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    Eli Lilly expects FDA decision on weight loss drug Zepbound for sleep apnea as early as end of the year

    Eli Lilly said it applied for U.S. approval of its weight loss drug Zepbound for the treatment of the most common sleep-related breathing disorder and expects regulators to make a decision as early as the end of the year.
    The company released additional data from two late-stage trials showing that Zepbound helped resolve obstructive sleep apnea in almost half of patients.
    The results add to growing evidence of additional health benefits tied to a buzzy class of weight loss and diabetes treatments, which have skyrocketed in popularity in the U.S. over the past year.

    An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, Dec. 11, 2023.
    Brendan McDermid | Reuters

    Eli Lilly on Friday said it applied for U.S. approval of its weight loss drug Zepbound for the treatment of the most common sleep-related breathing disorder and expects regulators to make a decision as early as the end of the year.
    If cleared by the Food and Drug Administration, the company plans to launch Zepbound for so-called obstructive sleep apnea “as quickly as we can” at the beginning of 2025, Patrik Jonsson, president of Eli Lilly diabetes and obesity, said in an interview.

    Also on Friday, the company released additional data from two late-stage trials showing that Zepbound helped resolve obstructive sleep apnea, or OSA, in almost half of patients. Eli Lilly presented the new data from the trials at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida, on Friday.
    “We’re super excited. … I think it actually went beyond what most external experts were hoping for,” Jonsson said of the new data demonstrating that Zepbound can help resolve the disorder in some patients.
    It adds to growing evidence that there could be further health benefits tied to a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages in the U.S. over the past year. The data also paves the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans.
    The pharmaceutical giant in April released initial results from the two studies, which showed that Zepbound was more effective than a placebo at reducing the severity of OSA in patients with obesity after a year. 
    OSA refers to interrupted breathing during sleep due to narrowed or blocked airways. An estimated 80 million patients in the U.S. experience the disease, Eli Lilly said in a press release. Around 20 million of those people have moderate-to-severe forms of the disease, but 85% of OSA cases go undiagnosed, according to Jonsson. 

    OSA can lead to loud snoring and excessive daytime sleepiness, as well as contribute to serious complications, including stroke and heart failure. Patients with the condition have limited treatment options outside of wearing masks hooked up to cumbersome machines while sleeping that provide positive airway pressure, or PAP, to allow for normal breathing.
    The first study examined the weekly injection in adults with moderate-to-severe OSA and obesity who were not on PAP therapy. The second trial tested Zepbound in adults with the same conditions, but those patients were on and planned on continuing PAP therapy. 
    The new results showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved “disease resolution,” according to a release. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively. 
    “This has huge impacts on patients’ lives,” Leonard Glass, senior vice president of medical affairs at Eli Lilly, diabetes and obesity, told CNBC. “Imagine not having to use a PAP machine, or not having to worry about waking up again in the middle of the night, or for your partners — not having to live with somebody with this condition.”
    Researchers came to those conclusions by examining a so-called apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition. 
    Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, according to Eli Lilly. It is also defined as a person having five to 14 AHI events per hour and scoring a certain number on a standard survey designed to measure excessive daytime sleepiness, the company said. 
    Among other new data, the company said 62.3% of patients in the first trial who took Zepbound saw a greater than 50% reduction in AHI events, compared with 19.2% of those on placebo. Meanwhile, 74.3% of people in the second study who took Eli Lilly’s drug saw a more than 50% reduction in AHI, compared with 22.9% of participants who received a placebo.
    Eli Lilly on Friday reiterated that Zepbound met the main goal of the trial, which was reducing AHI events. 
    Zepbound led to an average of 27.4 fewer AHI events per hour at 52 weeks in people who were not on PAP machines. That compares to an average reduction of 4.8 events per hour for those who received a placebo in the first trial. 
    The drug also led to an average of 30.4 fewer AHI events per hour at 52 weeks in patients who were on PAP machines, compared with an average reduction of six events per hour for people on the placebo in the second study.
    Eli Lilly previously announced that the FDA granted Zepbound “fast track designation” for patients with moderate-to-severe OSA and obesity. The designation ensures that drugs intended to both treat a serious or life-threatening condition and fill an unmet medical need get reviewed more quickly.

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    Home prices hit record high in May as sales stall

    The inventory of homes for sale jumped in May, up 6.7% month to month and 18.5% higher than in May last year.
    The median price of an existing home sold in May was $419,300, a record-high price in the Realtors’ recording, and up 5.8% year over year.

    Sales of previously owned homes are sitting at a 30-year low and didn’t move much in May as prices hit a new record and mortgage rates remain high.
    So-called existing home sales in May were essentially flat, down 0.7% from April to a seasonally adjusted, annualized rate of 4.11 million units, according to the National Association of Realtors, or NAR. Sales fell 2.8% from May of last year.

    This count of closed sales is based on contracts likely signed in March and April. The sluggish sales pace came as rates took a big leap in April.
    The average rate on the popular 30-year fixed loan started the month just below 7% and then rose to just over 7.5% by mid-April, before settling back slightly in May, according to Mortgage News Daily. That rate is now right around 7%.
    “Home sales refuse to recover,” said Lawrence Yun, chief economist at the NAR. “I thought we would see a recovery this spring. We are not seeing it.”

    Homes in the Issaquah Highlands area of Issaquah, Washington, US, on Tuesday, April 16, 2024. 
    David Ryder | Bloomberg | Getty Images

    Sales were unchanged month to month in all regions except the South, where they fell 1.6%.
    The biggest change in May is that the inventory of homes for sale jumped, up 6.7% month to month and 18.5% higher than in May last year. At the current sales pace, there is now a 3.7-month supply. While inventory is gaining, it is still very low given demographics and demand.

    “Eventually, more inventory will help boost home sales and tame home price gains in the upcoming months. Increased housing supply spells good news for consumers who want to see more properties before making purchasing decisions,” Yun added.

    Record prices

    That demand continues to push prices higher. The median price of an existing home sold in May was $419,300, a record-high price in the Realtors’ recording and up 5.8% year over year. The gain was the strongest since October 2022. Prices gained in all regions.
    The Realtors noted in a release that the mortgage payment for a typical home today is more than double what it was five years ago. Not only have rates climbed, but home prices are more than 50% higher than they were five years ago. That comes in part because the median is skewing to the higher end.
    Sales of homes priced below $250,000 were lower than a year ago, while sales priced between $250,000 and $500,000 were up just 1%. Sales priced between $750,000 and $1 million were 13% higher, and sales priced over $1 million were up nearly 23%.
    Cash is still king, accounting for 28% of sales. First-time buyers are hanging in at 31% of sales, up from 28% the year before.
    Two-thirds of homes went under contract in less than a month, so competition is still strong despite higher prices. Redfin, a real estate brokerage, is reporting that an increasing number of listings are becoming stale, so if a home comes on the market that is well-priced and doesn’t need much work, it goes fast. Other homes are sitting longer.

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    Experts say Shein’s U.S. IPO is all but dead

    Seven months since it filed for its U.S. IPO, Shein’s public debut may be all but dead, after it faced countless public hurdles and pivoted to the London market, according to experts.
    Shein has faced bipartisan public scrutiny along its road to an IPO due to national security concerns over its relationship to China, alleged links to forced labor and claims of an unfair competitive advantage due to customs law loopholes.
    The e-commerce company is taking market share from big-name retailers like Macy’s and Gap as it expands its U.S. presence.

    The Shein logo can be seen on a smartphone, while the Chinese online retailer’s website is open on a laptop. 
    Monika Skolimowska | Picture Alliance | Getty Images

    China-founded e-commerce company Shein’s hopes of going public in the United States are growing slimmer by the day, according to experts, as rising tensions between Beijing and the U.S. roil business and trade.
    The company, last valued at $66 billion, confidentially filed to go public in the U.S. in November. Since then, it has faced resistance as it tries to join the American retail sphere, including through numerous rejected attempts to become a member of the National Retail Federation, the industry’s largest trade association, CNBC previously reported.

    The e-commerce upstart filed to go public while becoming a household name in the U.S. by offering low prices and a facility to offer new styles quickly. The company is poised to take major market share from U.S. retailers, particularly Gap, TJX Companies and Macy’s, according to UBS data from last year, and continues to challenge Target, Walmart and Amazon.
    But as political resistance to its U.S. IPO mounts, Shein is seemingly shifting gears, as it reportedly prepares to confidentially file for a £50 billion offering in London in the coming weeks. The company likely would have preferred to list in the U.S., because the offering could bring a higher valuation than in the U.K., said Angelo Bochanis, an IPO analyst at Renaissance Capital, which provides pre-IPO research and IPO-focused ETFs. 
    But its path hasn’t been easy, as federal and state officials call on the Securities and Exchange Commission to scrutinize or even block the initial public offering in the U.S.
    “Scrutinizing companies with high-profiles and roots in China is very politically in-vogue right now in the United States,” Bochanis said.
    A London IPO could, in theory, be easier than a U.S. offering, according to Bochanis. With the British parliament dissolved and the London Stock Exchange “desperate for big wins” as it suffers an IPO drought, Shein could circumvent some of the hurdles that it might have otherwise faced, he said.

    If Shein’s London IPO succeeds, it is unlikely to keep pursuing a U.S. offering, said University of Florida finance professor Jay Ritter, who studies IPOs.
    Not all China-linked companies are getting tangled in the webs of rising political tensions. Chinese electric vehicle company Zeekr went public in the U.S. last month. It became one of the first prominent Chinese companies to do so in the U.S. even as the Biden administration has increasingly cracked down on Chinese-made electric vehicles.

    China ties and data privacy

    Shein is “one of the few” China-tied companies that have gained deep brand awareness with U.S. consumers, Bochanis said.
    The size of the potential offering, and the long, high-profile process accompanying it, have helped to make Shein an attractive target for politicians from both parties who want to look tough on Beijing-linked companies.
    Shein was founded in China and has since moved its headquarters to Singapore. But a good chunk of the company’s supply chain is still based in the country.
    In December, the House Committee on Energy and Commerce sent a letter to Shein seeking information about the company’s user data collection and its relationship to the Chinese government, calling a potential link to Beijing a “serious risk for e-commerce, consumer safety and people’s data privacy and security.”
    The panel sent a similar letter to TikTok, the popular social media platform owned by China-based parent ByteDance.
    The Chinese Communist Party can by law request any Chinese-owned company to share information on its customers, according to George Washington University professor Susan Ariel Aaronson. While Shein is headquartered offshore, its manufacturing ties in China and reports that it sought Beijing’s permission to go public in the U.S. raised concerns among U.S. officials about what data it could share with the Chinese government.
    That relationship helped to spark a proposed U.S. ban on TikTok. Legislation that Congress passed last month aims to force the platform to sell its U.S. assets by Jan. 19 or cease all activity in the country.
    ByteDance and several creators on the platform have filed lawsuits to block the bill.
    While Shein does not have access to the magnitude of data that a social media giant like TikTok has, the proposed ban has raised more doubts about a U.S. IPO for the company.
    “[Congress] just showed us that if a particular Chinese-owned company is perceived to be posing a threat, they can unify and pass a law, and that’s much stronger than an executive order or presidential order,” said Antonia Tzinova, a national security attorney at Holland & Knight.

    Shein shipping concerns

    The political scrutiny beyond data privacy may prove more difficult for Shein to overcome.
    The retailer has long been criticized for its alleged use of forced labor in its supply chain and poor working conditions for its employees.
    In 2021, the United States passed the Uyghur Forced Labor Prevention Act, which prohibits companies that manufacture goods in the Xinjiang region of China notorious for its Uyghur detention camps from selling in the U.S. Although U.S. government agencies claim Shein’s supply chain has links to the Xinjiang region, the company doesn’t manufacture its own goods and instead uses China-based micro-manufacturers that make materials tougher to track.
    Shein has repeatedly denied the forced-labor allegations, saying it implements a system to support compliance with the U.S. law within the company.
    The company has also come under fire for its use of U.S. customs law loopholes.
    Because the company doesn’t import its products in bulk to sell from a U.S. warehouse and instead ships on an order-by-order basis, it’s exempt from some of the heaviest U.S. import taxes. Rivals have criticized this practice as giving Shein an unfair competitive advantage.
    — CNBC’s Gabrielle Fonrouge and Reuters contributed to this report.

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    Forever 21 seeks rent concessions as fast fashion brand faces financial woes

    Forever 21 is asking some landlords for rent concessions as high as 50% as it faces financial difficulties, according to people familiar with the matter.
    The legacy fast fashion player, which filed for bankruptcy in 2019, isn’t weighing a second filing, the people said.
    The company is struggling to manage its sprawling store footprint and compete with savvier digital upstarts.

    A fashion retail Forever 21 store is pictured in in London on September 30, 2019. Fashion retailer Forever 21 has filed for Chapter 11 bankruptcy protection in the US.
    Alberto Pezzali | NurPhoto | Getty Images

    Forever 21 is asking landlords for a break on rent as the legacy fast fashion player’s sales decline and it struggles to keep up with savvier competitors, CNBC has learned.
    The retailer, which has more than 380 stores in the U.S., has asked some landlords to cut its rent by as much as 50%, people familiar with the matter told CNBC. 

    While the company is facing financial difficulties, it has yet to hire advisors and isn’t considering a second bankruptcy filing, the people said. It’s working to restructure its many leases so it can cut costs, they said. 
    Forever 21 faces a range of issues that have long plagued its business. It operates in the increasingly saturated fast fashion market, and struggles to manage inventory and understand and respond to its consumer, one of the people said.
    The retailer’s struggles come after it filed for bankruptcy in 2019 and was later bought by a consortium including brand management company Authentic Brands Group and landlords Simon Property Group and Brookfield Property Partners.
    When the company sought bankruptcy protection, it had more than 800 locations globally.
    Similar to many retailers, Forever 21’s massive store footprint weighed on its balance sheet when it first filed for bankruptcy. The retailer had expanded too quickly during its growth phase, leaving it unable to invest in its supply chain and rapidly respond to changing trends. 

    Closing hundreds of stores after filing for bankruptcy has not resolved its issues.
    Forever 21’s financial position has also hurt the performance of its operator Sparc Group — the joint venture that includes Authentic, Simon and as of last summer, Chinese-linked fast fashion behemoth Shein. Sparc runs Forever 21’s operations, as well as a number of other formerly-bankrupt retailers, including Aeropostale, Brooks Brothers and Lucky Brand. 
    Sparc declined comment to CNBC. Simon didn’t return a request for comment.

    Forever weighs on Sparc 

    Sparc has been scrutinizing its budgets and contending with its own financial struggles, people familiar with the matter said. 
    Many of Sparc’s challenges come from the difficulty of merging numerous legacy brands and attempting to centralize their teams, technology, marketing, e-commerce, sourcing and supply chains, one of the people said. It’s also contended with the issue of running brands that have long operated primarily in malls.
    Expensive leases for stores that perform poorly relative to their size can often weigh down retailers’ balance sheets and drain cash.
    Forever 21 has consistently paid its vendors late over the last year, according to data from Creditsafe, a business intelligence platform that analyzes companies’ financial, legal and compliance risks. The data shows Forever 21’s payment patterns to vendors have fluctuated, with some bills going more than 70 days past due in late 2023, according to Creditsafe.
    Plenty of companies, including many that are healthy, leave bills unpaid for weeks or months, but late payments can also signal larger financial troubles. The industry average hovered between 12 and 13 days past due for the last 12 months, said Creditsafe spokesperson Ragini Bhalla.

    Racing to compete

    In the past, Forever 21’s top rivals included H&M and Zara. These days, its biggest foes are ultra-fast fashion retailers like Shein and Temu. 
    “The speed is almost impossible to compete with. So if you juxtapose any brand that was around 20 years ago to these new, on-demand manufacturing fast fashion companies… it’s like comparing a mobile phone from 2000 to the newest iPhone. The speed, the quality, everything is just different,” one of the people said. “As soon as someone goes viral in a new outfit on TikTok, Shein is immediately making it and no regular brand can keep up with that.” 

    Shoppers walks past advertisements on the opening day of fast-fashion e-commerce giant Shein, which hosted a brick-and-mortar pop up inside Forever 21 at the Ontario Mills Mall in Ontario on Oct. 19, 2023.
    Allen J. Schaben | Los Angeles Times | Getty Images

    At the ICR conference in January, Authentic Brands CEO Jamie Salter said acquiring Forever 21 was “probably the biggest mistake” of his career, adding he also erred when he failed to recognize the competitive threat posed by Shein and Temu earlier. 
    He recalled a conversation he had with Simon’s CEO David Simon, who asked Salter why he wanted to partner with Shein. 
    “I said, ‘David, it’s the right decision, we cannot beat them. Their supply chain is too good. They know what’s going on. They’ve figured this out. We need to partner with them,'” Salter recounted. “So I was the brave one that said, ‘Let’s go partner with these guys.'”
    As part of the two retailers’ partnership, Shein will design, manufacture and distribute a line of co-branded Forever 21 apparel and accessories that will be sold primarily on Shein’s website. Forever 21 has also hosted Shein pop-up stores and begun accepting Shein returns, both of which have driven positive foot traffic to Forever 21’s shops, one of the people said. 
    The two originally linked up last August and under the terms of the agreement, Shein acquired about one-third of Sparc while Sparc took a minority stake in Shein. 
    Given the concerns that Forever 21 is having with its leases, and the success of Shein’s pop-up shops, some industry observers questioned whether the digital giant could soon take over Forever 21’s stores. However, one of the people said that’s unlikely because the retailer lacks experience in physical retail and its business model involves small-batch production and an inventory that constantly shifts based on trends. More

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    SpaceX unveils backpack-sized ‘Starlink Mini’ satellite internet antenna for $599

    SpaceX is rolling out a compact version of its satellite internet antennas called “Starlink Mini.”
    The company is offering a “limited number” of the Starlink Mini antennas for $599 each in an early access release.
    In addition to the upfront hardware cost, service for a Starlink Mini is effectively $150 per month for 50 gigabytes of data.

    Starlink Mini promotional image.
    SpaceX customer email sent June 19, 2024.

    SpaceX is rolling out a compact version of its Starlink antennas, which the company is advertising as a mobile option for its satellite internet customers.
    “Starlink Mini is a compact, portable kit that can easily fit in a backpack, designed to provide high-speed, low-latency internet on the go,” according to a customer email sent by SpaceX on Wednesday and viewed by CNBC.

    The company is offering a “limited number” of the Starlink Mini antennas for $599 each in an early access release. That’s $100 more than the base model “Standard” antenna sold with its Residential service, although the company aspires to reduce the price tag.
    “Our goal is to reduce the price of Starlink, especially for those around the world where connectivity has been unaffordable or completely unavailable,” SpaceX wrote in the email.

    Starlink Mini promotional image.
    SpaceX customer email sent June 19, 2024.

    In addition to the upfront hardware cost, service for a Starlink Mini is effectively $150 per month — as SpaceX is offering the service for a Mini as an additional $30 per month bundle on top of a $120 per month Residential service. The “Mini Roam” service “can be used anywhere in the United States” but has a cap of 50 gigabytes of data per month, with Starlink charging $1 per gigabyte for additional data.

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    The Starlink Mini antenna is about the size and weight of a laptop, at just over two pounds and measuring at about 12 inches by 10 inches by 1.5 inches. It’s roughly half the size and one-third the weight of Starlink’s Standard antenna.
    SpaceX’s email said Starlink Mini comes with a built-in WiFi router and “lower power consumption” than its other antennas, yet it still boasts download speeds of over 100 megabits per second.

    The email did not specify when Starlink Mini deliveries would begin. In a post on social media, Vice President of Starlink Engineering Michael Nicolls said the company is “ramping production” on Starlink Mini and that it “will be available in international markets soon.”
    SpaceX CEO Elon Musk wrote in a post Monday that setting up a Starlink Mini took less than five minutes.
    “This product will change the world,” Musk declared.
    SpaceX has steadily expanded its Starlink network and product offerings since debuting the service in 2020. There are about 6,000 Starlink satellites in orbit that connect more than 3 million customers in 100 countries, according to the company. SpaceX initially targeted consumer customers, but has expanded into other markets — including national security, enterprise, mobility, maritime and aviation — and disrupted the existing satellite communications sector.

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    Fast-food customers are shifting to casual-dining chains, Darden Restaurants CEO says

    Darden Restaurants CEO Rick Cardenas said certain casual-dining chains are stealing some fast-food restaurants’ customers.
    Chili’s, Applebee’s and other casual-dining chains have been trying to win over fast-food diners.
    McDonald’s has faced backlash from its customers, social media users and even House Republicans for its higher prices.

    Customers arrive at an Olive Garden location in San Antonio, Texas.
    Callaghan O’Hare | Bloomberg | Getty Images

    Casual-dining chains are gaining customers who have grown frustrated with higher fast-food prices, Darden Restaurants CEO Rick Cardenas said on Thursday.
    While Darden itself hasn’t benefited from the shift, its competitors, like Chili’s owner Brinker International and Applebee’s parent Dine Brands, have been reigniting a rivalry with their fast-food counterparts — and it seems to be working. Chili’s introduced an ad campaign that calls out the Big Mac and other fast-food burgers for their prices. Dine Brands CEO John Peyton told CNBC in May that Applebee’s has been leaning into deals to win over fast-food diners.

    On Darden’s quarterly earnings call Thursday, Cardenas told analysts that industry data is showing “a little bit of a shift from [quick-service restaurants] to some of those competitors” in casual dining.
    As of May, full-service menu prices had risen 3.5% over the last 12 months, compared with a 4.5% increase for those of limited-service eateries, according to Department of Labor data. The overall consumer price index rose 3.3% in that period.
    Consumers have been feeling the pinch of the more than two years of price hikes, even with fast-food chains, which typically benefit from tougher economic environments because consumers trade down to their cheaper meals. But both full-service restaurants and grocers alike have been highlighting their own value compared to fast-food meals, whether it’s the actual price or the overall experience and quality.
    In particular, McDonald’s has faced backlash from customers, social media users and even House Republicans for its higher prices. In an open letter in late May, the company’s U.S. president, Joe Erlinger, hit back at critics claiming its menu prices have doubled, saying its prices are up just 40% since 2019.
    Even so, the company has taken steps to try to appeal to price-conscious diners. On Thursday, McDonald’s announced a new $5 value meal, plus free French fries on Fridays with any purchase of at least $1 for its mobile app customers.

    Darden has been using a different strategy to win over diners. It has leaned on television advertising and kept its overall pricing lower than inflation to attract customers. In its fiscal fourth quarter, the company reported flat same-store sales growth and weaker-than-expected revenue, although its earnings beat Wall Street’s estimates.
    Cardenas said the company has dealt with a “consistently weaker consumer environment,” as well as increased discounting and marketing pressure from its rivals. Still, executives touted that its restaurants are outperforming the broader casual-dining segment.
    Shares of Darden rose more than 1% in morning trading on Thursday. The company’s stock has fallen 6% this year, dragged down by concerns about the consumer environment. More

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    Gilead’s twice-yearly shot to prevent HIV succeeds in late-stage trial

    Gilead’s twice-yearly medicine to prevent HIV succeeded in a Phase 3 trial.
    None of the roughly 2,000 women in the trial who received the lenacapavir shot contracted HIV.
    Gilead needs to replicate the results in another Phase 3 trial before seeking FDA approval. The company expects to share more data later this year or early next year.
    If the results are positive, lenacapavir for PrEP could reach the market as soon as late 2025.

    The logo of Gilead Sciences pharmaceutical company is seen in Oceanside, California, April 29, 2020.
    Mike Blake | Reuters

    Gilead’s experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday.
    None of the roughly 2,000 women in the trial who received the lenacapavir shot had contracted HIV by an interim analysis, prompting the independent data monitoring committee to recommend Gilead unblind the Phase 3 trial and offer the treatment to everyone in the study. Other participants had received standard daily pills.

    The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. Shares of the company rose about 7% on Thursday. 
    “What the world needs is people to have more PrEP options so they can make the choice of the option that’s going to work best for them,” said Jared Baeten, Gilead’s vice president of clinical development for HIV. 
    Before seeking approval from the Food and Drug Administration, Gilead will first need to replicate these results. The company expects to share data later this year or early next year from an ongoing Phase 3 study of men who have sex with men. If those results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025.
    More than a decade ago, Gilead’s Truvada became the first approved PrEP for people without HIV who are at high risk of acquiring it. Daily pills dominate the market, but drugmakers are now focusing on developing longer-acting shots.
    PrEP slashes the risk of getting HIV from sex by 99%, and from injected drug use by 74% when taken correctly. Yet only a little more than one-third of people in the U.S. who could benefit from PrEP take it, according to data from the Centers for Disease Control and Prevention.

    Health policymakers and advocates hope longer-acting options could reach people who can’t or don’t want to take a daily pill and better prevent the spread of a virus that caused about 1 million new infections globally in 2022. 
    “It’s really important to have more options than daily pills because the orals aren’t going to get us to the end of the epidemic,” said Bruce Richman, founding executive director of the nonprofit Prevention Access Campaign. “We need to make sure that people have options to fit with their lifestyles.”
    The FDA approved the first injectable PrEP in 2021. That drug, Apretude, is given every other month, or six times a year, by a medical professional. About 11,000 people take Apretude, according to its manufacturer, ViiV.
    Tim Oliver, a 28-year-old public health worker in New York, said he doesn’t mind going to the doctor for his Apretude shots. But he added that some of his friends have told him they’d rather keep taking a daily pill than get an injection. A longer-acting option could be more attractive to patients.
    RBC Capital Markets analyst Brian Abrahams expects Gilead’s shot will significantly increase the number of people interested in preventive HIV medicine. He estimates peak sales of nearly $2 billion. Gilead’s newer PrEP pill, Descovy, notched about $2 billion of revenue last year. 
    Activists have urged Gilead to ensure that people in countries where low- and middle-incomes predominate can get access to lenacapavir. The company has long faced criticism over the price of its HIV medicines. Descovy usage carries a list price of $26,000 a year.
    In its statement disclosing the lenacapavir trial results Thursday, Gilead said it plans to share an update on how it plans to address access in such countries where people suffer high incidence rates of HIV. — CNBC’s Leanne Miller contributed to this report.

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    Are manufacturing jobs really that good?

    If there is one thing politicians agree on these days, it is that manufacturing jobs are “good” jobs. Joe Biden is betting that huge subsidies for new factories will transform the outlook for America’s workers—and November’s election. His acting labour secretary recently embarked on a jolly-sounding “Good Jobs Summer Tour” to trumpet the president’s plans. Donald Trump, Mr Biden’s rival, is just as eager to get more wrenches into the hands of American workers, mostly by slapping tariffs on foreign goods. Politicians across the rich world believe that reversing the decades-long decline in manufacturing employment would leave workers better off.Your guest Bartleby is not convinced. He has, admittedly, never worked in a factory, and thus feels no nostalgia for hard hats and high-vis vests. Still, the idea that deindustrialisation has made work worse is hard to square with the fact that data on worker satisfaction have been steadily improving for years. More