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Bioventus to Co-Develop Next Generation Placental Tissue Product for Knee Osteoarthritis with MTF Biologics

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, has entered into a development collaboration agreement with MTF Biologics, the world’s largest tissue bank, to co-develop a next generation placental tissue product for the treatment of painful musculoskeletal conditions, with an initial focus on knee osteoarthritis (OA). Terms of the agreement were …

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Flexion Announces Publication of Analysis of Patients with Unilateral Knee OA from Pivotal Trial of Zilretta

BURLINGTON, Mass., April 24, 2019 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the results from a post-hoc analysis of data from the pivotal Phase 3 trial of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) were published in Advances in Therapy. The findings indicated that patients with unilateral osteoarthritis (OA) …

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Pfizer and Lilly Announce Top-Line Results from its Long-Term Phase 3 Study of Tanezumab in Osteoarthritis Patients

NEW YORK & INDIANAPOLIS–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory …

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Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain

Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at …

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Ampio Updates Status of Osteoarthritis Pivotal Clinical Trial of Ampion to be Carried Out Under a Special Protocol Assessment

ENGLEWOOD, Colo., Feb. 6, 2019 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it had received an initial response from the U.S. Food and Drug Administration (FDA), Office of Tissue and Advanced Therapies division regarding the Company’s submission of a proposed trial design for the treatment of KL4 …

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Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain

NEW YORK & INDIANAPOLIS–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain. The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 …

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Sorrento Announces Positive Interim Results from Phase 1b Trial of Resiniferatoxin in Patients with Osteoarthritis Knee Pain

SAN DIEGO, Jan. 22, 2019 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”) announced that the phase 1b study of its non-opioid, afferent nerve ablating drug candidate (resiniferatoxin or “RTX”) for the treatment of pain from osteoarthritis in the knee (intra-articular route of administration) interim data analysis of over …

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Flexion Submits sNDA to FDA for Zilretta Aiming to Revise Product Label with New Data Indicating Repeat Administration was Safe and Well Tolerated

BURLINGTON, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to revise the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension). The sNDA is based on data from an …

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FDA Grants Fast Track Designation to Galapagos’ Investigational Disease-Modifying Osteoarthritis Drug

Mechelen, Belgium; 27 November 2018, 22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of patients with osteoarthritis (OA). The US Food and Drug Administration’s (FDA’s) Fast Track program is designed to facilitate the development and expedite the …

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Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients

NEW YORK & INDIANAPOLIS–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced complete results from a Phase 3 study evaluating the efficacy and safety of subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, in patients with osteoarthritis (OA) pain treated for 16 weeks. The study met …

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