EU Accelerated Assessment Tracker: First Filing From Bluebird And Daiichi Keeping Mum
As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.
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All Or Nothing: Paratek Withdraws EU Filing For Nuzyra
A month after being asked to attend an oral explanation meeting with the European Medicines Agency, Paratek Pharmaceuticals has decided to withdraw the EU marketing application for its broad spectrum antibiotic, Nuzyra. The company is one of two drug sponsors that has withdrawn an EU marketing application in October.
Top Financings: 2018 Was A Remarkable Year For Biopharma Fundraising
Highlights from the past year's financings include BeiGene's $800m follow-on offering in the US and $903m Hong Kong IPO, Moderna's $560m Series G round and $604m IPO, and Allogene's $300m Series A and $373m IPO.
Daiichi Sankyo Seals Speedier Europe Review For Quizartinib
The acute myeloid leukemia drug is the lead candidate in the strong oncology pipeline the Japan-headquartered company has assembled over the past couple of years.