Osteoclast

Solarea Bio Announces the Beta Launch of Bondia™, a Novel Daily Medical Food Helping Menopausal Women Manage Bone Loss

Retrieved on: 
Wednesday, May 8, 2024
Mortality, Inflammation, Cell, Woman, Osteoclast, Health, GRAS, Partnership, Doctor of Philosophy, DEXA, Osteoporosis, Physician, BMD, Peri, Fruit, Quality of life, Menopause, Dietary supplement

BOSTON, May 8, 2024 /PRNewswire/ -- All peri- and postmenopausal women experience bone loss, which can lead to osteoporosis if left unmanaged. And although osteoporosis is exceedingly common, afflicting 1 in 3 women, most are unaware of their condition and the implications that it can have for their health. An osteoporotic injury can be devastating, significantly reducing quality of life and—in the worst cases—resulting in a 30% mortality rate in the first-year post-hip fracture.

Key Points: 
  • BOSTON, May 8, 2024 /PRNewswire/ -- All peri- and postmenopausal women experience bone loss, which can lead to osteoporosis if left unmanaged.
  • Initially debuting via a private beta program, their first-ever product, Bondia™ medical food, is a daily synbiotic capsule that helps address bone loss in peri- and postmenopausal women.
  • Bondia™ medical food is Journa's naturally developed, clinical solution to manage postmenopausal bone loss.
  • In preparation for its private beta program, Bondia™ medical food is currently undergoing a double-blind, placebo-controlled clinical food trial in 286 early postmenopausal women.

NiTime™-A New Generation Of Clear Aligners Solve for Patient Compliance: OrthoFX™ Announces Nationwide Availability Of The First and Only FDA Cleared Aligners Designed Explicitly For Shorter Wear Time

Retrieved on: 
Wednesday, May 1, 2024
FDA, Cell, Orthodontics, Only, Osteoclast, Movement, Elasticity, Osteoblast, Bone remodeling, American Association of Orthodontists, Science, Patient, Headache, Eating, Annual general meeting, AAO, Nickel titanium, Drinking, Dentistry

FREMONT, Calif., May 1, 2024 /PRNewswire/ -- Founded by a team of industry pioneers, OrthoFX™, today announced the new generation of advanced clear aligner polymer, NiTime™ Clear Aligners. NiTime is the first and only clear aligner system explicitly designed for shorter wear time and cleared by the U.S Food and Drug Administration (FDA) 510(k), and is now available nationwide for doctors to treat all classes of dental malocclusions. OrthoFX will showcase the new breakthrough material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.

Key Points: 
  • FREMONT, Calif., May 1, 2024 /PRNewswire/ -- Founded by a team of industry pioneers, OrthoFX™, today announced the new generation of advanced clear aligner polymer, NiTime™ Clear Aligners.
  • OrthoFX will showcase the new breakthrough material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.
  • Predictable Precision - Designed for better predictability and compliance, 92% of NiTime Aligner treatments were completed without refinements*.
  • NiTime Aligners are meticulously designed to support favorable cellular physiology, fostering an ideal environment for biological tissue remodeling.

FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease

Retrieved on: 
Thursday, April 25, 2024
Leg, FDA, Cancer, Hip, Medivir, Sequela, Priority review, Risk, Osteoclast, Osteoarthritis, Partnership, Depression, Disease, Obesity, Patient, Cathepsin K, ODD, Ageing, Pharmaceutical industry

The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age.

Key Points: 
  • The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age.
  • Pediatric diseases recognized as "rare", affect fewer than 200,000 people in the United States.
  • We are delighted that MIV-711 has been granted RPDD by the FDA with the potential to become the first approved treatment option.
  • To gain RPDD, there must be supportive data suggesting that the drug may be effective in the disease.

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

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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

NextCure Publishes Non-Clinical Data Demonstrating Anti-Siglec-15 Treatment Prevented Bone Loss Due to Immobilization from Acute Spinal Cord Injury

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Thursday, December 21, 2023
Veteran, Osteocalcin, Skeleton, Risk, Osteoporosis, Immobilization, Fracture, Messenger, Tibia, Tetraplegia, BSP, Society, Osteoblast, Cancer, Femur, Blood, S15, Manuscript, Patient, Therapy, Osteoclast, BMD, Medical imaging

The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.

Key Points: 
  • The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.
  • Following spinal cord injury, patients typically suffer rapid and extensive bone loss.
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone formation and quality.

Preclinical Data Demonstrate Anti-Siglec-15 Treatment Reduced Bone Loss and Enhanced Bone Quality in Mice with Moderate-to-Severe Osteogenesis Imperfecta (OI)

Retrieved on: 
Tuesday, October 17, 2023
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These results support development of NC605 as a potential highly effective treatment for osteogenesis imperfecta, a rare disease in which bones easily fracture.

Key Points: 
  • These results support development of NC605 as a potential highly effective treatment for osteogenesis imperfecta, a rare disease in which bones easily fracture.
  • Osteogenesis imperfecta is a rare disorder that results in high bone turnover, abnormal bone formation, bone fragility and recurrent fractures.
  • There is no cure for OI and current anti-resorptive treatments increase bone mineral density (BMD) primarily by inhibiting bone loss; however, these agents also inhibit bone formation.
  • Unlike anti-resorptive therapies, NC605 enhances osteoblast recruitment, resulting in overall enhanced bone quality.

Preclinical Data Demonstrate Potential Application of Anti-Siglec-15 Treatment in Bone Disease

Retrieved on: 
Tuesday, September 5, 2023
Osteoporosis, Therapy, Blood, Osteocalcin, Tibia, Cancer, Quality of life, Mount Sinai, BMD, Bone disease, Immobilization, Multiple sclerosis, Messenger, Military personnel, Osteoblast, BSP, Patient, Icahn School of Medicine at Mount Sinai, Femur, Osteoclast, SCI, Vaccine, Medical imaging, S15, Veteran, Medicine

While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.

Key Points: 
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • In preclinical testing, NC605 has been shown to prevent bone loss by inhibiting osteoclast maturation and bone resorption by binding S15, which is expressed on the cell surface of immature osteoclasts and upregulated in differentiated osteoclasts.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone quality.
  • Title: Development of a Novel Therapeutic, anti-Siglec-15 Antibody, to Reduce Bone Loss and Enhance Bone Integrity after Acute Spinal Cord Injury-induced Immobilization

FDA Grants SiSaf’s Innovative siRNA Therapy SIS-101-ADO Orphan Drug Designation and Rare Pediatric Disease Designation for the Treatment of Autosomal Dominant Osteopetrosis

Retrieved on: 
Monday, May 15, 2023
Bone, Osteopetrosis, Therapy, Paratriathlon, RNA, Transfection, Small RNA, Pain, CLCN7, Hydrolysis, Patient, Anomaly, Orphan, Silicon, Birth, Osteoclast, FDA, Particle size, Scoliosis, ADO, Pharmaceutical industry, Vaccine

In addition, due to the serious manifestations of this rare skeletal disorder in children, SIS-101-ADO has been granted Rare Pediatric Disease Designation for the treatment of Autosomal Dominant Osteopetrosis.

Key Points: 
  • In addition, due to the serious manifestations of this rare skeletal disorder in children, SIS-101-ADO has been granted Rare Pediatric Disease Designation for the treatment of Autosomal Dominant Osteopetrosis.
  • FDA Orphan Drug Designation provides SiSaf with incentives such as tax credits for clinical trials, exemption from user fees, and expanded marketplace exclusivity.
  • The Rare Pediatric Disease Designation entitles SiSaf to apply for a priority review voucher that can be used to have the drug approval process expedited by the FDA.
  • SiSaf’s Founder and CEO, Dr. Suzanne Saffie-Siebert, said, “Being granted Orphan Drug Designation and Rare Pediatric Disease Designation is a major milestone in our drive to move our revolutionary siRNA treatment forward to alleviate the pain and suffering that Osteopetrosis ADO2 inflicts.

NEW DATA FROM AMGEN'S PROLIA® (DENOSUMAB) DEMONSTRATES SIGNIFICANT REDUCTION IN OSTEOPOROTIC FRACTURE RISK COMPARED TO ALENDRONATE

Retrieved on: 
Monday, May 8, 2023
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THOUSAND OAKS, Calif., May 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia® (denosumab) injection reduced fracture risk in patients versus oral alendronate, a frequently prescribed bisphosphonate treatment. Treatment with Prolia was also associated with greater reductions in fracture risk over time. The data were presented during an oral presentation at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), in Barcelona, May 4-7, 2023.

Key Points: 
  • Treatment with Prolia was also associated with greater reductions in fracture risk over time.
  • The data were presented during an oral presentation at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), in Barcelona, May 4-7, 2023.
  • The study's results showed that Prolia reduced the relative risk of fracture across various fracture types.
  • These findings provide important insights into the effectiveness of Prolia versus oral alendronate on osteoporotic fracture outcomes in post-menopausal women with osteoporosis at high risk for fracture using real-world data.

Hospital for Special Surgery Research Institute Kyung-Hyun Park-Min, Ph.D., Discovers Therapeutic Targets for Treatment of Patients with Osteoporosis and Rheumatoid Arthritis

Retrieved on: 
Tuesday, December 20, 2022
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NEW YORK, Dec. 20, 2022 /PRNewswire/ -- Hospital for Special Surgery's. Kyung-Hyun Park-Min, Ph.D., Lead Researcher, was published in Cellular & Molecular Immunology for her team's work in identifying human osteoclast-specific signatures as new therapeutic targets for Antisense Oligo (ASO) therapy.

Key Points: 
  • Kyung-Hyun Park-Min, Ph.D. , Lead Researcher, was published in Cellular & Molecular Immunology for her team's work in identifying human osteoclast-specific signatures as new therapeutic targets for Antisense Oligo (ASO) therapy.
  • Their findings lead them to believe that ASO therapy could be used to target bone diseases associated with hyperactive osteoclasts, including osteoporosis and rheumatoid arthritis.
  • This is impactful as an estimated 1.3 million Americans have Rheumatoid Arthritis (RA) and suffer from the disease's debilitating symptoms.
  • Dr. Park-Min shared, "While regulators of osteoclast formation are well defined, the cell-specific regulatory mechanism controlling osteoclasts remains fairly unknown.