FDASIA

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

Retrieved on: 
Friday, September 22, 2023
Priority review, Food and Drug Administration Safety and Innovation Act, Innovation Act, IV, Prevalence, Amputation, Diabetes, QIDP, Methicillin, S. aureus, Methicillin-resistant Staphylococcus aureus, Infection, Act, MRSA, NDA, Fast Track, Osteomyelitis, ABSSSI, GAIN, Diabetic foot infection, Patient, Ulcer, Disease, DFI, Mortality, Toxic shock syndrome, Bacteria, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, Food, Pharmaceutical industry, FDASIA

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.

Key Points: 
  • Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.
  • Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA).
  • "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations."

Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation

Retrieved on: 
Wednesday, July 12, 2023
China Biologic Products, Biologics license application, Drug development, Food and Drug Administration Safety and Innovation Act, Innovation Act, QIDP, CAP, Infection, Omnibus spending bill, S, AMR, Staphylococcus, GAIN, Patient, Immunoglobulin G, VAP, Mab, Consolidated Appropriations Act, 2022, LOS, ICU, Saleh al Aridi, HAP, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Pneumonia, Food, Pharmaceutical industry, FDASIA

"Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.

Key Points: 
  • "Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.
  • This sought-after designation positions our AR-301 program extremely well as we continue to advance it through a confirmatory Phase 3 trial and license application."
  • AR-301 specifically targets S. aureus alpha-toxin, which has been implicated in the pathogenesis of pneumonia caused by S. aureus bacteria.
  • Aridis received positive feedback from the FDA in May 2023 on the Company's proposed single confirmatory Phase 3 study of AR-301.

Pharmaceutical Excipients Global Market Report 2022-2029: Source, Products, Functionality, and Dosage Forms Analysis & Forecasts - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 7, 2023
Health, Pharmaceutical, Therapy, Incidence, QBD, Growth, US, GDP, US FDA, Certification, ICH, Civil Rights Act of 1964, Excipient, Investment, GMP, FDA, Administration, FDASIA, Safety, WHO, PDG, Generic drug

The pharmaceutical excipients global market is expected to grow at mid single-digit CAGR from 2022 to 2029 to reach $15,439.6 million by 2029.

Key Points: 
  • The pharmaceutical excipients global market is expected to grow at mid single-digit CAGR from 2022 to 2029 to reach $15,439.6 million by 2029.
  • The pharmaceutical excipients market is segmented based on source, products, functionality, and dosage forms.
  • EXCiPACT is a pharmaceutical excipients certification scheme to provide independent third-party certification of manufacturers, suppliers, and distributors of pharmaceutical excipients worldwide.
  • The pharmaceutical excipients global market is highly competitive hence all the existing players in this market are involved in developing new and advanced therapeutics to maintain their market shares.