Growth hormones

Chiasma Announces Submission of Marketing Authorization Application for MYCAPSSA® to the European Medicines Agency

Retrieved on: 
Monday, June 28, 2021
Branches of biology, Organ systems, Hormones, Neuroendocrinology, Medical statistics, Clinical research, Growth hormones, Clinical trials, Acromegaly, Octreotide, Somatostatin, Clinical endpoint

The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA (oral octreotide capsules) in theEuropean Union.

Key Points: 
  • The MPOWERED trial was a global, randomized, open-label and active-controlled, 15-month trial intended to support approval of MYCAPSSA (oral octreotide capsules) in theEuropean Union.
  • This non-inferiority clinical trial was designed to compare MYCAPSSA to long-acting injectable somatostatin analogs (SSAs) for maintenance of biochemical response in patients with acromegaly.
  • The primary endpoint of the trial was time-weighted average of IGF-1
  • Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

Lumos Pharma Announces OraGrowtH212 Trial of LUM-201 in PGHD Is Open for Enrollment

Retrieved on: 
Monday, June 28, 2021
Life sciences, Growth hormones, Health sciences, Hormones, Peptide hormones, Growth disorders, Specialty drugs, Growth hormone, Lumos, Biopharmaceutical

Lumos Pharma believes an increase in the pulsatile release of endogenous growth hormone (GH) has the potential to produce a substantial improvement in height velocity in PGHD patients.

Key Points: 
  • Lumos Pharma believes an increase in the pulsatile release of endogenous growth hormone (GH) has the potential to produce a substantial improvement in height velocity in PGHD patients.
  • We are excited to announce the opening of the OraGrowtH212 Trial said Rick Hawkins, CEO, President and Chairman of Lumos Pharma.
  • Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases.
  • Lumos Pharmas lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule, currently being evaluated in a Phase 2b clinical trial, the OraGrowtH210 Trial, and a PK/PD clinical trial, OraGrowtH212 Trial, for the treatment of Pediatric Growth Hormone Deficiency (PGHD).

Newly Released Data on Three PGHD Patients Treated with LUM-201 in Prior Phase 2 Study To Be Presented in Lumos Pharma Key Opinion Leader Webinar

Retrieved on: 
Tuesday, April 27, 2021
Growth hormones, Endocrine system, Clinical medicine, Peptide hormones, Hormones, Growth disorders, Growth hormone therapy, Pediatrics, Growth hormone, Growth hormones, Endocrine system, Clinical medicine, Peptide hormones, Hormones, Growth disorders, Growth hormone therapy, Pediatrics, Growth hormone

Miller and Cassorla will be available to answer questions following the formal presentations.

Key Points: 
  • Miller and Cassorla will be available to answer questions following the formal presentations.
  • As has been previously disclosed in adults, LUM-201 increased the pulsatile release of growth hormone for 24 hours in Predictive Enrichment Marker (PEM) Positive subjects (N=2).
  • In children, this rare disorder is called pediatric growth hormone deficiency (PGHD).
  • LUM-201 has received Orphan Drug Designation in both the US and EU.\xc2\xa0For more information, please visit www.lumos-pharma.com .\n'

PRA’s remote patient monitoring platform selected by Merck KGaA, Darmstadt, Germany to work in combination with its human growth hormone treatment system

Retrieved on: 
Wednesday, April 7, 2021
Growth hormones, Clinical medicine, Medicine, Merck Group, Health care, Growth hormone therapy, Pediatrics, Recombinant proteins, Growth disorders, Serono, Growth hormone, Hormone therapy, Growth hormones, Clinical medicine, Medicine, Merck Group, Health care, Growth hormone therapy, Pediatrics, Recombinant proteins, Growth disorders, Serono, Growth hormone, Hormone therapy

RALEIGH, N.C. , April 07, 2021 (GLOBE NEWSWIRE) -- PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRAs remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system.

Key Points: 
  • RALEIGH, N.C. , April 07, 2021 (GLOBE NEWSWIRE) -- PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRAs remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system.
  • Human growth hormone treatments are frequently prescribed for children and adolescents with growth hormone deficiency, a condition that impacts approximately 1:4,000 to 1:10,000 children1 each year in the U.S.
  • Despite the prevalence of growth hormone deficiency and treatment options, one of the biggest challenges is ensuring patients adherence to the regimen.
  • PRA hosted a webinar called, How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation, to help create differentiation.

New Data Suggest Entera’s Platform Orally Delivers Human Growth Hormone, Study Results to be Presented at European Pharma Congress

Retrieved on: 
Tuesday, April 6, 2021
Growth hormones, Clinical medicine, Medicine, Peptide hormones, Recombinant proteins, Hormones, Growth hormone therapy, Pediatrics, Growth hormone, Growth hormone in sports

Prescription human growth hormone (hGH), a widely used therapeutic molecule, is currently only administered via subcutaneous injection for the treatment of growth hormone deficiency as well as other indications.

Key Points: 
  • Prescription human growth hormone (hGH), a widely used therapeutic molecule, is currently only administered via subcutaneous injection for the treatment of growth hormone deficiency as well as other indications.
  • In a preclinical study, Enteras hGH formulation was administered orally to mice and rats.
  • Plasma samples analyzed showed substantial gastrointestinal absorption of the oral hGH formulation and significant systemic exposure to the drug.
  • We are pleased to have our abstract accepted by the European Pharma Congress and look forward to presenting the data.

Data Presented at ENDO 2021 Differentiate LUM-201 from Standard Growth Hormone Secretagogues and Further Support LUM-201’s Potential as a Therapeutic for Pediatric Growth Hormone Deficiency

Retrieved on: 
Saturday, March 20, 2021
Endocrine system, Growth hormones, Hormones, Organ systems, Peptide hormones, Growth disorders, Pediatrics, Growth hormone secretagogue, Growth hormone deficiency, Growth hormone, GH, Secretagogue

The poster can be viewed on the ENDO website and may also be found on the Companys website in the Investors & Media section, under Posters & Publications .

Key Points: 
  • The poster can be viewed on the ENDO website and may also be found on the Companys website in the Investors & Media section, under Posters & Publications .
  • Poster 7102 presents an analysis of data from a prior clinical study comparing the peak growth hormone (GH) response of LUM-201 (formerly MK-0677) to that of standard GH secretagogues (clonidine, arginine, L-dopa, glucagon, insulin) in children nave-to-treatment, previously diagnosed with growth hormone deficiency (GHD).
  • The objective was to determine whether LUM-201 stimulates GH responses different from standard GH secretagogues.
  • You should, therefore, not rely on these forward-looking statements as representingthe Companysviews as of any date subsequent to the date of this press release.

Global Growth Hormone Deficiency Clinical Trials Review, H1 2021 Report - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 17, 2021
Pharmaceutical, Health, Clinical trials, Health sciences, Health, Clinical research, Pharmaceutical industry, Food and Drug Administration, Growth hormones, Design of experiments, Growth hormone therapy, Clinical trials

The "Growth Hormone Deficiency - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Growth Hormone Deficiency - Global Clinical Trials Review, H1, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Growth Hormone Deficiency - Global Clinical Trials Review, H1, 2021" provides an overview of Growth Hormone Deficiency Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Growth Hormone Deficiency.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.

Ascendis Pharma A/S Announces Seven Presentations at ENDO 2021, Demonstrating Commitment to People with Rare Endocrine Diseases

Retrieved on: 
Wednesday, March 10, 2021
Growth hormones, Growth hormone, Hormones, Clinical medicine, Medicine

Efficacy and Safety of up to 2 Years of Treatment with TransCon hGH (lonapegsomatropin) in Treatment-Nave and Treatment-Experienced Children with Growth Hormone Deficiency.

Key Points: 
  • Efficacy and Safety of up to 2 Years of Treatment with TransCon hGH (lonapegsomatropin) in Treatment-Nave and Treatment-Experienced Children with Growth Hormone Deficiency.
  • Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development.
  • Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.
  • Ascendis,Ascendis Pharma, theAscendis Pharmalogo, the company logo and TransCon are trademarks owned by theAscendis Pharma Group.

Lumos Pharma to Present Poster Demonstrating Greater GH Response to LUM-201 than to Standard GH Secretagogues in PGHD at the Endocrine Society (ENDO) 2021 Annual Meeting

Retrieved on: 
Tuesday, March 2, 2021
Growth hormones, Endocrine system, Hormones, Clinical medicine, Growth disorders, Peptide hormones, Growth hormone secretagogue, Growth hormone therapy, Growth hormone deficiency, Growth hormone, GH

AUSTIN, Texas, March 02, 2021 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, will present poster 7102 at the virtual Endocrine Society 2021 Annual Meeting, March 20th-23rd.

Key Points: 
  • AUSTIN, Texas, March 02, 2021 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, will present poster 7102 at the virtual Endocrine Society 2021 Annual Meeting, March 20th-23rd.
  • LUM-201 Elicits Greater GH Response than Standard GH Secretagogues in Pediatric Growth Hormone Deficiency will be presented by authors Bright, G., MD, et al.
  • on Saturday, March 20, 2021, at 11:00AM ET in Session P33 Growth and Growth Hormone.
  • At that time, the poster can be accessed in the Investors & Media section of our website on the Posters & Presentations page under Events & Presentations.

EMA Accepts Marketing Application for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Retrieved on: 
Friday, February 26, 2021
Oncology, Health, FDA, Clinical trials, Pharmaceutical, Biotechnology, Growth hormones, Branches of biology, Organ systems, Anatomy, Neuroendocrinology, Endocrine system, Growth hormone therapy, Pediatrics, Growth hormone deficiency, Growth hormone, Pituitary gland, Hypopituitarism, the Studies, Somatrogon, Growth Hormone Deficiency, GENOTROPIN® (somatropin), OPKO Health, Inc.

We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency.

Key Points: 
  • We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency.
  • The submission is supported by the results of a global, Phase 3 trial evaluating the safety and efficacy of somatrogon administered once-weekly to pediatric patients with GHD.
  • Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of growth hormone deficiency.
  • Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people.