ReportWire

Tag: New Products/Services

  • FDA approves first-ever pill for postpartum depression in new mothers

    FDA approves first-ever pill for postpartum depression in new mothers

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    The Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression.

    The medication, called zuranolone, and jointly developed by pharmaceutical companies Biogen Inc.
    BIIB,
    +0.44%

    and Sage Therapeutics
    SAGE,
    +0.25%
    ,
    is taken daily for two weeks, the FDA said in its release.

    In a pair of clinical trials involving women who experienced severe depression after having a baby, the drug improved symptoms including anxiety, trouble sleeping, loss of pleasure, low energy, guilt or social withdrawal as soon as three days after the first pill.

    “Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.

    ”And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” she said.

    Women who are breastfeeding or had mild or moderate depression weren’t included in the trials.

    Until now, the only available option for this condition has been an intravenous injection that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days.

    Postpartum depression affects one in eight new mothers in the U.S., according to the Centers for Disease Control and Prevention. Researchers suggest the actual rate may be higher and that half of such cases go undiagnosed. 

    Research finds that postpartum depression is more intense and lasts longer than the typical worries, sadness or tiredness that many women experience after giving birth. The condition can make it harder for mothers to bond with their babies and may increase the likelihood of developmental delays in infants.

    Drug overdoses and suicides are leading causes of maternal death in the U.S., contributing to nearly one in four pregnancy-related deaths, according to the CDC. 

    Zuranolone stimulates a brain receptor called GABA that slows down the brain and helps control anxiety and stress. The drug, through trials, is thought to calm women suffering from postpartum depression enough to allow them to rest, which also improves symptoms.

    Shares of Biogen are up 23% over the past year, and Sage has lost 14%, while the S&P 500
    SPX
    is up 8% over the same time.

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  • H&M to Launch in Brazil During 2025

    H&M to Launch in Brazil During 2025

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    By Dominic Chopping

    STOCKHOLM–Sweden’s Hennes & Mauritz Monday announced plans to launch physical and online stores in Brazil during 2025.

    The fashion retailer said it will initially enter major cities in southeast Brazil with a view to further increase its presence across the country over time.

    In Latin America, H&M is currently present in Mexico, Peru, Uruguay, Chile, Colombia, Ecuador, Guatemala, Panama, and Costa Rica, and it said that with a population of over 210 million in Brazil there is considerable potential for expansion.

    To support the initiative H&M said it is partnering with Dorben Group, a Latin American luxury and fashion retail partner.

    Write to Dominic Chopping at dominic.chopping@wsj.com

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  • FDA approves Alzheimer’s treatment Leqembi, clearing the way for Medicare coverage

    FDA approves Alzheimer’s treatment Leqembi, clearing the way for Medicare coverage

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    The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms.

    Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.

    The…

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  • Meta launches Threads, its app to rival Twitter, a day early

    Meta launches Threads, its app to rival Twitter, a day early

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    Meta Platforms Inc. launched Threads, its rival to Twitter, a day early Wednesday.

    “Let’s do this. Welcome to Threads,” Meta Chief Executive Mark Zuckerberg posted on the new app.

    The text-based app, a spinoff of Meta’s META Instagram, had been set to launch Thursday morning, but instead went live for users in the U.S. and more than 100 other…

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  • Meta’s Twitter-rival Threads: How to sign up, what it costs and what we know so far

    Meta’s Twitter-rival Threads: How to sign up, what it costs and what we know so far

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    Meta’s Twitter-rival Threads launches tomorrow: What we know so far

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  • Meta’s Twitter killer, Threads, is reportedly coming Thursday

    Meta’s Twitter killer, Threads, is reportedly coming Thursday

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    Meta Platforms Inc.’s answer to Twitter is poised to launch, according to a new report, as Elon Musk’s faltering microblogging app struggles to hold onto advertisers and over the weekend placed restrictions on posts viewed by users.

    The Wall Street Journal reported late Monday that Meta’s
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    -0.33%

    Threads will be released Thursday, and is expected to be built off of Instagram user data, giving it the potential to catch on and grow quickly.

    Bloomberg News also reported it would launch Thursday, citing a listing on Apple Inc.’s
    AAPL,
    -0.78%

    App Store.

    If Threads does launch Thursday, it could come at a perfect time for Meta to capitalize on anger toward Twitter. Late Monday, Twitter announced it was moving its popular TweetDeck viewing tool behind a paywall in 30 days, spurring widespread user outrage.

    Last week, the Threads app briefly appeared on Alphabet Inc.’s
    GOOGL,
    +0.17%

    GOOG,
    -0.34%

    Google Play Store in some regions.

    Threads allows users to port their Instagram username to a new platform that essentially opens direct-message chats on a more public forum. The Facebook parent company has been developing a text-based platform for some time.

    Read more: Musk vs. Zuckerberg: Which tech heavyweight is already winning the Wall Street cage match?

    Twitter, meanwhile, continues to seek ways to stem hemorrhaging advertising under new Chief Executive Linda Yaccarino as it puts a stranglehold on what subscribers can view. In a tweet Saturday, Musk — who acquired Twitter for $44 billion in October — said verified accounts were at one point limited to reading 6,000 posts a day. For unverified accounts, the number was 600 posts a day, while new account could only see 300. That number was later upgraded to 10,000, 1,000 and 500, respectively.

    Animosity between Musk and Meta co-founder and Chief Executive Mark Zuckerberg has been growing as the Twitter-rival app gets closer to market, culminating in Musk’s cage-fight challenge to Zuckerberg last month.

    Mike Murphy contributed to this report.

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  • Supreme Court knocks down Biden’s student-debt forgiveness plan

    Supreme Court knocks down Biden’s student-debt forgiveness plan

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    The Supreme Court knocked down the Biden administration’s plan to cancel up to $20,000 in student debt for a wide swath of borrowers, the court announced Friday. 

    The decision means that the White House won’t move forward with the plan for now, though it’s possible officials could try to launch a new version of the debt-forgiveness initiative using a different legal authority. Roughly 26 million borrowers applied for or were automatically eligible for debt relief under the Biden administration’s plan, which canceled up to $10,000 in student debt for borrowers earning less than $125,000 and up to $20,000 in federal loans for borrowers who met that criteria and also used a Pell grant in college. 

    Americans owe $1.7 trillion of student loans and the White House had estimated that more than 40 million borrowers would benefit from the initiative. But almost as soon as the Biden administration announced the debt-forgiveness plan last year, opponents looked for ways to challenge it legally. Ultimately, two cases made it to the high court. 

    In one case, two student-loan borrowers sued over the debt-relief plan in part because the Department of Education didn’t submit it for public comment. That, they said, resulted in an initiative that arbitrarily left out or limited the amount of relief available to some student loan borrowers, like themselves. The suit filed by the borrowers was backed by the Job Creators Network, a conservative advocacy organization co-founded by Bernard Marcus, the co-founder of Home Depot, who also supported former President Donald Trump. 

    Six Republican-led states brought the other case on the basis that canceling debt could harm their state coffers. 

    The court considered two issues in these cases. The first is whether the plaintiffs had standing, or the ability to bring a lawsuit because they’ve been directly harmed by the policy. The second is whether the Biden administration overstepped in its executive authority when issuing the policy. In order for the justices to reach the second issue, or the merits of the case, they had to find that the plaintiffs had standing to sue. 

    Legal experts, including some who believed the Biden administration didn’t have the authority to authorize the debt-relief plan, were skeptical of the notion that the parties bringing the cases had standing to sue. During oral arguments in February, the court’s three liberal justices also questioned whether the parties who challenged debt forgiveness were actually injured by the policy. 

    In addition, one of the members of the court’s conservative wing, Justice Amy Coney Barrett, asked pointed questions about the six states’ argument that they had standing to sue in part because the debt-relief plan would injure the state of Missouri. That claim surrounded the Missouri Higher Education Loan Authority, or MOHELA, a state-affiliated organization that services federal student loans. The states had argued if MOHELA lost accounts due to the debt-relief plan, its revenue would decline and that loss would hurt Missouri because of MOHELA’s ties to the state. 

    Despite these questions, Barrett agreed with the court’s five other conservative judges and found that the states have standing to sue. The three liberal justices dissented.

    “MOHELA is, by law and function, an instrumentality of Missouri,” Chief Justice John Roberts wrote in the majority opinion. “It was created by the State, is supervised by the State, and serves a public function. The harm to MOHELA in the performance of its public function is necessarily a direct injury to Missouri itself.”

    The court’s decision in the states’ suit allowed the justices to get to the merits of the case. The parties challenging the debt-relief plan argued that the Department of Education went beyond the authority Congress delegated it in discharging student debt. Solicitor General Elizabeth Prelogar argued to the justices that in canceling student debt, the Secretary of Education acted “within the heartland” of the authority Congress provided to him under the HEROES Act, a 2003 law that aims to ensure student-loan borrowers aren’t left worse off by a national emergency. 

    The court’s conservative majority sided with the states, with a 6-3 decision, striking down the debt-relief plan in its current form. 

    “The HEROES Act allows the Secretary to ‘waive or modify’ existing statutory or regulatory provisions applicable to financial assistance programs under the Education Act, but does not allow the Secretary to rewrite that statute to the extent of canceling $430 billion of student loan principal,” Roberts wrote.

    In the months leading up to the court’s decision, White House officials said there was no backup plan for if the Supreme Court knocked down the debt-forgiveness initiative. Advocates and activists have said that student-loan repayments shouldn’t resume until the Biden administration fulfills its promise to cancel some student debt.

    The bill President Joe Biden signed in June to raise the nation’s debt limit requires that the Department of Education end the pause on federal student loan, interest payments and collections 60 days after June 30, 2023. Interest on federal student loans will resume starting September 1 and payments will start to come due in October, according to the Department’s website.

    Advocates and activists have said for years that the Higher Education Act provides the Secretary of Education with the authority to discharge student loans. In ruling that the HEROES Act didn’t authorize the Biden administration’s debt-relief plan, the court left the option open for the Biden administration to create a loan-forgiveness program authorized under the HEA. 

    The court’s decision marks the latest development in a more-than-decade-long push to get the government to cancel student debt en masse. The idea, which has its origins in the Occupy Wall Street movement, made it to the presidential campaign stage during the 2020 cycle and was adopted by the White House last year.    

    Proponents of student debt cancellation and the Biden administration, have expressed concern that without some kind of relief a large swath of borrowers could slip into delinquency and default with the return of student loan payments later this year.

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  • Adobe Earnings Are Coming. The Focus Remains on AI.

    Adobe Earnings Are Coming. The Focus Remains on AI.

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    Adobe


    Systems reports financial results after the close of trading on Thursday, but the stock is more likely to move on any tidbits the company shares about its push into artificial intelligence—and the status of its pending $20 billion acquisition of the collaborative design software company Figma.

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  • The $3,499 Vision Pro headset, iOS 17, and everything else Apple just announced at WWDC

    The $3,499 Vision Pro headset, iOS 17, and everything else Apple just announced at WWDC

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    Apple Inc.’s $3,499 Vision Pro headset stole the show Monday as Apple kicked off its annual WWDC event.

    Chief Executive Tim Cook and other executives showed off the next chapter of Apple
    AAPL,
    -0.76%

    technology — “spatial computing” — during a keynote event that failed to maintain Apple’s record stock price. Shares had been on track to close at an all-time high before the event began, but were trading in the red once the event wrapped.

    While the Vision Pro and its eye-popping price tag was the biggest news from the presentation, Apple also teased forthcoming software enhancements and new Mac computers.

    Here’s everything that was announced Monday.

    The Vision Pro headset

    Apple was widely expected to roll out a mixed-reality headset at Monday’s event, but the announcement still brought a few surprises.

    While Apple was rumored to be planning a price tag in the range of $3,000 for its new Vision Pro headset, the actual price of $3,499 was higher. Also, Apple won’t be selling the device until early next year, later than expected, in a move that means the company will miss the holiday season.

    The company spent ample time during Monday’s presentation showing off what the Vision Pro can do in terms of bringing photographs, movies and everyday web browsing into physical spaces. Though the company discussed some gaming applications, and a partnership with Unity Software Inc.
    U,
    +17.16%
    ,
    executives didn’t dwell on gaming and focused the immersive experience more fully.

    See MarketWatch’s enhanced coverage of the Vision Pro launch here.

    New iPhone software

    Apple’s iPhone software enhancements are typically a focus of WWDC, an event aimed at developers who create apps for that and other Apple platforms. This year’s update — iOS 17 — will feature new ways to share contact information, journal and make use of the iPhone while it’s locked.

    With iOS 17 this fall, Apple users will also be able to set up contact “posters” for themselves, which will appear in full screen when they call others. They’ll be able to see live transcriptions of voice mails so they can determine whether to pick up calls they initially ignored.

    See MarketWatch’s full guide to the new iOS 17 features here.

    Read: Are thousand-dollar iPhones now a necessity? From reactions to Apple earnings, you sure might think so.

    A 15-inch MacBook Air

    Apple is making the MacBook Air bigger with a new 15-inch model that features the company’s M2 chip. This version will start at $1,299 and become officially available next week, though preorders begin today. The device gets 18 hours of battery life, is 11.5-millimeters thin and weighs just over 3 pounds.

    Mac Pro and Mac Studio

    Apple had set out to infuse its personal-computer lineup with custom chips, and the company rounded that out Monday with new Mac Pro and Mac Studio devices that feature Apple Silicon processing. The Mac Studio will start at $1,999, and the Mac Pro will begin at $6,999.

    Don’t miss: AI could give a big boost to profit margins — but there’s one key unknown, Goldman Sachs says

    New iPad software

    Apple will refresh its iPad software as well, with a new custom lock screen, widget enhancements, machine-learning tools that help with PDF editing and better annotation functions for PDFs. Plus, users will be able to at last set multiple timers.

    New Mac software

    Apple plans to upgrade its Mac operating system as well with a new version that will be called Sonoma. A key feature of this update is a redesign of the widgets function, giving users the ability to place widgets on their home screens and see these automatically fade when necessary so they don’t become distracting.

    The new Sonoma operating system will add various tools for web presentations, including a feature that lets people appear as overlays on top of their presentation content and new reaction animations that can show balloons and confetti in response to meeting content.

    Within Safari, family members will be more easily able to share passwords. The company will also let people create separate profiles for home, work, and school use of a Mac.

    Audio and video improvements

    Apple is adding Adaptive Audio to help AirPods users drown out distracting sounds when appropriate. The technology will proactively lower outside volume when someone is on a call and detect when someone is talking to a real-life companion in order to lower music volume for the duration of the conversation.

    Within video, Apple will let people use their phone cameras to engage in FaceTime conversations shown on an Apple TV. The company will also support AirPlay connectivity at hotels.

    Apple Watch software enhancements

    WatchOS 10, the new Apple Watch operating system, will let users retain their aesthetic watch faces but twist the digital crown to see widgets for information like weather, timers and events. The company is also looking to make the Apple Watch more useful for cyclists with advanced tracking features. One part of this allows users to pair an iPhone and see cycling data on the phone’s lock screen, which can be useful for those who dock their phones on a bike while also wearing the watch.

    Watch owners will receive a new hiking app as well, which will let users see elevation data and topographical information.

    Read: Apple could be cooking up 3 more $10 billion-plus businesses, one analyst says

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  • Apple’s new Vision Pro headset will cost $3,499, arrive in 2024

    Apple’s new Vision Pro headset will cost $3,499, arrive in 2024

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    Apple Inc. officially showed off its mixed-reality headset Monday, with the new Vision Pro device supporting 3-D content and featuring a price tag of $3,499.

    The Vision Pro, Apple’s
    AAPL,
    -0.76%

    first major new product category in eight years, will be available early next year and feature the ability for users to control the device with their hands, eyes and voice, a distinguishing feature of the headset in the current market. Chief Executive Tim Cook previewed the widely anticipated device during the keynote address of Apple’s WWDC developer event Monday.

    See also: Here are all the new software features coming to Apple’s iPhone this year

    Apple had been rumored for years to be developing a mixed-reality headset, which merges immersive augmented reality with real-life surroundings. Cook has long been excited about AR technology, and Monday’s event gave a sense for how he sees the theme playing into the business going forward as he announced WWDC’s “one more thing.”

    “It’s the first Apple product you look through and not at,” he said, adding that Vision Pro represents “spatial computing” and brings “a new dimension to powerful personal technology.”

    Users will be “no longer limited by a display,” Cook claimed.

    See also: Apple CEO Tim Cook explains why consumers would want a mixed-reality headset

    One key feature of the Vision Pro is the ability to see apps overlaid across real-world surroundings. Users will be able to determine how immersed they want to be by tweaking settings on a digital crown.

    The device will also allow users to rely only on their eyes, hands and voice to control content. Users can flick to scroll through options and tap their fingers together to select something with gestures that Apple says are subtle. Apple showed off how users will be able to arrange apps like FaceTime and Safari and then turn to the side to switch from one app to another. Their eyes will still be visible to people engaging with them in the real world.

    The company highlighted panoramic photos and noted that users will be able to capture “spatial” 3-D videos and photos using the headset. Apple teased that people would be able to make the surroundings of a plane disappear if they opted to watch 3-D video while flying.

    Robert Iger, Walt Disney Co.’s
    DIS,
    +0.25%

    CEO, appeared onstage to call the launch a “momentous event” that could help make Disney’s vision “a reality” through the advent of deeply immersive and personal stories. The Disney+ app will be available “on day one” through Vision Pro.

    Apple explained that users can either plug the Vision Pro in or use an external battery that will provide roughly two hours of use. The display has “more panels than a 4K TV for each eye.” The Vision Pro relies on Apple’s custom processing, including a new R1 chip that the company says helps reduce latency issues, which have plagued other devices.

    Users will be able to set up digital personas as part of the new visionOS operating system for the device.

    With the Vision Pro, Apple is wading into a market for augmented- and virtual-reality devices that has been underwhelming thus far as products from Meta Platforms Inc.
    META,
    -0.45%

    and others have failed to pick up meaningful traction with consumers. VR devices dominate the market, according to third-party data from IDC, but overall shipments plunged more than 50% in the latest quarter amid economic pressures and a general cooling of interest.

    Read: Apple debuts new 15-inch MacBook Air for $1,299, adds new Mac Pro and Studio PCs

    While Apple is sitting on a number of multibillion-dollar businesses now, the company’s current big moneymakers weren’t seen as slam dunks when they launched. Evercore ISI analyst Amit Daryanani noted that critics dinged the early iPhone for a lack of third-party apps and keyboard and pointed to fading interest in watch-wearing more generally at the time the Apple Watch debuted.

    Whether Apple can succeed again in making a once-questioned product category mainstream remains to be seen with the Vision Pro. The company could sell over 10 million units in the first five years, according to Daryanani, but that would make the device Apple’s slowest to ramp in the 21st century.

    See more: Apple could be cooking up 3 more $10 billion-plus businesses, one analyst says

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  • AstraZeneca Says US Approved Lynparza as a Prostate Cancer Treatment

    AstraZeneca Says US Approved Lynparza as a Prostate Cancer Treatment

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    By Anthony O. Goriainoff

    AstraZeneca said Thursday that its and MSD’s Lynparza cancer treatment had been approved in the U.S. for the treatment of metastatic castration-resistant prostate cancer, or mCRPC.

    The Anglo-Swedish pharma giant said Lynparza, in combination with abiraterone and prednisone, reduced the risk of disease progression or…

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  • Instagram is readying a Twitter-like service

    Instagram is readying a Twitter-like service

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    Embattled Twitter may soon have a serious rival: Facebook’s Instagram is planning to release a text-based app as a competitor.

    Instagram, a property of Meta Platforms Inc.
    META,
    -0.49%
    ,
    has been testing the service with creators, celebrities and influencers for months, according to people familiar with Meta’s strategy.

    “We’re exploring a standalone decentralized social network for sharing text updates. We believe there’s an opportunity for a separate space where creators and public figures can share timely updates about their interests,” a Meta spokesperson told MarketWatch.

    The app could debut as early as June, according to Lia Haberman, an adjunct professor at the University of California, Los Angeles, who teaches social and influencer marketing. She published a screenshot of an early description of the app, which may eventually be compatible with rival Twitter apps like Mastodon.

    Twitter has hemorrhaged users since Tesla Inc.
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    +1.84%

    Chief Executive Elon Musk began his chaotic leadership of the company late last year, prompting an exodus by disgruntled customers to alternative services like Mastodon and Bluesky.

    Jasmine Enberg, an analyst at Insider Intelligence, said the text-based service has been in the works for months alternately code-named P92 or Barcelona.

    “The big picture here is that there is clearly an appetite for Twitter-like services,” Enberg said in an interview. “With Twitter’s problems and so many alternatives, Meta’s new service looks like a mashup of Instagram and Twitter. Meta sees an opportunity to tap into this market, and it has a history of copying other popular apps [like Snap].”

    Meta’s stock was flat in Friday’s regular trading session.

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  • Tesla’s Elon Musk expects ‘a year of difficulty’ for the global economy

    Tesla’s Elon Musk expects ‘a year of difficulty’ for the global economy

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    Tesla Inc. Chief Executive Elon Musk said late Tuesday he foresees “a year of difficulty” for the global economy, with “lots of companies” going bankrupt, and said that the EV maker will not be immune to the downdraft, even as he teased two new products for Tesla in the future.

    “It’s is going to be a challenging 12 months, and Tesla is not immune to the global economic environment,” Musk said at the Tesla
    TSLA,
    +0.10%

    shareholder meeting in Austin, Texas, where he spoke for nearly two hours on a wide range of topics.

    The macroeconomic environment will be “difficult for at least the next 12 months,” Musk said. A turnaround, however, would come in the following 12 months, and long-term investors in Tesla will do “extremely well,” he said.

    A shareholder in the audience asked about “rumors” that Musk would be about to step down as CEO, ending with “say it ain’t so.” Musk responded with “it ain’t so,” but offered no further details.

    The executive also surprised the audience by saying that Tesla, which famously has eschewed traditional advertising, will now do it. “We will try advertising and see how it goes,” he said.

    Musk teased two new products to be unveiled in the future, and promised more details at a yet-to-be-detailed launch event. The unnamed products would be “head and shoulders above anything else” currently in the market, he said.

    Tesla has been working on a next-generation vehicle that would be cheaper than its current offerings, but nothing has been detailed.

    Musk promised a revamp for the Tesla Roadster in 2024, although he said that wasn’t a firm commitment. A new Roadster “will not be a huge contributor to revenue, but it will be sick,” he said.

    The CEO’s remarks were largely upbeat, to the applause of the shareholders at the event. Musk also spoke about autonomous driving and Tesla’s plans for alternative energy, and confirmed the Cybertruck, Tesla’s electric pickup truck which has been delayed a couple of times, is on track to be sold this year.

    “We will make as many as people want them” eventually, but the production ramp will be slow at first, he said.

    See also: Rivian, Lucid and Fisker navigate a ‘treacherous road’ as they struggle to match Tesla’s success

    Earlier, a preliminary tally indicated that shareholders voted yes on the proposals endorsed by the company, including approving the nomination of former Chief Technology Officer JB Straubel to the board.

    Some shareholders had questioned Straubel’s nomination, saying that Tesla’s board already had too many ties with Musk.

    A failed proposal, which had been introduced in previous years and called for a third-party audit into Tesla’s cobalt supply chain to prevent child and forced labor, ended up being embraced by Musk.

    “You know what, we will do a third-party audit,” although he said that Tesla products don’t use that much cobalt.

    Tesla shares gained 1.2% in after-hours trading. So far this year, Tesla has gained 35%, compared with gains of around 7% for the S&P 500 index
    SPX,
    -0.64%
    .

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  • Tesla’s Elon Musk expects ‘a year of difficulty’ for the global economy

    Tesla’s Elon Musk expects ‘a year of difficulty’ for the global economy

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    Tesla Inc. Chief Executive Elon Musk said late Tuesday he foresees “a year of difficulty” for the global economy, with “lots of companies” going bankrupt, and said that the EV maker will not be immune to the downdraft, even as he teased two new products for Tesla in the future.

    “It’s is going to be a challenging 12 months, and Tesla is not immune to the global economic environment,” Musk said at the Tesla
    TSLA,
    +0.10%

    shareholder meeting in Austin, Texas, where he spoke for nearly two hours on a wide range of topics.

    The macroeconomic environment will be “difficult for at least the next 12 months,” Musk said. A turnaround, however, would come in the following 12 months, and long-term investors in Tesla will do “extremely well,” he said.

    A shareholder in the audience asked about “rumors” that Musk would be about to step down as CEO, ending with “say it ain’t so.” Musk responded with “it ain’t so,” but offered no further details.

    The executive also surprised the audience by saying that Tesla, which famously has eschewed traditional advertising, will now do it. “We will try advertising and see how it goes,” he said.

    Musk teased two new products to be unveiled in the future, and promised more details at a yet-to-be-detailed launch event. The unnamed products would be “head and shoulders above anything else” currently in the market, he said.

    Tesla has been working on a next-generation vehicle that would be cheaper than its current offerings, but nothing has been detailed.

    Musk promised a revamp for the Tesla Roadster in 2024, although he said that wasn’t a firm commitment. A new Roadster “will not be a huge contributor to revenue, but it will be sick,” he said.

    The CEO’s remarks were largely upbeat, to the applause of the shareholders at the event. Musk also spoke about autonomous driving and Tesla’s plans for alternative energy, and confirmed the Cybertruck, Tesla’s electric pickup truck which has been delayed a couple of times, is on track to be sold this year.

    “We will make as many as people want them” eventually, but the production ramp will be slow at first, he said.

    See also: Rivian, Lucid and Fisker navigate a ‘treacherous road’ as they struggle to match Tesla’s success

    Earlier, a preliminary tally indicated that shareholders voted yes on the proposals endorsed by the company, including approving the nomination of former Chief Technology Officer JB Straubel to the board.

    Some shareholders had questioned Straubel’s nomination, saying that Tesla’s board already had too many ties with Musk.

    A failed proposal, which had been introduced in previous years and called for a third-party audit into Tesla’s cobalt supply chain to prevent child and forced labor, ended up being embraced by Musk.

    “You know what, we will do a third-party audit,” although he said that Tesla products don’t use that much cobalt.

    Tesla shares gained 1.2% in after-hours trading. So far this year, Tesla has gained 35%, compared with gains of around 7% for the S&P 500 index
    SPX,
    -0.64%
    .

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  • Disney to increase price of ad-free streaming again, add Hulu to Disney+ and remove some content

    Disney to increase price of ad-free streaming again, add Hulu to Disney+ and remove some content

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    Walt Disney Co. will increase the cost of ad-free Disney+ subscriptions this year while adding Hulu content to the Disney+ streaming service and removing some shows from streaming entirely, executives announced Wednesday.

    Disney
    DIS,
    -1.02%

    executives have been making changes to their streaming strategy in an attempt to lose less money from offering its content directly to consumers over the internet. The company launched an ad-supported version of Disney+ in the U.S. and other countries late last year, and increased the cost of its ad-free offering at the same time, while increasing costs of other services.

    “Pricing changes we’ve already implemented have proven successful, and we plan to set a higher price for our ad-free tier later this year to better reflect the value of our content offerings,” Chief Executive Robert Iger said in a conference call Wednesday related to Disney’s quarterly earnings. “As we look to the future, we will continue optimizing our pricing model to reward loyalty and reduce churn, to increase subscriber revenue for the premium ad-free tier, and drive growth of subscribers who offer the lower-cost ad supported option.”

    Full earnings coverage: Disney stock falls as Disney+ subscribers decline amid push to lose less money in streaming

    Iger returned as chief executive of Disney late last year, and has been overseeing the evaluation of Disney’s streaming strategy. One of the biggest question marks is Hulu, of which Disney now owns two-thirds, with the option to buy the remaining interest from Comcast Corp.
    CMCSA,
    +0.61%

    as early as January.

    Iger, though, has been rethinking the path for Hulu since returning. In an interview with CNBC earlier this year, he intimated that Disney could choose to sell the streaming service instead of buying the remaining interest. In his first big move with the service since returning, Iger said Wednesday that Hulu content would roll into Disney+ in the U.S. later this year.

    “As a significant step toward creating a growth business, I’m pleased to announce that we will soon begin offering a one-app experience domestically that incorporates our Hulu content via Disney+,” Iger said in the conference call. “While we will continue to offer Disney+, Hulu and ESPN+ as stand-alone options, this is a logical progression of our [direct-to-consumer] offerings that will provide greater opportunities for advertisers while giving bundle subscribers access to more robust and streamlined content, resulting in greater audience engagement and ultimately leading to a more unified streaming experience.”

    Iger later clarified that the two apps will be combined only for those who subscribe to both.

    “On the integrated app experience that we announced today, that’s more consumers that have subscribed to both services for now,” he said. “So in other words, it’s taking what we call the dual bundle and putting it together in one experience, which is obviously good for consumers. Why have to close out one app and open another one?”

    For more: Disney is undergoing a ‘drastic evolution’ in streaming, and more changes could be afoot

    After a wave of new streaming services appeared in recent years to compete with Netflix Inc.
    NFLX,
    +0.99%
    ,
    media companies are looking to combine some of their offerings as consumers deal with a web of potential subscriptions. Paramount Global
    PARA,
    -4.11%

    plans to combine its Paramount+ and Showtime streaming services, and Warner Bros. Discovery
    WBD,
    -2.76%

    is planning to combine HBO Max with Discovery+ while renaming the service Max.

    When an analyst on Wednesday’s call suggested that Disney’s move revealed that Iger had decided to purchase the rest of Hulu, Iger responded by saying “it’s not really been fully determined what will happen in that regard.”

    “Where we are headed is for one experience that would have general entertainment and Disney+ content together for the reasons that I just described,” Iger said. “How that ultimately unfolds is to some extent in the hands of Comcast and in the hands of basically a conversation or a negotiation that we have with them. I don’t want to be in any way predictive in terms of when or how that ends up.”

    While adding Hulu content to Disney+, Disney will also remove some content from its streaming services, which will allow the company to save money that would be paid out as residuals for airing the content. Warner Bros. Discovery made similar moves as it looked to cut costs for its HBO Max streaming service last year.

    “We will be removing certain content from our streaming platforms, and currently expect to take an impairment charge of approximately $1.5 billion to $1.8 billion,” Chief Financial Officer Christine McCarthy said in the conference call, without elaborating further.

    For more: As streaming services cut costs, TV shows — and residuals — vanish

    Iger did elaborate on his vision for streaming in his second earnings report since returning to the company, laying out his general thoughts about the path forward for Disney’s streaming portfolio — which also includes ESPN+ and a version of Disney+ in India and other parts of Asia refereed to as Disney+Hotstar.

    “First, it’s critical we rationalize the volume of content we’re creating, and what we’re spending to produce our content. Second, our legacy platforms enable us to expand our audiences and often augment our potential streaming success while at the same time, allowing us to amortize our content costs across multiple windows,” he said. “We also need to strike the right balance between our local and global programming, as well as our platform and program marketing. Finally, we must continue calibrating our investments in specific markets.”

    Disney shares declined in after-hours trading Wednesday following the release of quarterly results, which showed a sequential decline in Disney+ subscribers. The stock has gained 16.4% so far this year, as the S&P 500 index
    SPX,
    +0.45%

    has gained 7.3%.

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  • Biogen wins accelerated FDA approval for treatment for rare form of ALS

    Biogen wins accelerated FDA approval for treatment for rare form of ALS

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    The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or ALS.

    The accelerated program is used to approve drugs for serious conditions that have an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.

    In…

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  • U.S. Supreme Court preserves near-term access to abortion pill mifepristone

    U.S. Supreme Court preserves near-term access to abortion pill mifepristone

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    WASHINGTON (AP) — The Supreme Court on Friday preserved women’s access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues.

    The justices granted emergency requests from the Biden administration and New York–based Danco Laboratories, maker of the drug, called mifepristone. They are appealing a lower-court ruling that would roll back Food and Drug Administration approval of mifepristone.

    The drug has been approved for use in the U.S. since 2000 and more than 5 million people have used it. Mifepristone is used in combination with a second drug, misoprostol, in more than half of all abortions in the U.S.

    The court faced a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill would remain unchanged or be restricted while a legal challenge to its Food and Drug Administration approval goes on.

    The justices have been weighing arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of the drug, mifepristone, which is used in the most common abortion method in the United States.

    It has repeatedly been found to be safe and effective, and has been used by more than 5 million women in the U.S. since the FDA approved it in 2000.

    The Supreme Court had initially said it would decide by Wednesday whether the restrictions could take effect while the case continues. A one-sentence order signed by Justice Samuel Alito on Wednesday gave the justices two additional days, without explanation.

    Abortion opponents filed suit in Texas in November, asserting that FDA’s original approval of mifepristone 23 years ago and subsequent changes were flawed.

    Matthew Kacsmaryk, shown listening to a question during his confirmation hearing before the Senate Judiciary Committee in 2017, is the lone federal judge in his north Texas district — a fact that led to speculation among critics that the abortion-pill case had landed in his courtroom via judge shopping.


    Senate Judiciary Committee/AP

    Further context (March 2023): Trump appointee in single-judge federal district in Texas could bar nationwide access to the abortifacient mifepristone

    Also (April 2023): Access to abortion pill in limbo after competing rulings in Texas and Washington

    They won a ruling on April 7 by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, revoking FDA approval of mifepristone. The judge, the lone judge in his Amarillo, Texas, federal district, gave the Biden administration and Danco a week to appeal and seek to keep his ruling on hold.

    Responding to a quick appeal, two more Trump appointees on the 5th U.S. Circuit Court of Appeals said the FDA’s original approval would stand for now. But Judges Andrew Oldham and Kurt Englehardt said most of the rest of Kacsmaryk’s ruling could take effect while the case winds through federal courts.

    MarketWatch contributed.

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  • Tupperware’s stock craters after food-storage company warns it may go bust

    Tupperware’s stock craters after food-storage company warns it may go bust

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    Tupperware Brands Corp.’s stock slid 45% Monday to the lowest level in three years, after the maker of food-storage goods issued a going-concern warning late Friday, saying it has hired financial advisers to help navigate its near-term challenges.

    The news is just the latest blow to the company
    TUP,
    -46.90%
    ,
    whose products were once a fixture in American homes, made popular in the 1950s by stay-at-home moms who would gather at special parties to introduce the product line to friends and family.

    The company’s website opens on an image from the Amazon Prime show “The Marvelous Mrs. Maisel,” with the title character hosting her own party and showing friends a pastel-colored vintage line.

    That direct-selling model is no longer fashionable in the U.S., although it has traction in markets like Indonesia, where women have limited earnings opportunities but often gather to eat and drink.

    From the archive: You won’t believe what Tupperware says is a key challenge

    The company has struggled for years to retain its selling force, which has been shrinking thanks to the proliferation of other gig-economy opportunities around the world. 

    In March, the company told analysts on its fourth-quarter earnings call that the sales force fell 18% last year.

    That wasn’t even the worst news from that call, because Tupperware had warned in its earning release that it had identified weakness in internal control over financial reporting and that it expected to restate prior financials.

    On Friday, it said that once it finalizes its 10-K annual report, which is now late, that the numbers announced in March would differ significantly from the restated numbers. It expects to file the 10-K with the Securities and Exchange Commission in the next 30 days.

    Then there’s the issue of the company’s debt burden, which has led to repeated efforts to squeeze concessions from bank lenders so it can remain compliant with financial covenants.

    See now: Tupperware stock craters after company warns its debt burden may force it out of business

    Due “to the challenging internal and external business economics, coupled with the increased levels and cost of borrowings under its credit facility, the company currently forecasts that, if it is unable to obtain adequate capital resources or amendments to its credit agreement, it may not have adequate liquidity in the near term,” the company said on Friday.

    Chief Executive Miguel Fernandez said Tupperware had embarked on a journey to turn around its operations and address its capital and liquidity positions.

    The company is looking for additional financing and is discussing its options with potential investors or financing partners. Tupperware is also reviewing its real-estate portfolio with an eye toward potential sales or lease-back transactions, it said.

    On its third-quarter earnings call in November, Fernandez acknowledged that some of the company’s problems are of its own making. “The global macro environment continues to be challenging, and we are not executing internally at a level or consistency that we believe we should be,” he told analysts on the call, according to a FactSet transcript.

    One key challenge is connecting with younger consumers, who are unlikely to attend Tupperware parties. The company started to sell its goods at 1,900 Target
    TGT,
    +2.12%

    stores in the U.S. at the start of the third quarter as part of a strategy of reducing its reliance on direct selling.

    But those sales accounted for just 1% of total sales in the fourth quarter, suggesting the strategy has not gained traction.

    One challenge facing Tupperware is price. Amazon
    AMZN,
    -0.27%

    and other retailers such as dollar stores offer far cheaper food-storage containers. In addition, Americans are increasingly shopping online.

    Tupperware’s stock has fallen 98% in the last 12 months, while the S&P 500
    SPX,
    -0.12%

    has fallen 9%.

    Also from the archives: Think the Avon Lady is American? Think again

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  • Federal judge in Texas suspends FDA approval of abortion pill mifepristone

    Federal judge in Texas suspends FDA approval of abortion pill mifepristone

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    AUSTIN, Texas (AP) — A federal judge in Texas on Friday ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval.

    The abortion drug has been widely used in the U.S. since 2000 and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United…

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  • FDA pulls preterm-birth drug Makena and its generics from market after 12 years

    FDA pulls preterm-birth drug Makena and its generics from market after 12 years

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    The U.S. Food and Drug Administration said Thursday it had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment hit the market.

    The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition.

    The…

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