Category Archives: Biotech

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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Parsley, SAGE, Marathon, and Timing

–with apologies to Simon and Garfunkel, 1966 SIDE A NIR has long been an admirer of how SAGE Therapeutics has been able to leverage predictive power from tiny pilot studies in Severe Status Epilepticus (SRSE) and Post-Partum Depression (PPD)—but today’s … 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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Praying and Paying for Hope

The FDA’s approval of Sarepta Therapeutics’ eteplirsen for Duchenne Muscular Dystrophy (DMD) turned the spotlight on a decision process that has tapped fundamental fissures within the FDA and the scientific community, fractures that could reverberate in far larger scale in … Continue reading

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Allergan Gets It Right

It had seemed for a while that the headlines only reinforced the common public perception that the pharma industry had devolved into a snake pit of self-centered greed. Led by the Three Horsemen of the Pharmapocalypse, Shkreli, Pearson, and Bresch … Continue reading

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Academic Opioid Leapfrogs Field–Perhaps

Nature was the venue (8/18/16) for the publication of a paper from academic collaborators at UCSF, Stanford, UNC, Friedrich-Alexander-Universität Erlangen-Nürnberg, and Parelcus Medical University, a paper that reported the development of a highly refined, selective mu opioid agonist that–in animal … Continue reading

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Purdue’s Potemkin Village of Addiction-Prevention: Make Them Pay

The Los Angeles Times has published an appalling albeit impressive investigative piece (http://www.latimes.com/projects/la-me-oxycontin-part2/#nt=oft01a-1gp3; by Ruan, Girion, Glover) regarding Purdue Pharma’s handling of fraudulent Oxycontin prescriptions, and the part that this played in the opioid abuse crisis that has burgeoned in … Continue reading

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