Newsletter
Published: 22 Dec 2025, 15:08 IST

Welcome to this week’s PharmaSignal Weekly Brief – Global Pharma Roundup. This week, we have seen significant movement in the M&A landscape, with major deals reshaping the biotech and rare disease sectors. Meanwhile, the FDA has been active in granting approvals and fast passes, potentially altering the competitive dynamics in several therapy areas. In the R&D space, promising trial results and strategic funding rounds have made headlines, while policy signals and market trends continue to shape the global pharma landscape.

M&A and Strategic Deals

  • BioMarin has acquired Amicus in a $4.8 billion deal, strengthening its rare disease portfolio and expanding its gene therapy capabilities.
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  • Xoma’s strategic acquisition of Generation Bio signals a move to expand its biotech portfolio and leverage Generation Bio’s gene therapy platform.
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Regulatory and Approvals

  • Cytokinetics received FDA approval for Myqorzo, a heart drug that could provide a new treatment option for patients with heart failure.
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  • The FDA has granted a fast pass to J&J for their multiple myeloma regimen, potentially speeding up the development and review process.
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Pipeline and R&D Highlights

  • Lilly’s obesity pill showed promising results in a maintenance trial, potentially positioning it as a leading contender in the obesity treatment market.
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  • Vertex’s CRISPR therapy demonstrated promise in treating blood disorders, marking a significant step forward in the application of gene editing technologies.
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Market, Pricing and Policy Signals

  • A proposal by Crapo and Cassidy for an alternative to ACA subsidies could have significant implications for health plans and the wider healthcare market.
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  • The ACIP vaccine schedule is currently under review by a panel, potentially leading to changes in vaccination guidelines.
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