Growth hormone

Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes

Retrieved on: 
Tuesday, September 12, 2023
Agreement, SBS, Injection, OXM, Pfizer, Obesity, Teduglutide, Gastrointestinal tract, Growth hormone, Glucagon, Weight loss, Health, Nutrient, OPK, OPKO Health, Absorption, Appetite, Short bowel syndrome, Colon, Permeability, Patient, Conditional sentence, Peptide, Oxyntomodulin, Fine chemical, Pharmaceutical industry, Vaccine, Entera

JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX, “Entera”) and OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (NASDAQ: OPK, “OPKO”) have entered into a Research Collaboration Agreement.

Key Points: 
  • JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX, “Entera”) and OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (NASDAQ: OPK, “OPKO”) have entered into a Research Collaboration Agreement.
  • Under the terms of the Agreement, OPKO will supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology.
  • Entera recently published pre-clinical data demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections.
  • We look forward to working with Entera,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health.

Ascendis Pharma Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, September 5, 2023
GHD, Pharma, SG, Growth hormone, Pathway, EGFR, NDA, Hypoparathyroidism, Glomerular filtration rate, Achondroplasia, Type, Marketing, Hypertelorism, Patient, Cytokine release syndrome, Southern Transcon, Webcast, R, MAA, Marketing Authorisation Application, Research, FDA, All Our Relations: Finding the Path Forward, OLE, European Commission, Approach, Pharmaceutical industry, Cryptocurrency, EU

Remain on track for European Commission decision on Marketing Authorisation Application (MAA) for TransCon PTH during the fourth quarter of 2023.

Key Points: 
  • Remain on track for European Commission decision on Marketing Authorisation Application (MAA) for TransCon PTH during the fourth quarter of 2023.
  • Ended the second quarter of 2023 with cash, cash equivalents, and marketable securities totaling €431.1 million.
  • Total revenue for the second quarter of 2023 was €47.4 million compared to €6.2 million during the same period in 2022.
  • Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2023 financial results.

OPKO Health Reports Second Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Thursday, August 3, 2023
Intellectual property, Epstein–Barr virus, International, GeneDx, Growth hormone, COVID-19, Health, Research, COVID-19 testing, Sale, Modex, U.S. FDA, OPKO Health, Growth hormone therapy, PIN, Patient, Cancer, United Kingdom, Growth, Merck, Ageing, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PCR, Food, Pharmaceutical industry, Video game, EU, Pfizer

MIAMI, Aug. 03, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2023.

Key Points: 
  • MIAMI, Aug. 03, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2023.
  • Second quarter business highlights included the following:
    U.S. FDA approved NGENLA™ for pediatric growth hormone deficiency; OPKO earned a $90 million milestone payment from its commercial partner, Pfizer.
  • Operating income was $63.6 million in the second quarter of 2023, compared with $55.4 million in the second quarter of 2022.
  • Operating income for the second quarter of 2023 was $7.0 million compared with an operating loss of $10.7 million for the 2022 quarter.

Insights Revealed in 2023 Turner Syndrome Pipeline Report: 4+ Companies and 4+ Promising Drugs in Focus - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 25, 2023
Genetics, Pharmaceutical, Health, Drug development, Therapy, Turner syndrome, Pituitary gland, Research, GH, Endocrine gland, X chromosome, Growth hormone, Chromosome, Patient, Southern Transcon, Ibutamoren, Pharmaceutical industry

This report presents comprehensive insights into the Turner Syndrome pipeline landscape, featuring 4+ companies and 4+ pipeline drugs.

Key Points: 
  • This report presents comprehensive insights into the Turner Syndrome pipeline landscape, featuring 4+ companies and 4+ pipeline drugs.
  • Turner Syndrome, also known as congenital ovarian hypoplasia syndrome, is the most common sex chromosomal abnormality found in females.
  • In most cases, Turner Syndrome is not inherited and results from a random event during the formation of reproductive cells.
  • Apart from Lumos Pharma and Ascendis Pharma, the report covers other companies actively engaged in developing therapies for Turner Syndrome.

Kexing Biopharm Makes it into China's Top 20 Biopharmaceutical Enterprises (Blood Products, Vaccines and Insulin) for Two Consecutive Years

Retrieved on: 
Friday, July 7, 2023
Vaccine, Insulin, Marketing, Growth hormone, Pharmacy, Bacteriophage, COVID-19, Research, RMB, Hospital, Growth, Synthetic biology, Fine chemical, Pharmaceutical industry

Kexing Biopharmaceutical's inclusion can be attributed to its robust research and development, as well as its exceptional production capabilities and remarkable marketing prowess.

Key Points: 
  • Kexing Biopharmaceutical's inclusion can be attributed to its robust research and development, as well as its exceptional production capabilities and remarkable marketing prowess.
  • Kexing Biopharm has consistently prioritized and invested in scientific and technological advancements, which remain at the core of the company's mission and values.
  • Notably, its subsidiary, Kexing Animal Healthcare has rapidly established a robust portfolio of more than ten multivalent vaccines.
  • In a comprehensive demonstration of its innovation capability, product strength and brand influence, Kexing Biopharm has once again been recognized by China's Top 100 Pharmaceutical Enterprises.

Kexing Biopharm Makes it into China's Top 20 Biopharmaceutical Enterprises (Blood Products, Vaccines and Insulin) for Two Consecutive Years

Retrieved on: 
Friday, July 7, 2023
Vaccine, Insulin, Marketing, Growth hormone, Pharmacy, Bacteriophage, COVID-19, Research, RMB, Hospital, Growth, Synthetic biology, Fine chemical, Pharmaceutical industry

Kexing Biopharmaceutical's inclusion can be attributed to its robust research and development, as well as its exceptional production capabilities and remarkable marketing prowess.

Key Points: 
  • Kexing Biopharmaceutical's inclusion can be attributed to its robust research and development, as well as its exceptional production capabilities and remarkable marketing prowess.
  • Kexing Biopharm has consistently prioritized and invested in scientific and technological advancements, which remain at the core of the company's mission and values.
  • Notably, its subsidiary, Kexing Animal Healthcare has rapidly established a robust portfolio of more than ten multivalent vaccines.
  • In a comprehensive demonstration of its innovation capability, product strength and brand influence, Kexing Biopharm has once again been recognized by China's Top 100 Pharmaceutical Enterprises.

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

Retrieved on: 
Wednesday, June 28, 2023
Research, FDA, Children, Biotechnology, Health, Consumer, Pharmaceutical, Other Science, Science, GHD, Inc., EU, Pituitary gland, Growth hormone, PFE, Medicine, Puberty, OPKO Health, Patient, Standard of care, Ageing, Hybrid growth disorders, United, Regulation of tobacco by the U.S. Food and Drug Administration, Safety, NYSE, Food, Disease, Pharmaceutical industry, Birth control, Pfizer

Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
  • The study met its primary endpoint of NGENLA non-inferiority compared to somatropin, as measured by annual height velocity at 12 months.
  • “The approval of NGENLA will be significant for children with growth hormone deficiency in the U.S.
  • It holds potential to reduce the treatment burden that can come with daily growth hormone injections,” said Joel Steelman, M.D., Pediatric Endocrinologist, Cook Children’s Health Care System.

New Data Demonstrating Stable Biochemical and Symptom Levels with Two-Years of Oral Paltusotine Administration Presented at ENDO 2023

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Wednesday, June 21, 2023
ENDO, Rat, FISU World University Games, Pain, Graves' ophthalmopathy, A1C, Patient, Hypercalcaemia, Primary hyperparathyroidism, SST2, Health, Hyperthyroidism, Memory, PTH1R, Fatigue, Thyroid, Camp, PRO, Weakness, HHM, Acromegaly, Headache, Safety, Growth hormone, Cancer, Medicine, Biomarker, History, Calcium, ASD, Swelling, Autoimmune disease, Endocrine Society, Perspiration, Medical school, Human, Blood pressure, Exophthalmos, TSH, Malignancy, Osteoporosis, Endocrine system, Arthralgia, Sequoyah, Saint Andrew's Society, PHPT, Poster, TSHR, TED, Pharmaceutical industry, Entrepreneurship, Endocrinology

SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) presented efficacy, safety and patient-reported outcome (PRO) data at ENDO 2023 for paltusotine, an experimental, once-daily, oral, small molecule somatostatin receptor type 2 (SST2) agonist in Phase 3 clinical development for the treatment of acromegaly. The Endocrine Society’s annual meeting, ENDO 2023, was held June 15-18, 2023, in Chicago, Illinois.

Key Points: 
  • The Endocrine Society’s annual meeting, ENDO 2023 , was held June 15-18, 2023, in Chicago, Illinois.
  • The ASD score was a composite representing participants’ daily impressions of common acromegaly symptoms including headache, joint pain, sweating, fatigue, weakness, swelling, and numbness/tingling.
  • Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment.
  • The data presented in a poster at ENDO on June 17th show Crinetics’ PTH1R antagonist suppressing PTH-stimulated increases in ionized calcium, urinary cAMP, and bone resorption biomarkers in rats.

Self-Esteem of Kids with Short Stature Tied to Social Supports, Not Height

Retrieved on: 
Monday, June 12, 2023
The Journal of Pediatrics, Male, Body composition, Pfizer, CHOP, Parent, Friends, Growth hormone, Social support, Quality of life, Philadelphia, Quality, GH, Science, Journal, MD, Collection, Selection bias, Manuscript, DOI, Growth, Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Growth hormone deficiency, NIH, Caregiver, Female, Children's Hospital of Philadelphia, Nursing, Birth control, Toy, Pediatrics, Child

PHILADELPHIA, June 12, 2023 /PRNewswire/ -- Challenging the assumption that short stature negatively impacts children and adolescents' self-esteem, a new study by researchers at Children's Hospital of Philadelphia (CHOP) has found that in otherwise healthy short youth, quality of life and self-esteem are associated with coping skills and how supported they feel and not the degree of their short stature. The findings were published in The Journal of Pediatrics.

Key Points: 
  • "But our data show that self-esteem among short youth is tied to social support networks and adaptive coping strategies, not their stature.
  • However, its use has expanded to those with normal GH production who are short for their age, with the sole aim of augmenting height, based on the premise that short stature is debilitating and that height increases lead to improved quality of life.
  • First, children of taller parents may be told their short stature is temporary, given the height of the parents.
  • Short parents who view their own short stature as non-problematic may be less likely to seek care for their child's short stature, whereas short parents who are unhappy about their own height may be more inclined to express negative messaging about short stature and seek medical care for their child.

Amolyt Pharma Announces Initiation of Phase 1 Clinical Trial of Peptide Growth Hormone Receptor Antagonist (GHRA), AZP-3813, for Acromegaly

Retrieved on: 
Monday, June 5, 2023
Growth hormone, Hypoparathyroidism, Quality of life, Pharmacokinetics, Research, GH, Acromegaly, Patient, Safety, Disease, Pharmaceutical industry

LYON, France and CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced the initiation of a Phase 1 clinical trial of the Company’s peptide growth hormone receptor antagonist (GHRA), AZP-3813, which is being developed as a potential add-on to somatostatin analogs (SSAs) for the treatment of acromegaly.

Key Points: 
  • “Somatostatin analogs currently represent the standard of care first line therapy in the pharmacological management of acromegaly due to their demonstrated ability to reduce IGF-1 levels and control remnant tumor growth.
  • “We believe there is strong scientific rationale for combining SSAs with GHRAs to further decrease IGF-1 levels and to antagonize the peripheral effects of GH action.
  • Results of the Phase 1 trial are expected in the first quarter of 2024.
  • Following our recent announcement of the initiation of our Phase 3 trial for eneboparatide, our investigational PTH1 receptor agonist for the treatment of hypoparathyroidism, we are pleased to continue to build our clinical pipeline with AZP-3813,” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma.