This article was originally published in SRA
Egypt simplifies export requirements
You may also be interested in...
Japan approves a batch of new products and indications, including Daiichi Sankyo's Enhertu in a high-need indication after a rapid review and Takeda's Zejula, which will be made available to selected patients before its reimbursement listing.
Public Company Edition: Outside the US, Zai Lab raised more in its recent Hong Kong initial public offering – $766.4m – than PMV, Prelude, Taysha, Graybug and Greenwich combined. Also, Gilead priced debt to fund its $21bn Immunomedics buy and ADC Therapeutics raised $204m.
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.