FDA Approves HIV-Prevention Drug That Nearly Eliminated the Virus's Spread in Clinical Trials
Gilead Sciences announced June 18 that the Food and Drug Administration (FDA) has approved its twice-a-year shot to prevent HIV, with company executives touting the medication as a 'very real opportunity' at ending the HIV epidemic.
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Yahoo
2 hours ago
- Yahoo
Gilead's twice-yearly HIV prevention injection gets FDA approval
The US Food and Drug Administration has approved Gilead's (GILD) new HIV prevention drug. The drug, lenacapavir, only requires an injection every 6 months. Yahoo Finance Healthcare Reporter Anjalee Khemlani reports the details. To watch more expert insights and analysis on the latest market action, check out more Market Domination Overtime here. What's a big milestone for Gilead Sciences today. The Biotech Giant securing FDA approval for its latest HIV treatment. It's a significant step forward for that company and patients. Gilead also seeing a boost on that news. Our senior health reporter Anjali kamlani joins us now. Au, what is what is the big takeaway for for investors watching all this? Yeah, I think the big takeaway here is that investors have actually been waiting for this approval. They anticipate quick uptake and a high volume of uptake of this drug used as a pre-exposure prophylaxis, you know, prep as the common acronym for those types of drugs. Now, Gilead already has discovy for that, but the difference here is that this new use or new approval for Lenca Paviar, it is a twice yearly injectable. And that is the difference between the regular oral and this new approval. And so that is really going to help boost Gilead's revenues for the year. We know that already Lenca Paviar brings in about $60 million for the company, and they're anticipating that that will get boosted to about $150 to $195 million in revenue for the company for the year. That's the estimate that analysts are expecting with the approval, and they've been waiting for this approval for quite some time. So really good news. You can see that, you know, the stock is benefiting from this right now and is supposed to be a game changer for those patients. There are some questions about whether or not being a twice yearly drug, it will be more expensive than say a daily oral. And so that is something that Gilead has tried to addressing that they plan to have a insurance and non-insurance access point for patients as well. Thanks so much for joining us on this. Appreciate it. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
2 hours ago
- Yahoo
Urgent Nationwide Recall Issued on This Popular Item Sold at Aldi—Here's What to Know
Urgent Nationwide Recall Issued on This Popular Item Sold at Aldi—Here's What to Know originally appeared on Parade. From morning coffee to vitamins, there are plenty of must-have's that help set up a successful daily routine. In fact, according to Johns Hopkins Medicine, a whopping 50% of American adults take a multivitamin, vitamin or mineral supplement regularly. If you happen to be part of that group of consistent vitamin takers though, you'll want to double check your medicine cabinet. Because one lot of B12 vitamins is being voluntarily recalled by Vita Warehouse Corp thanks to the potential presence of undeclared peanuts. 🍳 SIGN UP to get delicious recipes, handy kitchen hacks & fun food news in our daily Pop Kitchen newsletter 🍳 Considering these Welby, Berkley Jensen and VitaGlobe vitamins are also sold by some of the most popular retailers like ALDI and Amazon, there's a good chance shoppers may unknowingly have a bottle. According to a company announcement shared by the U.S. Food and Drug Administration, this recall affects one lot of Aldi Welby B12 Energy Support gummies, Berkely Jensen B12 Vitamin gummies and Vitamin B12 Extra Strength gummies. The FDA warns that 'people with an allergy or severe sensitivity to peanuts run the potential risk of serious or life-threatening allergic reactions,' if they take these no illnesses or allergic reactions have been reported so far. The undeclared peanuts were actually discovered by ALDI. After conducting routine testing per its standard protocol, one of the tests 'indicated a potential presence of a peanut allergen.' While internal testing done by Vita Warehouse Corp. 'verified the absence of peanuts," the recall was issued out of caution. So, how do you know for sure if you have one of the affected vitamins? There are a few key ways. First, these were sold nationwide at ALDI and BJ's in-store. They were also sold online on ALDI's, BJ's and VitaGlobe's websites and on Amazon. Additionally, each product will have an expiration date of October 2026. The company says that each of the affected vitamins have the following UPC codes and Lot numbers. Aldi Welby: clear bottle with white cap, using green, red, and white labeling. UPC Code: 4099100290868 Lot #: 248046601* Berkeley Jensen: clear bottle with white cap, using red and pink labeling. UPC Code: 888670132487 Lot #: 248046601* VitaGlobe: clear bottle with white cap, using white and red labeling. UPC Code: 850005214670 Lot #: 248046601* The Lot codes and expiration dates can all be found printed on the bottom of each bottle. The FDA urges consumers who have a peanut allergy to return or throw away any affected vitamins ASAP. Customers who do return them can expect a full refund from the original store of purchase. Those with further questions can contact Vita Warehouse at 1-855-214-0100 Monday through Friday from 7:30 am to 4 pm Nationwide Recall Issued on This Popular Item Sold at Aldi—Here's What to Know first appeared on Parade on Jun 18, 2025 This story was originally reported by Parade on Jun 18, 2025, where it first appeared.
The Hill
3 hours ago
- The Hill
The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it
WASHINGTON (AP) — The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. 'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' twice a year to keep up their protection. Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain. Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere. About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners. A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV. Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up. 'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities. 'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.' Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs. Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute. Schmid worries the shot won't meet its potential because 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.' Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten. Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 'it will change nothing.' And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America. 'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.' ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
