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☆ Miami man pleads guilty to selling adulterated, misbranded HIV drugs across U.S.
▼ + stars: | 2023-09-26 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

A Miami man has pleaded guilty in federal court to distributing adulterated HIV drugs dispensed to U.S. patients. A Miami man pleaded guilty to distributing as much as $25 million worth of misbranded and adulterated HIV drugs that were dispensed by pharmacies across the U.S. to unsuspecting patients, federal prosecutors said. Herrera pleaded guilty in U.S. District Court in Miami on Monday to one count of conspiracy to introduce adulterated and misbranded drugs in the U.S. market, court filings show. Prosecutors said the wholesalers were involved in the criminal scheme, but the pharmacies were unaware that the drugs were altered or misbranded. The adulterated and misbranded drugs included Truvada, Biktarvy and other unnamed medications.

Persons: Armando Herrera, Herrera, Prosecutors Organizations: Miami, Gilead Sciences Locations: U.S, Miami, Texas , California, Washington

But Mintz also acknowledges that having more places to access PrEP likely will not be enough to substantially increase its use in more vulnerable communities. “There needs to be a couple of levers that need to be pulled for everybody to access PrEP who are eligible to access PrEP,” Mintz says. (Joe Raedle/Getty Images)Meanwhile, a pending ruling in a federal appellate court looms as a threat that could more broadly undermine PrEP coverage. “We don’t know what the 5th Circuit could do.”In the wake of the March court ruling, insurers expressed support for preventive services. “Right now, PrEP uptake is quite good among gay white men, but among people of color and among women PrEP access is quite limited,” Dawson says.

Persons: Apretude, ”, Omar Martinez Gonzalez, Sean Bland, we’re, ” Bland, Truvada, ” Martinez Gonzalez, Laura Mintz, Mintz, ” Mintz, Truvada –, AIDSVu, Joe Raedle, Laurie Sobel, “, ” Sobel, Lindsey Dawson, ” Dawson, Torrian Baskerville, Baskerville, ” Baskerville, who’d, Biden, Bland Organizations: U.S . Preventive Services Task Force, U.S . Food, Drug Administration, Affordable, AIDS Foundation Chicago, “, Centers for Disease Control, Santa Clara University School of Law, Georgetown University’s O’Neill Institute for National, Global Health, Blacks, PrEP, Emory University, Gilead Sciences, Black PrEP, Case Western Reserve University School of Medicine, Pride Network of, ViiV Healthcare, GlaxoSmithKline, U.S, Circuit, Appeals, Supreme, Human Rights, Navigators, Department of Health, Human Services Locations: U.S, Black, Cleveland, Gilead, –, Miami, Texas, Ohio

☆ PrEPVacc: HIV vaccine trial that could be ‘the last roll of the dice’ this decade is underway
▼ + stars: | 2023-08-28 | by ( Tom Page | Thomas Page | ) edition.cnn.com time to read: +24 min

CNN —A novel trial that has been described as “the last roll of the dice” for a generation of HIV vaccines has entered its latter stages. Nearly 40 years since HIV was identified as the cause of AIDS, and 36 years since the first HIV vaccine trial, the medical community still does not have a working vaccine. But that is not necessarily why they were chosen to participate, said Eugene Ruzagira, PrEPVacc trial director. Evaluating the combination of a trial HIV vaccine and PrEP is a first, say organizers. “I did my very first HIV vaccine trial in 1991,” recalled Weber.

Persons: PrEPVacc, ”, Jonathan Weber, Frank, Helena Herholdt, Eugene Ruzagira, Ruzagira, “, Weber, ” Ruzagira, “ We’ve, Mark Runnacles, Edward Jenner, Louis Pasteur, Galileo, Win McNamee, Humphry Davy, JEAN, SEBASTIEN EVRARD, Haydn West, Joe Raedle, ANNE, CHRISTINE POUJOULAT, Alexander Fleming, Fleming, wasn't, Louise Joy Brown, Sandy Huffaker, Daniel Acker, James Watson, Francis Crick, Rosalind Franklin, Watson, Crick, Raphael GAILLARDE, Sean Gallup, Wilhelm Conrad Röntgen, Thomas Edison's, INDRANIL MUKHERJEE, Descovy, Luwano Geofrey, Dr, Luke Dray, Geofrey, Nishanta Singh, Sharon Lewin, Lewin, “ it’s, it’s, ” Lewin, ” Geofrey Organizations: CNN, Imperial College Academic Health Science Centre, PrEPVacc, Medical Research, Uganda Virus Research Institute, European Union, Smithsonian National Museum of, Cleveland Clinic, Volvo, Bayer, U.S . Food, Drug Administration, Getty, Keystone, — Farmers, Food and Drug Administration, FDA, Bloomberg, PANTHAKY, PrEP, US Centers for Disease Control, Independent, The University of Melbourne, International AIDS Society, Muhimbili University of Health, Allied Sciences, Dar Locations: Entebbe, Uganda, Thailand, London, Mbeya, Tanzania, South Africa, Ugandan, Durban, Masaka, Salam, African, Africa, China, FPG, AFP, United States, America, U.S, Peoria , Illinois, Europe, “, Dar es Salaam, Rwanda

☆ Opinion: The good news about lower HIV infections comes with a big caveat
▼ + stars: | 2023-05-31 | by ( Opinion Lala Tanmoy Das | ) edition.cnn.com time to read: +6 min

But as of 2019, Black people accounted for 40% of people with HIV, and Hispanic and Latino people accounted for nearly 30%, according to the CDC. And shockingly, in 2021, only 11% and 20% of Black and Hispanic people, respectively, who would potentially benefit from PrEP, were prescribed it. To date, health care providers are the primary gatekeepers of PrEP prescriptions. For example, educational sessions in conferences, easily accessible virtual resources and academic journal clubs may help dispel myths among health care providers about PrEP. Several studies found that White men who have sex with men (MSM) have significantly higher PrEP awareness than Black and Hispanic MSM.

Persons: Lala Tanmoy, Tom, Das, Read, Lala Tanmoy Das Patricia Kuharic, it’s Organizations: Weill Cornell Medicine, CNN, for Disease Control, PrEP, The Joint Commission, California’s PrEP, MSM, Facebook, Pride Month, FDA, Twitter Locations: New York, White, Black

☆ Gilead Sciences didn't violate government patents on HIV prevention treatment, jury finds
▼ + stars: | 2023-05-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

The logo of Gilead Sciences pharmaceutical company is seen in Oceanside, California, April 29, 2020. A Delaware jury on Tuesday cleared Gilead Sciences of U.S. government allegations that it violated patents held by the Centers for Disease and Prevention on an HIV prevention drug. The U.S. government had sued Gilead in 2019 arguing that the company was profiting off CDC patents through the company's sales of Truvada and Descovy, oral medications taken to prevent HIV infection. But the jury found that the government's patent claims on an HIV prevention regimen called pre-exposure prophylaxis, or PrEP, were not valid after a multiday trial in federal court. "Today's decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it," Gilead general counsel Deb Telman said in a statement Tuesday.

☆ U.S. Loses Key Case on Rights to H.I.V.-Prevention Drugs
▼ + stars: | 2023-05-09 | by ( Rebecca Robbins | ) www.nytimes.com time to read: +1 min

A federal jury in Delaware on Tuesday found that the federal government did not have an ownership claim to lucrative drugs to prevent H.I.V. The Trump administration brought the lawsuit in 2019 in part because of concern over the high price Gilead was charging. The two versions of the drug — Truvada and the newer Descovy — have generated huge profits for Gilead. Lawyers for the federal government had argued that Gilead had violated three government patents that protected the concept of using Truvada to prevent H.I.V. The patents were granted to researchers at the Centers for Disease Control and Prevention for inventions stemming from experiments they conducted on monkeys in the mid-2000s.

☆ Gilead Sciences battles U.S. government in court over HIV prevention patent
▼ + stars: | 2023-05-02 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The U.S. is trying to enforce four patents issued to the Centers for Disease Control and Prevention on a two-drug regimen known as pre-exposure prophylaxis, or PrEP for short. The government accuses Gilead of reaping billions of dollars in PrEP sales without paying royalties to the CDC. Gilead has rejected U.S. allegations that the company's sales of its PrEP oral medications, Truvada and Descovy, infringe on any CDC patents. "Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC." Gilead rejects CDC claims that agency scientists developed the the PrEP regimen.

Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it. The government received four patents for HIV prevention drug regimens that CDC researchers invented. Its lawsuit claims the patents also cover Gilead's pre-exposure prophylaxis (PrEP) drug regimen for lowering HIV infection risk. The U.S. Food and Drug Administration approved Gilead's Truvada for HIV prevention in 2012 and approved its related drug Descovy for the same purpose in 2019. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.

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