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Regulatory and Compliance Updates news
20 July 2026
GSK Bexsero: EMA accepts submission to add single-dose booster for 10+ years
Phase 3b data indicate a single Bexsero booster at age 10+ boosts immunity in those primed in infancy; full study results will be presented at IPNC in September.
17 July 2026
European Commission Electrification Action Plan and ETS review
Sets a 46% electrification target by 2040, reforms the EU ETS to drive investment and stability, and mobilises funding and regulatory measures to lower electricity costs and speed grid rollout.
16 July 2026
Takeda: Zasocitinib achieves high, consistent clearance at hard-to-treat psoriasis sites
Phase 3 secondary data show ~75% scalp and ~70% palmoplantar clearance at week 16; significant nail improvement; responses sustained to week 24; common AEs: URTI, nasopharyngitis, acne.
16 July 2026
Gasunie positions the Netherlands as Europe’s CO₂ hub
Five connected CCS projects (Porthos, Aramis, CO₂next, DRC, DSC) will capture, transport and store CO₂ under the North Sea and link industry across the Netherlands, Belgium and Germany.
16 July 2026
Merck’s LIPFENDRA — first FDA‑approved once‑daily oral PCSK9 inhibitor
Oral macrocyclic peptide enlicitide (20 mg) lowers LDL-C ~56–59% at week 24 in Phase 3 trials; approved as adjunct to diet and exercise for adults with hypercholesterolemia, including HeFH.
15 July 2026
Repsol, Toyota, BMW and Bosch pilot cars on 100% renewable gasoline
Six-month Spanish trial uses existing cars, 100% renewable gasoline and digital tracking to demonstrate drop-in fuel scalability without new vehicles or infrastructure.
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15 July 2026
Novo Nordisk wins EU authorisation for Wegovy pill and single‑dose 7.2 mg pen
OASIS data showed ~17% mean weight loss and ~1 in 3 reached ≥20%; safety comparable to injectable semaglutide; wider roll‑out planned in H2 2026.
15 July 2026
Johnson & Johnson Q2 2026 results and raises 2026 outlook
Quarterly sales topped $25.3B; adjusted net earnings and EPS rose, free cash flow improved, and full-year revenue guidance was raised above $100B for the first time.
15 July 2026
Roche: FDA grants Priority Review for Gazyva/Gazyvaro (obinutuzumab) in primary membranous nephropathy
Priority Review follows MAJESTY phase III showing 36.9% complete remission at two years vs 5.7% with tacrolimus; FDA decision expected by Nov 2026.
14 July 2026
Genentech’s Gazyva (obinutuzumab) granted FDA priority review for primary membranous nephropathy
FDA granted priority review for obinutuzumab in pMN after Phase III MAJESTY showed markedly higher complete remission vs tacrolimus; FDA decision expected Nov 2026.
14 July 2026
Olin and Huntsman: SEC Declares S‑4 Effective for Planned Merger
SEC declared the Form S‑4 effective; special shareholder meetings set for Aug 25; closing expected H1 2027; transaction targets >$400M in synergies and broader vertical integration.
13 July 2026
GSK’s Jemperli shows sustained clinical complete responses in dMMR/MSI‑H locally advanced rectal cancer
Interim phase II results met primary endpoint (cCR12); trial suggests some patients may avoid chemo, radiation and surgery. Data to be shared with regulators including for US accelerated review.
13 July 2026
Takeda and Indonesia to build national plasma ecosystem for PDMPs
Fractionation license granted; $30M pilot to open plasma donation centers and assess local PDMP manufacturing, first donation center expected 2027.
11 July 2026
Novo Nordisk: denecimig (Mim8) shows positive long-term Phase 3 FRONTIER4 results in haemophilia A
Interim FRONTIER4 data show consistent safety and efficacy of denecimig across weekly, biweekly and monthly dosing, with low injection-site reactions and high zero-bleed rates.
10 July 2026
Merck: FDA approves KEYTRUDA and KEYTRUDA QLEX with Padcev for perioperative MIBC
FDA clears PD‑1 inhibitor plus antibody‑drug conjugate regimens with enfortumab vedotin as neoadjuvant and adjuvant therapy around cystectomy for adults with muscle‑invasive bladder cancer.
10 July 2026
Hansoh Pharma: Ris‑Rez (risvutatug rezetecan) ARTEMIS‑008 shows overall survival benefit in Chinese SCLC patients
Phase III trial met overall survival endpoint in advanced or relapsed small‑cell lung cancer in China, with consistent secondary benefits and no new safety signals.
10 July 2026
European Commission adopts CRCF certification methodologies for carbon farming
Technical rules set for certifying three carbon farming activities, enabling schemes to seek recognition under the CRCF framework and link land managers to finance.
10 July 2026
POSCO HOLDINGS expands into lithium and energy under 'Triple-core' portfolio
Triple-core portfolio to shore up supply chains; aims Global Top 5 lithium by 2033, KRW 16.7T investment in 2026–2028, and KRW 187T revenue by 2035.
9 July 2026
INEOS and Recuro to build advanced pyrolysis recycling plant at Bamble (33,000 t/yr)
Advanced pyrolysis plant at Bamble will process 33,000 t/yr of end-of-life plastics, powered by renewable energy to produce recycled ethylene and virgin-quality recycled polyethylene.
9 July 2026
PwC study for Gasunie: CCS, low‑carbon hydrogen and hybrids are most cost‑effective for Dutch industry decarbonisation
CCS, low‑carbon hydrogen and hybrid electrification are the cheapest routes to cut industrial CO2 — timely CO2/H2 infrastructure is essential.
9 July 2026
Roche Elecsys IGRA TB gains CE mark for automated latent‑TB blood test
Automated IGRA blood test delivers results in under 24 hours, with 19-minute per-patient processing and integration with high-throughput immunoassay systems to scale TB infection testing.
7 July 2026
LYB and Mondelez launch Marabou wrappers with 75% recycled content
Flexible food-grade film made from chemically recycled mixed plastic via ISCC PLUS mass-balance; MoReTec-1 to supply 50,000 t/yr feedstock; Taghleef and Amcor handled film and conversion.
6 July 2026
Genmab: EC approves TEPKINLY (epcoritamab) + lenalidomide and rituximab for relapsed/refractory follicular lymphoma
First bispecific‑based, chemotherapy‑free second‑line option in Europe after Phase 3 showed major PFS benefit and high complete response rates.
6 July 2026
INEOS' Sir Jim Ratcliffe urges von der Leyen to protect Europe's chemical industry
Warns China is dumping excess chemical capacity into Europe, calls for faster trade safeguards and ETS Investment Booster support for Project ONE (€5bn) low‑carbon ethylene.
2 July 2026
XRG gains equity across all Rio Grande LNG trains
Acquired an additional 7.6% in Trains 4–5, giving equity across all five construction trains; Trains 4–5 add ~12 MTPA and the project targets production in 1H 2027.
2 July 2026
Commissioner Hoekstra pushes CCS scale-up across Europe
EU aims for 50 Mtpa geological CO₂ storage by 2030; stakeholders call for investment in transport and storage, faster permitting, market demand and cross‑border cooperation.
2 July 2026
Roche: Divarasib outperforms first‑generation KRAS G12C inhibitors in phase III Krascendo 1
Head‑to‑head phase III in previously treated KRAS G12C NSCLC: divarasib improved progression‑free and overall survival versus sotorasib/adagrasib with a consistent safety profile.
1 July 2026
Genentech's divarasib outperforms approved KRAS G12C inhibitors in Phase III NSCLC trial
Head-to-head Phase III shows divarasib improves progression-free and overall survival versus sotorasib/adagrasib; safety consistent; data to be filed and presented.
1 July 2026
Motherson and PureCycle produce Class-A bumper with 30% recycled polypropylene
Class-A automotive bumper prototype uses 30% recycled polypropylene; technical details to be presented at Startup Autobahn Expo; aligns with upcoming EU ELV recycled-content mandates.
1 July 2026
EU Commission opens antidumping probe into Chinese polyether polyols after PCC Rokita complaint
Antidumping probe targets Chinese imports of polyether polyols; provisional tariffs possible within 7 months, final measures in up to 14 months.
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