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Regulatory and Compliance Updates news
22 September 2026
Genentech's sefaxersen reduces proteinuria in Phase III IgAN interim analysis
Phase III interim data show significant proteinuria reduction at 37 weeks; drug targets liver-derived factor B via monthly subcutaneous dosing; blinded follow-up continues to week 105 eGFR.
22 September 2026
CATL Debrecen starts trial production in new cell building
Trial operations began 22 Sept 2026 in the new Debrecen cell factory, activating the first two production lines after occupancy and IPPC preconditions were met.
22 September 2026
Merck updates WINREVAIR label with Phase 3 HYPERION data for newly diagnosed PAH
FDA updates PAH therapy label to include HYPERION data showing a 76% reduction in clinical worsening when added to background therapy for patients diagnosed within 12 months.
22 September 2026
Elkem awarded 1.3 million extra EU ETS allowances for 2021–2025
Follows Norway's finding that domestic producers were under‑allocated versus EU peers; five plants to receive EU‑aligned allocations for 2026–2030.
22 September 2026
LANXESS at SEPAWA 2026: preservatives, Cosmelin esters and Scopeblue offerings
Shows preservative solutions for pet care, launches biodegradable Cosmelin esters as a silicone alternative, presents Scopeblue lower‑carbon preservatives and an Oct 16 LCA talk.
21 September 2026
EU adopts provisional safeguard measures on grain-oriented electrical steel
Measures effective 25 Sept 2026–end Feb 2027 to curb surging, heavily subsidised GOES imports from Asia and protect the transformer supply chain.
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21 September 2026
Novo Nordisk: CagriSema outperforms tirzepatide 5 mg for weight loss
CagriSema 1.0/1.0 delivered greater weight loss than tirzepatide 5 mg and 21% vs 2% vs placebo in obesity trial; HbA1c reduction was non‑inferior. FDA decision expected Q4 2026.
21 September 2026
Merck’s KEYTRUDA QLEX approved in Japan for subcutaneous use across all KEYTRUDA indications
First subcutaneous immune‑checkpoint inhibitor in Japan; can be given in as little as one minute and showed comparable exposure and response to IV pembrolizumab in a phase‑3 trial.
21 September 2026
Roche: European Commission approves Susvimo for nAMD
Continuous ranibizumab delivery via the Contivue refillable implant offers an alternative to monthly intravitreal injections, with as few as two treatments per year.
18 September 2026
Eli Lilly: FDA approves Inluriyo (imlunestrant) plus Verzenio for ER+, HER2–, ESR1‑mutated advanced/metastatic breast cancer
FDA grants full approval to the all‑oral imlunestrant + abemaciclib combination for adults with ER+, HER2–, ESR1‑mutated advanced or metastatic breast cancer after prior endocrine therapy.
18 September 2026
Merck wins CHMP positive opinion for KEYTRUDA plus Padcev in resectable MIBC
CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.
18 September 2026
Novo Nordisk’s Sogroya recommended by EMA CHMP for idiopathic short stature in children
Once-weekly somapacitan (Sogroya) receives CHMP positive opinion for children with idiopathic short stature; European Commission decision expected later this year.
18 September 2026
Hynetwork (Gasunie) opens North Sea Canal Area hydrogen network draft for public review
Draft project decision, EIA and permits open for comment 18 Sep–29 Oct 2026; route crosses Beverwijk, Velsen, Zaanstad, Haarlemmermeer and Amsterdam.
18 September 2026
Roche: CHMP recommends Ocrevus for paediatric relapsing MS (age 10+)
CHMP backs ocrelizumab for relapsing MS in patients aged 10 and older after Phase III showed stronger lesion suppression and comparable relapse control versus fingolimod.
17 September 2026
EASA: EU SAF supply surpasses 2025 ReFuelEU target
SAF reached 1.1 Mt (2.8% share), a near sixfold rise from 2024; supplied at 121 airports, 84% produced in the EU, and 18 Member States host production projects.
17 September 2026
Novo Nordisk: Denecimig tolerated after direct switch from emicizumab in FRONTIER5
Phase 3b switch study shows denecimig well tolerated after direct switch from emicizumab; pen injector preferred and thrombin generation rose to normal without excess clotting.
17 September 2026
Roche: Lunsumio plus lenalidomide improves PFS in relapsed/refractory follicular lymphoma
Phase III CELESTIMO interim analysis showed a statistically significant, clinically meaningful PFS benefit versus rituximab+lenalidomide; OS immature; safety consistent with known profiles.
17 September 2026
EnergyPathways and Hycamite advance low‑carbon hydrogen and graphite plant at Port of Barrow
Plans target 20,000 t/yr hydrogen and ~60,000 t/yr graphite using methane decomposition; ties into MESH long‑duration storage to capture surplus wind power and cut emissions.
16 September 2026
European Commission raises objections to MMG's proposed acquisition of Anglo American's nickel business
Regulator flags risk that the deal could curtail low-carbon ferronickel supply into Europe, raising stainless-steel production costs and weakening resilience.
16 September 2026
Genentech: Lunsumio plus lenalidomide improves PFS in Phase III CELESTIMO for relapsed/refractory follicular lymphoma
Phase III CELESTIMO showed a statistically significant, clinically meaningful progression‑free survival benefit for Lunsumio plus lenalidomide versus rituximab plus lenalidomide in relapsed/refractory FL after ≥1 prior therapy.
16 September 2026
Chugai: FoundationOne CDx approved as companion diagnostic for tovorafenib in BRAF‑altered/fusion glioma
Approval allows FoundationOne CDx to detect BRAF V600 alterations and BRAF fusion genes to guide tovorafenib treatment in glioma and expands companion indications to nine cancer types.
15 September 2026
European Commission allocates €430M in EU ETS allowances to airlines for SAF in 2025
5.2 million ETS allowances (~€430m) to 130 airlines for 2025 SAF; combined ETS incentives ~€565m; >530,000 t SAF claimed; 1.7Mt CO2 abated.
14 September 2026
Asahi Kasei launches Phase II pediatric trial of Cresemba in Japan
Phase II study in Japanese children (1–17 years) to evaluate safety and pharmacokinetics of isavuconazonium sulfate for invasive fungal infections.
14 September 2026
Takeda: FDA accepts NDA for zasocitinib (TAK-279) under Priority Review
FDA granted priority review to an oral TYK2 inhibitor after Phase 3 data from nearly 3,000 patients showed rapid, durable skin clearance; PDUFA target Q1 2027.
13 September 2026
GSK: registrational data support first-line expansion of Jideytro in ROS1‑positive NSCLC
Phase I/II ARROS‑1 data show 94% ORR, 90% progression‑free at 12 months and strong intracranial activity; supplemental US submission planned for 2026.
13 September 2026
Roche/MediLink: Tam‑Peli phase III shows large survival gain in Chinese relapsed SCLC
Phase III in China: Tam‑Peli halved mortality risk and sharply improved PFS and response rate versus topotecan in relapsed small‑cell lung cancer.
11 September 2026
Covestro, Fertiglobe and MB Energy explore ammonia supply chain via proposed Hamburg terminal
MoU to evaluate ammonia imports through a proposed Blumensand (Hamburg) terminal, offtake for feedstock/hydrogen, and transport links to industrial customers across Europe.
11 September 2026
Johnson & Johnson: RYBREVANT OS and tolerability updates at WCLC 2026
Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
11 September 2026
EU submits Sustainable Investment Facilitation Agreement with Ecuador to Council
Aims to ease investment, tackle bureaucratic hurdles and regulatory uncertainty; includes first-time SIFA provisions for sustainable energy and raw materials; aligned with Global Gateway; €9.1bn FDI stock in 2024.
11 September 2026
European Commission: EU battery recycling targets remain fit for purpose
Assessment finds no need to revise current recycling efficiency and material recovery targets; calls for continued monitoring and sets next review by 18 August 2031.
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