Another Nail in the Coffin for Anti-Amyloid Development in Alzheimer’s
Roche has pulled the plug on late-phase development for its anti-amyloid MAb crenezumab for...
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In Alzheimer Phase 3 Development, Yet Another One Bites the Dust
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US Development (or “Development”) of Benznidazole Reaches a Hitch and It’s All About Money
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Another Priority Review Voucher (PRV) Sold, This Time for $125 Million
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More on the Closed Distribution of Daraprim: Should Shkreli Have Really Been “Shocked” by It?
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In Alzheimer Phase 3 Development, Yet Another One Bites the Dust
This time it’s Axovant’s 5HT6 antagonist, intepirdine. The drug was intended as a symptomatic...
US Development (or “Development”) of Benznidazole Reaches a Hitch and It’s All About Money
UPDATE: The codevelopment agreement between Savant HWP and Humanigen for the US approval of benznidazole is...
Another Priority Review Voucher (PRV) Sold, This Time for $125 Million
Here’s an important follow-up from Zach Brennan at the RAPS website on the FDA’s priority review...
More on the Closed Distribution of Daraprim: Should Shkreli Have Really Been “Shocked” by It?
On December 21, 2016, Senators Susan Collins (R-Maine) and Claire McCaskill (D-Missouri), the respective...
Zach Brennen at Regulatory Focus: The FDA’s PRV Program Is at a Legislative Juncture
This is a MUST READ from Zachary Brennen at RAPS/Regulatory Focus on the review and potential...