pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

FDA 111

FDA 111

pharmaphorum

NOVEMBER 24, 2021

The DTx – also known as Pear-009 – is still in the proof-of-concept trial stage, but draws on the same cognitive behavioural therapy (CBT) deployed in Pear’s commercial-stage products reSET and reSET-O for people living with substance and opioid use disorders. Photo by thom masat on Unsplash.

FDA 59

FDA 59

pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. Here we go again.

FDA 40

FDA 40

pharmaphorum

JUNE 8, 2021

In a statement on the approval, ICER said the view of many experts was that current evidence is simply not enough to support the use of aducanumab in Alzheimer’s patients, and the FDA had “moved the goalposts” by not holding Biogen’s drug to the standards of other therapies. Broad label questioned.

FDA 98

FDA Labelling 98