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.

Drugs 109

Drugs FDA Approval Trials Marketing 109

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.

Production 57

Production Development Trials 57

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 Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

XTalks

JUNE 9, 2021

Not only is aducanumab the first new treatment approved for Alzheimer’s since 2003, it is also the first therapy that targets the pathophysiology of the disease. It is administered monthly as an intravenous infusion to treat early Alzheimer’s disease and was developed for patients with mild cognitive impairment, not severe dementia.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 23, 2021

As Dr. Grill alluded to, one of the largest questions that Alzheimer’s researchers must address is whether new investigational therapies should continue to be compared to a placebo in Alzheimer’s clinical trials going forward. Are Placebo Arms Still Ethical in Alzheimer’s Clinical Trials?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

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.

Drugs 98

Drugs Marketing FDA Approval Trials 98