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Latest From Ardelyx Inc.
Keeping Track: Biogen’s Aducanumab Headlines Midsummer Submission Round-Up
The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
Power Of Proprietary Drug Names To Be Studied By US FDA
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Finance Watch: IPOs Are In A Slump, But Already Public Companies Have Rallied
Public Company Edition: The last biopharma initial public offering in the US was on 11 November, but follow-on and other offerings are generating hundreds of millions of dollars. Among RNA drug developers, Ionis issued more than $500m in new debt, while Arrowhead raised $266.8m.
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