| | FDA Letters Made Public Are Creating New Risks | By Louis Garguilo, chief editor, Outsourced Pharma | There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake. |
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| With CDMOs Like This, Who Needs Biotechs? | By Louis Garguilo, chief editor, Outsourced Pharma | The question struck like a thunderbolt, writes Chief Editor Louis Garguilo. “Where are CDMOs going with all this?” asked Edward Ahn, CEO, Medipost, Inc., referring to the remarkable growth of some CDMOs. “When CDMOs aim to offer every service, capability, and the requisite capacities for an entire drug life cycle – from discovery to clinic to commercialization – what’s actually left for a biotech sponsor to do?” A forward discussion on an evolving outsourcing dynamic. |
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| Kodak Flips The Script To Biopharma Manufacturing In Rochester | By Louis Garguilo, chief editor, Outsourced Pharma | Well, that didn’t work out as planned, writes Chief Editor Louis Garguilo, referring to Kodak's plan in 2018 to revitalize the Eastman Business Park in Rochester, NY. The incoming chairman and now CEO, Jim Continenza, didn’t like that movie, and flipped the script. Instead, Kodak has, so to speak, returned to itself – back to a domestic specialty materials and chemicals supplier, intent on serving biopharma in that capacity. |
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