Emergent BioSolutions, Inc., released an update on Friday of the status of its 2011 procurement contract for BioThrax with the U.S. Centers for Disease Control and Prevention (CDC).
BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA). The vaccine is... Read More »
The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) recently moved forward with the development of the anthrax vaccine NuThrax.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Emergent... Read More »
Emergent BioSolutions, Inc., announced on Friday that it has signed a multi-year contract for the advanced development and delivery of NuThrax (vaccine adsorbed with CPG 7909 adjuvant), the company’s next-generation anthrax vaccine candidate.
The contract, signed with the Biomedical Advanced... Read More »
Elusys Therapeutics, Inc., published data on Thursday on more than 450 healthy adult subjects from five clinical trials used to support recent U.S. Food and Drug Administration (FDA) marketing approval of ANTHIM injection.
ANTHIM is used in adult and pediatric patients for the treatment of... Read More »
The U.S. Food and Drug Administration (FDA) recently approved Emergent BioSolutions, Inc.’s supplemental Biologics License Application (sBLA) for the manufacture of BioThrax (Anthrax Vaccine Adsorbed) at the company’s large-scale Building 55 manufacturing facility in Lansing,... Read More »
Altimmune, Inc., and the Biomedical Advanced Research and Development Authority (BARDA) are set to advance the first clinical trial later this month of an anthrax vaccine that could be administered in a single dose.
The trial was initiated from a two-year, $14 million contract between BARDA and... Read More »
Scientists at the National Institutes of Health (NIH) on Monday described how combining engineered anthrax toxin proteins and existing chemotherapy drugs could potentially yield a therapy to reduce or eliminate cancerous tumors.
Data was provided by the National Institute of Allergy and... Read More »
The U.S. Department of Health and Human Services (HHS) issued two solicitation notices on Tuesday related to the development and procurement of anthrax vaccines for the Strategic National Stockpile (SNS), a move that Emergent BioSolutions, Inc., said shows the government’s intent to maintain an... Read More »
The U.S. Food and Drug Administration (FDA) completed its Pre-Approval Inspection (PAI) of Emergent BioSolutions, Inc.’s Building 55 for the large-scale manufacturing of BioThrax (anthrax vaccine adsorbed).
Following the PAI’s conclusion, Emergent BioSolutions received a No Action Indicated... Read More »
Emergent BioSolutions, Inc.’s supplemental Biologics License Application (sBLA) seeking approval for the manufacture of BioThrax (anthrax vaccine adsorbed) at the company’s Building 55 was accepted for review by the U.S. Food and Drug Administration (FDA) this week.
“Emergent’s... Read More »
The U.S. Food and Drug Administration (FDA) granted orphan drug status to Emergent BioSolutions, Inc., on Wednesday for BioThrax (anthrax vaccine adsorbed) for post-exposure prophylaxis of anthrax disease from suspected or confirmed exposure to Bacillus anthraces.
BioThrax is the only... Read More »
The Energy and Commerce Committee Subcommittee on Health held a hearing entitled “Examining H.R. 3299, Strengthening Public Health Response Act” on Thursday to examine legislation meant to better prepare the U.S. to fight biological threats.
The Strengthening Public Health Emergency Response... Read More »
The U.S. Department of Health and Human Services (HHS) announced on Monday that one of the nation’s Centers for Innovation in Advanced Development and Manufacturing (CIADM) will support the development of NasoShield, a second-generation anthrax vaccine.
“Anthrax remains a material threat to... Read More »
Emergent BioSolutions, Inc., submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) on Monday for the approval of the manufacture of BioThrax (Anthrax Vaccine Adsorbed) in the company’s large scale Building 55 manufacturing... Read More »
The U.S. Food and Drug Administration (FDA) on Friday approved the Anthim injection to treat inhalation anthrax in combination with appropriate antibacterial drugs.
Anthim is also approved to prevent inhalation anthrax when alternative therapies are not available or appropriate.
“As... Read More »