FDA fast track designation for AstraZeneca’s MEDI3902

24 September 2014
2019_biotech_test_vial_discovery_big

Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) global biologics R&D arm, MedImmune has received fast track designation from the US Food and Drug Administration for its investigational monoclonal antibody (MAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa, a highly drug-resistant bacterial pathogen that causes serious disease in hospitalized patients.

The FDA’s Fast Track program is a process designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

This should have been positive news for AstraZeneca, but the company’s shares were down 5.4% to £43.315 on Tuesday on the back of the  news of the US Treasury crack down on tax inversion deals by US companies. Investors were still expecting Pfizer to come back with a renewed bid for AstraZeneca after the cooling off period following its failed attempt to buy the UK-based firm.

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 account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • 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



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology