REGULATORY
Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
The MHLW said on March 27 that it has granted sakigake fast-track designation, a Japan version of the US FDA’s breakthrough therapy status, to six drugs including what is hoped to be the world’s first renal function-improving agent. The six…
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





