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Regulatory and Compliance Updates news
(page 4)
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
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.
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.
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.
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.
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.
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28 March 2026
Amgen: Repatha cuts first major cardiovascular events 31% in high‑risk patients without significant atherosclerosis
VESALIUS‑CV subgroup (3,655 high‑risk diabetics without known atherosclerosis) showed a 31% reduction in first major CV events vs placebo; median LDL‑C 44 mg/dL over ~4.8 years.
28 March 2026
Takeda’s Zasocitinib: Once‑daily pill achieves rapid, durable clearance in plaque psoriasis
Phase 3: ~70% reached sPGA 0/1 at week 16; PASI90 up to 61%, PASI100 up to 33%. Responses rose through week 24 and >90% of responders maintained effect to week 60. Safety consistent with prior studies
27 March 2026
EMA recommends Amgen’s Imdylltra for relapsed extensive‑stage SCLC
EMA backs EU approval for a bispecific T‑cell engager for relapsed extensive‑stage SCLC post‑platinum; phase 3: OS 13.6 vs 8.3 months. Main risks: CRS, ICANS
27 March 2026
Rompetrol Rafinare completes Petromidia and Vega turnarounds
Mechanical works finished; refineries return to staged full capacity after 700+ maintenance jobs, 6 catalyst swaps, ~900 equipment checks and ~1,200 pipeline tests; authorizations recertified.
27 March 2026
RWE approved for Nordseecluster B offshore wind farm
Planning approval granted for Nordseecluster B, adding 900 MW to reach 1.6 GW (660 MW A under construction). Full output ~6.5 TWh/yr; B due early 2029; 110 MW PPA with Amazon.
27 March 2026
GSK bepirovirsen accepted for EMA review for chronic hepatitis B
EMA accepted bepirovirsen MAA for chronic hepatitis B after Phase III B‑Well 1/2 showed higher functional cure rates vs standard of care; safety profile acceptable.
26 March 2026
FDA approves Novo Nordisk Awiqli, first once-weekly basal insulin for adults with type 2 diabetes
ONWARDS trials (~2,680 pts) showed A1C reductions vs daily basal; safety aligned with class. Key risks: hypoglycemia, injection-site reactions, weight gain. US launch pending
26 March 2026
Equinor completes investigation into Mongstad benzene exposure
Probe: prolonged benzene exposure during filling—task overran; no re-assessment; respirators insufficient. Naphtha→glycol; more PPE, detector training and a safety engineer; authorities notified.
26 March 2026
Novo Nordisk gains US approval for Awiqli, first once‑weekly basal insulin for adults with type 2 diabetes
ONWARDS phase‑3 (~2,680 adults) showed HbA1c reductions vs daily basal insulin with similar safety. US launch planned H2 2026; also approved in EU and 13 other countries.
26 March 2026
BASF pressure-sensitive adhesive for PET labels compatible with recycling
RecyClass-approved acResin UV 3532 PSA enables filmic labels to wash off in standard PET recycling, supporting high-clarity, design-friendly recyclable bottles.
25 March 2026
EU dialogue on cement industry's low‑carbon transition
Stakeholders urged lead markets, funding (Industrial Decarbonisation Bank), standards, CCS, CO2 transport & storage, skills, stable ETS to speed decarbonisation and competitiveness
25 March 2026
Nouryon secures halal certification in China for personal care and cleaning ingredients
Chinese Boxing and Ningbo plants gained halal certification for fatty amines, quats and chelating agents, enabling wider access to halal personal-care and cleaning markets worldwide.
25 March 2026
Merck to acquire Terns Pharmaceuticals, adding TERN‑701 for CML
Acquirer to buy target biotech at $53/share (~$6.7B equity, ~$5.7B net). Lead oral allosteric BCR::ABL1 TKI showed week‑24 molecular responses in Phase1/2; expected Q2 2026.
25 March 2026
Boehringer Ingelheim launches two late-stage medicines, 2025 sales up 7.3%
R&D spend rose to €6.4bn (22.9% of sales); reached 70M patients; Human Pharma and Animal Health grew—JARDIANCE and OFEV expanded; Animal Health up 6.5% with NEXGARD leading; pipeline >80 projects.
25 March 2026
Mitsui Chemicals Obtains ISCC PLUS Certification for ACTCOL
Nagoya Works gained ISCC PLUS for ACTCOL (Jan 2026). Certification covers ACTCOL PPG and polymer polyol resin premix; group to expand mass‑balance biomass and chemically recycled products (~50 total).
24 March 2026
Brenntag opens Asia Pacific’s first VDA-certified AdBlue site
VDA-certified AdBlue plant in Samut Prakan, Thailand delivers ISO 22241-compliant production with closed handling and controlled filling, ensuring pure, traceable diesel exhaust fluid supply.
24 March 2026
MOL cleared by US to proceed with NIS majority‑stake acquisition talks
U.S. OFAC extended the negotiation license to 22 May 2026, allowing finalization of sale documents and U.S. banks' participation; deal would transfer 56.15% stake, pending approvals.
24 March 2026
WuXi Biologics posts record 2025 results
2025 revenue +16.7% to RMB21.8bn; gross margin +500bps to 46%; EBITDA +38%; net profit +45%; 209 new integrated projects; backlog US$23.7bn; bi-/multi-specifics >120% growth
24 March 2026
UPM and Paramelt launch bio-based paper food packaging
Bio-based paper food-packaging with strong grease barrier at low coat weights. Recyclable and home-compostable. Runs on existing packaging lines; suited to bakery/fast-food
23 March 2026
WACKER expands silicone emulsion production in India
New Panagarh GMP-certified silicone emulsion plant boosts local capacity, adds 60 jobs, serves cosmetics/personal-care customers, lets Amtala shift toward R&D and innovation.
23 March 2026
TotalEnergies ends U.S. offshore wind projects, returns leases to DOI
Signed settlements to relinquish Carolina Long Bay and New York Bight offshore wind leases, recover fees and reinvest equal funds into U.S. gas/LNG and power, citing cost and affordability concerns.
23 March 2026
Ercros: EcoVadis Gold, 85/100
Ranks in the 98th percentile; environment & ethics 91, labour & human rights 90. Advanced management, many KPIs provided; 100/100 for endorsements, measures and certifications
23 March 2026
BASF converts Ludwigshafen acid chlorides and chloroformates to 100% renewable electricity credits
Average product carbon footprint cut ~19% in 2025; plant modernization raised capacity ~30%; customers get lower‑PCF supplies without recertification, aiding Scope 3 reductions.
23 March 2026
Chugai obtains MHLW approval for Lunsumio–Polivy combo in relapsed/refractory large B‑cell lymphoma
Japan approves Lunsumio + Polivy for relapsed/refractory large B‑cell lymphoma after Phase III SUNMO: ORR 69.7%, PFS 11.5 vs 3.8 months (59% lower progression/death risk); manageable safety.
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