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The Trump administration’s newly negotiated trade deal with Canada and Mexico threatens to keep American drug prices high, two dozen-plus consumer, health, trade and other organizations warned this week in a letter to the U.S. Trade Representative. Read More
The FDA may accept safety analyses drawn and projected out from pooled clinical trial data as long as sponsors have carefully planned their evaluations and are willing to show their work, the agency says in new draft guidance issued Tuesday. Read More
The FDA released final guidance Tuesday for sponsors of fixed-combination hypertension drugs, with several clarifications of the draft document. Read More
Importing prescription drugs to cut U.S. drug prices and improve access to medicines poses safety risks, the Council for Affordable Health Coverage (CAHC) argued, warning the FDA against expanded drug importation policies. Read More
Novartis subsidiary Sandoz abandoned its pursuit of U.S. approval for its biosimilar of Roche’s blockbuster cancer drug Rituxan (rituximab) and said it plans to focus on other products in the biosimilar pipeline. Read More
FDA Commissioner Scott Gottlieb defended the FDA’s approval of a powerful opioid that critics say is more addictive and susceptible to diversion than fentanyl — and said the agency plans to consider the merits of any new drug along with efforts to address the opioid epidemic. Read More