martes, 26 de febrero de 2019

It all comes out in the FDA wash

The Readout
Damian Garde

It all comes out in the FDA wash


In 2017, the company Karyopharm halted a study of its blood cancer drug, saying in a press release that it had no hope of meeting its goals. What the company didn’t say, however, was that taking its drug actually hastened patients’ deaths compared to placebo, a revelation that didn’t come until Friday.

That’s because, as STAT’s Adam Feuerstein reports, Karyopharm’s drug is now under FDA review, which means the agency gets to publicly divulge its side of the development story. In that trial, overall survival for patients who got Karyopharm’s drug was 94 days compared to 170 days for patients treated with chemotherapy, a fact not mentioned in the 2017 press release.

The news adds Karyopharm’s name to a growing list of biotech companies caught downplaying bad news by the harsh light of FDA scrutiny.

Read more.

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