Lipoglycopeptide

FDA Approves AEMCOLO™ (rifamycin), the First Antibiotic Approved for the Treatment of Travelers' Diarrhea in Over a Decade

Retrieved on: 
Monday, November 19, 2018
Medicine, Bacteria, Microbiology, Pathogenic bacteria, Escherichia coli, Diarrhea, Rifamycin, Escherichia, Lipoglycopeptide, Pathogenic Escherichia coli

In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for AEMCOLO.

Key Points: 
  • In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for AEMCOLO.
  • AEMCOLO was approved based on data from two randomized, multi-center, controlled Phase 3 clinical trials.
  • AEMCOLO (rifamycin) is an orally administered, minimally absorbed antibiotic approved for the treatment of Travelers' Diarrhea caused by non-invasive strains of Escherichia coli in adults.
  • AEMCOLO is indicated for the treatment of travelers' diarrhea caused by non-invasive strains of Escherichia coli in adults.

Cipher Pharmaceuticals Receives Health Canada Approval of Xydalba™ (dalbavancin hydrochloride)

Retrieved on: 
Monday, September 10, 2018
Antibiotics, Lipoglycopeptide, Glycopeptide antibiotics, Dalbavancin, Skin and skin structure infection

MISSISSAUGA, ON, Sept. 10, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced it received Health Canada approval of Xydalba (dalbavancin hydrochloride), the first and only one-dose treatment option for acute bacterial skin and skin structure infections (ABSSSI) in adults and available in Canada.

Key Points: 
  • MISSISSAUGA, ON, Sept. 10, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) today announced it received Health Canada approval of Xydalba (dalbavancin hydrochloride), the first and only one-dose treatment option for acute bacterial skin and skin structure infections (ABSSSI) in adults and available in Canada.
  • "Xydalba is the first and only 30-minute, single-dose treatment option for ABSSSI in Canada that delivers a full course of IV therapy.
  • Cipher acquired Xydalba through the acquisition of the Canadian business portfolio of Cardiome Pharma Corp., which was completed in May 2018.
  • Xydalba for injection is a second-generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone.

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

Retrieved on: 
Wednesday, June 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.