Tags : Osteoarthritis

Pfizer and Eli Lilly Report the US FDA Acceptance of

Shots: The US FDA has accepted to review a BLA for tanezumab (2.5 mg, SC), being evaluated for patients with chronic pain due to mod. to sev. OA with inadequate pain relief with other analgesics The regulatory submission is based on data from 39 P-I-III clinical studies assessing tanezumab in 18,000 patients, including three P-III […]Read More

Pfizer & Eli Lilly Report Results of Tanezumab in Long-Term

Shots: The P-III A4091058 study involves assessing of Tanezumab (2.5 & 5mg, q8w) vs NSAIDS (naproxen 500 mg/celecoxib 100 mg/diclofenac extended release 75 mg, q2d) in 3,021 patients with moderate-to-severe OA in ratio 1:1:1 for 56wks. across globe + 24-week safety follow-up study The P-III A4091058 results: composite 1EPs for safety (3.8% & 7.1% vs […]Read More

Pfizer and Eli Lilly Report Results of Tanezumab in P-III

Shots: The P-III OA study involves assessing of tanezumab (2.5mg/5mg, SC) vs PBO in 849 patients in the ratio (1:1:1) with moderate-to-severe OA pain of the knee or hip across EU and Japan for 24 wks. The study showed a meeting in all 1EPs improvement in pain, physical function with well-tolerated results and has shown […]Read More

FDA Reports Newly Added Guidelines for Drug and Device Makers

Shots: Opioid Abuse – Giving special priority to medication-assisted treatment(MAT) for patients to develop novel medicines for treatment of opioid use disorder encouraging drug sponsors to adapt new processes for evaluating effect and clinical benefit of MAT Depression– Plans to examine the onset of action of MDD for long-term or short- term usage; including those […]Read More