Bronchopulmonary dysplasia

Orphan designation: Azithromycin dihydrate Prevention of bronchopulmonary dysplasia, 14/01/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Diagnosis, Civil service commission, Bronchopulmonary dysplasia, Ureaplasma urealyticum infection, BPD, Prevalence, Protein, Disease, Infection, Clinical, Inflammation, Patient, Committee, Bacteria, EMA, IRIS, Update, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the prevention of bronchopulmonary dysplasia in the European Union on 14 January 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Real-World Data on Human Milk-Based Fortification Reveals Limitations of Protocol Designs of Two RCTs

Retrieved on: 
Tuesday, February 6, 2024
Growth, Mortality, Bronchopulmonary dysplasia, Hospice and palliative medicine, NEC, Standard of care, BPD, NICU, Disease, Patient, Incidence, Sepsis, RCT, Clinical study design, Isabella Tree, BMBF, Risk, Exclusive, Vulnerable, FAAP, Birth weight, Standard, Necrotizing enterocolitis, Gestational age, Hospital, Dietary supplement

DUARTE, Calif., Feb. 6, 2024 /PRNewswire/ -- Optimizing nutrition for premature infants remains an important focus in neonatal care. More than 20 peer-reviewed studies of 5,000+ preterm infants demonstrated that, compared to bovine milk-based fortifiers (BMBF), Prolacta Bioscience's human milk-based fortifiers (HMBF) improve growth and development1-7 and provide clinically significant reductions in comorbidities.1,2,8-20 The health benefits from the use of HMBF have also shown significant annual cost savings for hospitals.8 More than 100,000 critically ill and preterm infants have received Prolacta's human milk-based nutritional products.21

Key Points: 
  • While the RCTs were intended to provide a head-to-head comparison between fortifier products, the feeding protocols fundamentally differed.
  • HMBF recommendations for best outcomes regarding the day fortification should begin and the speed at which feeds are advanced were not followed in either study.
  • Given these known risks, randomizing extremely premature infants to day-one fortification with BMBF would unjustly endanger this vulnerable patient population.
  • Extensive real-world data affirm EHMD adoption enables critical health improvements for premature infants and major cost reductions for hospitals.

Chiesi Group and Oak Hill Bio announce License and Development Agreement to develop, manufacture, and commercialize OHB-607, a potentially transformative neonatal therapy

Retrieved on: 
Tuesday, January 9, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Development, Guggenheim Partners, BPD, Mother, Neonatology, Gestational age, Place of birth, License, Risk, Disease, Premature, Bronchopulmonary dysplasia, Pharmaceutical industry

OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of fetal growth and development, and its binding protein, IGFBP-3.

Key Points: 
  • OHB-607 is a recombinant version of insulin-like growth factor-1 (IGF-1), a key driver of fetal growth and development, and its binding protein, IGFBP-3.
  • For the developing fetus, mothers are the primary source of IGF-1.
  • Clinical studies conducted to date have demonstrated OHB-607’s potential to significantly reduce the risk of severe BPD1.
  • Their deep expertise in neonatology will help to rapidly advance this promising therapy to patients.”
    Guggenheim Securities LLC acted as exclusive financial advisor to Oak Hill Bio and Goodwin Procter LLP served as its legal advisor.

Prolacta's Human Milk-Based Nutrition Has Touched the Lives of 100,000 Premature and Critically Ill Infants Globally

Retrieved on: 
Friday, November 17, 2023
Hospice and palliative medicine, Necrotizing enterocolitis, Disease, Premature, NICU, Pediatrics, Medical Center, BPD, Prenatal care, Neonatology, Mortality, ROP, Monica E. Peek, Place of birth, Retinopathy, Division, Health, Bronchopulmonary dysplasia, Exclusive, MD, Mother, Death, Extrapyramidal system, Hospital, Singing, NEC, Dietary supplement, Nursing, Birth control

DUARTE, Calif., Nov. 17, 2023 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, proudly commemorates Prematurity Awareness Month 2023 by announcing a significant milestone: more than 100,000 preterm and critically ill infants' lives have been touched by Prolacta's Exclusive Human Milk Diet (EHMD) in hospitals worldwide.1

Key Points: 
  • "We're proud that for more than two decades, Prolacta's 100% human milk-based nutritional products have supported hospitals on the forefront of progressive care to help so many fragile infants in need."
  • The Peeks advocated for Leah Michelle to be on an EHMD and asked the hospital to fortify Brandi's breast milk with a Prolacta fortifier.
  • All types of hospitals have seen the benefits of an EHMD to treat the critically ill, premature infants in their care, including those supporting underserved populations.
  • One example is Los Angeles General Medical Center (formerly LAC+USC Medical Center), among the largest public hospitals in the U.S.

Prolacta Bioscience Recognizes Advances in Preterm Care During NICU Awareness Month

Retrieved on: 
Tuesday, September 19, 2023
Breast Cancer Awareness Month, University, Pediatrics, BPD, NICU, Hospital, Late preterm infant, VLBW, Nicu Ceaușescu, Infant, Retinopathy, Premature, Risk, Master of Science, BioMed Central, ROP, Intensive care unit, Heart rate, Health, Bronchopulmonary dysplasia, NEC, Dairy, Birth control, Health insurance, MD

DUARTE, Calif., Sept. 19, 2023 /PRNewswire/ -- There have been incredible breakthroughs in neonatal care over the last decade, with premature infants born as early as 22 weeks now surviving and thriving. From heart rate monitoring to lung therapies, one of the biggest changes in the NICU has been how these fragile, premature infants are fed. This Neonatal Intensive Care Unit (NICU) Awareness Month, Prolacta Bioscience® recognizes how proper care, including critical nutrition in the NICU — with 100% human milk-based nutrition — has improved the health and well-being of preterm infants.

Key Points: 
  • From heart rate monitoring to lung therapies, one of the biggest changes in the NICU has been how these fragile, premature infants are fed.
  • This Neonatal Intensive Care Unit (NICU) Awareness Month, Prolacta Bioscience ® recognizes how proper care, including critical nutrition in the NICU — with 100% human milk-based nutrition — has improved the health and well-being of preterm infants.
  • Today, the world's leading clinicians and NICUs offer Prolacta's human milk-based nutritional products as the standard of care because they have been shown to reduce some of the most serious complications of prematurity.
  • "NICU Awareness Month reminds us to take a step back and reflect upon how far we've come in neonatal care over the last decade.

Global Enteral Feeding Formulas Market Trends Analysis Report 2023-2030: Advancements in Disease-Specific Formulas Drive Enteral Feeding Market - ResearchAndMarkets.com

Retrieved on: 
Friday, August 18, 2023
Health, Medical Supplies, Medical Devices, Bronchopulmonary dysplasia, Medicaid, Drug development, BPD, Prevalence, Diabetes, Malnutrition, Late preterm infant, NCBI, NPO Splav, Cancer, Nutrient, HEN, USD, Movement, Patient, Non-governmental organization, Risk, Treatment, Child, UN, Preterm birth, Immune system, Cystic fibrosis, ROP, Conditional sentence, Growth, ASPEN, Retinopathy, Liver failure, Retail, Dietary supplement, Premature

The "Enteral Feeding Formulas Market Size, Share & Trends Analysis Report By Product, By Flow Type, By Stage, By Indication, By End-user, By Sales Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Enteral Feeding Formulas Market Size, Share & Trends Analysis Report By Product, By Flow Type, By Stage, By Indication, By End-user, By Sales Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global enteral feeding formulas market size is expected to reach USD 10.5 billion by 2030, expanding at 5.5% CAGR from 2023 to 2030
    Increasing incidences of targeted diseases and advancements in drug development are expected to drive the demand for disease-specific formulas.
  • Clinical nutrition is increasingly used for the personalized treatment of diseases, such as cancer and cystic fibrosis.
  • Standard formula was the largest product segment, accounting for 57.0% of the market share in 2022, in terms of revenue.

Advent Therapeutics Receives FDA Rare Pediatric Disease Designation for Retinol Palmitate for Prevention of Bronchopulmonary Dysplasia in Premature Infants

Retrieved on: 
Thursday, July 20, 2023
Bronchopulmonary dysplasia, Place of birth, BPD, Marketing, Food and Drug Administration, NDA, Vitamin A, EMA, Orphan drug, European, Advent, FDA, Therapy, US FDA, Food, New Drug Application, Pharmaceutical industry

FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases.

Key Points: 
  • FDA’s Rare Pediatric Disease Designation and Priority Voucher Program is intended to facilitate the development of new drugs for the prevention and treatment of rare pediatric diseases.
  • This program is intended to encourage the development of new drugs and biologics for the treatment of rare pediatric diseases.
  • “We are acutely focused on BPD as an area of high unmet medical need that presently has no FDA-approved therapies for prevention or treatment.
  • The FDA Rare Pediatric Disease Designation is an important addition to the Orphan Drug designations previously granted by the US FDA and the European EMA for our vitamin A metabolic and reparative respiratory drugs,” said Dave L. Lopez, CEO of Advent Therapeutics.

Lundquist Institute Investigator Dr. Virender Rehan and Advent Therapeutics Awarded $3 Million NIH Small Business Innovation Research Grant for Life-saving Premature Infant Research

Retrieved on: 
Tuesday, July 18, 2023
National Center for Advancing Translational Sciences, David Geffen School of Medicine at UCLA, Bronchopulmonary dysplasia, Place of birth, Pediatrics, SBIR, Eye, National Heart, Lung, and Blood Institute, NCATS, Vitamin A, Lung, Bangladesh Technical Education Board, NHLBI, Patient, Division, Orphan, UCLA, Therapy, NIH, Pharmaceutical industry, Nursing, EU, BPD, Advent, Neonatology

The funding will directly support the groundbreaking work of Dr. Rehan Virender, which focuses on developing a first-of-its-kind aerosolized vitamin A formulation.

Key Points: 
  • The funding will directly support the groundbreaking work of Dr. Rehan Virender, which focuses on developing a first-of-its-kind aerosolized vitamin A formulation.
  • This innovative treatment aims to counteract Bronchopulmonary Dysplasia (BPD), a life-threatening condition affecting premature infants, with an eye towards commercialization by 2025.
  • Each year, BPD, the leading severe complication in premature infants, impacts an estimated 20,000-30,000 newborns in the United States.
  • The aerosolized vitamin A therapy under development by Dr. Rehan and Advent Therapeutics represents a pivotal advancement in neonatal care.

Advent Therapeutics Awarded $3 Million NIH Grant for Novel Neonatal Lung Therapy

Retrieved on: 
Tuesday, July 18, 2023
National Center for Advancing Translational Sciences, Institute of Health and Biomedical Innovation, Bronchopulmonary dysplasia, Disease, BPD, Marketing, SBIR, Biotechnology, National Heart, Lung, and Blood Institute, NCATS, Vitamin A, Research, Lung, National Institutes of Health, Bangladesh Technical Education Board, Infant, NHLBI, Division, Risk, Small Business Innovation Research, Orphan, Mortality, UCLA, Therapy, Harbor–UCLA Medical Center, NIH, Neonatal intensive care unit, Family, David Geffen School of Medicine at UCLA, Pharmaceutical industry, EU, Pediatrics, Neonatology, Medicine

DOYLESTOWN, Pa., July 18, 2023 (GLOBE NEWSWIRE) -- Advent Therapeutics, Inc., a biotechnology company pioneering an optimized retinol palmitate (vitamin A) drug product as a breakthrough non-invasive inhaled neonatal lung therapy, has been awarded a $3 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB grant.

Key Points: 
  • DOYLESTOWN, Pa., July 18, 2023 (GLOBE NEWSWIRE) -- Advent Therapeutics, Inc., a biotechnology company pioneering an optimized retinol palmitate (vitamin A) drug product as a breakthrough non-invasive inhaled neonatal lung therapy, has been awarded a $3 million National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Phase IIB grant.
  • This grant allows the Company to position its novel aerosolized vitamin A formulation for commercialization in 2025 to prevent Bronchopulmonary Dysplasia (BPD).
  • With this grant, the Company has now received in excess of $6 million from NIH for its neonatal programs.
  • Dr. Virender continued, “I am extremely pleased to be involved in developing Advent’s novel form of inhalable vitamin A therapy.

New Study Shows Prolacta's Human Milk-Based Nutritional Fortifiers Save Hospital NICUs Up to $3.4M Annually

Retrieved on: 
Tuesday, June 27, 2023
Hospice and palliative medicine, Exclusive, University, Pediatrics, BPD, NICU, Late preterm infant, VLBW, Retinopathy, Hospital, Premature, Master of Science, BioMed Central, ROP, Infant, Bronchopulmonary dysplasia, NEC, Nursing, Birth control, Health insurance, MD

DUARTE, Calif., June 27, 2023 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced a peer-reviewed report demonstrating significant annual cost savings that ranged from $500,000 to $3.4 million per hospital after the implementation of Prolacta's Exclusive Human Milk Diet (Prolacta's EHMD) for preterm infants in the neonatal intensive care unit (NICU).

Key Points: 
  • DUARTE, Calif., June 27, 2023 /PRNewswire/ -- Prolacta Bioscience , the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today announced a peer-reviewed report demonstrating significant annual cost savings that ranged from $500,000 to $3.4 million per hospital after the implementation of Prolacta's Exclusive Human Milk Diet (Prolacta's EHMD) for preterm infants in the neonatal intensive care unit (NICU).
  • NICU leaders from seven U.S. hospitals varying in size, geographic setting, patient population, and funding levels contributed to the publication in BMC Pediatrics titled "Implementing an Exclusive Human Milk Diet for Preterm Infants: Real-World Experience in Diverse NICUs."
  • The study found:
    Of the five hospitals reporting financial data, all realized significant cost avoidance after implementing Prolacta's EHMD, with savings ranging from $515,113 to $3,369,515 per institution annually from a reduction in comorbidities and shorter lengths of stay among very low birth weight (VLBW) infants.1
    Implementation of Prolacta's EHMD resulted in a reduction in the total (medical and surgical) necrotizing enterocolitis (NEC) rate, regardless of the size or level of care of the NICU, as well as reductions in bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), and late-onset sepsis — all common complications of prematurity.1
    VLBW infants fed Prolacta's EHMD also experienced shorter NICU stays at five of the seven hospitals, savings ranging from $307,916 to $2,520,000 per institution annually.1
    The study emphasizes that the cost of Prolacta's EHMD represents a fraction of the usual cost of care for a VLBW infant — approximately $12,500 per infant for an EHMD over a 90-day NICU stay, compared to a total NICU cost of $693,000 to $774,000 for 90 days, depending on level of care.2,3
    "This study provides real-world evidence that an EHMD is not only effective in reducing comorbidities in very preterm infants but also saves money regardless of the institution's size or level of care," said lead author Jonathan R. Swanson, MD, MSc, of the University of Virginia Children's Hospital in Charlottesville.