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.

With the goal of introducing the first adenosine A2a antagonist for Parkinson’s disease in North America and Europe, Biotie plans to start a Phase III study of tozadenant in almost 900 Parkinson’s patients this summer.