Streptococcus

Paratek Withdraws European Marketing Authorization Application for Oral and Intravenous NUZYRA in Skin Infections and Pneumonia

Retrieved on: 
Thursday, October 17, 2019

Based on the review of the data and the application, the EMA has recommended approval for NUZYRA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP).

Key Points: 
  • Based on the review of the data and the application, the EMA has recommended approval for NUZYRA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP).
  • NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
  • Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
  • PARATEK and the Hexagon Logo are registered trademarks of Paratek Pharmaceuticals, Inc. NUZYRATM and its design logo are trademarks of Paratek Pharmaceuticals, Inc.

Streptococcus Pyogenes Infections Pipeline Review, H1 2019 Edition - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 8, 2019

The "Streptococcus pyogenes Infections - Pipeline Review, H1 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Streptococcus pyogenes Infections - Pipeline Review, H1 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Streptococcus pyogenes Infections - Pipeline Review, H1 2019, provides comprehensive information on the therapeutics under development for Streptococcus pyogenes Infections (Infectious Disease), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type.
  • The Streptococcus pyogenes Infections (Infectious Disease) pipeline guide also reviews of key players involved in therapeutic development for Streptococcus pyogenes Infections and features dormant and discontinued projects.
  • The pipeline guide reviews pipeline therapeutics for Streptococcus pyogenes Infections (Infectious Disease) by companies and universities/research institutes based on information derived from company and industry-specific sources.

GenePOC Obtains FDA Clearance for its GenePOC™ Strep A Test in the US

Retrieved on: 
Thursday, March 21, 2019

QUBEC CITY, March 21, 2019 /PRNewswire/ --GenePOC Inc., member of the DebiopharmGroup, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the revogene device.

Key Points: 
  • QUBEC CITY, March 21, 2019 /PRNewswire/ --GenePOC Inc., member of the DebiopharmGroup, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the revogene device.
  • GAS is the most common bacterial etiology of pharyngitis accounting for 15 to 30% cases in children and 5 to 20% in adults1.
  • In the United States, approximately 11 to 13 thousand cases of invasive GAS disease occur each year2.
  • The GenePOC Strep A assay is a qualitative in vitrodiagnostic test for the detection of Streptococcus pyogenes nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis.