Regulatory and Compliance Updates news (page 11)

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  9 April 2026

  Novo Nordisk: Wegovy injection approved for up to 48-hour controlled‑temperature delivery in the EU

  EMA change reduces last‑mile cold‑chain needs, lowering packaging/transport costs, enabling discrete home and online dispensing; SmPC updated for healthcare providers; patient leaflet unchanged.
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  9 April 2026

  Evonik showcases high-performance polymers and additives at CHINAPLAS 2026

  Highlights materials for energy transition, EV battery cooling, eVTOL structures, hydrogen, smart manufacturing, 3D-printed medical implants, recycling additives and doubled PA12 capacity
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  9 April 2026

  Boehringer Ingelheim and BioNTech partner on ES‑SCLC immunotherapy trial

  Phase Ib/II trial will test DLL3/CD3 T‑cell engager plus PD‑L1/VEGF‑A bispecific in extensive‑stage SCLC to boost durable antitumor immunity; dosing to start H2 2026
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  8 April 2026

  Infinium’s Project Atlas Wins SABA Next‑Gen SAF Procurement

  Selected eSAF project will supply SAF certificates via book-and-claim; airline to take delivery and manage logistics. ~100,000 MTPA, ~95% lifecycle CI reduction, RFNBO-compliant; production by 2029
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  8 April 2026

  BASF at Techtextil 2026 — Practical textile solutions

  At Techtextil 2026: showcases include mass‑balanced & biocircular polyamides, loopamid recycling, advanced binders and resins, and stretchable, PFAS‑free microporous TPU membranes.
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  8 April 2026

  Nobian secures RFNBO certification for Frankfurt green hydrogen

  Frankfurt site gets ISCC EU RFNBO certification: up to 6,000 t/yr green H2 from chlor‑alkali electrolysis using renewable power, with full traceability, emissions compliance and market supply

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  8 April 2026

  GSK’s Exdensur approved in China for CRSwNP

  China approves Exdensur (depemokimab) as biannual add-on for adults with CRSwNP uncontrolled by systemic steroids or surgery. ANCHOR trials showed reduced polyp size and obstruction; well tolerated.
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  8 April 2026

  Clariant showcases sustainable plastics innovations at Chinaplas 2026

  PFAS-free PPAs for film extrusion and food contact; halogen/antimony‑free Exolit OP 1266 for 800V+ e‑mobility; rice‑bran wax food‑approved additives; titanium catalysts to replace antimony
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  6 April 2026

  Moeve: Green molecules could cut Europe’s energy dependency by half by 2040

  Renewable hydrogen, advanced biofuels and biomethane could cut Europe’s imported energy share from 57% to 28% by 2040 and replace up to 50% of fossil demand by 2050.
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  6 April 2026

  Amgen reports positive Phase 3 topline results for subcutaneous TEPEZZA in moderate-to-severe thyroid eye disease

  Phase 3 subcutaneous TEPEZZA met primary endpoint in moderate-to-severe TED: 76.7% proptosis response vs 19.6% placebo; mean −3.17 mm reduction; safety consistent; mild injection-site AEs
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  6 April 2026

  Fluor awarded FEL-2 contract by X‑energy for Seadrift SMR project

  FEL-2 will define and plan four 80 MW SMRs at Seadrift to supply power and steam. DOE-backed; construction permit under NRC review; intended as first industrial advanced reactor in N.A.
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  2 April 2026

  FDA approves Lilly's Foundayo (orforglipron), oral GLP‑1 for anytime dosing

  Oral GLP‑1 produced ~12% mean weight loss (~27 lb) at 72 weeks in Phase 3. Available via direct home delivery with low‑cost copays; carries thyroid tumor and GI side‑effect warnings.
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  2 April 2026

  Bilfinger completes acquisition of Teknokon businesses in Türkiye

  Deal closed April 1, 2026: adds ~1,000 specialists, upper double‑digit million‑€ revenue; positions as regional hub linking Eastern Europe and Middle East; full integration within a year.
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  2 April 2026

  Sasol's Sasolburg Operations Retains Green Drop Certification

  Plant scored 96.8% (92.9% WSI), ranked 2nd; won Best Private Technical Site TSA (94%); top scores in capacity and effluent compliance; treats 27.01 kL/d and supports local sanitation projects.
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  2 April 2026

  Perpetual Next selects Bilfinger for Methanol Moerdijk permitting

  Covers EIA, environmental and nature permitting, stakeholder coordination and QA in sprint-based delivery for a large biomethanol plant - ~216,000 t/yr output.
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  2 April 2026

  EU approves Merck's KEYTRUDA with paclitaxel ± bevacizumab for PD‑L1 (CPS≥1) platinum‑resistant recurrent ovarian cancer after 1–2 prior regimens

  Phase 3 KEYNOTE‑B96 showed significant progression‑free and overall survival gains versus placebo+paclitaxel (±bevacizumab), supporting EU approval as the first PD‑1 inhibitor option.
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  2 April 2026

  Chugai: Lilly’s Foundayo (orforglipron) FDA-approved for weight loss

  FDA approved an oral GLP-1 for adults with obesity or overweight and weight-related conditions; used with calorie restriction and increased activity to lose and maintain weight
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  1 April 2026

  ABO Energy Advances German Wind Projects

  Won tariffs for 16.4 MW; secured permits for Olpe‑Rehringhausen (21 MW), Tholey (14 MW) and St. Gangloff (35 MW); sold Nonnenholz II (6 MW); activated Ortenberg financing; 650 MW permitted.
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  1 April 2026

  Meva Energy secures EBC certification for Kisa biochar

  EBC-certified biochar from biogas by-product meets purity and climate criteria. Made from local sawmill residues via gasification; enhances soil and locks carbon long-term
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  31 March 2026

  BASF launches Butyl and 2‑Ethylhexyl Acrylate RE with Avery Dennison

  Launches butyl and 2‑ethylhexyl acrylates made using attributed Texas renewable electricity; drop‑in for coatings and adhesives, reducing manufacturing CO2; commercialization supported by partner.
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  31 March 2026

  Kemira completes first US full-scale trial of chlorine-free KemConnect DEX

  Trial with Capital Region Water shows a performic-acid, chlorine-free treatment cut bacteria rapidly at low doses, auto-degraded to biodegradable compounds and auto-adjusted dosing.
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  31 March 2026

  LanzaTech Q4 & FY2025 Financial Results

  Closed $20M private placement; awarded €40M EU grant; completed LanzaJet share transfers (peak 53%, later ~46% after Series A); revenue $55.8M; net loss $49M; opex -21%
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  31 March 2026

  Johnson Matthey DPFi DPF earns Canadian CSA certification

  Electrically regenerating diesel particulate filter certified by CSA for Canadian underground mining/tunnelling; also certified by Canmet and VERT and approved by US MSHA.
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  31 March 2026

  BASF launches biomass‑balanced Ultrason® P 3010 BMB PPSU

  New Ultrason P 3010 BMB is ISCC‑PLUS certified, 20% biomass‑balanced PPSU (mass‑balance), matches standard grade in properties and certifications, drop‑in replacement made with green electricity.
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  30 March 2026

  Merck enlicitide decanoate, an oral PCSK9 inhibitor, reduces LDL‑C more than guideline non‑statins at 8 weeks

  Phase 3 CORALreef AddOn: enlicitide lowered LDL‑C 64.6% at 8 weeks; 78.2% achieved ≥50% reduction and LDL‑C <55 mg/dL; safety comparable to oral non‑statins; FDA CNPV awarded
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  30 March 2026

  LKAB raises mineral resources by 900 million tonnes to 7.2 billion tonnes

  Exploration added volume and confidence; reserves ~0.9 Gt. Resources grew mainly at Malmberget; Per Geijer hosts 2.2 Mt REO in situ and phosphorus. EU strategic status granted.
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  30 March 2026

  UBE obtains food-contact approval for UBECycle recycled PE/PA films

  Accredited migration testing plus RecyClass‑certified recycling (following Paulowsky acquisition) confirm regulatory compliance and open use of mechanically recycled PE/PA in regulated packaging.
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  30 March 2026

  GSK's bepirovirsen accepted for regulatory review in China for chronic hepatitis B

  China NMPA accepted NDA for bepirovirsen after Phase III B-Well trials showed significant functional cure rates in treated CHB patients; granted Breakthrough Therapy; acceptable safety.
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  30 March 2026

  GSK’s Exdensur approved in China for severe eosinophilic asthma

  First ultra-long-acting IL-5 biologic for eosinophilic severe asthma; twice-yearly dosing cut annual exacerbations by ~48–58% in SWIFT trials and lowered hospital/ED visits.
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  29 March 2026

  Merck: WINREVAIR Phase 2 CADENCE shows proof‑of‑concept in CpcPH‑HFpEF

  Met primary endpoint with significant PVR reduction at 24 weeks vs placebo. Also favorable mPAP/PAWP, NT‑proBNP and 6MWD trends, delayed clinical worsening; safety consistent with known profile.