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Regulatory and Compliance Updates news
(page 12)
1 March 2026
Genentech's Fenebrutinib Shows Promise as BTK Inhibitor for MS in Phase III Study
Fenebrutinib reduced relapses by 51% in RMS, consistent with prior studies. Data will be submitted to regulators. Safety profile comparable to teriflunomide; further analysis on fatalities ongoing.
28 February 2026
Merck's KEYTRUDA and WELIREG Combo Reduces RCC Recurrence Risk by 28%
Phase 3 trial shows KEYTRUDA and WELIREG improve disease-free survival in RCC. FDA accepts priority review for adjuvant treatment. Safety profile consistent with previous studies.
28 February 2026
Merck and Eisai: WELIREG and LENVIMA Reduce Disease Progression Risk by 30% in Advanced RCC Trial
Phase 3 trial shows WELIREG plus LENVIMA improves progression-free survival in advanced RCC, with FDA reviewing new drug applications.
27 February 2026
CATL and BMW MOU on Battery Passport and Decarbonization
MOU to run pilots for cross-border Battery Passport data exchange, carbon accounting and Catena‑X standards, aligning tech, policies and EU compliance to boost low‑carbon competitiveness.
27 February 2026
FDA Approves Novo Nordisk's Sogroya for New Pediatric Uses
Sogroya, a once-weekly growth hormone, is now approved for children with ISS, SGA, or NS, offering an alternative to daily injections and expanding treatment options.
27 February 2026
Merck's KEYTRUDA Plus Paclitaxel Boosts Survival in Platinum-Resistant Ovarian Cancer
KEYTRUDA plus paclitaxel improves overall survival in platinum-resistant ovarian cancer, regardless of PD-L1 status, as shown in the KEYNOTE-B96 trial.
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27 February 2026
Lilly's Olumiant Gains CHMP Nod for Adolescent Alopecia Areata in EU
CHMP backs Olumiant for severe alopecia areata in adolescents, based on Phase 3 study showing 42% achieved 80% scalp hair coverage at 36 weeks. Awaiting European Commission decision.
26 February 2026
GSK's Bepirovirsen Under Review in Japan for Chronic Hepatitis B Treatment
Japan reviews bepirovirsen for chronic hepatitis B. Phase III trials show higher functional cure rates and acceptable safety. SENKU designation granted for expedited review.
26 February 2026
GSK's Linerixibat Gets Priority Review in China for PBC-Related Itch
Linerixibat shows significant improvement in cholestatic pruritus in PBC patients, based on GLISTEN phase III trial data. Regulatory reviews ongoing in US, EU, UK, and Canada.
26 February 2026
MOL Accuses JANAF of Legal Violations Over Russian Oil Transit
MOL demands JANAF allow unsanctioned Russian oil via sea, citing EU/US rules. Non-compliance may lead to legal action and claims for damages.
26 February 2026
FDA Approves Boehringer Ingelheim's HERNEXEOS for HER2-Mutant NSCLC
HERNEXEOS gains FDA approval for HER2-mutant NSCLC, showing a 76% response rate in trials. Further confirmation required for continued approval.
26 February 2026
BASF Introduces Biomass Balance Autofroth Foam for North American Market
BMB Autofroth foam cuts carbon emissions by 18-20%, offers a drop-in solution for sustainability without process changes, and suits various applications.
26 February 2026
Lilly's Orforglipron Outperforms Semaglutide in Diabetes Trial
Orforglipron 36 mg reduced A1C by 2.2% and weight by 9.2%, surpassing semaglutide in a 52-week trial with 1,698 participants. Results published in The Lancet.
25 February 2026
Merck Animal Health's NUMELVI: FDA-Approved JAK Inhibitor for Canine Allergic Dermatitis
FDA approves NUMELVI for dogs 6+ months, a JAK inhibitor for allergic dermatitis, offering rapid itch relief and easy dosing. Available spring 2026.
25 February 2026
Merck Presents Phase 3 Trial Results for HIV-1 Treatment DOR/ISL at CROI 2026
DOR/ISL shows non-inferiority and similar safety to BIC/FTC/TAF in HIV-1 treatment-naïve adults and maintains suppression in those switching from other therapies.
25 February 2026
MOL and Janaf Agree on Adria Pipeline Capacity Tests
Long-term tests will assess Adria pipeline capacity. MOL seeks clarity on Russian oil shipments and criticizes Janaf's pricing. Two competitive routes are vital for regional supply security.
25 February 2026
Regulation Essential for OCCS Investment in Maritime Decarbonization
A DNV report highlights the need for clear regulations to advance OCCS technology, crucial for maritime decarbonization, with pilot projects showing technical feasibility and economic potential.
25 February 2026
Clariant Gains EU Approval for Rice Bran Wax in Food-Contact Plastics
EU approval allows rice bran wax additives in PET, PLA, and PVC for food-contact, offering a sustainable alternative to montan wax with lower carbon footprint and supply chain benefits.
24 February 2026
Johnson & Johnson Seeks FDA Approval for IMAAVY® to Treat wAIHA
IMAAVY® targets wAIHA by blocking FcRn, reducing IgG. Phase 2/3 study shows improved hemoglobin and fatigue.
24 February 2026
Rompetrol Rafinare Schedules Turnaround for Petromidia and Vega Refineries
Petromidia and Vega refineries will halt operations for a 20-day scheduled maintenance, focusing on inspections, equipment cleaning, and component replacements to ensure safety and efficiency.
23 February 2026
Johnson & Johnson's RYBREVANT® Approved for New Dosing Options in EGFR-Mutated Lung Cancer
European Commission approves subcutaneous RYBREVANT® for flexible dosing in advanced EGFR-mutated NSCLC, offering reduced clinic time and fewer reactions.
23 February 2026
Novo Nordisk: CagriSema Shows 23% Weight Loss in Trial, Misses Primary Endpoint
CagriSema achieved 23% weight loss in 84 weeks but didn't match tirzepatide. Further trials will explore higher doses. Safe profile with mild gastrointestinal effects.
21 February 2026
Johnson & Johnson's TREMFYA® Shows Sustained Remission in Ulcerative Colitis Over 3 Years
TREMFYA® maintains clinical, endoscopic, and histologic outcomes in ulcerative colitis through 140 weeks, with high patient retention and no new safety concerns.
20 February 2026
Chugai Launches Japan's First Regenerative Treatment for Duchenne Muscular Dystrophy
ELEVIDYS, a one-time therapy for DMD, targets ambulatory patients aged 3-7. Safety measures and post-marketing studies are in place following reports of liver failure cases.
20 February 2026
Roche's Giredestrant NDA Accepted by FDA for Advanced Breast Cancer
FDA accepts giredestrant NDA based on phase III data showing reduced disease progression risk in ER-positive breast cancer. Decision expected by December 18, 2026.
19 February 2026
Zenyaku's Rituxan Approved for Autoimmune Hemolytic Anemia Treatment
Rituxan gains approval for treating autoimmune hemolytic anemia, targeting B cells to reduce autoantibodies. Effective for warm AIHA, CAD, and PCH, offering an alternative to steroids.
19 February 2026
Genentech's Venclexta and Acalabrutinib Combo Approved by FDA for Untreated CLL
FDA approves all-oral, fixed-duration regimen for CLL, reducing treatment time. AMPLIFY study shows 35% lower risk of progression or death compared to chemoimmunotherapy.
19 February 2026
BASF Introduces Circalo for Low Carbon Ethanol Production
Circalo connects farmers and ethanol producers to reduce carbon intensity, aligning with Section 45Z, using xarvio tools for data verification and compliance.
19 February 2026
Trinseo's Rho Plant Achieves ISO 9001 Certification
The Rho facility's ISO 9001:2015 certification highlights its quality management and ability to produce high-quality recycled monomers. Other Trinseo sites also hold this certification.
19 February 2026
Merck Reports Positive Phase 3 Trial Results for ENFLONSIA in High-Risk Infants and Children
ENFLONSIA shows consistent safety and efficacy in high-risk infants over two RSV seasons, supporting expanded use for children under 2.
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