The ID Pipeline: FDA Activity from the Week of April 14, 2019
Here is a look at infectious disease-related US Food and Drug Administration news from the week of April 14, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 14, 2019.
Seqirus Announces Plans to Manufacture a Cell-Based Influenza Vaccine
On Monday, April 15, 2019, Seqirus announced it will file an Annual Strain Update with the FDA stating its decision to manufacture a cell-based imfluenza vaccine (FLUCELVAX® QUADRIVALENT) for the 2019-2020 season. The vaccine candidate would cover all 4 influenza strains recommended by the World Health Organization.
"Egg-based vaccines are the standard of care and continue to play a critical role in the fight against influenza, but it's important to continuously evolve approaches to vaccine development," Gordon Naylor, president of Seqirus, said in a company statement. "While we continue to manufacture and distribute egg-based vaccines globally, cell-based influenza vaccines represent a significant advancement in influenza protection. Seqirus is proud to continue to innovate this promising technology as part of our leading role on the front line of influenza prevention and pandemic preparedness."
The full press release is available here.
FDA Clears Early Sepsis Indicator
On Thursday, April 18, 2019, the FDA granted 510(k) clearance for the Early Sepsis Indicator to Beckman Coulter. The Early Sepsis Indicator is hematology-based cellular biomarker designed to help emergency department physicians identify patients with sepsis or at an increased risk of developing sepsis.
The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with different for adult emergency department patients. A positive result signals a higher probability of sepsis and a negative result signals lower probability of sepsis.
“Knowing sooner and acting faster is the name of the game in the fight against sepsis, and we believe that the Early Sepsis Indicator has the potential to revolutionize the clinical approach to sepsis triage and diagnosis,” said Peter Soltani, PhD, senior vice president and general manager of the hematology business at Beckman Coulter
The full story is available here.