Acceleron Pharma, Inc.
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Latest From Acceleron Pharma, Inc.
From the Aduhelm approval to exuberant stock markets, life sciences investor and In Vivo Rising Leader John Cassidy shares insights into industry trends, highlighting areas where decisions may have moved away from scientific fundamentals.
The ReDUX4 study missed its biomarker-driven primary endpoint, making it unclear if an additional trial will be needed for regulatory submission.
Adding non-transfusion-dependent anemia patients to the Reblozyl label is a key strategy for the product, which BMS expects to reach $4bn in annual sales.
More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’
‘Vast majority’ of 40 parties who received pre-notices of non-compliance with reporting requirements took action, FDA says. First noncompliance letter to Acceleron has prompted speedy response from sponsors.
- Large Molecule