FDA Deals Setback To CytoDyn's HIV Drug; Gilead Reprimanded By British Firms For HIV Drug Claims

The Food and Drug Administration's refusal to accept CytoDyn's drug application could cause a lengthy setback for the drug. Meanwhile, Britain's pharmaceutical trade group spoke out against Gilead for disseminating information that unfairly compared one of its HIV drugs with a rival medicine sold by ViiV Healthcare, which is working toward an injectable medicine that prevents AIDS.

Stat: FDA Refuses Application For HIV Drug From CytoDyn

The Food and Drug Administration refused to accept an application seeking the approval of a drug to treat HIV from CytoDyn — a setback that could delay a decision for months, if not years. The so-called Refuse-to-File letter, issued by the FDA against CytoDyn’s drug called leronlimab, is also the most damning evidence yet that CEO Nader Pourhassan and other company executives might be misleading investors. (Feuerstein, 7/13)

Stat: Gilead Scolded Again For Misleading Information About Rival HIV Drug

For the second time in less than two years, Gilead Sciences (GILD) has been reprimanded by a U.K. pharmaceutical industry trade group for disseminating information that unfairly compared one of its HIV drugs with a rival medicine sold by ViiV Healthcare. But this time, the drug maker was slammed for being a repeat offender and discrediting the entire industry. (Silverman, 7/13)

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