Novartis drops development of albinterferon and Mycograb in candidiases, taking $590 million charge
Switzerland-based Novartis (NOVN: VX) and US biotech partner Human Genome Sciences (Nasdaq: HGSI) have decided to stop the further development of albinterferon alfa-2b as a treatment for adults with chronic hepatitis C and the Swiss drug major is also dropping an investigational candidiasis candidate.
Albinterferon carries the trade name Zalbin in the USA and Jouleferon in Europe, where Novartis withdrew is marketing authorization for the drug April (The Pharma Letter April 20).This decision was based on the findings from a Phase II study conducted with a monthly dose of albinterferon, as well as feedback received from US and European Union regulatory authorities.
The US firm revealed that, as expected, it has received a complete response letter from the Food and Drug Administration regarding the company’s Biologics License Application (BLA) for 900mcg Zalbin dosed every two weeks for the treatment of chronic hepatitis C, with the agency saying it had concerns about this dose, which HGS previously indicated light not be approvable (TPL June 15).
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze