Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration, leading to increased bone fragility and fracture risk.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
Q1 2026 sleep medicine trends include broader use of AI, expanding obstructive sleep apnea and narcolepsy treatments, and policy changes affecting reimbursement and access.
Biocon has launched denosumab biosimilars Bosaya and Aukelso in the United States following FDA approval with interchangeable designation. The products target osteoporosis and bone metastases, entering a market where denosumab products generated approximately $5 billion in U.S. sales in 2024. The launch represents a strategic expansion of Biocon's biosimilar portfolio amid competitive market conditions.
Recent studies examine self-management strategies for breast cancer treatment-related cardiotoxicity and highlight risks of vertebral fractures after discontinuing denosumab therapy in patients receiving aromatase inhibitors.
The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
New research links GLP-1 drugs like Ozempic to increased scurvy risk through appetite suppression and poor nutrition. University of Florida researchers are testing a GLP-1 implant for obese cats as feline obesity affects nearly 60% of US cats.
The FDA has approved labeling changes to six menopausal hormone therapy products, removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia that had been in place since 2003.
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07597850 |
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status |
RECRUITING | PHASE2 |
| NCT07595991 |
Post-osteoporotic Fracture Exercise Program |
NOT_YET_RECRUITING | NA |
| NCT07594639 |
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP) |
NOT_YET_RECRUITING | |
| NCT07584785 |
Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly |
COMPLETED | NA |
| NCT07546552 |
Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis |
RECRUITING | NA |
| NCT07538167 |
Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults |
NOT_YET_RECRUITING | NA |
| NCT07512453 |
Study in Patients With Osteoporosis and Fragility Fractures to Estimate the Extent and Impact of Delayed Administration of Anti-fracture Therapy |
NOT_YET_RECRUITING | |
| NCT07508553 |
Comparison of Bone Mineral Density in the Third Trimester Between Women in Singleton and Twin Pregnancies Using Questionnaires and REMS Densitometric Examination |
RECRUITING | NA |
| NCT07487688 |
Five-Year CT Follow-Up of Vertebral Fracture Risk Using Opportunistic Osteoporosis Screening |
COMPLETED | |
| NCT07474571 |
Evaluation of Musculoskeletal Aging and Related Disorders Via Advanced Clinical Imaging |
RECRUITING |
