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ARIA Ridaforolimus FDA Advisory Committee Behavioral Analysis
On March 20, 2012, the Oncologic Drugs Advisory Committee will meet to discuss new drug application 022576, Taltorvic (ridaforolimus) for the proposed treatment of metastatic soft tissue sarcoma or...
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Upcoming Obesity EMDAC: Parallels Between Diabetes and Obesity Drug Regulation
There are striking parallels between the state of obesity drug regulation today and diabetes drug regulation three years ago. If obesity drug regulation is following in the footsteps of diabetes drug...
View ArticleSite News and ARNA
Site News I came in 3rd place in Adam Feuerstein’s latest FDA drug approvals contest, finishing with a 12-3 record. I removed “FDA Tracker Futures” from the website. Ninety-six people registered since...
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ARNA Lorcaserin FDA Advisory Committee Behavioral Analysis
On May 10, 2012, the Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss new drug application 22-529 for lorcaserin, submitted by Arena Pharmaceuticals (ARNA). We conducted a...
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ONXX Onyx Pharmaceuticals – Carfilzomib’s Accelerated Approval
On June 20, 2012, the Oncologic Drugs Advisory Committee will meet to discuss new drug application 202714, Kyprolis (carfilzomib) for the proposed treatment of patients with relapsed and refractory...
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How Onyx Pharmaceuticals Should Make the Case for Carfilzomib at the ODAC Panel
Following the release of the FDA briefing documents for the carfilzomib advisory committee meeting, the AP story headline read: FDA focuses on toxic side effects with Onyx drug. ONXX fell 4% on the...
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ONXX Carfilzomib FDA Advisory Committee Behavioral Analysis
On June 20, 2012, the Oncologic Drugs Advisory Committee will meet to discuss new drug application 202714, Kyprolis (carfilzomib), submitted by Onyx Pharmaceuticals ONXX). We conducted a behavioral...
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Previewing CRTX Lixivaptan’s CRDAC Panel
On September 13, 2012, the Cardiovascular and Renal Drugs Advisory Committee will meet to discuss new drug application 203009, lixivaptan, for the proposed treatment of symptomatic hypervolemic and...
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CRTX Lixivaptan FDA Advisory Committee Behavioral Analysis
On September 13, 2012, the Cardiovascular and Renal Drugs Advisory Committee will meet to discuss new drug application (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the...
View ArticleThe Contrast Effect Between AEGR and ISIS
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet on October 17 and 18 to discuss lomitapide capsules (submitted by AEGR) and mipomersen injection (submitted by ISIS),...
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