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The Journal of the American Heart Association (JAHA) published an article in December saying that paclitaxel-coated balloons and stents manufactured by Boston Scientific and others had an increased risk of death.
As opioid lawsuits continue to wind through the courts, some drugmakers are focused on developing treatments for opioid addiction.
The partial government shutdown is 31 days old, yet the U.S. Food and Drug Administration has maintained a steady list of drug approvals throughout that time. However, that approval rate could change next month.
The U.S. Food and Drug Administration (FDA) approved South Korea’s Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab).
Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee had a split vote, 8 to 8, on whether the overall benefits of Zynquista (sotagliflozin) outweiged the risk in order to support approval. This sends things back to the agency to make a final decision, which has a target action date of March 22, 2019.
Immunomedics was hoping for a green light from the U.S. Food and Drug Administration for its triple-negative breast cancer treatment, sacituzumab govitecan. However, this morning the company announced that approval will not likely be coming any time soon.
The Food & Drug Law Institute (FDLI) is pleased to announce the addition of two new members to the Board of Directors: Cathy Burgess, Partner, Alston & Bird; and Carla Cartwright, Director, Global Regulatory Policy, Johnson & Johnson.
This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.”
Although that is good news, cancer is the second-most common cause of death in the U.S., with more than 1.7 million new cancer cases each year and more than 600,000 cancer deaths. The report notes that one of the biggest factors in decreased cancer rates are lower tobacco smoking rates.
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