Hypercalcaemia

Sandoz receives FDA approval for first and only denosumab biosimilars

Retrieved on: 
Tuesday, March 5, 2024
Bone fracture, Fracture, Woman, Hypocalcemia, Osteoporosis, Bone disease, Hypercalcaemia, FDA, Quality of life, Food, Cancer, Denosumab, Metastasis, Risk, Breast, Safety, Mitigation, Novartis, REMS, Benign tumor, Disease, Patent, Patient, Medicine, Multiple myeloma, Ageing, Dietary supplement

Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.

Key Points: 
  • Keren Haruvi, President Sandoz North America, said: "Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients.
  • I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."
  • Wyost® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
  • Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this time.

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

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Tuesday, January 2, 2024
Patient, Urine, Medical Subject Headings, Marketing, INN, Risk, Fracture, Alkaline phosphatase, Woman, Allergy, Heart rate, Vitamin D, ATC, Hypercalcaemia, Menopause, International, Diet, Parathyroid hormone, Headache, Disease, Osteosarcoma, Nausea, Blood, Language, Calcium, Osteoblast, Palpitations, Cancer, Heart, Dizziness, Abdomen, European Medicines Agency, Spine, Back pain, Hypercalciuria, Select, System, Safety, Cardiovascular disease, Anatomy, Arthralgia, Bone fracture, Female, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, INN, Risk, Woman, Hypercalcaemia, Menopause, Man, Cancer, Avascular necrosis, Risk management, Anatomy, Female, IIA, Osteitis, Jaw, Osteoclast, CHMP, Fever, Fracture, ATC, Pain, European, Disease, Calcium, Kidney, Paget's disease, Glucocorticoid, Neoplasm, Arthralgia, Hypocalcemia, Patient, Medical Subject Headings, Hip, Trauma, European Commission, Vitamin D, International, Language, Mouth, Select, Medicine, Paget's disease of bone, Allergy, Headache, Ibuprofen, Spine, Myalgia, Committee, Cell, Necrosis, Dietary supplement

Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Date of authorisation: 15/04/2005, Revision: 32, Status: Authorised

Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development

Retrieved on: 
Tuesday, November 14, 2023
Woman, Absorption, Annual general meeting, Bone fracture, Type, Peptide, Stress fracture, D&O, Patient, Research, Oxyntomodulin, Hypoparathyroidism, Osteoporosis, Safety, Food, Teduglutide, Fracture, Intellectual property, BMD, OPKO Health, Athlete, Society, Type D, NDA, Three Months, PTH, Risk, Insurance, Consultant, Short bowel syndrome, Appetite, Pharmacokinetics, Nutrient, SBS, Glucagon, Teriparatide, SABRE, OXM, Disease, Tablet, FDA, Obesity, Hypercalcaemia, Injection, Weight loss, Fine chemical, Pharmaceutical industry, Cryptocurrency, Jews, Entera

“Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.

Key Points: 
  • “Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.
  • We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training.
  • Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:
    EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.
  • Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections.

American Regent Introduces Potassium Phosphates, USP; FDA-Approved and "AP" Rated¹

Retrieved on: 
Thursday, October 19, 2023
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In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.

Key Points: 
  • In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.
  • Vein Damage and Thrombosis: Potassium Phosphates Injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition.
  • You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
  • You are encouraged to report adverse drug events (ADEs) to American Regent:
    ADEs may also be reported to the FDA:

BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Retrieved on: 
Tuesday, October 10, 2023
Annual general meeting, Calcium, Partnership, Walking, Cancer, Urine, Hypocalcemia, Research, PTH, The New England Journal of Medicine, Standard of care, Kidney failure, Society, American Society for Bone and Mineral Research, National Institute of Dental and Craniofacial Research, Vitamin D, Craniofacial, Kidney, Parathyroid hormone, Hypercalciuria, Hypercalcaemia, Bangladesh Technical Education Board, Blood, Endocrine Society, Patient, Quality of life, NIH, PALO, Pharmaceutical industry, Dietary supplement

“Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.

Key Points: 
  • “Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.
  • But this burdensome regimen may also increase urine calcium levels above normal, which can damage the kidney, leading to kidney failure in worst-case scenarios.
  • People with ADH1 need better treatments, so they are not constantly walking on a tightrope.
  • As part of the Phase 2b study, participants completed one or two 5-day inpatient dose-ranging periods, followed by a 24-week outpatient period.

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

Retrieved on: 
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.

eGenesis Announces Publication in Nature Communications Characterizing Renal Physiology and Endocrine Function in Non-Human Primates Post Xenograft Transplant

Retrieved on: 
Tuesday, June 13, 2023
RAAS, PTH, Biotechnology, Transplant, Gene editing, Survival, Nature Communications, NHP, Chronic kidney disease, Hypophosphatemia, Hypercalcaemia, Risk, Pelvic floor dysfunction, Pharmaceutical industry, Vaccine

“Taken together, our collective findings provide additional evidence demonstrating the ability of the xenotransplanted kidneys to carry out normal physiological function over extended periods,” said Katherine Hall, Ph.D., Principal Scientist of eGenesis.

Key Points: 
  • “Taken together, our collective findings provide additional evidence demonstrating the ability of the xenotransplanted kidneys to carry out normal physiological function over extended periods,” said Katherine Hall, Ph.D., Principal Scientist of eGenesis.
  • “They also inform areas for monitoring and potential pharmaceutical intervention in the first-in-human clinical setting for renal xenotransplantation.
  • Chronic kidney disease affects between 8 and 16 percent of the population worldwide, and demand for donor kidneys far outpaces supply.
  • One approach to alleviating this global issue is xenotransplantation, or the transplantation of organs from one species to another.

Amolyt Pharma Announces Research Agreement and Licensing Option with XOMA

Retrieved on: 
Tuesday, January 24, 2023
Hypercalcaemia, Antibody, Malignancy, PHPT, Hypoparathyroidism, Degenerative disease, PTHR1, Parathyroid hormone, Primary hyperparathyroidism, Patient, Calcium, Parathyroid hormone-related protein, Biology, HHM, PTH, Bone loss, Research, Hypophosphatemia, Pharmaceutical industry, Vaccine

LYON, France and CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma (“Amolyt,” “Amolyt Pharma” or the “Company”), a global company specialized in developing innovative therapies for rare endocrine and related diseases, today announced that the Company has entered into a research agreement and licensing option with XOMA Corporation (“XOMA”) for the pre-clinical evaluation of a select set of monoclonal antibodies that arose from XOMA’s legacy discovery efforts as potential treatments for primary hyperparathyroidism (“PHPT”) and humoral hypercalcemia of malignancy (“HHM”). Amolyt has the option to license one or more of these candidates from XOMA for further clinical development worldwide.

Key Points: 
  • LYON, France and CAMBRIDGE, Mass., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Amolyt Pharma (“Amolyt,” “Amolyt Pharma” or the “Company”), a global company specialized in developing innovative therapies for rare endocrine and related diseases, today announced that the Company has entered into a research agreement and licensing option with XOMA Corporation (“XOMA”) for the pre-clinical evaluation of a select set of monoclonal antibodies that arose from XOMA’s legacy discovery efforts as potential treatments for primary hyperparathyroidism (“PHPT”) and humoral hypercalcemia of malignancy (“HHM”).
  • Amolyt has the option to license one or more of these candidates from XOMA for further clinical development worldwide.
  • “We are continuing to build our portfolio for rare endocrine and related diseases while moving, in parallel, our lead program for hypoparathyroidism into a pivotal trial.
  • We look forward to watching Amolyt’s progress, as PHPT and HHM patients are underserved by current standards of care.”

Crinetics Pharmaceuticals to Present Corporate and Clinical Update at 41st Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 9, 2023
American Association of Clinical Endocrinologists, Carcinoid syndrome, Malignancy, Congenital hyperinsulinism, Congenital adrenal hyperplasia, Event, Polycystic kidney disease, Injection, Conference, Webcast, Patient, Chronic kidney disease, Drug discovery, Diabetes, SST2, SAN, GPCR, Graves' ophthalmopathy, ACTH, Primary hyperparathyroidism, Hypercalcaemia, Acromegaly, Obesity, Pharmaceutical industry

SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, will provide a company update at the 41st Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 9-12, 2023.

Key Points: 
  • SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that Scott Struthers, Ph.D. , founder and chief executive officer of Crinetics, will provide a company update at the 41st Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 9-12, 2023.
  • The presentation will feature an overview of Crinetics’ key priorities and anticipated milestones for 2023.
  • These include:
    The continued advancement of the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials of once-daily oral paltusotine in acromegaly.
  • “Crinetics is entering 2023 with strong momentum and potentially transformative milestones expected over the next year,” said Dr. Struthers.