Pfizer's Exubera: Breathing New Life Into Inhaled Insulin
Dragging a host of safety concerns, Exubera hardly inspired confidence when it went before an FDA advisory committee. But Pfizer proposed an aggressive risk management scheme that won it a dramatic "yes" vote. How one company addressed a drug's safety concerns head-on to win the confidence of FDA's advisors.
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Insulin Delivery: Still Waiting to Exhale
After the commercial failure of Exubera, is inhaled insulin dead? Not at all. Exubera failed for very specific reasons: a cumbersome device, non-standard dosing, and no real clinical utility. The Exubera snafu has eroded the commercial value of inhaled insulin, but Nektar may be the best-positioned company currently competing in the inhaled insulin space. Nektar can afford to re-partner its version for less, because Pfizer has already paid for the bulk of the drug development work.
Pyramid Schemes and Pipeline Dreams: Adapting to a Tiered Regulatory System for New Drugs
FDA's new drug safety authorities suggest that the focus of drug development and lifecycle management strategies need to change. It is no longer a question of what it takes to get approval from FDA, but rather what kind of approval you can get.
The Death of Arcoxia: Drug Regulation in a "Whistleblower" Climate
There may not be a worse time to push a new drug through FDA-especially a "me-too" product with a questionable benefit-risk profile. Until Congress releases its grasp on the approval process, FDA isn't taking any chances. Unfortunately for industry, a few drugs are getting caught in the crossfire. Merck seemed unprepared for the new climate with Arcoxia; will other sponsors learn the lesson?