Regulatory and Compliance Updates news (page 3)

• 

  3 June 2026

  Novo Nordisk launches Wegovy pill in UAE

  Oral semaglutide tablet now available in UAE for weight management; shows ~17% mean weight loss in trials and is approved to reduce certain cardiovascular risks.
• 

  3 June 2026

  AkzoNobel: Nippon Paint and Sherwin‑Williams withdraw public offer

  Two bidders have confirmed they will not pursue a public takeover; the company’s boards still back a planned merger of equals with Axalta.
• 

  3 June 2026

  argenx: Efgartigimod shows sustained myositis benefit, maintained response in Sjogren’s with consistent safety

  ALKIVIA+ 52‑week data show sustained Total Improvement Score gains; RHO+ shows maintained response after switch to biweekly dosing; safety consistent across indications.
• 

  2 June 2026

  QEMETICA sells salt assets to K+S and launches Resource Recovery unit

  Divests evaporated salt business for €350–€380m to fund a new Resource Recovery segment focused on waste-to-energy and energy security.
• 

  2 June 2026

  Roche: FDA accepts priority‑review NDA for giredestrant in ER‑positive early‑stage breast cancer

  FDA accepted priority NDA for oral SERD giredestrant as adjuvant in ER‑positive, HER2‑negative stage I–III breast cancer after phase III lidERA showed 30% iDFS risk reduction; PDUFA 30 Nov 2026.
• 

  2 June 2026

  WuXi Biologics Repeats CDP Supplier Engagement A-List

  Named to CDP SEA A List again for supplier climate engagement; praised for governance, Scope 3 disclosure, SBTi-aligned targets (net-zero by 2050), supplier audits, training and incentives.

• 

  1 June 2026

  Amgen: EC approves IMDYLLTRA (tarlatamab) for ES‑SCLC after platinum therapy

  EU marketing authorisation for tarlatamab as monotherapy for extensive‑stage small cell lung cancer after progression on platinum‑based chemo; Phase 3 showed survival gain.
• 

  1 June 2026

  Genentech: FDA accepts NDA for giredestrant after positive Phase III adjuvant results in early ER‑positive breast cancer

  lidERA Phase III: giredestrant reduced invasive recurrence/death by 30% (HR 0.70); 3‑yr iDFS 92.4% vs 89.6%. Priority review; PDUFA Nov 30, 2026; well tolerated in >4,100 pts.
• 

  1 June 2026

  Dow and Univar Solutions agree long-term distribution of Decarbia low‑carbon products

  Long-term deal expands access to low‑carbon products with verified PCF certificates across beauty, home care, food, pharma and industrial markets; aids Scope 3 reductions.
• 

  1 June 2026

  Linde 2025 Sustainability Report

  2025: 10% absolute GHG cut vs 2021; 50% electricity from low-carbon/renewables; customers avoided ~98M tCO2e; conserved 1B+ gallons water; diverted 200M lbs waste; supported ~2,100 orgs, 400k people.
• 

  1 June 2026

  OCI agrees to sell 50% of OCI Nitrogen to AGROFERT

  Divests 50% for ~€55m (subject to adjustments); buyer gains operational control. Put/call on remaining 50% exercisable from 2 years post-close at 7x two-year avg. pro-forma adj. EBITDA. Target H2 2027.
• 

  1 June 2026

  EEW updates Green Financing Framework; ISS-Corporate issues Second Party Opinion

  Publishes updated Green Financing Framework aligned with ICMA and LMA standards and the EU Taxonomy; covers energy, circular economy, carbon capture; independent SPO confirms quality
• 

  1 June 2026

  Vopak and Gasunie take conditional FID to extend EemsEnergyTerminal

  Conditional FID approved for extension of EemsEnergyTerminal, advancing LNG infrastructure; final FID pending permits. Customer contracts secured for LNG supply 2028–2036.
• 

  1 June 2026

  CATL opens world’s largest energy-storage testbed for real-world validation

  10-ha, RMB3bn Xiamen facility offers open station-level validation across five labs: 35kV/100MVA grid sim, 1kV–500kV HV tests, 20MW combustion, -50–100°C climate chambers, EMC for 40-ft containers
• 

  31 May 2026

  Lilly: Retevmo reduces recurrence/death risk by 83% as adjuvant in early‑stage RET‑fusion NSCLC

  Phase 3 LIBRETTO-432 randomized 151 early-stage RET‑fusion NSCLC patients; at 24‑month follow‑up EFS rates 92% vs 61% (treatment vs placebo). Safety: elevated ALT/AST manageable with dose changes.
• 

  31 May 2026

  Johnson & Johnson PROTEUS Phase 3: Perioperative ERLEADA reduces risk of metastasis or death by 20%

  Perioperative apalutamide + ADT (6 months pre/post-surgery) raised pCR/MRD to 8.9% vs 1%, delayed need for further therapy >6 vs 3.5 years, met dual primary endpoints; safety profile as expected.
• 

  31 May 2026

  Johnson & Johnson: RYBREVANT FASPRO shows durable responses in advanced head and neck cancer

  Phase 1b/2 OrigAMI-4: subcutaneous amivantamab + hyaluronidase achieved 42% ORR (15% CR) in pretreated recurrent/metastatic HNSCC; median DOR not reached (11.8 mo FU); manageable safety.
• 

  29 May 2026

  EU advances carbon removals and carbon farming market

  CRCF Days launched rollout: certification schemes may seek CRCF recognition; Buyers’ Club to aggregate demand; removals and carbon‑farming methodologies near adoption; financing and de‑risking needed
• 

  29 May 2026

  Johnson & Johnson: RYBREVANT + LAZCLUZE yields 41‑month median OS in first‑line atypical EGFR‑mutant NSCLC

  CHRYSALIS-2 Phase1/1b (n=49): first-line atypical EGFR‑mutant NSCLC showed ORR 57%; 3‑yr OS 55%, 4‑yr OS 46%; 41% remained on treatment ≥2 years; safety consistent with prior reports.
• 

  29 May 2026

  Rompetrol Rafinare Q1 2026: Turnover up 8%, net profit achieved

  Q1: EBITDA $27.5M; March shutdown (700+ tasks) completed; Petromidia processed ~1.2Mt, white product yield 83.76%; domestic fuel share 66%; state contribution $577M
• 

  29 May 2026

  Johnson & Johnson: TECVAYLI improves PFS and OS in second-line multiple myeloma

  Phase 3 MajesTEC‑9: teclistamab cut progression/death risk 71% (HR 0.29) and death 40% (HR 0.60) vs PVd/Kd in early RRMM; higher ≥CR (65.9% vs 16.8%); infections and CRS increased
• 

  29 May 2026

  EU Innovation Fund Net‑Zero Call: 358 applications, €17.5bn requested (6× budget)

  Applicants across 27 countries submitted large/medium/small projects, pilots and cleantech manufacturing for energy‑intensive, carbon management, renewables and storage; results Oct 2026
• 

  29 May 2026

  Merck: FDA Grants Breakthrough Designation to Calderasib (MK‑1084) for First‑Line KRAS G12C‑Mutant Metastatic NSCLC

  Supports calderasib plus pembrolizumab in PD‑L1 ≥1% newly diagnosed metastatic KRAS G12C NSCLC; positive Phase 1 KANDLELIT‑001 data; multiple Phase 3 trials planned; developed with Taiho/Astex
• 

  29 May 2026

  Uniper appoints Tina Hinz General Counsel & Chief Compliance Officer

  Tina Hinz becomes General Counsel & CCO on June 1, 2026. Ex-Linklaters, at the firm since 2016; led financings, trading compliance, crisis stabilisation and EU compliance rollout.
• 

  29 May 2026

  AGC verifies AFLAS FFKM fluorine as 100% recycled under UL 2809

  Mass-balance allocation applied to AFLAS FFKM; product offers strong chemical/heat/plasma resistance for semiconductor seals. Part of effort to recycle plant fluorine waste and advance circularity.
• 

  29 May 2026

  KazMunayGaz 2025 Sustainability Report

  2025 report (GRI 2021) discloses 2023-2025 economic, environmental and social KPIs; includes SASB, IFRS S2 climate reporting with scenario analysis, GHG targets and independent verification
• 

  28 May 2026

  Johnson & Johnson: FDA approves TREMFYA label update for PsA joint‑damage inhibition

  APEX Phase‑3b: in biologic‑naïve PsA patients, 24‑week results met ACR20 and significantly inhibited structural joint damage vs placebo; placebo switchers had 57% less radiographic progression to Week 48; safety unchanged.
• 

  28 May 2026

  GSK’s bepirovirsen: 19% functional cure in Phase III chronic hepatitis B trials

  Pooled Phase III trials: 26% functional cure in patients with ≤1000 IU/mL HBsAg; 49% reached qHBsAg ≤100 IU/mL at 1 year; acceptable safety; regulatory reviews and anticipated Q3 2026 decisions.
• 

  28 May 2026

  TotalEnergies Files Authorization for 1.5 GW Centre Manche Energies Offshore Wind

  Operator submitted Single Authorization for Normandy offshore wind farm; expects ~6 TWh/yr, >1M homes, €4.5bn investment, 2,500 construction jobs, ongoing stakeholder consultations
• 

  28 May 2026

  ORLEN Group Q1 2026: solid results and lowest fuel prices in the EU

  Q1 results: LIFO EBITDA PLN14.1bn, revenue PLN75.8bn, net profit PLN8.1bn; operating cash flow PLN8.5bn; record PLN9.3bn dividend; PLN5.4bn capex on energy security and low-carbon projects