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Business & Regulation Business Practice, Standards & Regulation, Small Molecules

Business in Brief: Powder testing, NASH and new appointments

  • TFF Pharmaceuticals has signed a production and manufacturing agreement with CDMO Irisys LLC for an inhalable lung medication being investigated for the treatment of challenging to manage severe lung conditions – including COVID-19. Irisys will be responsible for the initial production and testing of the investigational powder product for inhalation.
  • Inventiva has received Breakthrough Therapy designation from the FDA for lanifibranor for the treatment of nonalcoholic steatohepatitis (NASH). It is the first potential NASH therapy to receive this status since January 2015. Lanifibranor is an orally-available small molecule that induces anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms. A phase III trial is due to begin in the first half of 2021.
  • SPI Pharma has named Scott Thomson as its new CEO. Thomson previously spent 29 years at BASF, holding leadership roles in both North America and Germany, including Senior VP of BASF's Global Pharmaceutical Solutions Business. His most recent position was Senior VP Care Chemicals Division, North America.
  • Morningside Pharmaceuticals has appointed Tim Brady as its new CEO. Brady has over 30 years’ experienceworking in pharmaceuticals, including building businesses from the ground up and as a European executive for global life sciences businesses. Brady will replace founder Nik Kotecha, who will step into the role as Chairman of the Board.

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