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NASDAQ:BLUE 9 August 2025 - 17 August 2025

Breakthrough Cures, Big Deals, and Global Health Alerts – Biotech & Health News Roundup (Aug 16–17, 2025)

Breakthrough Cures, Big Deals, and Global Health Alerts – Biotech & Health News Roundup (Aug 16–17, 2025)

Pfizer’s sickle cell drug inclacumab failed a Phase 3 trial, missing its main goal and deepening setbacks from its $5.4 billion Global Blood Therapeutics acquisition. In contrast, Pfizer and Merck’s Padcev-Keytruda combo improved survival in muscle-invasive bladder cancer. Novo Nordisk’s Wegovy won FDA approval for treating metabolic dysfunction-associated steatohepatitis.
Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

Breakthrough Cures, FDA Shake-Ups & Pharma Mega‑Deals: Global Health News Roundup (Aug 9–10, 2025)

China researchers reported a hydrogel “smart” wound dressing that closed 90% of diabetic ulcers in mice within 12 days by delivering microRNA vesicles. The FDA approved Boehringer Ingelheim’s Hernexeos for advanced non-squamous NSCLC, with 75% of treated patients seeing tumors shrink or disappear. U.S. IV saline shortages ended as Baxter’s North Carolina plant resumed production after hurricane damage.
Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

The FDA approved Boehringer Ingelheim’s lung cancer drug Hernexeos and a companion diagnostic on Aug 8, citing trial data showing tumor shrinkage in 75% of eligible patients. The agency restricted Bluebird Bio’s Skysona gene therapy to patients lacking a matched donor due to blood cancer risk. Stealth BioTherapeutics’ Barth syndrome drug was rejected for a third time. The FDA declared the U.S. IV saline shortage over.
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