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Regulatory and Compliance Updates news
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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14 June 2026
Lilly: Jaypirca plus venetoclax‑rituximab lowers progression risk 45% in relapsed/refractory CLL/SLL
Phase 3 BRUIN CLL-322 found adding pirtobrutinib to a two‑year venetoclax+rituximab regimen reduced progression or death by 45% versus venetoclax+rituximab alone.
13 June 2026
Johnson & Johnson: TALVEY plus DARZALEX FASPRO shows superior PFS and OS in Phase 3 MonumenTAL‑3
GPRC5D bispecific plus anti‑CD38 combo cut progression risk and delivered 24‑month PFS up to 81% and OS up to 89% in earlier‑line relapsed/refractory multiple myeloma.
13 June 2026
Genmab: Epcoritamab shows high response rates in elderly first‑line DLBCL with mono and R‑mini‑CHOP regimens
Fixed‑duration subcutaneous epcoritamab produced rapid, durable responses and high MRD negativity in elderly newly diagnosed DLBCL patients ineligible for full‑dose anthracycline therapy.
12 June 2026
Roche VENTANA PTEN (SP218) FDA-cleared as PTEN companion diagnostic in prostate cancer
First FDA-cleared IHC companion diagnostic to detect PTEN protein loss and select patients for capivasertib (TRUQAP) plus abiraterone therapy.
12 June 2026
Merck: FDA approves KEYTRUDA and KEYTRUDA QLEX with WELIREG for adjuvant ccRCC
FDA cleared PD‑1 plus HIF‑2α adjuvant regimens after Phase 3 showed 28% lower recurrence risk and 81% vs 74% 24‑month DFS; notable anemia, hypoxia and treatment discontinuations.
12 June 2026
BASF’s Tinosorb S (bemotrizinol) approved by FDA as first new U.S. sunscreen active in 27 years
FDA clears bemotrizinol, a broad‑spectrum, photostable UV filter that enables longer‑lasting, stronger UVA/UVB protection and improved formulation stability.
12 June 2026
Chugai files Tecentriq for maintenance therapy after definitive chemoradiotherapy in locally advanced esophageal cancer
Submission seeks approval of an anti‑PD‑L1 agent as maintenance therapy after definitive chemoradiotherapy, supported by SKYSCRAPER‑07 Phase III interim results.
12 June 2026
GSK’s momelotinib gains orphan drug status in US and EU for VEXAS
Orphan designations back development of momelotinib for VEXAS; ATLAS phase II/III underway with design to be shown at EHA 2026.
11 June 2026
Novo Nordisk: Wegovy pill approved in UK as first daily GLP-1 weight-loss tablet in Europe
Daily 25 mg semaglutide tablet approved as adjunct to diet and exercise for adults with obesity or overweight plus a weight‑related condition; private prescriptions expected soon.
11 June 2026
Johnson & Johnson’s IMAAVY shows rapid, durable hemoglobin gains in Phase 2/3 wAIHA trial
Nipocalimab 30 mg/kg produced rapid hemoglobin rises and ~3× more durable responders versus placebo at 24 weeks, with early fatigue improvement and reduced steroid use.
11 June 2026
Takeda's zasocitinib outperforms deucravacitinib in Phase 3 psoriasis head-to-head
Once-daily oral TYK2 inhibitor showed statistical superiority to deucravacitinib for PASI100 and key secondary endpoints, with >35% achieving complete skin clearance at week 16.
11 June 2026
European Commission secures stronger MSR safeguards for ETS2 (buildings & road transport)
Strengthened MSR for ETS2 doubles allowance injections, extends reserve validity past 2030, enables earlier gradual releases, and starts early auctions in 2027 with a €3bn frontloading facility.
11 June 2026
Evonik launches low‑carbon peracetic acid for Europe
Peracetic acid produced using bio-based acetic acid and low‑carbon hydrogen peroxide; mass‑balance accounting lets customers lower Scope 3 emissions transparently.
10 June 2026
Genentech: FDA grants Priority Review for Tecentriq plus chemotherapy in stage III dMMR/MSI‑H colon cancer
FDA accepted an sBLA for adjuvant PD‑L1 therapy plus chemotherapy in stage III dMMR/MSI‑H colon cancer; agency decision expected Oct 9, 2026.
10 June 2026
Aptar N‑Sorb patent allowed by USPTO for packaging-based nitrosamine mitigation
USPTO allowed a patent for N‑Sorb, a packaging material that reduces nitrosamines across multiple APIs and may support FDA Orange Book strategies.
10 June 2026
dsm-firmenich: FDA approves bemotrizinol (PARSOL® Shield) for U.S. suncare
FDA clears bemotrizinol (PARSOL® Shield), the first new U.S. sunscreen active in 25+ years, enabling broad‑spectrum, photostable formulas with low‑concentration efficacy.
9 June 2026
Moeve 2025 Environmental Statement for La Rábida and Palos
Annual report shows €33.8m+ invested in environmental upgrades, 100% renewable power in 2025, major waste recovery and water-use cuts, plus EU funding for green hydrogen project.
9 June 2026
Lilly gains FDA approval for EBGLYSS every‑eight‑week maintenance dosing
New every‑eight‑week maintenance option offers as few as six injections per year and can be used without mandatory topical therapy from treatment start.
9 June 2026
Takeda: FDA accepts sBLA for IV ENTYVIO in pediatric UC and Crohn’s
FDA accepted an sBLA to extend IV vedolizumab (ENTYVIO) to children aged 2+ with moderately to severely active UC and Crohn’s; PDUFA Q1 2027.
9 June 2026
PureCycle & Innovia Films produce white, cavitated BOPP using PureFive Choice™ recycled PP
White, cavitated BOPP film made with >40% post‑consumer recycled polypropylene showed virgin‑like processing and comparable mechanical, barrier and sealing performance.
9 June 2026
GSK to acquire Nuvalent for $10.6 billion
Includes two late-stage ROS1 and ALK NSCLC inhibitors under FDA review for 2026 decisions, plus a HER2 candidate; expected to be accretive to profit from 2027 and funded by debt and cash.
8 June 2026
Honeywell expands OT Cybersecurity Suite with AI monitoring and secure media controls
Adds five OT security capabilities — AI monitoring, secure media scanning, data diode, Cyber GRC automation and a managed OT SOC — for manufacturing, energy and critical infrastructure.
8 June 2026
Lilly's Foundayo (orforglipron) outperforms oral semaglutide, dapagliflozin and placebo in ACHIEVE trials
Oral GLP‑1 orforglipron reduced A1C and body weight more than oral semaglutide, dapagliflozin or placebo across three Phase‑3 trials; FDA filing planned by end of Q2 2026.
8 June 2026
Gilead and Merck: Phase 3 ISLEND trials show positive topline results for once‑weekly islatravir/lenacapavir
Once‑weekly oral islatravir 2 mg/lenacapavir 300 mg met Week 48 primary endpoint, non‑inferior to Biktarvy and daily standard‑of‑care; safety profile comparable across arms.
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