Keeping Track: First Gliomas Imaging Agent Wins Approval; Amgen Hopes New Repatha Data Boosts Prospects
The latest drug development news and US FDA highlights from our Performance Tracker.
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FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends
Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.
Finance Watch: NDA-Ready Impact Gets Commitment For Another $90m
Start-up Impact's new structured financing – its second fundraising event this month – will pay out in increments as fedratinib nears the market. Also, Ablynx closed its $200m US IPO; Chi-Med follow-on brings in $262m; and VCs gives Cydan $34m to launch new companies.
Praluent Injunction Goes Unmentioned At PCSK9 Patent Case Appeal
Three-judge US federal appellate panel focuses on evidentiary rulings and patent validity in the dispute between Repatha marketer Amgen and Sanofi/Regeneron; lower court’s permanent injunction barring sales of Praluent did not come up at oral arguments.