Strategy Focus: Big Pharma and Rare Diseases
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AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals earlier this year was yet another move by a large bio/pharmaceutical company to strengthen its portfolio in drugs to treat rare diseases. What are…

Drug Pricing Reform: The Impact on Drug Development
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The Congressional Budget Office (CBO) released a simulation model for analyzing the impact of US legislative drug pricing proposals on new drug development. The CBO projects that certain proposals, if…

Global API Sourcing: Will Policy Impact Current Practice?
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The US and the EU are continuing to advance their assessment of their supply chains for regulatory starting materials, intermediates, and APIs for essential medicines. Where do those assessments now…

Organon: What’s Next for the New Merck & Co. Spin-off?
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Kevin Ali, the CEO of Organon, the new company formed from the spin-off of Merck & Co.’s women’s health, established brands, and biosimilars businesses, is leading the new, independent company…

Injectable and Solid Dosage Drug Delivery: Key Deals
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Drug delivery is important not only for ensuring bioavailability for therapeutic benefit but also for product differentiation and market success. DCAT Value Chain Insights highlights technology advances in drug delivery for injectable…

Ranking the Top 25 Supply Chains: Who Made the Mark? 
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Supply-chain resiliency and agility are characteristics of companies ranked with the top supply chains according to a recent analysis and ranking by The Gartner Group of the Top 25 supply…

Industry, FDA Advance Drug Supply-Chain Security Plan
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The bio/pharma industry is moving to meet a November 2023 deadline, under the Drug Supply Chain Security Act (DSCSA), which requires manufacturers to set up electronic systems to track their…

Industry, FDA Meet Over Nitrosamine Impurities in APIs
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A joint industry group of innovator and generic-drug makers and consumer healthcare companies met with the FDA to go over the challenges the industry is facing in implementing a FDA…

CDMOs/CMOs: The Top Moves Thus Far in 2021
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What have been the key deals thus far in 2021 by CDMOs/CMOs? Biomanufacturing, including for cell- and gene-therapies, continues to be an active target for mergers and acquisitions. The largest…

Global Pharma Watchlist: India
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Last month (June 2021), India’s Department of Pharmaceuticals issued operational guidelines for the country’s new production-linked incentive (PLI) scheme for starting materials, intermediates, and APIs. The PLI scheme is intended…