Regulatory and Compliance Updates news (page 2)

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  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.
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  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.
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  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.
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  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.
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  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.

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  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.
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  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.
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  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
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  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
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  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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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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.
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  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
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  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.
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  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.
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  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.
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  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
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  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.
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  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.
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  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.
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  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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  14 April 2026

  RWE installs two substations for Nordseecluster A

  Two offshore substations (~40×22 m; 1,800 & 2,500 t) were installed ~50 km north of Juist after transport from Saint‑Nazaire by heavy‑lift Gulliver. Nordseecluster A: 660 MW (2027); B: +900 MW (2029)
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  14 April 2026

  thyssenkrupp-backed European Resilience Alliance launches to scale clean hydrogen deployment

  CEO-led alliance white paper diagnoses bottlenecks—fragmented rules, high power costs, weak demand certainty—and urges bankable demand, simpler support, de-risk finance and cross-border infrastructure