Tag Archives: FDA

Assorted Interim Comments

1) Scott Gottlieb as FDA Commissioner: Gottlieb was Deputy Commissioner during the all-too-brief tenure of Mark McClellan, and we have followed his commentaries with interest and generally with agreement over the past decade+. We do believe that he has more … Continue reading

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Alkermes, ALKS5461, and the FDA

Alkermes late yesterday announced that the third of the ALKS 5461 antidepressant Phase III trials had yielded positive results for the high dose, utilizing an SPCD trial design and an alternative parsing of the MADRS as the primary endpoint. The … Continue reading

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Setting the Bar Low

BioCentury Extra for 2/12/14, regarding a FDA/Institute of Medicine conclave: <The second day planned for Thursday was postponed due to weather; FDA said it would be rescheduled for April or May and would focus on communicating uncertainty.> An excellent example … Continue reading

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She Blinded Me With Pseudo-Science*

Vanda Pharmaceuticals had received considerable attention and improved valuation for tasimelteon, whose NDA has been filed in the treatment of circadian rhythm disruption associated with blindness. Now, Adam Feuerstein (Street.com) has outlined in devastating detail what went into the making … Continue reading

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Et tu, Dr. Drew?

Bearing witness to the commercial maneuvers of the Pharma Industry has never been a task suitable for anyone prone to queasiness. The latest reminder of the moral banana peel upon which Big Pharma slips and slides is GSK‘s $3 billion … Continue reading

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Finally-A Pivotal Role for CNS Surrogates

Pfizer’s tafamidis program for Transthyretin Familial Amyloid Polyneuropathy (acquired via the buyout of FoldRx) has reached the FDA, and the CNS Advisory Committee charged with assessing tafamidis in the treatment of this rare disease has made an equally rare, and … Continue reading

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Of Persistence and Ethics in Phase III

Persistence paid off for Lundbeck and Takeda, whose first Phase III program for their antidepressant Lu AA21004 failed. With revised dosing, they ran another extensive set of pivotal trials, have announced that they will be filing for regulatory approval in … Continue reading

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