A sign of Gilead Sciences stands next to its headquarter, surrounded by shrubs — biotech coverage from STAT
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Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

Now that Gilead Sciences has won U.S. regulatory approval for its groundbreaking HIV prevention drug, the company has another hurdle to clear — ensuring the medicine can be accessed in low-income countries where the disease remains a stubborn problem.

As far as Gilead is concerned, the groundwork exists to meet that goal.

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Last October, the drugmaker reached voluntary licensing agreements to eventually make lenacapavir available in 120 mostly low- and lower-middle-income countries. Then, the President’s Emergency Plan for AIDS Relief, or PEPFAR, and the Global Fund to Fight AIDS, Tuberculosis, and Malaria crafted an arrangement to cover dosing for 2 million people over three years in numerous poor countries.

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