Deals Shaping The Medical Industry, September 2020
Derived from Biomedtracker, the Deal-Making column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing.
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Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
Adolescents In COVID-19 Vaccine Trials: As Pfizer Starts Dosing, US FDA Encouraging Other Sponsors
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.
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