Novartis & Pfizer withdraw drug application in Europe

...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Reply New Message

Prev Message Back To Forum Threaded View Next Message

KOO-KOO2

Rank: Treasurer [?]

Points: 10765 [?]

Votes: 39 Score: 2.3 [?]

Your Vote:

Please Log In to Vote

Did you know? You can earn activity points by filling your profile with information about yourself (what city you live in, your favorite team, blogs etc.)

Novartis & Pfizer withdraw drug application in Europe

posted on Dec 23, 2018 09:20AM

Bear I'm not sure if you reported on this lately.

https://www.biopharmadive.com/news/novartis-pfizer-withdraw-drug-applications-in-europe/544529/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20BioPharma%20Dive%2012-22-2018&utm_term=BioPharma%20Dive%20Weekender

Novartis pulled back on canakinumab and Pfizer on Fyzoclad.

"Novartis has encountered difficulty in getting canakinumab, the active ingredient in Ilaris, past regulators for broader indications. In October, U.S. regulators rejected the drug as a treatment for cardiovascular risk reduction. The pharma seems to have had no better luck in Europe."

and

"Meanwhile, Pfizer's reasons for withdrawing were much less clear, with its letter only stating a change in strategy. It did clarify it's reasons were not about the efficacy or safety of the Humira (adalimumab) biosimilar."