A major overhaul is in progress for Sawai’s Upsher-Smith business, after the Japanese parent company announced leadership changes and a “drastic restructuring” of the US unit in the wake of a significant impairment charge and a hefty annual operating loss that dragged down Sawai’s overall results.

Emerging Company Profile: Harvesting blood and tissue samples from patients treated with PD-1 immunotherapy, OncoResponse is developing antibodies it believes can transform cold solid tumors into hot.

The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.

Sawai’s Upsher-Smith unit has launched three further strengths of isotretinoin capsules in the US. The company has also partnered with Australia’s Mayne Pharma on US distribution for the rivals to Sun’s Absorica dermatology brand.