Category: North America

May 4, 2017 Off

FDA takes Pfizer’s sNDA for psoriatic arthritis drug

By Dino Mustafić

United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily (BID) and XeljanzXR extended release 11 mg once daily use the treatment of adult patients with active psoriatic arthritis (PsA).

April 25, 2017 Off

Bristol-Myers and Transgene testing combination of their cancer drugs

By Dino Mustafić

Bristol-Myers Squibb and Transgene have entered a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1.