Drugs

Gilead Fights Government Patents on Truvada Research

A Washington Post article reports that Gilead Sciences is fighting to prevent the U.S. government from reaping any financial benefit for discovering a use for an HIV drug on which the company makes $3 billion annually. Federal grants from the Centers for Disease Control funded research that proved Gilead’s Truvada was effective in preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead.

Gilead argues that the government’s patents for Truvada for preventing HIV are invalid, and the government has failed to reach a deal for royalties or other concessions from the company. “With the amount of effort and time and taxpayer money that went into it, for CDC and Gilead not to come to an agreement, so the taxpayer could get some of that money, is really unconscionable,’’ said one researcher involved with the therapy.

As the Post notes, this current standoff between the CDC and a drug company over patent rights raises a big question for the Trump administration: How aggressively should the government attempt to enforce its patents against an industry partner? And activists want the government to take a more aggressive stance against Gilead. Their complaints are part of a broader wave of anger over drug companies reaping hefty financial rewards by capitalizing on taxpayer-funded research.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome