Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Orphan Tag for Pfizer’s Gene Therapy Up for Panel Review on June 1
A key health ministry panel will discuss on June 1 whether to grant an orphan status to Pfizer’s fidanacogene elaparvovec, a gene therapy for hemophilia B. The product contains a bio-engineered adeno-associated virus capsid and a high-activity human coagulation factor…
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REGULATORY
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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