Regulatory and Compliance Updates news (page 3)

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  2 July 2026

  Roche: Divarasib outperforms first‑generation KRAS G12C inhibitors in phase III Krascendo 1

  Head‑to‑head phase III in previously treated KRAS G12C NSCLC: divarasib improved progression‑free and overall survival versus sotorasib/adagrasib with a consistent safety profile.
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  1 July 2026

  Genentech's divarasib outperforms approved KRAS G12C inhibitors in Phase III NSCLC trial

  Head-to-head Phase III shows divarasib improves progression-free and overall survival versus sotorasib/adagrasib; safety consistent; data to be filed and presented.
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  1 July 2026

  Motherson and PureCycle produce Class-A bumper with 30% recycled polypropylene

  Class-A automotive bumper prototype uses 30% recycled polypropylene; technical details to be presented at Startup Autobahn Expo; aligns with upcoming EU ELV recycled-content mandates.
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  1 July 2026

  EU Commission opens antidumping probe into Chinese polyether polyols after PCC Rokita complaint

  Antidumping probe targets Chinese imports of polyether polyols; provisional tariffs possible within 7 months, final measures in up to 14 months.
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  1 July 2026

  Eni and Mercuria form equal global energy trading joint venture

  Independent holding with international trading hubs to manage commercialization and trading across oil, biofuels, gas, LNG and related logistics and infrastructure rights.
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  30 June 2026

  WuXi Biologics secures ANVISA GMP for MFG2, DP1 and DPPC to enable commercial anti‑PD‑L1 manufacturing

  ANVISA certified three Wuxi facilities with zero findings, allowing end‑to‑end commercial manufacture and supply of an anti‑PD‑L1 cancer immunotherapy and support for Latin America entry.

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  30 June 2026

  IHI-led seven-company low-carbon ammonia plan certified under Japan's price-gap scheme

  Low-carbon ammonia from India will be supplied to Japan for power, chemical and industrial use; certification enables price-gap support under the Hydrogen Society Promotion Act.
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  30 June 2026

  Roche’s Enspryng wins FDA Priority Review for at‑home subcutaneous TED treatment

  FDA accepted an sBLA and granted Priority Review for the first at‑home subcutaneous option for thyroid eye disease; decision expected 15 Oct 2026.
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  29 June 2026

  Genmab: EPCORE DLBCL-4 shows PFS benefit for epcoritamab plus lenalidomide

  Phase 3 topline: fixed‑duration subcutaneous epcoritamab + lenalidomide significantly reduced progression/death versus R‑GemOx in relapsed/refractory DLBCL; safety consistent with known profiles.
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  26 June 2026

  AIQBE posts record €827M investment in industrial infrastructure

  827M€ for new plants; 23,303 jobs linked; €272M environmental/efficiency spend and €179M R&D; Andalusia aims to make Huelva a net-zero industrial valley.
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  26 June 2026

  Novo Nordisk to present denecimig and concizumab data at ISTH 2026

  Phase‑3 FRONTIER4 interim denecimig data across ages and monthly/biweekly/weekly dosing, plus first paediatric explorer10 concizumab 32‑week results for children up to 11 with inhibitors.
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  26 June 2026

  Johnson & Johnson: CHMP recommends TECVAYLI plus daratumumab for relapsed/refractory multiple myeloma

  CHMP recommendation follows MajesTEC-3 Phase 3 data showing HR 0.17 for PFS and HR 0.46 for OS at ~3 years in adults with RRMM after ≥1 prior therapy, with manageable safety.
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  26 June 2026

  Lilly's Jaypirca recommended by CHMP for EU approval in CLL across all therapy lines

  CHMP issued a positive opinion for pirtobrutinib for adults with CLL across all lines of therapy; application now referred to the European Commission for final decision.
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  25 June 2026

  OCI court-appointed independent non-exec directors continue review of NNS cash offer

  They stress independence under an Enterprise Court mandate, aim to finalise assessment by end-June 2026, and have not authorised an EGM to approve the proposed transaction.
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  25 June 2026

  Vattenfall: Swedish state to acquire 60% of Videberg Kraft

  Risk‑sharing and financing terms agreed to enable new nuclear on the Värö Peninsula; ownership structure effective 2027; Rolls‑Royce SMR selected to supply three small modular reactors.
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  25 June 2026

  Qatar pushes EU to amend Methane Regulation in joint open letter

  Urges targeted clarifications to the EU Methane Regulation and requests stop‑the‑clock, grandfathering and penalty relief ahead of January 2027 provisions.
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  24 June 2026

  GSK commences tender offer for Nuvalent

  Tender offer launched at $124 per share; requires majority of Class A shares tendered and HSR clearance; no guaranteed delivery; offer set to expire July 14, 2026.
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  24 June 2026

  Clariant HYTREAT ECO — OSPAR‑compliant low‑dosage anti‑agglomerant for North Sea

  First LDHI anti‑agglomerant to meet OSPAR rules; controls hydrates at <1–2% water‑volume dosing, proven in Norway and the UK under deepwater conditions.
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  24 June 2026

  Merck: EU approves pembrolizumab plus enfortumab vedotin for cisplatin‑ineligible resectable MIBC

  First PD‑1 inhibitor plus ADC approved in EU as neoadjuvant then adjuvant therapy for cisplatin‑ineligible resectable muscle‑invasive bladder cancer.
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  23 June 2026

  Port of Rotterdam Authority rejects demands to force fossil-fuel cuts

  Says it supports a climate-neutral port by 2050 but cannot unilaterally ban fossil activities; warns local bans risk supply security, emissions leakage and harm to industry.
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  22 June 2026

  Merck: Tulisokibart meets primary and key secondary endpoints in Phase 3 ATLAS‑UC induction study

  First anti‑TL1A antibody to show clinical remission at 12 weeks in a Phase 3 induction trial for moderately to severely active UC; safety profile consistent with Phase 2.
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  22 June 2026

  OMV Petrom commissions aromatics unit at Petrobrazi

  EUR 140m aromatics unit adds 150,000 t/y capacity for toluene and benzene; toluene output rises to ~100,000 t/y while replacing a 1961 unit with BAT.
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  19 June 2026

  Teijin: MHLW approves XEOMIN for cervical dystonia and blepharospasm

  Japan expands XEOMIN label to two focal dystonias, adding to existing spasticity and sialorrhea indications.
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  19 June 2026

  Zenyaku/Chugai: Rituxan approved in Japan for adult-onset frequently relapsing or steroid‑dependent nephrotic syndrome

  Approval adds adult-onset indication with specified IV dosing; Phase III showed 87.4% relapse‑free at Week 49 versus 38.0% for placebo; safety consistent with prior data.
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  19 June 2026

  Chugai wins MHLW approval for Avastin as first treatment for neurofibromatosis type 2

  MHLW adds NF2 to Avastin label after a Japanese Phase II BeatNF2 study showed hearing improvements and tumor-volume trends; recommended dose 5 mg/kg IV every two weeks.
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  19 June 2026

  Chugai files Japanese NDA for sparsentan in IgA nephropathy

  Application to Japan's health ministry follows global and Japanese Phase III trials showing large UPCR reductions and suggested eGFR benefit.
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  18 June 2026

  BASF Adapzo Active classified as FRAC Group Code 56

  New HDAC-inhibitor fungicide gets its own FRAC code; targets Asian soybean rust in South America, shows ~6 bags/ha yield gain and no cross-resistance to current solutions.
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  18 June 2026

  WuXi Biologics Suzhou biosafety lab wins fourth EMA GMP certificate enabling 19 EU products

  EMA found zero critical findings in a four-day GMP inspection supporting EU marketing authorization for 19 biologics from 13 clients.
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  18 June 2026

  Roche: FDA accepts sBLA for subcutaneous Lunsumio VELO plus Polivy in relapsed/refractory LBCL

  sBLA accepted based on phase III SUNMO showing 59% reduction in progression risk; FDA decision expected by 9 Feb 2027.
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  17 June 2026

  ArcelorMittal, thyssenkrupp Steel and voestalpine urge ETS reform to protect EU steelmaking

  They want a temporary pause in ETS cost increases, funding and support for first movers, and measures to address import/export competitiveness to preserve European steel value chains.