FDA Updates Plan for Mfg Inspections in China in Wake of Coronavirus Outbreak
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The US Food and Drug Administration (FDA) is providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from…

Sanofi To Create New, Standalone API Mfg Company in Europe
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Sanofi plans to create a new European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (APIs). Sanofi expects the new manufacturing company to bring…

Mallinckrodt Reaches Agreement in Principle for $1.6-Bn Global Opioid Settlement
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Mallinckrodt and its specialty generics-focused subsidiaries Mallinckrodt LLC, SpecGx LLC and certain other affiliates (collectively, “Specialty Generics”) have reached a $1.6-billion global agreement in principle that would resolve all opioid-related…

Lilly Completes $1.1-Bn Acquisition of Skin Therapy Company Dermira
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Eli Lilly and Company has completed its previously announced acquisition of Dermira, a biopharmaceutical company that develops new therapies for chronic skin conditions, for approximately $1.1 billion. Lilly says the acquisition expands…

Gilead Sciences, GSK, Moderna Advance Treatments Against Coronavirus
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Gilead initiates Phase III studies for remdesivir, an investigational antiviral drug, Moderna ships batch of vaccine for Phase I study, and GSK provides adjuvants. Gilead Sciences Initiates Studies of Investigational…

Fujifilm Diosynth, Dipharma, Aphena Expand; Univercells Secure $54 M in Funding
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The latest news from CDMOs, CMOs, and suppliers featuring news from Dipharma, Fujifilm Diosynth Biotechnologies, Univercells, and Aphena Pharma Solutions. Chemicals/Chemical API Manufacturing Dipharma Completes Construction of New cGMP Suite…

Pharma Groups Address Impact of API Mfg and Supply in EU Due to Coronavirus
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Pharmaceutical groups, including Medicines for Europe, address the impact on starting regulatory materials, intermediates, and APIs in the EU after the coronavirus outbreak in China. Medicines for Europe address impact…

Merck KGaA To Divest its Allergy Business Allergopharma to Dermapharm
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Merck KGaA has agreed to sell its allergy business, Allergopharma, to Dermapharm Holding, a manufacturer of off-patent branded medicines for selected markets in Germany, for an undisclosed purchase price. The…

Sanofi, Regeneron, Other Pharma Companies Advance Coronavirus Treatments
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The latest news from pharma companies on vaccine and antibody development for the novel coronavirus, including from Sanofi and Regeneron Pharmaceuticals. Sanofi Joins with HHS for Coronavirus Vaccine Development Sanofi…

FDA Outlines Supply-Chain Surveillance Plan in Wake of Coronavirus Outbreak
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The US Food and Drug Administration (FDA) Commissioner Stephen Hahn outlined the agency’s supply-chain surveillance plan in the wake of the coronavirus (COVID-19) outbreak in China, including the steps the…