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  • Novo Nordisk’s Ziltivekimab Misses Primary Endpoint in Pivotal Cardiovascular Trial
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Novo Nordisk’s Ziltivekimab Misses Primary Endpoint in Pivotal Cardiovascular Trial

Novo Nordisk's ziltivekimab failed its pivotal cardiovascular outcomes trial, capping a day of scattered signals in which an FDA panel unexpectedly backed Replimune's melanoma therapy, AbbVie's Skyrizi closed in on Humira's all-time peak, and Washington set up higher 2027 Medicare drug-plan premiums.
pharminent August 1, 2026 (Last updated: August 1, 2026)

STRATEGIC NEWS WATCH — July 31, 2026

Novo Nordisk’s ziltivekimab failed its pivotal cardiovascular outcomes trial, capping a day in which an FDA panel unexpectedly backed Replimune’s melanoma therapy, AbbVie’s Skyrizi closed in on Humira’s all-time peak, and Washington set up higher 2027 Medicare drug-plan premiums.

Today’s top developments:

  • Novo Nordisk’s anti-inflammatory candidate ziltivekimab failed to significantly cut major adverse cardiovascular events in its pivotal outcomes trial, a fresh setback for the company’s push to diversify beyond GLP-1s (CNBC)
  • An FDA advisory committee voted 10–3 that Replimune’s oncolytic immunotherapy RP1 is evaluable and clinically meaningful in advanced melanoma, reversing a roughly 30% share slide after staff earlier called the single-arm data “not interpretable,” ahead of an August 2 decision (Reuters)
  • AbbVie’s Skyrizi posted $5.55 billion in Q2 sales, up 24% and nearly matching Humira’s best-ever quarter, as AbbVie lifted its full-year forecast to $21.7 billion despite new IL-23 pill competition (Fierce Pharma)
  • Eli Lilly and contract manufacturer Resilience committed $750 million to expand U.S. capacity for Lilly’s KwikPen injector used to deliver its diabetes and obesity medicines, a build-out expected to add at least 400 jobs near Cincinnati (BioSpace)
  • Medicare’s Part D Premium Stabilization Demonstration will end after 2026, likely raising stand-alone drug-plan premiums for roughly 25 million beneficiaries starting in January 2027 (Forbes)

What to Watch

  • Replimune’s August 2 decision — With advisers voting 10–3 in favor, watch whether the FDA follows the panel and clears RP1 by its deadline; approval would validate single-arm accelerated-approval packages in melanoma just days after the agency’s own staff questioned the data.
  • Novo Nordisk’s pipeline reset — With ziltivekimab effectively shelved, watch how Novo reframes its cardiovascular and diversification narrative ahead of upcoming investor events, and whether it accelerates external business development to fill the gap beyond GLP-1s.
  • Psoriasis market share battle — Skyrizi is still adding patients despite the launch of J&J’s oral IL-23 pill Icotyde; watch whether that convenience eventually pressures injectable IL-23 leaders or, as AbbVie contends, mainly erodes older orals such as Otezla and Sotyktu.
  • Obesity manufacturing race — Lilly’s $750 million KwikPen expansion signals that device and fill-finish capacity, not just trial data, is now a competitive front in obesity; watch how quickly incretin leaders convert soaring demand into deliverable, U.S.-made supply.
  • Medicare Part D 2027 premiums — With CMS ending the premium demonstration, watch how sharply stand-alone drug-plan premiums climb before the December 7 open-enrollment deadline, and whether the increases draw political or industry pushback ahead of the January 2027 effective date.

This brief highlights the edition’s top stories. Read the full July 31, 2026 edition → for all stories and analysis — or browse the Strategic News Watch archive.

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