On June 17, 2021, representatives from PWSA | USA, FPWR and experts in the field of Prader-Willi syndrome research met with the FDA’s Center for Drug Evaluation and Research to discuss issues related to PWS clinical trials. The purpose of this meeting was to promote dialogue between PWSA | USA, FPWR and members of the...
On behalf of Radius Health, Inc: Boston, Mass., July 22, 2021 — Radius Health, Inc. announced Wednesday, July 21, 2021 that it has recently received the written meeting minutes from a June Type C meeting held with the U.S. Food and Drug Administration (FDA) regarding RAD011, a synthetic cannabidiol oral solution. RAD011 is initially to...
More than $3 billion in funding is set to be dispersed to schools around the country to meet the needs of students with disabilities after the fallout from COVID-19. Some of the funding will be used to support:Special Education programs for students between 3- and 21-years-oldPreschool offerings, specifically for infants and toddlers with disabilities
Rare Disease Week will take place July 14, 2021 – July 22, 2021 and it’s a chance to make your voice heard! EveryLife Foundation will be leading Rare Disease Week, which educates those of the rare disease community on federal legislative issues, meet other advocates, and share their unique stories with legislators. If you are...
FDA agrees to review additional data to determine adequacy for submission of NDA Soleno Therapeutics, Inc. provided an update on Tuesday, July 7, 2021 following a recent interaction with the FDA regarding the development of DCCR, a potential treatment for PWS. According to Soleno Therapeutics, on July 2, 2021 they received news from The FDA,...
Read Levo Therapeutic, Inc.’s Full Article HERE. CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for review and...
On June 17, 2021, PWSA | USA and FPWR held a Patient Listening Session with the FDA to share our community’s experiences related to Prader-Willi syndrome (PWS). The purpose of this meeting was to promote dialogue between the FDA and members of the PWS patient community to ensure the FDA has a full understanding of...
We are pleased to announce that Dr. Moris Angulo M.D. has opened a new clinic, located in Bablyon, NY, and is accepting patients. Location: Center for Pediatric Specialty Care, 655 Deer Park Avenue, Babylon, NY 11702 To schedule an appointment, call 631-321-2100 ——————————————– Moris A. Angulo, M.D., was born in El Salvador, Central América and...
We request the flexibility afforded to other orphan indications when considering whether applications for treatments for PWS should be accepted for review. In a continuation of our joint advocacy efforts supporting the full review of potential drugs for PWS, FPWR and PWSA | USA have submitted a petition letter to the FDA requesting that they...
Click Here to View and Download Harmony Biosciences’ PWS Trial Infographic
FOR IMMEDIATE RELEASE: January 14, 2021 Sarasota, Florida: Prader-Willi Syndrome Association | USA (PWSA | USA) is pleased to announce its upcoming 36th National Convention is moving to an all-new virtual format. Due to the ongoing health concerns brought forth by the COVID-19 pandemic, the organization will provide members of the Prader-Willi syndrome community with a variety...
Rhythm Pharmaceuticals Inc., a company developing medicines for rare genetic disorders of obesity, has won FDA approval for its first product, Imcivree (setmelanotide), following a priority review. The drug is designed to restore a biological pathway that, when disrupted, can lead to constant hunger. The approval covers the treatment of three types of ultrarare early...
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.