• RoundupsRoundups

    Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Analysis of Paclitaxel-Coated Device Data Finds no Safety Signal   The Therapeutic Goods Administration (TGA) has analyzed Australian adverse event data on patients with paclitaxel-coated devices in light of a meta-analysis published last year. The meta-analysis found a link between the devices and increased risk of death, but no safety signal was seen in the TGA...
  • Regulatory NewsRegulatory News

    Early FDA Review Finds Increased Mortality for Some Treated With Paclitaxel-Coated Devices

    The US Food and Drug Administration (FDA) said Friday that a preliminary review of long-term follow-up data has identified a “potentially concerning signal of increased long-term mortality” in study subjects treated for peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents when compared to patients treated with uncoated devices. “Of the three trials with 5-year follow-up data, each showed higher mortality in subjects treated with pacl...