Tags : Osteoarthritis

Biotech

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5

Shots: Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program Two P-I studies were completed with M6495 where NCT03224702 in healthy volunteers demonstrated safety and tolerability and reduction of […]Read More

Biotech

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

Pharma

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

Pharma

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