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Latest From Kyowa Kirin Co., Ltd.
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
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Scrip Asks…What Does 2023 Hold For Biopharma? Part 5: Technological Advances
The confluence of data science and molecular biology fuels expectations among biopharma industry leaders for another year of breakthrough innovation in human therapeutics. More than 70 executives and experts reveal what they are most excited about on the technology front.
REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
Deal Watch: AbbVie Leads J.P. Morgan Deal Rush, But BI, Genentech And Lilly Also Big Players
As the usual flurry of deals coincides with the J.P. Morgan Healthcare Conference, AbbVie signed an mRNA pact with Anima and a cancer research tie-up with Immunome.
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