News That Matters

Tag: setback

Promising new drug for aggressive stage IV breast cancer encounters setback

Promising new drug for aggressive stage IV breast cancer encounters setback

Health
Federal approval of a highly anticipated breast cancer drug was delayed by the Food and Drug Administration this week. The drug, sacituzumab govitecan, which is produced by Immunomedics, was previously designated a "breakthrough therapy" by the FDA “based on preliminary evidence that it demonstrates substantial improvement over existing therapies for a life threatening disease.” According to Michael Pehl, president and CEO of Immunomedics, the reason the medication was not approved for wide availability was due to “issues...exclusively focused on chemistry, manufacturing and control matters” and that “no new clinical or preclinical data need[s] to be generated.” He added, “We are going to request a meeting with the FDA as soon as possible &hell...
Mid-term elections: Democrats win House in setback for Trump

Mid-term elections: Democrats win House in setback for Trump

World
Media playback is unsupported on your device The Democrats have taken control of the US House of Representatives in the mid-term elections, dealing a blow to President Donald Trump.A Democratic majority in the lower chamber for the first time in eight years will restrict his ability to steer his programme through Congress.But Mr Trump's Republicans are set to strengthen their grip on the Senate.Tuesday's vote was seen as a referendum on a polarising president, even though he is not up for re-election till 2020.The election confirms a historical trend for the party that is not in the White House to make gains in the mid-terms. Media playback is unsupported on your device House Democratic leader Nan...