Glycopeptide antibiotics

DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

Retrieved on: 
Friday, July 23, 2021

NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE(dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.

Key Points: 
  • NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE(dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.
  • "This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI."
  • ABSSSI are bacterial infections of skin and associated tissues primarily caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes.
  • Results from the clinical trial in pediatric patients show that the safety findings of DALVANCE in pediatric patients were similar to those observed in adults.

Summit Therapeutics Presents Breakthrough Research Data from Phase II Studies, including Evidence Validating Microbiome Preservation, for its Investigational Drug Ridinilazole

Retrieved on: 
Monday, July 12, 2021

Ridinilazole is Summit Therapeutics investigational first-in-class drug currently in two pivotal Phase III Ri-CoDIFy clinical trials.

Key Points: 
  • Ridinilazole is Summit Therapeutics investigational first-in-class drug currently in two pivotal Phase III Ri-CoDIFy clinical trials.
  • In a Phase II study, treatment with ridinilazole compared to vancomycin demonstrated a significant sparing effect on the gut microbiome, supporting the production of protective secondary bile acids.
  • This is believed to be the primary mechanism through which ridinilazole elicits its bactericidal action against C. difficile bacteria.
  • The combination of these studies and discoveries provide us with further data in support of the intended efficacy of ridinilazole.

Melinta Therapeutics Announces Commercial Availability of KIMYRSA™ (oritavancin)

Retrieved on: 
Wednesday, July 7, 2021

As an oritavancin product, KIMYRSA has three bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity.

Key Points: 
  • As an oritavancin product, KIMYRSA has three bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity.
  • The efficacy and safety of KIMYRSA were established in the SOLO clinical trials with another oritavancin product, ORBACTIV.
  • The adverse reactions occurring in 2 patients receiving KIMYRSA in the PK study were hypersensitivity, pruritus, chills and pyrexia.
  • Melinta Therapeutics provides innovative therapies to people impacted by acute and life-threatening illnesses.

‍Pharmacy and Healthcare Professionals Nationwide Recognize Patient Safety Benefits of New Consensus Vancomycin Dosing Guidelines, But Fewer than One in Three Plan to Adopt Them

Retrieved on: 
Wednesday, July 8, 2020

According to the findings of a survey released today by InsightRX , 98% of pharmacy and healthcare professionals nationwide said they personally believe that the new vancomycin guidelines are important for patient safety.

Key Points: 
  • According to the findings of a survey released today by InsightRX , 98% of pharmacy and healthcare professionals nationwide said they personally believe that the new vancomycin guidelines are important for patient safety.
  • "Vancomycin, like many other medications, requires tailored dosing regimens to maximize patient efficacy and safety," said InsightRX CEO Sirj Goswami, PhD.
  • "The antibiotic is highly effective in combating infections caused by staph bacteria, but its effects vary significantly from person to person."
  • "Respondents are nearly unanimous in their personal belief that the new consensus guidelines are important for patient safety," said Goswami.

VigiLanz® Announces Precision Dosing Powered by Tabula Rasa HealthCare’s DoseMeRx™

Retrieved on: 
Thursday, April 2, 2020

MOORESTOWN, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Tabula Rasa HealthCare, Inc(TRHC) (NASDAQ: TRHC), a healthcare technology company advancing the field of medication safety, has partnered with VigiLanz, the leading provider in clinical surveillance, to integrate with DoseMeRx, TRHCs precision dosing solution.

Key Points: 
  • MOORESTOWN, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Tabula Rasa HealthCare, Inc(TRHC) (NASDAQ: TRHC), a healthcare technology company advancing the field of medication safety, has partnered with VigiLanz, the leading provider in clinical surveillance, to integrate with DoseMeRx, TRHCs precision dosing solution.
  • Our partnership with Tabula Rasa HealthCare and DoseMeRx enables providers to easily optimize the dosing of vancomycin and other high-risk antimicrobials, said VigiLanz Chairman and CEO David Goldsteen, MD.
  • Adding DoseMeRx will enable VigiLanz customers to easily implement the new national dosing guidelines for vancomycin one of the most commonly used antibiotics in hospitals today.
  • To learn more about VigiLanz Precision Dosing, powered by DoseMeRx, visit info.vigilanzcorp.com/precision-dosing .

Vancomycin-Resistant Enterococcus faecium Infections - Pipeline Review, H2 2019 - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 9, 2020

The "Vancomycin-Resistant Enterococcus faecium Infections - Pipeline Review, H2 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Vancomycin-Resistant Enterococcus faecium Infections - Pipeline Review, H2 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This Pharmaceutical and Healthcare latest pipeline guide Vancomycin-Resistant Enterococcus faecium Infections - Pipeline Review, H2 2019, provides comprehensive information on the therapeutics under development for Vancomycin-Resistant Enterococcus faecium Infections (Infectious Disease), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type.
  • The Vancomycin-Resistant Enterococcus faecium Infections (Infectious Disease) pipeline guide also reviews of key players involved in therapeutic development for Vancomycin-Resistant Enterococcus faecium Infections and features dormant and discontinued projects.
  • Formulate corrective measures for pipeline projects by understanding Vancomycin-Resistant Enterococcus faecium Infections (Infectious Disease) pipeline depth and focus of Indication therapeutics.

Xellia Pharmaceuticals Expands Available Doses of VANCO READYTM in the US (Ready-to-Use Premixed Vancomycin Injection Bags)

Retrieved on: 
Monday, December 9, 2019

This is the fourth presentation of Xellias RTU premixed vancomycin to be made available in the US market so far this year.

Key Points: 
  • This is the fourth presentation of Xellias RTU premixed vancomycin to be made available in the US market so far this year.
  • Progress is underway to file three additional VANCO READYTM doses to expand the portfolio to seven doses, which should be made available to the US as early as 2020.
  • Carl-ke Carlsson, Xellias CEO said: With four of our seven VANCO READYTM presentations now launched, Xellia is well on the way to be able to service the full needs of the vancomycin injection market.
  • Craig Boyd, Xellias North American President said: Our room temperature stable VANCO READYTM premix has been critical in providing a truly ready Vancomycin Injection product.

TRHC’S DoseMe® to Provide Precision Dosing Services for St. Joseph’s/Candler

Retrieved on: 
Wednesday, November 13, 2019

With the deployment of DoseMes web-based dose optimization solution, DoseMeRx, St. Josephs/Candler will transition to an AUC-based vancomycin dosing strategy.

Key Points: 
  • With the deployment of DoseMes web-based dose optimization solution, DoseMeRx, St. Josephs/Candler will transition to an AUC-based vancomycin dosing strategy.
  • DoseMes Bayesian dosing platform will make it easy and cost-effective for our pharmacists to apply the new national dosing recommendations for vancomycin.
  • The first in the world to develop precision dosing software for clinical practice, DoseMes solutions help to optimize dosing and streamline operations, reduce adverse drug events and decrease costs.
  • DoseMe is a Tabula Rasa HealthCare Company (NASDAQ: TRHC) and is the first company in the world to develop precision dosing software - DoseMeRx - developed specifically for clinical practice.

Aptorum Group Has Initiated IND-Enabling Studies For Its ALS-4 Small Molecule Candidate For The Treatment Of Infections Caused By Staphylococcus Aureus Including MRSA

Retrieved on: 
Monday, September 9, 2019

S. aureus is a bacteria which is a leading cause of blood, lung, skin, bone and device-related infections, as well as toxin-related diseases1.

Key Points: 
  • S. aureus is a bacteria which is a leading cause of blood, lung, skin, bone and device-related infections, as well as toxin-related diseases1.
  • MRSA and vancomycin-intermediate and resistant S. aureus have also been classified by the World Health Organization (WHO) as high priority pathogens for research and development4.
  • ALS-4 is a small molecule drug candidate that is believed to inhibit dehydrosqualene desaturase of S. aureus (incl.
  • Aptorum Group Limited (Nasdaq: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs.

The Lancet Infectious Diseases Publishes Results from Paratek’s Phase 3 Oral only Dosing Study of NUZYRA® (omadacycline) for Skin Infections

Retrieved on: 
Friday, August 30, 2019

Once-daily, oral NUZYRA met all primary and secondary clinical study endpoints and was shown to be safe and effective for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Key Points: 
  • Once-daily, oral NUZYRA met all primary and secondary clinical study endpoints and was shown to be safe and effective for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • NUZYRA is a modernized tetracycline that is a once-daily intravenous (IV) and oral formulation for the treatment of community-acquired bacterial pneumonia (CABP) and ABSSSI.
  • The incidence of skin infections that require hospitalization has substantially increased due, in part, to the emergence of community-acquired MRSA.
  • Efficacy was consistent across study populations, type of skin infection and causative pathogen including methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MRSA) infections.