Pediatric Trials Network

Shionogi Advances Ensitrelvir Fumaric Acid COVID-19 Antiviral Clinical Program

Retrieved on: 
Wednesday, February 15, 2023
Health, COVID-19, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ministry of Health (Saudi Arabia), MHLW, AIDS Clinical Trials Group, Epidemic, Standard of care, SARS-CoV-2, Therapy, Urinary tract infection, ACTIV, World Health Organization, Diagnosis, Bangladesh Technical Education Board, NIH, Safety, Patient, Pediatric Trials Network, Ensitrelvir, HIV, Medicines Patent Pool, Ministry, Risk, WHO, NIAID, ACTG, Head, Partnership, Generic, Ministry of Health, Labour and Welfare, AIDS, Public, Prevalence, Infection, Developing country, Pharmaceutical industry, Vaccine, Shionogi

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • The program includes several Phase 3 clinical studies evaluating ensitrelvir’s safety and effectiveness across a wide range of COVID-19 patient populations.
  • Ensitrelvir is the first drug to be evaluated in the STRIVE program, a new agile research approach set up to rapidly assess interventions during epidemics adversely affecting public health.
  • Pediatric Trial: Shionogi plans to initiate a Phase 3 pediatric study evaluating the safety and effectiveness of ensitrelvir for children ages 6-12 in Japan, starting in early 2023.

Ocuphire Provides Corporate Update: Announcing Enrollment Completion of Phase 3 Nyxol Trial, Enrollment Initiation of Nyxol Pediatric Trial, and an Investor R&D Day in January

Retrieved on: 
Wednesday, January 5, 2022
Lists of people executed in the United States, Safety, COVID-19, Vision, Retina, Internet, Diabetic retinopathy, DR, Optometry, Founder, Review, Panel discussion, Patient, Neurotransmission, Landscape, Year, Gender equality, Pupil, Presbyopia, DLD, Risk, Pediatric Trials Network, GLARE, Private Securities Litigation Reform Act, CEO, NASDAQ, MBA, OCUP, SEC, Pediatrics, FDA, NVD, GLOBE, Mitchell Jackson, Host, Nasdaq, GlobalData, Maintenance, Light, DME, Night vision, NDA, Pharmaceutical industry, Online gambling, Mydriasis, Reversal, RM

This update includes recent progress on Nyxol trials, the Companys cash position, and the announcement of an Investor R&D day in late January.

Key Points: 
  • This update includes recent progress on Nyxol trials, the Companys cash position, and the announcement of an Investor R&D day in late January.
  • A positive outcome in MIRA-3 will position us to submit an NDA for Nyxol for RM in late 2022.
  • We look forward to providing clinical updates on Nyxol in presbyopia and RM as well as APX3330 in diabetic retinopathy at our upcoming Virtual Investor R&D Day.
  • Completed Enrollment of LYNX-1 Study in Night Vision Disturbances: Enrollment has been completed in the LYNX-1 Phase 3 clinical trial investigating Nyxol for the treatment of NVD.

Emmes Study Leads to Pediatric Drug Labeling Change for Ampicillin

Retrieved on: 
Tuesday, January 21, 2020
Health, Articles, Clinical research, Pharmaceutical industry, Pharmaceuticals policy, Clinical trials, Food and Drug Administration, Pharmacovigilance, Ampicillin, Pediatric Trials Network

FDA's approval was based in part on a National Institute of Child Health and Human Development (NICHD)-funded study , conducted under the Best Pharmaceuticals for Children Act (BPCA).

Key Points: 
  • FDA's approval was based in part on a National Institute of Child Health and Human Development (NICHD)-funded study , conducted under the Best Pharmaceuticals for Children Act (BPCA).
  • Emmes provided full-service data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses for the ampicillin study, and facilitated the study protocol design.
  • Emmes is in the third year of a 10-1/2 year contract supporting pediatric clinical trials aimed at improving the labeling of drugs for pediatric use.
  • Ampicillin is one of the newest drug labeling changes resulting from study data submitted to and approved by the FDA, and it represents another step forward in helping doctors safely prescribe medication to their youngest patients."

Emmes Studies Contribute to FDA Approval of a Medical Device That Estimates the Weight of Infants

Retrieved on: 
Monday, January 6, 2020
Food and Drug Administration, United States Public Health Service, Health, Articles, Pediatric Trials Network

Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments.

Key Points: 
  • Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments.
  • This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries.
  • Emmes coordinated operations and analyzed the data from the NIH-funded studies for the original Mercy TAPE devices, which are used in children ages 2-16 years.
  • These were the first weight estimation devices developed under the BPCA program and the first weight estimation devices to be cleared by the FDA.

Data to be Highlighted at the American Society of Hematology 2019 Annual Meeting

Retrieved on: 
Thursday, December 5, 2019
Health, Drugs, Breakthrough therapy, Monoclonal antibodies, Hemophagocytic lymphohistiocytosis, Histiocytosis, Emapalumab, Food and Drug Administration, Pediatric Trials Network, Phases of clinical research

The adaptive design of a study evaluating the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH will be presented.

Key Points: 
  • The adaptive design of a study evaluating the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH will be presented.
  • The initial phase will enrol 10 adult patients and the study is expected to open later this year.
  • The latest clinical data and ongoing trials with the potential to impact the care of patients with HLH will also be reviewed.
  • The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).

Innovation Pharmaceuticals Clinical Trial of Oral Brilacidin in Ulcerative Colitis Program Expected to Commence in December; Top-Line Data in Q1 2020

Retrieved on: 
Thursday, October 3, 2019
Health, Chemical compounds, Medical research, Clinical research, Design of experiments, Pyrrolidines, Pharmaceutical industry, Brilacidin, Guanidines, Clinical trial, Pediatric Trials Network

Document submissions are expected to be completed early in October, keeping the clinical trial on track for commencement in December.

Key Points: 
  • Document submissions are expected to be completed early in October, keeping the clinical trial on track for commencement in December.
  • Assessments will include the safety, toleration, pharmacokinetics of Brilacidin, and whether it is being dispersed directly in the colon.
  • An expedient clinical trial, dosing of all cohorts is expected to be completed within three weeks of commencement.
  • We look forward to providing more details on the planned Phase 1 trial of oral Brilacidin in the near future.

Emmes-Supported Study Results in the First Pediatric Drug Labeling Change for 2019

Retrieved on: 
Tuesday, April 2, 2019
RTT, Infectious diseases, Biology of bipolar disorder, Herpes simplex, Aciclovir, Medical specialties, Organ systems, Pediatric Trials Network

In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: "With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients."

Key Points: 
  • In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: "With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients."
  • The Herpes Simplex Virus in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.
  • One of its goals involves conducting clinical trials and research for on- and off-patent drug products meriting further study for children.NICHD activities are aimed at improving pediatric drug therapies through preclinical and clinical testing that lead to drug labeling change.
  • Acyclovir is the first BPCA drug labeling change in 2019, and others are likely to follow.

Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients

Retrieved on: 
Monday, March 18, 2019
Ceftazidime/avibactam, Pediatrics, Pediatric Trials Network

This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade.

Key Points: 
  • This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade.
  • Across the trials, 128 pediatric patients 3 months to less than 18 years of age were treated with AVYCAZ.
  • Overall, the findings from the pediatric studies were similar to the previous determination of safety for AVYCAZ for the treatment of adult patients with cIAI or cUTI, and no new safety concerns were identified in pediatric patients.
  • The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared to meropenem-treated patients.