Clostridium difficile

IVD Industry Battles AMR, Touts Biotin-Free Immunoassays and Smaller Footprints at the 2018 American Association for Clinical Chemistry Meeting

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목요일, 8월 2, 2018
Bacteria, Clostridiaceae, Gram-positive bacteria, C. Diff, Diarrhea, Clostridium difficile, Clostridium, Infection

Close to 250,000 people are hospitalized every year for a Clostridium difficile (C. difficile) infection, and 14,000 of them die.

Key Points: 
  • Close to 250,000 people are hospitalized every year for a Clostridium difficile (C. difficile) infection, and 14,000 of them die.
  • Roche Diagnostics highlighted their Liat systems that can quickly assess flu or strep, and thus reduce unnecessary treatment.
  • The company, a member of the AMR Industry Alliance, displayed its BacT/Alert Virtuo at the meeting.
  • BacT/Alert Virtuo is an advanced, automated blood culture system incorporating improved automation and an enhanced detection algorithm to shorten time to detection.

FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection

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수요일, 6월 20, 2018
Bacteria, Clostridiaceae, Gram-positive bacteria, Diarrhea, Antibiotics, Clostridium difficile infection, RTT, Clostridium difficile, Clostridium, Food and Drug Administration, Lipoglycopeptide

The QIDP designation was granted by the FDA for the treatment of patients with Clostridium difficile infection (CDI).

Key Points: 
  • The QIDP designation was granted by the FDA for the treatment of patients with Clostridium difficile infection (CDI).
  • Under QIDP designation, ACX-362E will now be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act).
  • Further, if ultimately approved by the FDA, ACX-362E is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity.
  • The CDC (Centers for Disease Control & Prevention) has designated Clostridium difficile bacteria as an urgent threat highlighting the need for new antibiotics to treat CDI.

Rebiotix Microbiota Restoration Therapy™ Products, Microbiome Health Index™ to Take Center Stage at Digestive Disease Week 2018

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월요일, 6월 4, 2018
Bacteria, Clostridiaceae, Gram-positive bacteria, Diarrhea, C. Diff, Clostridium difficile, Clostridium, Infection, Breakthrough therapy, Fecal microbiota transplant, Antibiotic-associated diarrhea

Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff)infection.

Key Points: 
  • Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff)infection.
  • RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection.
  • In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy platform.
  • Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women's health, and in specialty areas within gastroenterology and urology.

Rebiotix Presents Posters at ECCMID 2018 Highlighting Microbiome Health Index™ Value Potential and RBX2660 Phase 2 Clinical Program Data

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화요일, 4월 24, 2018
Bacteria, Health, Epidemiology, Medicine, C. Diff, Clostridium difficile, Clinical trial, Infection, Pharmacomicrobiomics

Collectively, the posters add to the growing library of data recently published and presented by Rebiotix highlighting the company's microbiome drug products, clinical programs, and pioneering research involving microbiome composition and health.

Key Points: 
  • Collectively, the posters add to the growing library of data recently published and presented by Rebiotix highlighting the company's microbiome drug products, clinical programs, and pioneering research involving microbiome composition and health.
  • "Moreover, the data presented at ECCMID 2018 exemplify an ongoing mission at Rebiotix to conduct scientific research to explore the potential of our microbiome drug products and to advance the understanding of the human microbiome itself."
  • These two controlled studies provided the foundational data for advancing RBX2660 into the current, ongoing Phase 3 clinical trial for the prevention of rCDI.
  • Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff)infection.