QIDP

RedHill Announces New USPTO Patent Covering Talicia® Through 2034

Retrieved on: 
Monday, March 11, 2024
QIDP, Rifabutin, Face, Patent, Patient, Amoxicillin, Regulatory affairs, Helicobacter pylori, Gastroenterology, Omeprazole, Senior, BMI, FDA, TEL, GAIN, Pharmaceutical industry

TEL AVIV, Israel and RALEIGH, N.C., March 11, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent covering Talicia1 as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori (H. pylori) infection (Patent No. 11,931,463 to be issued March 19, 20244). Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population and this patent is expected to provide protection for Talicia until February 12, 2034.

Key Points: 
  • 11,931,463 to be issued March 19, 20244).
  • Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population and this patent is expected to provide protection for Talicia until February 12, 2034.
  • "Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori.
  • Its components and formulation are optimized to provide patients with the right medications for successful H. pylori eradication with an optimized resistance profile, which is significant in the face of growing microbial resistance to clarithromycin-based regimens," said Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024
Intellectual property, Death, Clostridioides difficile infection, Patient, Research, DSM-IV codes, Hospital, Health, Urine, Dark Enlightenment, Colitis, Tuberculosis, UTI, Clostridioides difficile, DCS, Tetracycline, QIDP, Risk, Infection, Cephalosporin, Pulmonary fibrosis, Sepsis, FDA, Priority review, Penicillin, New Drug Application, Pyelonephritis, Urinary tract infection, Literature, Contra, NMDA, CNS, Pharmaceutical industry

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

CorMedix Inc. Announces Partnership With The Leapfrog Group

Retrieved on: 
Monday, December 4, 2023
Patient, Policy, Food, HIT, Risk, CVC, FDA, Kidney failure, Male, Patient safety, Health, Diabetes, Nausea, Incidence, Thrombocytopenia, Hypersensitivity, Dizziness, Death, Breastfeeding, Infection, Patient safety organization, Infant, GAIN, CLS, Safety, Organization, QIDP, Female, Heparin, Vomiting, Pharmaceutical industry

BERKELEY HEIGHTS, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.

Key Points: 
  • As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.
  • “An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix.
  • “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs).
  • Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.

Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

Retrieved on: 
Tuesday, December 5, 2023
Other Health, Research, Managed Care, Pharmaceutical, Hospitals, Clinical Trials, Science, Surgery, Biotechnology, FDA, Other Science, Health, CDTX, Lancet, NDA, Priority review, Disease, Safety, Food, Melinta Therapeutics, European Medicines Agency, Therapy, NTAP, Injection, Randomized controlled trial, QIDP, The Lancet, MAA, Mortality, Restore, EMA, Patient, Caspofungin, CHMP, Marketing, Advanced Therapy Medicinal Product, New Drug Application, CMS, MPH, Medicare, Hospital, Pharmaceutical industry, MD, Fungemia

These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.

Key Points: 
  • These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.
  • On March 22, 2023, the FDA approved REZZAYO for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
  • REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over fifteen years.
  • In October, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.

NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Monday, December 18, 2023
CNS, World Health Organization, Composition, Urinary tract infection, Dark Enlightenment, Urine, QIDP, IND, GWU, Baylor University, DCS, Nick Cuti, Learning, Hope, NMDA, Sepsis, Patient, FDA, UTI, Friends, George Washington University, Tropical medicine, Bacteria, University, Composition of matter, MD, Accenture, Engineering, Death, Failure, Microbiology, Hospital, GSK plc, Pharmaceutical industry, Urology, Immunology

"Complicated Urinary Tract Infections afflict approximately 3 million Americans each year, and pathogens have become increasingly resistant to commonly used antibiotics.

Key Points: 
  • "Complicated Urinary Tract Infections afflict approximately 3 million Americans each year, and pathogens have become increasingly resistant to commonly used antibiotics.
  • New treatment options are urgently needed" stated Jonathan Javitt, MD MPH, Founder and Chief Scientist of NRx Pharmaceuticals.
  • "The D-cycloserine (DCS) component of NRX-101 is well known as an antibiotic and is excreted unmetabolized in the urine.
  • The company awaits the FDA's response to its request for Qualified Infectious Disease Product (QIDP) designation, expected next month.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Aridis Pharmaceuticals Announces Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Friday, November 3, 2023
FDA, Research, Sale, National Institute of Allergy and Infectious Diseases, AstraZeneca, Ventilator-associated pneumonia, Antibiotic, Cystic Fibrosis Foundation, VAP, Omicron, NIAID, European Medicines Agency, OTCQB, Tenant, Development, Pharmacokinetics, Priority review, Data monitoring committee, Common stock, QIDP, Pseudomonas aeruginosa, Expense, Nature Communications, COVID-19, Cystic fibrosis, S. aureus, Emory University, EMA, Staphylococcus, Gallium, NIH, Safety, Infection, Patient, Administration, Mab, BLA, Bangladesh Technical Education Board, Respiratory tract, DSMB, ICU, Pharmaceutical industry, Vaccine, Security (finance)

LOS GATOS, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTCQB: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today reported financial and corporate results for its third quarter ended September 30, 2023.

Key Points: 
  • OTCQB companies must be current in their financial reporting and undergo an annual verification and management certification process.
  • We remain optimistic of successful outcomes from these efforts in the coming months,” commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.
  • Due to fair value option valuation of our notes payable, there was no interest expense recorded during the third quarter of 2023.
  • Other Income: Other income increased to $26,000 for the quarter ended September 30, 2023, compared to approximately $23,000 for the quarter ended September 30, 2022.

MannKind Expands Patent Portfolio With New Clofazimine Formulation Patent

Retrieved on: 
Monday, October 30, 2023
FDA, Prevalence, Infection, United States Patent and Trademark Office, Cough, Environment, QIDP, Lung, Quality of life, MannKind Corporation, Disease, Risk, Doctor of Pharmacy, Bacteria, Urinary tract infection, Clofazimine, Woman, Patient, NTM, Fatigue, Pharmaceutical industry, Patent

11,793,808) issued by the United States Patent and Trademark Office covering clofazimine inhalation suspension (MNKD-101), which is under development for the potential treatment of nontuberculous mycobacterial (NTM) lung disease.

Key Points: 
  • 11,793,808) issued by the United States Patent and Trademark Office covering clofazimine inhalation suspension (MNKD-101), which is under development for the potential treatment of nontuberculous mycobacterial (NTM) lung disease.
  • The patent will expire on June 8, 2039.
  • “We believe this patent represents important protection for our lead pipeline asset, MNKD-101, that could potentially improve therapy for a disease that is increasingly on the rise globally,” said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation.
  • “Patients living with NTM typically rely on a series of drug treatments that often may be associated with severe side effects.

Basilea announces acquisition of novel clinical-stage antifungal for treatment of Aspergillus mold infections

Retrieved on: 
Thursday, October 19, 2023
FDA, Isavuconazonium, Gravitas, US Foods, Safety, I.V. (song), QIDP, LR, USD, Therapy, Patient, Infection, Pharmaceutical industry, Aspergillus, Allschwil

David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.
  • Based on its novel mechanism of action which results in rapid fungicidal activity in vitro, BAL2062 could become a valuable treatment option against difficult-to-treat invasive mold infections.
  • To define the optimal positioning and the most efficient clinical development path, we will initiate a focused preclinical profiling program.
  • In addition, Basilea will pay tiered royalties on sales starting in the low single-digit percentage range, going to the mid-single-digit percentage range.

Melinta Therapeutics Announces Expanded Reimbursement and Access for REZZAYO™ (rezafungin for injection)

Retrieved on: 
Monday, October 2, 2023
Health, FDA, Hospitals, Surgery, Managed Care, Pharmaceutical, Biotechnology, Priority review, Centers for Medicare & Medicaid Services, CMS, NTAP, IV, QIDP, Food, Candidiasis, Fungemia, Medicare, Hospital, Patient, Physician, Injection, Echinocandin, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Pharmaceutical industry, Health insurance, Melinta Therapeutics

Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced expanded reimbursement and access for REZZAYO™ (rezafungin for injection).

Key Points: 
  • Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced expanded reimbursement and access for REZZAYO™ (rezafungin for injection).
  • “These two important milestones will help facilitate access to this innovative treatment option in both inpatient and outpatient settings.
  • Last year, Melinta acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics.
  • “This is another opportunity for Melinta to deliver on our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”