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Daiichi Sankyo Co. Ltd.

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Latest From Daiichi Sankyo Co. Ltd.

AstraZeneca Buys Priority Review Voucher With Two Big Filings On The Horizon

AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.

Drug Review Launches

Asia Trial Setbacks, Asset Returns Symptomatic Of Industry Challenges?

While deal-making in the Asian pharma space shows no signs of slowing down, the past few months have been marked by a series of high-profile cases involving the return of rights by licensees or setbacks in clinical trials. Scrip's regional team looks at some of the factors at work.

Asia Pacific Commercial

Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing

CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject. 

Research & Development Drug Approval Standards

Daiichi Must Follow Turalio Patients For 10 Years To Assess Liver Safety

As the US FDA suggested during its advisory committee review, a long-term safety study is among the postmarketing commitments for the tenosynovial giant cell tumor treatment.

Approvals Cancer
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