Category Archives: BioFollies

Pharma Shrugged

We take issue with the commonly-held view that pushing a drug price as much as the market will bear is a fiduciary and ethical obligation: Draining every possible penny from the health care ecosystem jeopardizes the longterm health of that … Continue reading

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Pfallergan Round II?

<<Trump Executive Order Could Revive Allergan-Pfizer Merger -Emily Stewart   TheStreet.com    April 22,  2017 The Trump administration’s executive order on tax regulations could revive the defunct Allergan-Pfizer merger. The White House on Friday unveiled a new executive order instructing the Treasury … 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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ToneDeaf Therapeutics

(from NeuroPerspective Jan-Feb 2017) (Cambridge, MA 12/8/16):  ToneDeaf Therapeutics, a startup company based in Cambridge, today announced they have obtained seed funding from undisclosed investors with which they will take their cutting-edge Auditory-Reception-Facilitation device, ARF, into IND-preparation. “It is tragic … Continue reading

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Acadia Outsources Compassion and Math

On their quarterly call, Acadia Pharmaceuticals announced the pricing for Nuplazid, freshly approved by the FDA for the treatment of Parkinsonian psychosis (PDP). The price has been set at $1950 per month, about $23,400 per year. A quick scan of … Continue reading

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New Literacy Requirement for Physicians

“FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be … Continue reading

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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

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