References in periodicals archive ?
Life sciences company Emergent BioSolutions Inc (NYSE:EBS) reported on Friday the receipt of an agreement, valued at USD100m, for the delivery of BioThrax (Anthrax Vaccine Adsorbed) to the Strategic National Stockpile (SNS).
Life sciences company Emergent BioSolutions Inc (NYSE:EBS) reported on Friday that it has signed an agreement, valued at USD100m, for the delivery of BioThrax (Anthrax Vaccine Adsorbed) to the Strategic National Stockpile (SNS).
The randomized, blinded study aims to demonstrate consistency of three BioThrax vaccine lots manufactured in the new facility, Building 55, based on lot-to-lot equivalence, as well as to demonstrate comparability with lots from the approved facility based on non-inferiority.
Even though the BioThrax program has been around for more than a decade, the company is trying to figure out ways to make it more efficient.
The BioThrax market authorization for India follows the publication in 2008 of the National Disaster Management Guidelines by the Indian National Disaster Management Authority (NDMA), which is the government body that oversees disaster management.
In addition to the further development of AV7909, Emergent's franchise of anthrax countermeasures includes: BioThrax - the only vaccine licensed by the FDA to prevent anthrax.
Finally, according to VaxGen, the purchase of BioThrax for the stockpile as a stopgap measure raised the bar for the VaxGen vaccine.
We are extremely pleased that the FDA has taken this step as we continue our efforts to expand the label indication for BioThrax to include, in combination with antibiotics, its use for post-exposure prophylaxis for anthrax infection," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.
Under the modified contract, the company is required to complete delivery of a total of five million doses of BioThrax to HHS prior to May 31, 2007, for a fixed price of $120 million.
Contracts and grants revenue for 2012 is primarily attributable to revenues from our contracts with BARDA for large-scale manufacturing of BioThrax and for development of PreviThrax(TM) (Recombinant Protective Antigen Anthrax Vaccine, Purified).
M2 EQUITYBITES-August 16, 2016-Emergent BioSolutions wins US FDA approval for Building 55 for large-scale manufacturing of BioThrax
M2 PHARMA-August 16, 2016-Emergent BioSolutions wins US FDA approval for Building 55 for large-scale manufacturing of BioThrax