cDC recommends updated covid-19 vaccine
CDC Recommends Updated COVID-19 Vaccine for Fall/Winter Virus Season: https://www.cdc.gov/media/releases/2023/p0912-COVID-19-Vaccine.html
announcement from neurocrine biosciences
September 12, 2023
Neurocrine Biosciences Announces Positive Top-Line Data from Phase 3 Study of Crinecerfont in Adults for the Treatment of Congenital Adrenal Hyperplasia (CAH). Follow link: https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-positive-top-line-data-phase-3
Neurocrine Biosciences Announces Positive Top-Line Data from Phase 3 Study of Crinecerfont in Adults for the Treatment of Congenital Adrenal Hyperplasia (CAH). Follow link: https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-announces-positive-top-line-data-phase-3
nadf leadership update
August 2023
Acknowledging that both the Executive Director and Board President roles are pivotal to the success, growth and future of NADF, we are pleased to share an exciting change in our leadership. Each of the aforementioned positions requires unique responsibilities, expertise, and leadership qualities. By shifting roles within our leadership team this August, we aim to create an even more dynamic and interconnected structure that leverages the strengths of the individuals involved.
Erin Foley-Moudry and Kalina Warren have served as Co-Presidents of the Board of Directors for the past few years, with Lori Engler at the helm of the day-to-day operations in the role of Executive Director. As a triad, this team has a unique chemistry and has found great success in working together. We intend to continue doing just that—with some role shifts to better meet the needs of NADF and its community.
Acknowledging that both the Executive Director and Board President roles are pivotal to the success, growth and future of NADF, we are pleased to share an exciting change in our leadership. Each of the aforementioned positions requires unique responsibilities, expertise, and leadership qualities. By shifting roles within our leadership team this August, we aim to create an even more dynamic and interconnected structure that leverages the strengths of the individuals involved.
Erin Foley-Moudry and Kalina Warren have served as Co-Presidents of the Board of Directors for the past few years, with Lori Engler at the helm of the day-to-day operations in the role of Executive Director. As a triad, this team has a unique chemistry and has found great success in working together. We intend to continue doing just that—with some role shifts to better meet the needs of NADF and its community.
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Lori Engler (currently NADF’s Executive Director) will become NADF Board Co-President. In this role she will focus on Governance and Board Management and Financial Oversight. Lori has demonstrated exceptional leadership and strategic vision, playing a crucial role in the foundation's tremendous growth and achievements over the last several years. Her experience in managing the organization's operations and programs have been invaluable, and she will continue to maintain a focus in these areas and on NADF’s financial management, but from a Board perspective. She has also been instrumental in fostering collaborations with key leaders in Pharma, Medical Associations and with other adrenal disease organizations. Specifically, Lori’s work to create a new international consortium has strengthened NADF’s relationships with adrenal disease patient organizations all over the globe.
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Erin Foley-Moudry will continue in her role as Co-President, working closely with Lori to lead the NADF Board. In this role, Erin will continue to have a strong focus on Strategic Planning and External Communications Oversight. Erin’s energy and her contributions—based on 20+ years of healthcare industry and life sciences marketing communications experience—will continue to make a make an impactful difference for the organization.
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Kalina Warren (currently Co-President of the NADF Board) will become NADF’s Executive Director. Kalina recently retired from her career as an Environmental Administrator at The Florida Department of Environmental Protection, allowing her to dedicate more of her time to NADF. Kalina will lead the day-to-day operations for NADF, with an additional special focus on Adrenal Research and Government/FDA Relations. Even with a full-time career, Kalina has shown tremendous dedication to the foundation's mission for more than a decade. Her leadership of the Board of Directors, has enabled the development of strong relationships with stakeholders, and has made a significant impact on our organization. As Co-President, she has been instrumental in raising awareness, expanding our network, and fostering collaborations with medical professional organizations, researchers, and key leaders in the adrenal disease community.
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After careful consideration and approval of the Board, these changes will become effective in August 2023. As a leadership team, we believe these changes will bring new perspectives, fresh ideas, and enhanced collaboration along with improved efficiencies within our organization. We also strongly believe that this restructure will invigorate our staff and volunteers, and offer NADF stronger—and more dynamic—leadership through the combined expertise, passion, and dedication of Lori, Erin and Kalina. We look forward to continuing drive the success of The National Adrenal Diseases Foundation forward, together.
recreating the adrenal gland in a petri dish
Read about this important study that could lead to new therapies for adrenal insufficiencies and a deeper understanding of the genetics of such disorders. https://penntoday.upenn.edu/news/penn-vet-recreating-adrenal-gland-petri-dish
IMPORTANT AUTOINJECTOR STUDY SPONSORED BY HALOZYME*
*Halozyme is not involved in the patient recruitment process.
NADF is sharing this important request to those with adrenal insufficiency. See details here
NADF is sharing this important request to those with adrenal insufficiency. See details here
antares pharma announces positive result from phase i study for auto-injector
JANUARY 12, 2022
Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. See Antares Pharma's full press release here.
Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. See Antares Pharma's full press release here.
Pediatric Adrenal Insufficiency Action Plan with Pictograms
Health information related to adrenal insufficiency can seem unfamiliar and complicated. Instructions can seem overwhelming to caregivers and are often presented in ways that make it difficult to understand and act on. That’s why NADF was excited to support the work of Dr. Patrick Reeves at the Walter Reed National Military Medical Center. Dr. Reeves desire was to improve pediatric adrenal insufficiency literacy using pictograms and he enlisted NADF to help the effort.
The objective of the tool is to improve the ability for parents and clinicians to fully comprehend and take appropriate medical action for children with adrenal insufficiency. The new Action Plan tool and video instructions can be viewed here the full article below.
The objective of the tool is to improve the ability for parents and clinicians to fully comprehend and take appropriate medical action for children with adrenal insufficiency. The new Action Plan tool and video instructions can be viewed here the full article below.
nadf meeting with fda
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July 12, 2021
We are an adrenal disease community bonded by our shared experiences, and finally, the US Food and Drug Administration (FDA) had a chance to hear about it. Organized by Lori Engler, NADF Executive Director, the session described topics that are most important to the community. The presentation was conducted by several NADF leaders to educate and bring awareness to these topics, clearly explain how they affect our community and to suggest solutions.
Patient Listening Sessions help the FDA understand what is important to patients, caregivers, and advocates when medical products are being developed. The format was a one-hour discussion designed to help those involved in the drug approval process understand the obstacles and unmet needs of patients with adrenal insufficiency.
Here's a summary of topics discussed during NADF’s meeting with the FDA. For each topic, NADF discussed possible solutions, including immediate needs: Modified release hydrocortisone options, Autoinjector for hydrocortisone, and better protection of life-preserving medications to prevent shortages.
According to the FDA, “Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients for their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.” The FDA hopes to better understand the burdens that diseases and treatments have on our daily lives and to learn what is important for our community.
This was a strong starting point and a very important new direction for NADF. Just a couple of days after the meeting the FDA shortage database was updated…a positive sign that they really were listening.
We are an adrenal disease community bonded by our shared experiences, and finally, the US Food and Drug Administration (FDA) had a chance to hear about it. Organized by Lori Engler, NADF Executive Director, the session described topics that are most important to the community. The presentation was conducted by several NADF leaders to educate and bring awareness to these topics, clearly explain how they affect our community and to suggest solutions.
Patient Listening Sessions help the FDA understand what is important to patients, caregivers, and advocates when medical products are being developed. The format was a one-hour discussion designed to help those involved in the drug approval process understand the obstacles and unmet needs of patients with adrenal insufficiency.
Here's a summary of topics discussed during NADF’s meeting with the FDA. For each topic, NADF discussed possible solutions, including immediate needs: Modified release hydrocortisone options, Autoinjector for hydrocortisone, and better protection of life-preserving medications to prevent shortages.
- Topic I: How can the FDA help create significant drug innovation in the management of adrenal insufficiency? How can we place a higher priority on new adrenal insufficiency treatments given patients’ lower quality of life and higher mortality rates?
Novel modified-release hydrocortisone preparations are available in Europe and have been shown to improve quality of life, improve innate immunity responses, lead to weight reduction, and reduce hemoglobin. NADF leaders also emphasized the need for Solu-Cortef Emergency Administration Technology and explained adrenal crisis is recognizable by its typical symptoms of diarrhea, vomiting and nausea. Unfortunately, the delay between the start of these symptoms and the administration of emergency treatment is the principal cause of death. - Topic II: Drug shortages have been a significant problem especially given the lack of options for treatment of life-preserving medications. Drug shortages can be a matter of life and death.
NADF discussed the issues created by shortages including treatment interruption, transitions to less-effective treatments, and rationing of life-saving treatments.
According to the FDA, “Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients for their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.” The FDA hopes to better understand the burdens that diseases and treatments have on our daily lives and to learn what is important for our community.
This was a strong starting point and a very important new direction for NADF. Just a couple of days after the meeting the FDA shortage database was updated…a positive sign that they really were listening.
NEWS ON ETON'S ACQUISITION RIGHTS TO US CROSSJECT'S ZENEO® HYDROCORTISONE NEEDLELESS AUTOINJECTOR
June 15, 2021
Adrenal crisis is recognizable by its typical symptoms of diarrhea, vomiting and nausea. Unfortunately, the delay between the start of these symptoms and the administration of emergency treatment is the principal cause of death.
On June 15, 2021 Eton announced the acquisition of US rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector. The link to the press release below.
https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-acquires-us-and-canadian-rights-zeneor
Please see Zeneo® Hydrocortisone Autoinjector FAQs.
Adrenal crisis is recognizable by its typical symptoms of diarrhea, vomiting and nausea. Unfortunately, the delay between the start of these symptoms and the administration of emergency treatment is the principal cause of death.
On June 15, 2021 Eton announced the acquisition of US rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector. The link to the press release below.
https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-acquires-us-and-canadian-rights-zeneor
Please see Zeneo® Hydrocortisone Autoinjector FAQs.
New international Adrenal disease Organization Consortium
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February 2021
We are excited to announce the launch of an Adrenal Patient Organization Consortium, created to work collaboratively with an international network of adrenal disease organizations who share a common bond. See the full article here: https://www.nadf.us/adrenal-disease-consortium.html |
Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States
November 24, 2020
DEER PARK, Ill., (GLOBE NEWSWIRE): Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States.
SEE FULL ANNOUNCEMENT: https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-availability-orphan-drug-alkindir
DEER PARK, Ill., (GLOBE NEWSWIRE): Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the full availability of ALKINDI® SPRINKLE for sale and distribution in the United States.
SEE FULL ANNOUNCEMENT: https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-availability-orphan-drug-alkindir
eton pharmaceuticals announces fda approval of orphan drug alkindi® sprinkle (hYDROCORTISONE) AS REPLACEMENT THERAPY IN PEDIATRIC PATIENTS WITH ADRENOCORTICAL INSUFFICIENCY
September 29, 2020
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children. Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020.
SEE ARTICLE: https://www.globenewswire.com/news-release/2020/09/29/2101010/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Orphan-Drug-ALKINDI-SPRINKLE-hydrocortisone-as-Replacement-Therapy-in-Pediatric-Patients-with-Adrenocortical-Insufficiency.html
PREVENTION OF ADRENAL CRISIS: CORTISOL RESPONSES TO MAJOR STRESS COMPARED TO STRESS DOSE HYDROCORTISONE DELIVERY
July 2020
A recent paper published by The Journal of Clinical Endocrinology & Metabolism* provided updated information on the most appropriate mode of hydrocortisone delivery in patients with adrenal insufficiency that are hospitalized with major surgery or major stress from severe infection. That paper can be found on our website here. https://www.nadf.us/medical-publications.html
The conclusion they came to is that continuous intravenous hydrocortisone infusion should be favored over intermittent bolus administration in the prevention and treatment of adrenal crisis during major stress. This keeps the circulating cortisol in target range over the period of time needed to treat an adrenal crisis.
*The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 7, July 2020, Pages 2262–2274, https://doi.org/10.1210/clinem/dgaa133
A recent paper published by The Journal of Clinical Endocrinology & Metabolism* provided updated information on the most appropriate mode of hydrocortisone delivery in patients with adrenal insufficiency that are hospitalized with major surgery or major stress from severe infection. That paper can be found on our website here. https://www.nadf.us/medical-publications.html
The conclusion they came to is that continuous intravenous hydrocortisone infusion should be favored over intermittent bolus administration in the prevention and treatment of adrenal crisis during major stress. This keeps the circulating cortisol in target range over the period of time needed to treat an adrenal crisis.
*The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 7, July 2020, Pages 2262–2274, https://doi.org/10.1210/clinem/dgaa133
