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    FDA approves Gilead’s twice-yearly HIV prevention injection, offering a powerful and convenient new option

    The Food and Drug Administration approved Gilead’s twice-yearly antiviral drug for preventing HIV.
    The company and some experts say it is a milestone that could help bring the world closer to ending the decadeslong epidemic caused by the virus. 
    But the launch of the injectable drug, lenacapavir, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts. 

    Mike Blake | Reuters

    The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus. 
    But the launch of the injectable drug, which will be marketed under the name Yeztugo, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts. 

    In two groundbreaking clinical trials in 2024, Gilead’s injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That’s a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month. 
    That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. 
    The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O’Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.
    “It’s hard to overstate the importance of this for global public health,” O’Day said, adding that the injection “really will bend the arc of the epidemic as we roll this out across the globe.”
    But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. 

    Pricing, access, efficacy

    Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance, a Gilead spokesperson said in an email. That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. 
    A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year. One dose of GSK’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.
    “We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,” the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options.
    The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.
    Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year.
    Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment.
    O’Day said the company is also committed to supplying the drug for that use globally as the virus “knows no boundaries.” Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.
    Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O’Day said. 
    PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men.
    Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu, a public resource for HIV surveillance data from Gilead in partnership with Emory University’s Rollins School of Public Health.
    “Unfortunately, there’s still enormous amount of stigma and cultural challenges when it comes to HIV prevention,” Johanna Mercier, Gilead’s chief commercial officer, said in an interview. “Getting a twice-a-year injection really gives you that privacy that people have been looking for.”
    She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the company’s injection.
    In one late-stage trial, 99.9% of patients who took Gilead’s injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead’s daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth.
    Another trial, on more than 5,000 cisgender women, found that none of the roughly 2,000 participants who received Gilead’s injection contracted an HIV infection, demonstrating 100% efficacy. 

    Proposed federal funding cuts pose a threat

    In the U.S., ensuring access to underserved populations will also require broad insurance coverage. Most PrEP users are under commercial plans, according to the HIV+Hepatitis Policy Institute. But the federal Medicaid program is also crucial to reaching lower-income communities.
    Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults who have HIV, according to health policy research organization KFF. That makes Republicans’ proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access.
    Mercier said that, as of now, Gilead believes that Medicaid will continue to cover HIV services and support.
    “There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up,” she said, also pointing to Gilead’s programs for uninsured individuals.
    But PrEP4All’s Johnson said the “entire foundation for HIV prevention in America is under attack at this moment.”
    Other proposed federal funding cuts could make it harder to get Gilead’s injection into the hands of physicians and patients, Johnson said. For example, the White House’s proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those that are run through the CDC.
    While some funding streams are continuing, Johnson said they are doing so “in a way that would completely destabilize the entire field of HIV prevention.”
    He said if Congress does not push back on the White House’s proposed cuts, people currently taking PrEP “could start to slip off” and HIV infections could rise in many communities.  More

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    Nike pushes back Skims launch with Kim Kardashian due to production delays

    Nike is delaying the launch of its highly anticipated NikeSKIMS activewear line, according to a person familiar with the matter.
    The companies do not have a new launch date, but they are expecting to debut the apparel later this year.
    Nike is betting big that the popular Skims brand will reinvigorate the brand.

    NikeSKIMS, a new brand from Nike Inc. and SKIMS.
    Courtesy: NikeSKIMS

    Kim Kardashian fans are going to have to wait a little longer for the highly anticipated NikeSKIMS line.
    The activewear line will launch later this year instead of in the spring, like the companies had originally announced, because of production delays, according to a person familiar with the matter who requested anonymity to speak candidly. The person added that the delays are internal and not because of a supplier or shipping issue.

    No date has been determined for the new launch date, the person added.
    The person also said the relationship with Kardashian and the brand is still strong and that everyone is on the same page, but they want to make sure they take their time and get the products right.

    Nike and SKIMS collaboration featuring Kim Kardashian, co-founder and chief creative officer of SKIMS.
    Courtesy: Nike Inc.

    Nike first announced the Skims partnership in February and said it would include apparel, footwear and accessories. Since then, Heidi O’Neill, one of the key leaders behind the partnership, has left the company.
    New Nike CEO Elliott Hill has been betting big on the Skims brand as he looks to reinvigorate the company after recent declines in sales and its business. For Skims, which was last valued at $4 billion, the partnership with Nike brings a growth opportunity as it expands into athleisure.
    Nike’s stock is down more than 20% year to date.

    “The origin of NikeSKIMS is rooted in a desire to bring something new and unexpected to an industry that is craving something different, and to invite a new generation of women into fitness with disruptive product designed to meet their needs in both performance and style,” the company said about the line when they introduced it.
    The news was first reported by Bloomberg.

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    Fed holds key rate steady, still sees two more cuts this year

    The Federal Reserve kept its key borrowing rate targeted in a range between 4.25%-4.5%, where it has been since December.
    However, the central bank expects inflation to remain elevated and sees lower economic growth ahead.
    Still, the Federal Open Market Committee expects to make two rate reductions later this year, according to the closely watched “dot plot.”

    WASHINGTON – The Federal Reserve on Wednesday kept interest rates steady amid expectations of higher inflation and lower economic growth ahead, and still pointed to two reductions later this year.
    With markets expecting no chance of a central bank move this week, the Federal Open Market Committee kept its key borrowing rate targeted in a range between 4.25%-4.5%, where it has been since December.

    Along with the rate decision, the committee indicated, through its closely watched “dot plot,” that two cuts by the end of 2025 are still on the table. However, it lopped off one reduction for both 2026 and 2027, putting the expected future rate cuts at four, or a full percentage point.
    The plot indicated continued uncertainty from Fed officials about the future of rates. Each dot represents one official’s expectations for rates. There was a wide dispersion on the matrix, with an outlook pointing to a fed funds rate around 3.4% in 2027.
    Seven of the 19 participants indicated they wanted no cuts this year, up from four in March. However, the committee approved the policy statement unanimously.
    Economic projections from meeting participants pointed to further stagflationary pressures, with participants seeing the gross domestic product advancing at a 1.4% pace in 2025 and inflation hitting 3%.

    GDP forecast comes down

    The revised forecasts from the last update in March represented a decrease of 0.3 percentage point for GDP and an increase of the same amount for the personal consumption expenditures price index. Core PCE, which eliminates food and energy prices, was projected at 3.1%, also 0.3 percentage point higher. The unemployment outlook saw a small revision, up to 4.5%, or 0.1 percentage point higher than March and 0.3 percentage point above the current level.

    The FOMC statement changed little from the May meeting. Broadly speaking, the economy grew at a “solid pace,” with “low” unemployment and “somewhat elevated” inflation, the committee said.
    Moreover, the committee indicated less concern about the gyrations of the economy and the clouds over White House trade policy.
    “Uncertainty about the economic outlook has diminished but remains elevated. The Committee is attentive to the risks to both sides of its dual mandate,” the committee said.
    During a news conference, Federal Reserve Chairman Jerome Powell suggested there is time to wait for more clarity.
    “For the time being, we are well positioned to wait to learn more about the likely course of the economy before considering any adjustments to our policies,” Powell said.
    U.S. stocks were wavering near flatline in the wake of the announcement.

    Trump pushes for rate cuts

    While the Fed’s statement did not elaborate on why uncertainty has ebbed, President Donald Trump has eased some of his fiery trade rhetoric and the White House is in the midst of a 90-day negotiating period over tariffs.
    Trump’s rhetoric toward the Fed, however, has not softened.
    Earlier Wednesday, the president again slammed Powell and his colleagues for not easing. Trump said the fed funds rate should be at least 2 percentage points lower and derided Powell as “stupid” for not pushing the committee to cut.
    Fed officials have been reluctant to move, fearful that tariffs Trump implemented this year could cause inflation in the coming months. Price gauges so far have not indicated that the duties are having much of an impact. A delay in feed-through of the tariffs along with softening consumer demand and a buildup of inventories ahead of the April 2 “liberation day” announcement have helped deflect their impact.
    “Everyone that I know is forecasting a meaningful increase in inflation in coming months from tariffs because someone has to pay for the tariffs,” Powell said.
    The conflict between Israel and Iran adds another wild card to the policy mix, with prospects of higher energy prices a potential additional factor in keeping the Fed from cutting. The statement did not mention influence from the Middle East fighting.
    A gradually softening economy could provide incentive to cut later this year.
    Recent labor market data shows layoffs creeping higher, long-term unemployment also rising and consumers spending less. Retail sales tumbled nearly 1% in May and recent data has reflected a cooling housing market, with starts hitting their lowest level in five years.
    “Effectively they are sitting on their hands, waiting to see if tariffs increase inflation or the jobs market starts to falter, and whichever part of their dual mandate is impacted first will likely guide whichever direction they take, although the bias is still toward cutting rates (or at least keeping rates unchanged; not raising rates),” said Chris Zaccarelli, chief investment officer at Northlight Asset Management.
    Zaccarelli wasn’t surprised that rates held steady. However, he said the market was surprised by the comment that uncertainty had “diminished.”
    For Trump, though, the importance of lower rates stems from the high cost the government is paying to finance its $36 trillion debt.
    Interest on the debt is on track to total $1.2 trillion this year and exceeds all other budget items except Social Security and Medicare. The Fed last cut in December, and Treasury yields have held higher throughout the year, putting additional pressure on a budget deficit likely to approach $2 trillion, or more than 6% of GDP.
    Correction: The meeting participants expect gross domestic product to advance at a 1.4% pace in 2025. An earlier version of the story misstated the year.

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    Fed sees its preferred inflation gauge topping 3% this year, higher than previous forecast

    U.S. Federal Reserve Chair Jerome Powell speaks during a conference marking the 75th anniversary of the International Finance Division of the Federal Reserve Board in Washington, D.C., on June 2, 2025.
    Andrew Caballero-Reynolds | AFP | Getty Images

    The Federal Reserve sees inflation rising again to top 3% this year amid the uncertainty around President Donald Trump’s trade policies and intensifying geopolitical risk.
    Federal Open Market Committee participants said at their June meeting that they expect the core personal consumption expenditures price index, which excludes food and energy, to increase at a 3.1% rate in 2025, higher than their prior forecast of 2.8% in March.

    The PCE price index was at 2.1% in April, matching its lowest level since February 2021. Excluding food and energy, core PCE stood at 2.5%. The latter is a gauge Fed officials believe to be a better measure of longer-term trends.
    Central bank officials also see further slowing in economic growth, projecting the gross domestic project expanding just 1.4% this year. In March, they expected a 1.7% pace in GDP growth.
    Fed Chair Jerome Powell said in the post-meeting news conference that the recent uptick in inflation expectations could be tied to tariffs.
    “Everyone that I know is forecasting a meaningful increase in inflation in coming months from tariffs because someone has to pay for the tariffs,” Powell said. “It will be someone in that chain that I mentioned, between the manufacturer, the exporter, the importer, the retailer, ultimately somebody putting it into a good of some kind or just the consumer buying it.”
    “All through that chain, people will be trying not to be the ones who can take up the cost but ultimately, the cost of the tariff has to be paid. And some of it will fall on the end consumer,” he said.

    Fed officials have been reluctant to lower rates, worrying that Trump’s tariffs could cause inflation to reaccelerate in the coming months. The conflict between Israel and Iran adds another wild card to the policy mix, as high oil prices could prevent the Fed from easing policy. 
    Still, the so-called dot plot — which indicates individual members’ expectations for rates — showed officials see their benchmark lending rate falling to 3.9% by the end of 2025. That’s equivalent to a target range of 3.75% to 4%, pointing to two reductions later this year.
    Seven of the 19 participants indicated they wanted no cuts this year, up from four in March. Participants also see fewer cuts in 2026 and 2027.
    Here are the Fed’s latest targets from 19 FOMC members, both voters and nonvoters:

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    Here’s what changed in the new Fed statement

    This is a comparison of Wednesday’s Federal Open Market Committee statement with the one issued after the Fed’s previous policymaking meeting in May.
    Text removed from the May statement is in red with a horizontal line through the middle.

    Text appearing for the first time in the new statement is in red and underlined.
    Black text appears in both statements.

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    RFK Jr.’s new vaccine advisors will vote on flu shots containing mercury

    A revamped government panel of vaccine advisors appointed by Health and Human Services Secretary Robert F. Kennedy Jr. will soon vote on a shot preservative that contains mercury, which is safely used in some flu jabs but has been incorrectly linked to autism in the past. 
    The Advisory Committee on Immunization Practices will hear a presentation about and vote on the preservative, called thimerosal, at a planned meeting on June 26. It is unclear what will be discussed or what exactly the panel will vote on.
    It is the panel’s first meeting with Kennedy’s newly appointed members, many of whom are well-known vaccine critics.

    Health and Human Services Secretary Robert F. Kennedy Jr. and Secretary of Education Linda McMahon attend a Make America Healthy Again Commission event, in the East Room of the White House in Washington, May 22, 2025.
    Evelyn Hockstein | Reuters

    A key, revamped government panel of vaccine advisors appointed by Health and Human Services Secretary Robert F. Kennedy Jr. will soon vote on a shot preservative that contains mercury, which is safely used in some flu jabs but has been incorrectly linked to autism in the past. 
    The Advisory Committee on Immunization Practices, or ACIP, will hear a presentation about the preservative, called thimerosal, at a planned meeting on June 26. The panel will also vote on “thimerosal-containing vaccine” recommendations, according to a draft agenda for the two-day meeting posted Wednesday. 

    It is the panel’s first meeting with Kennedy’s newly appointed members, many of whom are well-known vaccine critics. He named the eight advisors last week after firing the previous 17 members of the committee, which advises the Centers for Disease Control and Prevention on vaccine policy.
    It is unclear what will be discussed in the presentation or what exactly the panel will vote on.
    Thimerosal has been widely used for decades as a preservative to prevent the growth of harmful bacteria in several medicines and vaccines with multiple doses. But its use in approved vaccines has dropped sharply as manufacturers have shifted to single-dose packaging for their shots, which don’t require preservatives. 
    Some multi-dose forms of flu vaccines for adults still contain thimerosal, including Sanofi’s Fluzone and two shots from biotech company CSL Seqirus. All vaccines routinely recommended for children 6 years of age and younger in the U.S. are available in formulations that do not contain thimerosal, according to the Food and Drug Administration.
    The FDA and other health bodies have emphasized that many well-conducted scientific studies have found no link between thimerosal and autism, despite unfounded concerns decades ago about a potential connection.

    “The scientific evidence collected over the past 20+ years does not show any evidence of harm, including serious neurodevelopmental disorders, from use of thimerosal in vaccines,” the FDA said on its website.
    The new ACIP members will play a significant role in shaping immunization policy in the U.S., as the panel reviews vaccine data and makes recommendations that determine who is eligible for shots and whether insurers should cover them, among other efforts. The committee is also scheduled to review data and vote on other vaccines, including shots for Covid and RSV, during the two-day meeting. More

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    Investors ignore world-changing news. Rightly

    Missile warfare has erupted in the Middle East. On June 13th, as the bombs began to fly, S&P 500 futures fell by 1.6%. But as the hours passed, the stockmarket steadily climbed. The index has now recovered to around 6,000, a hair’s breadth from an all-time high. More

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    Trump says ‘stupid’ Powell ‘probably won’t cut’ rates when Fed meeting ends Wednesday

    With the Federal Reserve just hours away from its latest decision on interest rates, President Donald Trump on Wednesday lambasted Chair Jerome Powell, calling him “stupid” while doubting the central bank would cut.
    In his latest in a series of attacks on Powell that go back years, Trump said the Fed’s key borrowing rate should be at least 2 percentage points lower.

    “So we have a stupid person. Frankly, you probably won’t cut today,” Trump said in impromptu remarks just outside the White House. “Europe had 10 cuts, and we had none. And I guess he’s a political guy, I don’t know. He’s a political guy who’s not a smart person, but he’s costing the country a fortune.”
    The remarks came just about four hours before the rate-setting Federal Open Market Committee was to release its statement on interest rates, along with an update of where it sees policy and several key economic measures heading over the next several years.
    Market pricing indicates no probability of a cut at this meeting, with the next move expected in September. The Fed currently targets its overnight borrowing rate in a range between 4.25%-4.50%.
    Powell and his colleagues have expressed hesitation about adjusting rates with so many unanswered questions regarding the economy.
    For one, the longer-term impact of Trump’s tariffs is not known. Inflation indicators are little changed since the tariffs were implemented in April, but various factors have colluded to blunt the impact.

    Trump, though, said higher interest rates are costing the U.S. “hundreds of billions” of dollars in financing costs that could be saved if the Fed would ease.
    “If he’s worried about inflation, that’s OK. I understand that. I don’t think there’s going to be any. So far there hasn’t,” Trump said.
    “But now we have a man that just refuses to lower the Fed rate, just refuses to do and he’s not a smart person,” the president added. “I don’t even think he’s that political. I think he hates me, but that’s OK.”
    Trump and Powell recently met at the White House, though little has been disclosed about what was discussed. Powell and his colleagues have vowed they will not be swayed by political pressure, which has ramped up to include other administration officials, such as Vice President JD Vance.
    Trump even mused about appointing himself as Fed chair, saying, “I’d do a much better job than these people.”
    Powell’s term expires in May 2026, and Trump has said he intends to name a successor soon.

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