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The regulator has received reports that a group of patients treated with Adzynma had neutralizing antibodies against the protein the therapy replaces.

After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.

Dr. Cristy Page will also serve as dean of the UNC School of Medicine and vice chancellor for medical affairs at UNC-Chapel Hill. 

The company has stepped up its interest in M&A since making a $4.1 billion divestiture that strengthened its balance sheet.

The chief medical officer for the new J&J unit discussed intravascular lithotripsy’s rapid growth and what to expect from the pipeline in a conversation with MedTech Dive.

After revoking Sarepta’s designation in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.

Independence Health has been struggling financially. WVU Health promises to invest $800 million over five years into upgrading Independence’s facilities.

AnaptysBio has separately alleged that GSK subsidiary Tesaro breached “certain requirements” under their 2014 license agreement involving a program that would become GSK’s Jemperli.

While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug in a prior multiple sclerosis study.

Amid an aggressive savings push, Moderna has cut three assets and taken on a loan to increase “flexibility.”