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  • EMA CHMP Recommends Twelve New Medicines for Approval at July 2026 Meeting
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EMA CHMP Recommends Twelve New Medicines for Approval at July 2026 Meeting

Twelve CHMP positive opinions headlined a regulator-heavy day, as a narrowly split FDA panel opened the door to compounded peptides and back-to-back R&D cuts at Sanofi and Roche reshaped the immunology and obesity pipelines.
pharminent July 24, 2026 (Last updated: July 24, 2026)

STRATEGIC NEWS WATCH — July 24, 2026

Twelve CHMP positive opinions headlined a regulator-heavy day, as a narrowly split FDA panel opened the door to compounded peptides and back-to-back R&D cuts at Sanofi and Roche reshaped the immunology and obesity pipelines.

Today’s top developments:

  • The EMA’s CHMP recommended twelve new medicines for EU marketing authorization at its 20–23 July meeting, including the cholesterol-lowering combination Evlarco (obicetrapib/ezetimibe) (EMA)
  • A narrowly divided FDA advisory panel voted to recommend adding four peptides — KPV, TB-500, BPC-157, and MOTS-c — to the 503A compounding bulks list the agency had banned three years ago (BioPharma Dive)
  • Sanofi abandoned its OX40 ligand blocker amlitelimab in atopic dermatitis after a strategic review, a fresh blow to the OX40 class following Kyowa Kirin’s rocatinlimab exit (Pharmaceutical Technology)
  • Roche discontinued Carmot obesity asset acmopatide to concentrate on enicepatide, which produced up to 22.5% placebo-adjusted weight loss over 48 weeks in Phase 2 (BioSpace)
  • Novo Nordisk sought a preliminary US court injunction to halt Eli Lilly’s Zepbound and Mounjaro advertising, escalating the comparative-marketing suit it filed July 21 (Reuters)

What to Watch

  • FDA peptide decision — The FDA usually, but not always, follows its advisers; watch whether it formally adds KPV, TB-500, BPC-157, and MOTS-c to the 503A bulks list, plus the July 24 vote on Emideltide, Semax, and Epitalon.
  • Roche enicepatide Phase 3 — A broad program spanning weight loss, type 2 diabetes, and cardiovascular outcomes is set to begin, with an obesity regulatory submission possible as early as 2028.
  • OX40 class under pressure — Watch whether remaining sponsors retreat from OX40 blockers in first-line eczema after Sanofi’s and Kyowa Kirin’s back-to-back exits amid efficacy and safety questions.
  • Novo v. Lilly injunction ruling — A court decision on Novo’s motion could force Lilly to pull comparative weight-loss ads and reset how GLP-1 claims are marketed to consumers.
  • EU launch wave — Twelve CHMP positive opinions typically convert to European Commission authorizations within weeks, setting up near-term commercial launches across multiple therapeutic areas.

This brief highlights the edition’s top stories. Read the full July 24, 2026 edition → for all stories and analysis — or browse the Strategic News Watch archive.

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