07:00 , Mar 28, 2016 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab regulatory update

FDA approved a BLA from Elusys for Anthim obiltoxaximab to treat inhalational anthrax in combination with antibacterial drugs and prevent inhalational anthrax when alternative therapies are not available or are inappropriate. Anthim was approved under...
01:11 , Mar 22, 2016 |  BC Extra  |  Company News

FDA approves Elusys' Anthim for inhalational anthrax

FDA approved Anthim obiltoxaximab from Elusys Therapeutics Inc. (Pine Brook, N.J.) to treat inhalational anthrax in combination with antibacterial drugs, and to prevent inhalational anthrax when alternative therapies are not available or are inappropriate. Anthim...
08:00 , Nov 16, 2015 |  BC Week In Review  |  Company News

Elusys, Department of Health and Human Services infectious news

Elusys said it received a $44.9 million order for investigational anthrax therapy Anthim obiltoxaximab from HHS’s Biomedical Advanced Research and Development Authority (BARDA) for the U.S. Strategic National Stockpile. A BLA for the liquid formulation...
02:44 , Nov 13, 2015 |  BC Extra  |  Company News

Elusys gets $44.9M BARDA order

Elusys Therapeutics Inc. (Pine Brook, N.J.) said it received a $44.9 million order for investigational anthrax therapy Anthim obiltoxaximab from the Biomedical Advanced Research and Development Authority for the U.S. Strategic National Stockpile. A BLA...
07:00 , Jun 15, 2015 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab regulatory update

FDA accepted a BLA for Anthim obiltoxaximab from Elusys to treat and prevent inhalational anthrax. The PDUFA date is March 18, 2016. The high-affinity humanized mAb against the Bacillus anthracis protective antigen inhibits binding of...
08:00 , Feb 19, 2015 |  BC Innovations  |  Translation in Brief

Single shot for anthrax

It has been over a decade since anthrax filled the headlines and while stockpiles of vaccine have been stored for emergency use, the only marketed vaccine in the U.S. - Emergent BioSolution Inc.'s BioThrax -...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

Elusys said data from a double-blind, placebo-controlled, U.S. Phase III trial in 280 healthy adult volunteers support the safety and tolerability of single 16 mg/kg dose of IV obiltoxaximab. The most common adverse events related...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

An open-label, U.S. Phase III trial in 40 healthy adult volunteers showed that the addition of ciprofloxacin to a single dose of 16 mg/kg IV obiltoxaximab led to no increase in the frequency of adverse...
07:00 , Oct 13, 2014 |  BC Week In Review  |  Clinical News

Anthim obiltoxaximab: Phase III data

A double-blind, placebo-controlled, U.S. Phase III trial in 70 healthy adult volunteers showed that repeat doses of 16 mg/kg IV obiltoxaximab on day 14 or day 120 did not increase the number of adverse events...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Anthim: Completed pivotal trial enrollment

Elusys completed enrollment of 280 adult volunteers in a double-blind, placebo-controlled, U.S. pivotal trial evaluating a single dose of 16 mg/kg IV ETI-204. The compound has Orphan Drug and Fast Track designations in the U.S....