Breaking News
The FDA approved Pegozafermin (89bio) for nonalcoholic steatohepatitis (NASH), marking a major step forward in metabolic liver disease after decades of failed attempts: FDA Press Release. Novo Nordisk also secured approval for Icozenpeg (survodutide) for obesity and metabolic dysfunction-associated steatohepatitis, tightening its lead over Eli Lilly in the metabolic space. Meanwhile, layoffs at Novo Nordisk were reported in U.S. commercial divisions, reportedly tied to portfolio realignment amid increasing competition from Eli Lilly’s Zepbound (tirzepatide) and rising pressure to support clinical development of next-gen GLP-1/GIP agents (Reuters).
Regulatory Updates
- The European Medicines Agency (EMA) announced a fast-track review for Bayer’s finerenone label expansion to include heart failure with preserved ejection fraction (HFpEF), following positive results from the FIGARO-HF2 trial (EMA).
- The FDA also issued new draft guidance on decentralized clinical trials (DCTs), emphasizing digital endpoint validation and patient-centric risk monitoring, aimed at addressing quality gaps exposed in the COVID-era remote trial boom.
Clinical Results
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AstraZeneca announced positive Phase 3 data for datopotamab deruxtecan (Dato-DXd) in hormone receptor–positive breast cancer, showing improved progression-free survival versus chemotherapy (Nature Medicine, 2025).
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Moderna reported promising results for its combination flu/COVID mRNA vaccine, with higher neutralizing titers and reduced side effects relative to monovalent boosters (NEJM, 2025).
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Regeneron released Phase 2 results for RGLX-314, an investigational gene therapy for geographic atrophy, demonstrating early signs of slowing lesion growth (The Lancet).
Industry & R&D Trends
- AI integration continues to accelerate in trial operations.
- Pfizer and Medidata announced a strategic partnership to build real-time predictive enrollment dashboards across global studies, integrating EHR and site activation data. The move reflects broader trends toward AI-driven resource forecasting to combat the ongoing bottlenecks in site activation timelines and recruitment inefficiencies.
- Illumina confirmed its divestiture of Grail to Roche for $6.8 billion, resolving long-standing antitrust disputes in the U.S. and EU (Bloomberg). The transaction signals a re-consolidation of precision oncology under major pharma umbrellas.
Summary
| FDA Approvals | Pegozafermin (89bio) for NASH; Icozenpeg (Novo Nordisk) for obesity/MASH | FDA |
| Regulatory Guidance | FDA releases new DCT guidance on digital endpoints and risk monitoring | FDA |
| EMA Review | Finerenone (Bayer) for HFpEF under accelerated evaluation | EMA |
| Clinical Results | Dato-DXd (AstraZeneca), combo mRNA flu/COVID vaccine (Moderna), RGLX-314 (Regeneron) | NEJM, Nature Medicine, The Lancet |
| M&A | Illumina sells Grail to Roche for $6.8B | Bloomberg |
| Industry Trends | Pfizer & Medidata launch AI-powered enrollment forecasting tool | Stat News |
With back-to-back obesity and NASH approvals, metabolic drug development is officially hot again. But beneath the headlines, the industry faces a new era of competition, supply-chain constraints, and regulatory recalibration—especially as the FDA pushes for smarter, digitally enabled trial oversight. The next few months will test which players can scale fast enough without breaking their systems.
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