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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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Teva and Regeneron Announce Positive Results from Phase 3 Trial of Fasinumab in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

JERUSALEM & TARRYTOWN, N.Y.–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary …

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Pfizer and Lilly Announce Positive Top-Line Results from Late-Stage Trial of Tanezumab for Treatment of Osteoarthritis Pain

NEW YORK, & INDIANAPOLIS–(BUSINESS WIRE)–Pfizer Inc.(NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses …

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Anika’s Drug Combo Fails to Meet Primary Endpoint in Phase 3 Trial in Knee Osteoarthritis

BEDFORD, Mass.–(BUSINESS WIRE)–Jun. 19, 2018– Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (HA) technology platform, today announced results from its CINGAL® 16-02 clinical trial, an active-comparator Phase III study being conducted to support U.S. registration. CINGAL has previously been evaluated …

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Centrexion Therapeutics’ CNTX-4975 Receives Fast Track Designation from the FDA for Treatment of Knee Osteoarthritis Pain

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975 for the treatment of pain associated with knee osteoarthritis. CNTX-4975, Centrexion’s Phase 3 ready lead therapy, is a …

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Ampio Pharmaceuticals Announces Positive Late-Stage Results for its Knee Osteoarthritis Drug

ENGLEWOOD, Colo., Dec. 14, 2017 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today reported that the Phase 3 clinical trial of Ampion™ met its primary endpoint with 71% of Ampion™ treated patients meeting the OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment …

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Bioventus Receives FDA Approval for Durolane for Treatment of Pain Associated with Knee Osteoarthritis

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has received US FDA approval for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis (OA). Hyaluronic acid is a naturally occurring molecule that provides the lubrication and …

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Servier Licenses GLPG1972 in Osteoarthritis from Galapagos

28 July 2017 – As a result of their research collaboration, Servier announces today that it has exercised its option to develop novel osteoarthritis molecule GLPG1972/S201086 from Galapagos NV (Euronext/NASDAQ: GLPG), thus obtaining global commercial rights outside the U.S. Osteoarthritis (OA) is a highly prevalent and disabling pathology, considered as …

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Anika Therapeutics’ Cingal Wins CE Mark Approval for Pain Associated with Osteoarthritis of the Knee

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid “HA” technology, today announced that it received CE Mark approval for CINGAL® as a medical device to treat pain associated with osteoarthritis of the knee. CINGAL is the …

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