Monthly Archives: March 2016

http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees

Questions and Answers Regarding Advisory Committee Membership What is an FDA Advisory Committee? Advisory committees provide FDA with independent advice from outsiders and political cover in the event that something goes wrong. The committees provide advice to the Agency, but … Continue reading

Posted in Big Pharma, BioFollies, Biotech | Tagged , , , | Leave a comment

Forum and CIAS

Forum Pharmaceuticals (formerly EnVivo) announced today that their two Phase III trials of FRM-6124 in CIAS (Cognitive Impairment Associated with Schizophrenia) failed to hit their co-primary endpoints.   No details were provided, but there apparently are signs of a treatment effect … Continue reading

Posted in Biotech, Science | Tagged , , | 1 Comment

Kerrisdale Provides Less than Sage Advice

On March 23, a number of NeuroPerspective subscribers and sources forwarded to us a ‘report’ prepared by Kerrisdale Capital on SAGE Therapeutics. Subheaded ‘Overhyped Lead Drug Headed for Failure,’ it gave the illusion of a detailed, seemingly well-researched critique of … Continue reading

Posted in BioFollies, Biotech, Muddled Media | Tagged , , , , | Leave a comment

Valeant Needs Autopsy, Not CPR

Neurogram/August 2015: “This brings us to Valeant Pharmaceuticals. We despise Valeant, a company that routinely treats acquired companies like poachers who have machine-gunned an elephant in the veldt, stripping the tusks while leaving the carcass to rot in the tropical … Continue reading

Posted in Big Pharma, BioFollies, Biotech, Muddled Media | Tagged , | 1 Comment