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Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Axsome Succeeds In Narcolepsy Phase III, But Is That Enough?

Analysts say reboxetine looks approvable for cataplexy related to narcolepsy, but debate how broadly the drug may be adopted in a generic-laden therapeutic space.

Delayed Onset Of Tramadol IV Creates Risk Of ‘Opioid Stacking,’ US FDA Finds

Avenue Therapeutics seems unlikely to get advisory committee support for its opioid analgesic over the agency’s conclusion that the drug’s ‘minimal benefit’ is outweighed by a potential risk from its delayed onset of pain relief. FDA has issued two complete response letters and denied Avenue’s first request for a formal dispute resolution.

Takeda Halts Phase II Studies For Key R&D Asset TAK-994 In Narcolepsy

The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth. 

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