Lipoglycopeptide

Global $13.8 Billion Antimicrobial Resistance Market, 2027 | Opportunity Breakdown by Disease, Pathogen, Drug Class, End-user and Region - ResearchAndMarkets.com

Retrieved on: 
Monday, September 27, 2021
Biotechnology, Pharmaceutical, Health, Infection, Ceftolozane/tazobactam, DDD, Subclinical infection, Research, Vaccine, WHO, Health, CAGR, University, Overalls, ABSSSI, Mind, Patient, Cephalosporin, AMR, Lipoglycopeptide, Physician, 2-Oxazolidone, Clifton Springs Hospital & Clinic, Tetracycline, National Rural Development Partnership, One Health, Public health, Death, Merck, Local government, Gaps, Allergan, Heel, Growth, CDI, Melinta Therapeutics, Contract, COVID-19, Philippe Ciais, IDSA, Achilles, Ceftazidime/avibactam, Tuberculosis verrucosa cutis, Meropenem/vaborbactam, Electronic Healthcare Network Accreditation Commission, BSI, BAA, OECD, Investment, Government, Frazier Healthcare Partners, US, Contract research organization, Antibiotics, Pharmaceutical industry

The global antimicrobial resistance market was valued at US$ 9.39 billion in 2020, and is estimated to reach US$ 13.8 billion in 2027, with a CAGR of 4.68% from 2021-2027.

Key Points: 
  • The global antimicrobial resistance market was valued at US$ 9.39 billion in 2020, and is estimated to reach US$ 13.8 billion in 2027, with a CAGR of 4.68% from 2021-2027.
  • The emergence and spread of drug-resistant pathogens which have acquired new resistance mechanisms, leading to antimicrobial resistance, continues to threaten our ability to treat common infections.
  • New antibacterial are urgently needed - for instance, to treat carbapenem-resistant gram-negative bacterial infections as identified in the WHO priority pathogen list.
  • Europe was the second largest regional market in the global arena in 2020, supported largely by growing number of antibiotic-resistant infections.

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

Retrieved on: 
Friday, July 23, 2021
Medical specialties, Microbiology, Bacteriology, Bacterial diseases, Glycopeptide antibiotics, Gram-positive bacteria, Pathogenic bacteria, Dalbavancin, Antibiotics, Lipoglycopeptide, Staphylococcus aureus, Streptococcus pyogenes

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.

Vibativ® Effectively Helps Treat Secondary Bacterial Infections In COVID-19 Patients

Retrieved on: 
Monday, June 21, 2021
Antibiotics, Medical specialties, Pneumonia, Astellas Pharma, Telavancin, Infectious diseases, Medicine, Clinical medicine, Bacterial pneumonia, Lipoglycopeptide

The dossier of patient case studies outlines five real-world instances where Vibativ effectively and safely treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.

Key Points: 
  • The dossier of patient case studies outlines five real-world instances where Vibativ effectively and safely treated hospital-acquired and ventilator-associated bacterial pneumonia in COVID-19 patients.
  • These cases illustrate the clear need for an antibiotic like telavancin, which rapidly and effectively eradicates secondary bacterial pneumonia that can develop in patients with COVID."
  • Cumberland's Vibativ (telavancin) has been used across the country to help COVID-19 patients who develop secondary bacterial infections in their lungs.
  • Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including HABP and VABP that can result from COVID-19, flu and other infections.

CorMedix Inc. to Participate at the 7th Annual Truist Securities Life Sciences Summit

Retrieved on: 
Wednesday, April 28, 2021
Medicine, Clinical medicine, Catheters, Medical specialties, Central venous catheter, Parenteral nutrition, Food and Drug Administration, Bloodstream infections, Hemodialysis, Peripheral venous catheter, Lipoglycopeptide

The Company is focused on developing its lead product DefenCath\xe2\x84\xa2, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.

Key Points: 
  • The Company is focused on developing its lead product DefenCath\xe2\x84\xa2, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.
  • DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need.
  • QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA.
  • CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients.

RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease

Retrieved on: 
Wednesday, January 6, 2021
Life sciences, Health, Antibiotics, Pharmaceuticals policy, Fast track, Food and Drug Administration, Orphan drug, Priority review, New Drug Application, Lipoglycopeptide, Ridinilazole

With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).

Key Points: 
  • With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).
  • Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
  • RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.
  • In addition to FDA Fast Track designation, RHB-204 has been granted FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval.

RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease

Retrieved on: 
Wednesday, January 6, 2021
Life sciences, Health, Antibiotics, Pharmaceuticals policy, Fast track, Food and Drug Administration, Orphan drug, Priority review, New Drug Application, Lipoglycopeptide, Ridinilazole

With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).

Key Points: 
  • With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).
  • Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
  • RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.
  • In addition to FDA Fast Track designation, RHB-204 has been granted FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval.

SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections

Retrieved on: 
Monday, December 7, 2020
Health, Vagina, Vaginal yeast infection, Prescription Drug User Fee Act, Food and Drug Administration, Candidiasis, Antifungal, VVC, Infection, Infectious disease, Lipoglycopeptide

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 1, 2021.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 1, 2021.
  • "As the first oral, non-azole treatment for this particularly symptomatic condition, we believe ibrexafungerp has the potential to change the antifungal treatment landscape.
  • Ibrexafungerp benefits from both Qualified Infectious Disease Product (QIDP) and Fast Track designations granted by the FDA for the treatment of VVC and prevention of recurrent VVC.
  • It is currently under review by the FDA as a treatment for vaginal yeast infections and in late-stage development for multiple life-threatening fungal infections in hospitalized patients.

RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections

Retrieved on: 
Wednesday, October 14, 2020
Health, Pharmaceuticals policy, Articles, Biotechnology law, Drug discovery, Orphan drug, Food and Drug Administration, Lipoglycopeptide

Along with the QIDP designation already granted to RHB-204 by the FDA, the Orphan Drug Designation extends potential market exclusivity to a total of 12 years.

Key Points: 
  • Along with the QIDP designation already granted to RHB-204 by the FDA, the Orphan Drug Designation extends potential market exclusivity to a total of 12 years.
  • The FDAgrants orphan status to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S.
  • The Orphan Drug Designation extends U.S. market exclusivity for RHB-204 by an additional seven years, for a potential total of 12 years upon FDA approval.
  • NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure2.

Nabriva Therapeutics Granted New Technology Add-On Payment for XENLETA® (lefamulin) and CONTEPO™ (fosfomycin) by Centers for Medicare & Medicaid Services

Retrieved on: 
Thursday, September 10, 2020
Medical specialties, RTT, Medicine, Health, Antibiotics, Urinary tract infection, Food and Drug Administration, Pyelonephritis, Fosfomycin, Lipoglycopeptide

Nabriva also announced today that CMS has granted an NTAP for CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval.

Key Points: 
  • Nabriva also announced today that CMS has granted an NTAP for CONTEPO (fosfomycin), making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval.
  • CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
  • This additional payment is provided to offset some of the costs of new drugs and devices when certain criteria are met.
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.

Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injection

Retrieved on: 
Saturday, June 20, 2020
Medical specialties, Medicine, Antibiotics, Health, RTT, Epoxides, Fosfomycin, Urinary tract infection, Pyelonephritis, Infection, Lipoglycopeptide

Nabriva plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDAs plans for completing foreign facility inspections.

Key Points: 
  • Nabriva plans to request a Type A meeting with the FDA to discuss appropriate next steps and the FDAs plans for completing foreign facility inspections.
  • CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of serious infections, including cUTI.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis.