Tag Archives: Diabetes mellitus type 2

Ever Bullish, Al Mann Says Afrezza is Coming in Mid-April

Post Exubera, inhaled insulin has been an uphill struggle with regulators. Alfred Mann and MannKind are nonetheless determined to push Afrezza, an ”ultra” rapid-acting mealtime insulin, over the regulatory peak and into the market. Will they succeed, or is MannKind doomed to play Sisyphus on mount FDA? It would be in large part due to […]
Posted in FDA, People, pricing, R&D, Regulatory, Safety, Strategy, Technology | Also tagged , , , , , , | 3 Comments

Judgment Day for Avandia

Judgment Day has finally arrived for GSK’s Avandia. FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees met July 13 and 14 to finally recommend, after months of deck-stacking against GSK, that the drug be severely restricted, if not outright pulled from the market. In the vote, 12 of 33 panelists […]
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