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Regulatory and Compliance Updates news
19 August 2026
Merck and Moderna: Phase 3 INTerpath-001 shows intismeran plus KEYTRUDA improves RFS and DMFS in resected stage IIB–IV melanoma
First Phase 3 success for an individualized mRNA neoantigen therapy; trial met RFS and DMFS in completely resected stage IIB–IV melanoma; OS pending; safety consistent.
18 August 2026
Aramco and Maaden JV to explore copper and energy‑transition minerals in Saudi Transition Zone
Explore ~182,000 km² Transition Zone (~10% of Saudi land) for copper and other energy‑transition minerals using AI and high‑performance computing; subject to regulatory approvals.
14 August 2026
LanzaTech Q2 2026 financial results
Cost cuts and an equity valuation gain lift results; advancing ISCC EU recycled-fuel certification in China and selecting Ghent for a commercial-scale SAF facility.
14 August 2026
Chugai files for Tecentriq adjuvant indication in MSI‑High colon cancer
Filing in Japan for adjuvant treatment of MSI‑High colon cancer after Phase III ATOMIC showed reduced recurrence risk and improved 3‑year DFS.
13 August 2026
Röhm PLEXIGLAS® proTerra for automotive circularity
Grades use recycled PMMA or certified feedstocks to help automakers meet new EU end-of-life vehicle recycled-plastics quotas.
13 August 2026
thyssenkrupp Q3 2025/26: sales up and adjusted EBIT improves as strategic realignment advances
Order intake fell to €7.7bn; adjusted EBIT forecast raised to €600–900m; shareholders approved tk accelis spin-off; TKMS backlog >€20bn with major July contract wins.
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13 August 2026
WACKER expands into EU pet‑food additives with fermented L‑cysteine and L‑cystine
EU approval allows plant‑based, fermented L‑cysteine/L‑cystine as sensory additives for all animal species; products suit multiple dosage forms and are supplied from Europe.
11 August 2026
Novo Nordisk launches Awiqli once-weekly basal insulin in US
First once-weekly basal insulin for adults with type 2 diabetes; one weekly injection replaces seven daily doses, available at 70,000+ pharmacies with affordability options from $35/month.
7 August 2026
Viva Energy and Nestlé use recycled polypropylene for KitKat wrappers
Proof-of-concept converts soft-plastics pyrolysis oil into food-grade polypropylene for a limited KitKat wrapper run, with full processing completed in Victoria.
6 August 2026
DuPont Liveo Pharma TPE Ultra‑Low Temp Tubing wins 2026 R&D 100 Award
Sterilizable, weldable TPE tubing retains flexibility to −86°C for single‑use bioprocessing; produced in an ISO Class 7 cleanroom and backed by regulatory/validation data.
6 August 2026
PureCycle Technologies Q2 2026 results and commercial ramp
Revenue $4.5M; first P&G resin deliveries; PureFive approved as post‑consumer recycled content in New Jersey; Ironton compounding online; liquidity $236.9M.
6 August 2026
Merck seeks FDA sBLA to extend ENFLONSIA protection for high‑risk under‑2s through second RSV season
FDA accepted an sBLA to add children under two at increased risk for severe RSV for a second-season dose; PDUFA Mar 22, 2027; EMA accepted a parallel filing.
6 August 2026
ORLEN Group posts record Q2 2026 profits and PLN 14.7bn H1 capex
Q2 results: revenue PLN 76.5bn, LIFO EBITDA PLN 13.9bn, net profit PLN 7.7bn; record foreign retail profits and H1 capital expenditure PLN 14.7bn.
5 August 2026
Eli Lilly Q2 2026 results: revenue +48%, raises guidance; retatrutide package complete
Revenue rose 48% to $23.0bn driven by Mounjaro and Zepbound; updated 2026 revenue guidance to $85–87bn; retatrutide Phase 3 package complete supporting a Q1 2027 BLA.
5 August 2026
Takeda's ORZEYFUL (oveporexton) approved by FDA for narcolepsy type 1
First-in-class oral OX2R agonist for adults with NT1; Phase 3 showed symptom-wide benefit including daytime sleepiness and cataplexy; DEA scheduling pending before distribution.
3 August 2026
LANXESS launches Disflamoll Advance platform and Disflamoll Advance OT
Platform delivers plasticizing flame retardants with TPP below 0.1%, strong flame- and smoke-control, reduced antimony use and up to 40% lower carbon footprint.
3 August 2026
Eli Lilly: olomorasib receives FDA Breakthrough Therapy for previously treated KRAS G12C advanced pancreatic cancer
Breakthrough designation covers olomorasib monotherapy for adults with advanced pancreatic cancer harboring KRAS G12C after at least one prior systemic therapy.
31 July 2026
Chugai files for Enspryng indication to prevent relapses in MOGAD in Japan
Regulatory submission seeks approval of satralizumab to prevent relapse in MOG antibody‑associated disease after Phase III showed a 68% risk reduction.
31 July 2026
Clariant Q2 2026: margins improve and Amsterdam court dismisses Shell ethylene claim
Q2 comparable sales roughly flat; EBITDA margin up 80bp; performance-savings target raised to CHF100m; Amsterdam court dismissed Shell and Stichting Ethylene Claims suits.
30 July 2026
Viva Energy and Cleanaway: NGERs reform recognises co‑processed low‑carbon fuels
Australia’s NGERs now let eligible co‑processed renewable diesel, LPG and kerosene be reported with zero Scope 1 emissions for the biogenic portion, supporting local feedstock use and refinery production.
30 July 2026
Johnson & Johnson: FDA Priority Review for potential first-in-class subcutaneous RYBREVANT FASPRO in recurrent/metastatic HNSCC
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
28 July 2026
Hansoh Pharma/GSK: Ris‑Rez meets PFS endpoint in China phase III ARTEMIS‑011 (relapsed osteosarcoma)
ARTEMIS‑011 showed significant PFS benefit versus chemotherapy in relapsed osteosarcoma after ≥2 prior therapies; OS benefit and expected safety observed; data to support Chinese submission.
24 July 2026
Roche’s Susvimo recommended by CHMP for nAMD
First continuous‑delivery ranibizumab implant for nAMD receives CHMP backing; designed to maintain vision with as few as two refills per year versus monthly injections.
24 July 2026
MOL Group launches court challenge to Hungary CO2 quota tax
Seeks refund after Tax Authority rejection; challenges follow EU court ruling that the tax breaches directives. Dispute valued at HUF 126.0 billion (~USD 395m).
23 July 2026
Genmab and AbbVie clarify EPCORE DLBCL-1 US primary endpoint not met
The trial's sole U.S. primary endpoint—overall survival—did not reach statistical significance; additional results will be submitted for peer review.
23 July 2026
BioBTX starts construction of PETRA circular aromatics plant
First commercial plant directly converting mixed plastic waste into 10,000 t/yr BTX plus 8,000 t by-products; construction begins early 2027, start-up mid‑2028.
23 July 2026
Johnson & Johnson: TECVAYLI + TALVEY reduce progression risk 89% and death risk 62% in earlier-line RRMM
Phase 3 MonumenTAL-6 shows BCMA+GPRC5D bispecific combo and talquetamab+pomalidomide both significantly improved PFS versus investigator’s choice in patients with 1–4 prior lines.
23 July 2026
Lilly's retatrutide shows large weight and A1C reductions in Phase 3 TRIUMPH‑2 and TRIUMPH‑3
First‑in‑class triple agonist delivered large 80‑week weight losses and meaningful A1C and cardiometabolic improvements in difficult‑to‑treat obesity populations.
22 July 2026
GSK's Jideytro (zidesamtinib) approved in US for ROS1‑positive NSCLC
FDA clears zidesamtinib for adults with advanced ROS1‑positive NSCLC after prior ROS1 inhibitor; ARROS‑1 showed 44% ORR and durable responses, including in brain metastases.
22 July 2026
Takeda’s ORZEYFUL (oveporexton) approved in China as first OX2R agonist for narcolepsy type 1
China approves first oral OX2R-selective orexin agonist for narcolepsy type 1 for patients 16 and older; Phase 3 trials reported improvements in sleepiness and cataplexy.
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