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Pharma in a Post-Brexit World: What’s Next?
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The European Parliament formally approved last month the EU–UK pact under Brexit, which governs trade and customs issues. The pact has been applied conditionally since the beginning of 2021, but…

AstraZeneca’s $39-Bn Buy of Alexion: Will It Pay Off?
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AstraZeneca took a step forward in its $39-billion acquisition of Alexion Pharmaceuticals with approval of the deal from the US Federal Trade Commission last month. The deal, which is expected…

Industry Raises Red Flags Over Drug-Pricing Bill in the US
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The Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America have raised concerns over recently re-introduced legislation in Congress over drug pricing. The bill includes measures for international…

The Pharma Pulse: Product Innovation & Emerging Pharma
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New product development is the lifeblood of any industry. Smaller bio/pharmaceutical companies are accounting for an increasingly larger portion of new products as measured by recent new molecular entity approvals.…

The EU and Fine Chemicals: What’s Next
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The European Commission took another step to address ways to improve the resilience of the EU’s pharmaceutical manufacturing value chain by issuing a revised roadmap for its Pharmaceutical Strategy for…

FDA Issues New Guidance on Remote Inspections
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Last week (April 14, 2021), the FDA issued final guidance on remote inspections, which the FDA has used in lieu of onsite inspections due to COVID-19 restrictions. The FDA is…

CDMO/CMO Expansion Update: Biomanufacturing
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Driven by increased biologic-based drug development and industry capacity needs, biomanufacturing is an active area of investment for CDMOs/CMOs with several large-scale expansions recently announced or underway. What CDMOs/CMOs are…

President Biden Proposes New Agency for Pharma Innovation
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The Biden Administration has proposed $6.5 billion in funding to establish a new federal agency within the National Institutes of Health to drive bio/pharmaceutical innovation in areas such as cancer,…

Generic Drugs: What’s Next for Viatris?
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Viatris, the new company formed from the combination of Mylan and Upjohn, Pfizer’s off-patent branded and generic established medicines business, is proceeding with a $1-billion restructuring initiative, which includes a…
FDA

FDA Provides Update on GMP Inspections
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Janet Woodcock, Acting Commissioner of the FDA, provides an update on the FDA’s inspection activity during the COVID-19 pandemic, including what new tools the agency has used for inspections, which…