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US Senators Call on FDA for More Action in Advanced Mfg for US Drug Supply
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Two US senators have directed a letter to the FDA Commissioner to promote domestic pharmaceutical supply chain resilience through the implementation of programs to manufacture drugs and APIs using advanced manufacturing technologies.
Supplier Risk Management: The Double-Edged Sword
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Mitigating supplier risk is imperative, but how can that goal be balanced with the challenges of supplier consolidation, industry capacity limitations, internal constraints, and other uncertainty to assure supply? An upcoming DCAT webinar will provide a “buy-and-sell side” view on best practices and new insights on how to better assess and mitigate risk in sourcing and supplier selection and the initial make-versus-buy decision.
Manufacturing and Supply Lines: Cell & Gene Therapies
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Although a niche market, cell and gene therapy development and manufacturing is an active area of investment by select bio/pharmaceutical majors, CDMOs/CMOs and smaller bio/pharmaceuticals. Which companies are expanding? DCAT Value Chain Insights rounds up the latest developments.
US Drug Pricing Reforms: Gov’t Releases Negotiated Prices for 10 Drugs
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In an historic first, the US government has released the prices negotiated with the industry of the first 10 drugs selected under the the Medicare Drug Price Negotiation Program. The negotiated prices, which will go into effect in January 2026, represent the first slate of drugs targeted for price negotiations under the Inflation Reduction Act. Which products are affected?