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Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Novo Nordisk and Eli Lilly are duking it out in the market, but dozens of competitors are waiting in the wings.
US FDA releases two letters on the same day citing two different kinds of advisements for two different kinds of products, but both with a classic problem: overstatement of efficacy. And while sending multiple letters at once can be seen as bid to draw attention to its enforcement action, the move also underscores just how few letters the agency has been sending lately.
BMS, which acquired MyoKardia in 2020 months after LianBio acquired rights in certain Asia-Pacific territories, said the deal would help expand its footprint in China.
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