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Axsome Is Latest To Falter With Technology For Unlocking Meloxicam’s Analgesic Potential

 
• By Bowman Cox

Axsome’s CRL was not the first from the US FDA for the nearly insoluble NSAID as sponsors try different technologies for delivering its pain relief quickly.

Is it a mirage or an oasis?
A mirage or oasis: speedy meloxicam pan relief • Source: Alamy

Axsome Therapeutics, Inc., New York, NY, has become the latest sponsor entranced by the analgesic potential of meloxicam to stumble on the BCS class II drug’s virtual insolubility.

Like others before it, Axsome has proposed to unlock the non-steroidal anti-inflammatory drug’s potential with a trademarked technology, only to...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
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What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
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