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Liver disease progression is an important endpoint, but assessing it can be challenging as the endpoints can occur infrequently until late in the course of chronic HBV progression. Read More
The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it. Read More
The European Medicines Agency issued an updated action plan to encourage advanced therapy medicinal products (ATMPs) — including the release by year’s end of draft guidelines for clinical trial sponsors. Read More
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as long as sponsors have carefully planned their evaluations and are willing to show their work, the agency says in new draft guidance issued Tuesday.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