Growth hormone

NSF Marks Milestones in Personal Care for Athletes

Retrieved on: 
Thursday, March 21, 2024

These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.

Key Points: 
  • These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.
  • "The spirit of clean athletic competition is something we all connect with,” said David Trosin, Senior Director, Global Certification at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

CBD Healthcare Company Becomes the First-Ever Worldwide to Earn Prestigious NSF International Certifications in Personal Care for Athletes (NSF Guideline 527 and NSF Certified for Sport)

Retrieved on: 
Friday, March 15, 2024

CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.

Key Points: 
  • CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.
  • "The spirit of clean athletic competition is something we all connect with,” said David Lonza, Vice President, Health Sciences at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

Truly Grass Fed Showcases Latest Product Innovations at Natural Products Expo West

Retrieved on: 
Monday, March 11, 2024

CHICAGO, March 11, 2024 /PRNewswire/ -- Truly Grass Fed, a premium brand of sustainably-produced dairy products from the green fields of Ireland, will be showcasing several new product innovations at this year's Natural Products Expo West in Anaheim, CA from March 12-16, 2024.

Key Points: 
  • CHICAGO, March 11, 2024 /PRNewswire/ -- Truly Grass Fed, a premium brand of sustainably-produced dairy products from the green fields of Ireland, will be showcasing several new product innovations at this year's Natural Products Expo West in Anaheim, CA from March 12-16, 2024.
  • Truly Grass Fed Natural Maker's Blend Cheddar Cheese: A premium natural aged cheddar cheese with notes of parmesan.
  • "We're thrilled to be back for another year at Natural Products Expo West highlighting even more ways for consumers to enjoy Truly Grass Fed products," said Jaclyn Crabbe, Marketing Director for Truly Grass Fed.
  • For more information about Truly Gluten Free Oat Milk, please visit www.trulyglutenfree.com and to learn more about Truly Grass Fed, please visit www.trulygrassfed.com .

Chiesi Global Rare Diseases Launches “Rethink Acromegaly” Campaign to Provide Important Disease Education and Support to the Acromegaly Community

Retrieved on: 
Friday, March 1, 2024

BOSTON, March 01, 2024 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, today announced the launch of Rethink Acromegaly, a disease education program. Intended to provide audiences with the latest information and resources, RethinkAcromegaly.com serves as a resource to empower people living with acromegaly, their caregivers, and healthcare professionals.

Key Points: 
  • Intended to provide audiences with the latest information and resources, RethinkAcromegaly.com serves as a resource to empower people living with acromegaly, their caregivers, and healthcare professionals.
  • Acromegaly is a rare endocrine disorder characterized by excessive growth hormone production, typically stemming from a benign pituitary tumor.
  • "At Chiesi Global Rare Diseases, we understand that developing medicines for underserved patient communities is just one piece of the puzzle.” Giacomo Chiesi, Head of Chiesi Global Rare Diseases, said.
  • “Equipping individuals with rare diseases, caregivers, and their healthcare providers with the knowledge and resources they need to navigate their disease is equally vital.

Renowned Neurologist Unveils Technological Breakthrough in Achieving Deeper Sleep Says Soltec Health

Retrieved on: 
Wednesday, January 31, 2024

MINNEAPOLIS, Jan. 31, 2024 /PRNewswire/ -- Dr. Dan Cohen, a trailblazer in automated sleep diagnostics and the innovator behind the Breathe Right nasal strip, has dedicated the past decade to developing a revolutionary technology aimed at enhancing sleep quality, especially deep (delta) sleep and reducing stress.

Key Points: 
  • Results involving sixty-seven subjects who used the Soltec System for an average of 116 nights revealed significant improvements in Sleep Time, Delta sleep, and Non-REM sleep quality.
  • In summary, the Soltec System, employing specific low-frequency magnetic waves synchronized with the user's sleep stage, was proven effective in enhancing Delta Sleep and increasing Sleep Time.
  • Non-REM quality emerged as an early sensitive indicator of improved sleep quality, which occurred as Light sleep transitioned to more Delta sleep.
  • Upon completion, Soltec Health provides users with a $700 credit toward the purchase of the Soltec System.

Juvena Therapeutics Receives FDA Orphan Drug Designation for JUV-161 for the Treatment of Myotonic Dystrophy Type 1

Retrieved on: 
Tuesday, January 23, 2024

Juvena Therapeutics , a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161.

Key Points: 
  • Juvena Therapeutics , a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161.
  • JUV-161 is an investigational therapeutic for the treatment of Myotonic Dystrophy Type 1 (DM1), a rare, multi-systemic, autosomal dominant inherited disease and the most common form of adult muscular dystrophy.
  • “People living with DM1 deserve safe, effective, and rejuvenating treatments that can repair and restore tissue health to improve muscle function and metabolism,” said Dr. Hanadie Yousef, Co-Founder and CEO of Juvena Therapeutics.
  • Additionally, Juvena has identified multiple secreted protein hits that induce disease-modifying effects across several metabolic organs and therapeutic areas.

Ascendis Pharma Introduces Vision 2030

Retrieved on: 
Sunday, January 7, 2024

COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030.
  • Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com .

Specialised Therapeutics signs exclusive agreement with Ascendis Pharma A/S for distribution and commercialisation of three endocrinology therapies in Australia and select South-East Asia countries

Retrieved on: 
Sunday, January 7, 2024

Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).

Key Points: 
  • Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).
  • The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
  • Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine.
  • "We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said.

HSS Study Reveals Concerning Link Between Growth Hormone Therapy and Growth Plate Fractures in Children

Retrieved on: 
Thursday, January 4, 2024

NEW YORK, Jan. 4, 2024 /PRNewswire/ -- Human growth hormone has long been used to treat certain medical conditions in children. New research from surgeon-scientists at Hospital for Special Surgery (HSS) shows that there may be a previously unknown complication.

Key Points: 
  • In children, human growth hormone therapy has been used for decades to treat growth hormone deficiency due to underlying medical conditions such as Turner syndrome, very small weight at birth, Prader-Willi syndrome and chronic renal insufficiency.
  • Given the volume of patients we treat, we were able to investigate the relationship between tibia growth plate fractures and growth hormone therapy in pediatric patients."
  • Therefore, the odds of taking growth hormone therapy were 15 times higher among patients with proximal tibia physeal avulsion fractures than the comparison group.
  • "Further research is required to tease out whether limiting specific high-impact sports will mitigate the risk of tibia growth plate fractures in active children and adolescents."

TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

Retrieved on: 
Tuesday, December 19, 2023

COPENHAGEN, Denmark, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).

Key Points: 
  • The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH and daily hGH.
  • For patients with IGF-1 SDS levels ≤ 1.75 at Week 38:
    Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily hGH -2.59%)
    TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily hGH.
  • “TransCon hGH, our once-weekly growth hormone, is designed to deliver unmodified somatropin, thereby preserving the same overall endocrine benefits inherent in endogenous and daily hGH,” said Jan Mikkelsen, Ascendis Pharma’s President and CEO.
  • “Next year, we plan to submit a supplemental Biologics License Application to the U.S. FDA for the adult GHD indication and look forward to reporting data from our Phase 2 program in Turner syndrome.”