus erythematosus (SLE)
ALLEGORY phase III: SRI‑4 response 76.7% vs 53.5% (adj diff 23.1%), doubled remission rates, fewer flares and reduced steroid use. FDA decision expected by Dec 2026.
20 April 2026
FDA Accepts Genentech sBLA for Gazyva in SLE
FDA accepted sBLA for an anti‑CD20 in SLE after Phase III ALLEGORY: SRI‑4 responders 76.7% vs 53.5%, higher remission, fewer flares and steroid reduction; decision due Dec 2026.
20 April 2026
PPG launches end-to-end data center protective coatings and application services
At Data Center World: demos of IEEE/UL‑compliant coating systems plus application and paint‑line design services; features EMI shielding, fire and corrosion protection, thermal reflectivity.
20 April 2026
Merck: FDA grants priority review for KEYTRUDA/KEYTRUDA QLEX with Padcev in cisplatin‑eligible MIBC
FDA granted priority review for two sBLAs after Phase 3 KEYNOTE‑B15 showed EFS and OS benefit; PDUFA Aug 17, 2026. If approved, first perioperative options for MIBC regardless of cisplatin eligibility.
20 April 2026
Novo Nordisk: Etavopivat meets phase‑3 HIBISCUS endpoints — reduces VOCs and increases haemoglobin in sickle cell disease
HIBISCUS phase‑3 (n=385, ≥12 yrs): etavopivat cut VOCs by 27% and delayed first VOC ~4 months; 48.7% had >1 g/dL Hb rise at 24 weeks vs 7.2% placebo. Well tolerated; filing H2 2026.
20 April 2026
Siemens and Vulcan Energy team up to scale Europe’s sustainable lithium supply
Framework deal names a preferred automation/digitalization supplier for Lionheart, Europe's first integrated lithium+renewables project: 24,000 t LHM/yr; 275 GWh power; 560 GWh heat; 30-yr life
20 April 2026
Asahi Kasei Acquires Aicuris to Expand Infectious-Disease Pharma Portfolio
Acquisition adds three antiviral assets - royalties from Prevymis, pritelivir (FDA Priority Review; PDUFA Q4 2026) and AIC468 - aims $500M revenue by 2030 and transplant/infectious-disease growth.
20 April 2026
GSK's Blenrep approved in China for 2L+ relapsed/refractory multiple myeloma
Approved with bortezomib+dexamethasone for adults after ≥1 prior line; DREAMM‑7: 3x PFS (36.6 vs 13.4m) and 42% lower death risk; outpatient ADC; ocular AEs manageable.
17 April 2026
EMA recommends Nobivac NXT HCPChFeLV, EU’s first self‑amplifying RNA cat vaccine
Protects cats vs five pathogens (herpes, calici, panleuk, FeLV, Chlamydia). Trials show adequate immunity, reduced disease/shedding; 1–3 yr protection; well tolerated.
17 April 2026
European Commission approves Merck’s ENFLONSIA for infant RSV prevention
Single 105 mg IM, non-weight-based dose gives ~5 months' RSV protection; trials showed ~60% fewer medically attended LRIs and ~84% fewer RSV hospitalizations; safety similar to placebo
16 April 2026
Repsol to raise oil production in Venezuela
Agreed with Venezuela and PDVSA to resume Petroquiriquire operations, ensure payments and raise output 50% in 12 months and 3x in 3 years if conditions hold; OFAC GL50A permits transactions.
16 April 2026
Rotterdam bunker sales down 25% in Q1 2026
Largest declines in fossil oils: VLSFO -44%, HSFO -25%, ULSFO -13%; MGO -7%, MDO -11%. (Bio-)LNG & methanol +6.4%, bioblends +2.7%; RED III, pricing, regs cited.
16 April 2026
Lilly ACHIEVE‑4 confirms Foundayo cardiovascular safety and cardiometabolic benefits
ACHIEVE-4: Foundayo non-inferior vs insulin glargine for MACE-4 (HR 0.84); improved A1C (-1.6 vs -1.0) and weight (-8.8% vs +1.7%) at 52 wks; 57% lower all-cause death; GI AEs; FDA filing planned.
14 April 2026
ERA launches to accelerate clean hydrogen for EU industrial competitiveness and energy independence
CEO-led alliance published a white paper urging governments to boost demand certainty, lower electricity costs, simplify RFNBO rules, de-risk finance and fund a hydrogen backbone to speed FIDs.
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