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Regulatory and Compliance Updates news
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
17 June 2026
Genentech seeks FDA approval for Lunsumio VELO plus Polivy in relapsed/refractory LBCL
sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.
17 June 2026
GSK/Spero: Utebzi (tebipenem pivoxil) approved in US for adults with cUTIs
First oral carbapenem approved in the US for complicated UTIs; PIVOT-PO showed non-inferiority to IV imipenem-cilastatin; expected US availability by end of 2026.
16 June 2026
Solvay: EPO upholds unitary soda-ash purge-stream recycling patent
EPO sustains a unitary patent on recycling purge streams used in soda ash and bicarbonate production after opposition; related Dutch injunction over a sister patent is under appeal.
16 June 2026
PureCycle advances food-contact PCR for New Jersey 2027 mandate
NJDEP confirms PureFive resin qualifies as PCR; 20% food-contact PCR required Jan 2027, rising to 50% by 2036; Amcor produced compliant containers.
16 June 2026
MOL and Serbian government sign shareholders' agreement on NIS governance
Defines governance and decision-making for NIS, secures Pancevo refinery operation and market supply with a 10‑year capacity commitment, but closing awaits seller agreement and OFAC approval.
15 June 2026
Takeda’s oveporexton improved function, cognition and nighttime sleep in narcolepsy type 1
Phase 3 secondary/exploratory endpoints showed benefits across daily functioning, cognitive measures and REM sleep patterns; NDA has Priority Review with a Q3 PDUFA goal date.
15 June 2026
LKAB granted environmental permit for expanded Malmberget operations
Court allows continued and expanded mining and processing in Malmberget, including a demo fossil-free sponge iron plant and an apatite processing line for Luleå supply.
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