Upsher-Smith Laboratories, LLC
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Latest From Upsher-Smith Laboratories, LLC
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.
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.
Plus deals involving Biosplice/Haisco, SciClone/Tarveda, Everest/Sinovent/SinoMab, Kyowa Kirin/AM-Pharma, Sandoz/Bio-Thera, Dr. Reddy’s/Citius, Jiangsu Hengrui/Mabworks, GeneQuantum/BrightGene, Innovent/GenFleet and Takeda/Mirum.
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