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BrainStorm Eyes New Phase III Trial For NurOwn In Mild ALS Following BLA Withdrawal

 
• By Sue Sutter

Highly negative FDA advisory committee review and subsequent discussions with the agency made clear the only path forward was a new study, company executives said. Troubled application shows the limits of FDA’s willingness to exercise regulatory flexibility.

Line not crossed
NurOwn shows there is a line that FDA will not cross when it comes to regulatory flexibility. • Source: Shutterstock

BrainStorm Cell Therapeutics Inc. expects to focus a new Phase III trial for NurOwn (debamestrocel) on amyotrophic lateral sclerosis patients with mild or less advanced disease, the company said in announcing withdrawal of the US biologics license application for the mesenchymal stromal cell therapy.

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• By Neena Brizmohun

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Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.

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Stand-Alone PDP Market Lives to Fight Another Day, Enrollment Data Shows

 
• By Leslie Small

No mass exodus was seen from stand-alone prescription drug plans to Medicare Advantage drug plans between 2024 and 2025, according to one actuary.

Gene Therapy Sponsor INTERACT, Pre-IND Meeting Confusion Lingers Despite FDA Guidance

 
• By Sue Sutter

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Europe Should Pay Drug Prices More In Line With US, Two Pharma CEOs Argue

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.