Emergent BioSolutions Says FDA Accepts AV7909 Anthrax Vaccine Candidate BLA For Review

RTTNews | 1134 gün önce
Emergent BioSolutions Says FDA Accepts AV7909 Anthrax Vaccine Candidate BLA For Review

(RTTNews) - Emergent BioSolutions Inc. (EBS) announced Friday that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).

AV7909 is the company's new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.

The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

The rolling BLA submission, completed in April 2022, is based on data from the pivotal phase 3 clinical study of AV7909 that evaluated the lot consistency, immunogenicity, and safety of the vaccine candidate following a two-dose schedule administered intramuscularly in healthy adults.

It also included data from the phase 2 study that evaluated non-interference between AV7909 and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease.

Etiketler: EBS
read more
U.S. Construction Spending Unexpectedly Sees Further Downside In June

U.S. Construction Spending Unexpectedly Sees Further Downside In June

The Commerce Department released a report on Friday unexpectedly showing a continued decrease by U.S. construction spending in the month of June. The report said construction spending fell by 0.4 percent to an annual rate of $2.136 trillion in June after sliding by 0.5 percent to a revised rate of $2.144 trillion in May.
RTTNews | 7s 0 dakika önce
U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July

U.S. Consumer Sentiment Improves Marginally Less Than Previously Estimated In July

Revised data released by the University of Michigan on Friday showed consumer sentiment in the U.S. improved marginally less than previously estimated in the month of July. The University of Michigan said its consumer sentiment index for July was downwardly revised to 61.7 from a preliminary reading of 61.8. Economists had expected the index to be upwardly revised to 62.0.
RTTNews | 7s 4 dakika önce
U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July

U.S. Manufacturing Index Unexpectedly Dips To Nine-Month Low In July

Manufacturing activity in the U.S. unexpectedly contracted at a slightly faster rate in the month of July, according to a report released by the Institute for Supply Management on Friday. The ISM said its manufacturing PMI edged down to 48.0 in July after inching up to 49.0 in June with a reading below 50 indicating contraction.
RTTNews | 7s 6 dakika önce
Eurozone Inflation Steady At 2% ECB Target

Eurozone Inflation Steady At 2% ECB Target

Euro area consumer price inflation was unchanged at the European Central Bank's 2 percent target in July, easing the pressure for more easing. The harmonized index of consumer prices increased 2.0 percent year-on-year in July, the same rate of increase as seen in June. Inflation was forecast to ease marginally to 1.9 percent.
RTTNews | 7s 53 dakika önce