In late January, a bill to amend the Pharmaceuticals and Medical Devices Act cleared key legislation review processes by the…
REGULATORY
Will Japan Reinstate Sakigake Status for Aducanumab? Many See It Unlikely
Speculation is growing that Japanese regulators will not reinstate its sakigake fast-track designation for Biogen’s Alzheimer’s drug aducanumab, which made a surprising comeback last month with the company announcing a plan to seek approval. The word is that the medicine…
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