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Tag: new products

  • Chips Held Hostage in Trade War Start Flowing Again to Auto Suppliers

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    Nexperia microchips are leaving China again, easing a shortage of simple but ubiquitous parts that threatened to paralyze the auto industry.

    German automotive supplier Aumovio, which was recently spun out of tire giant Continental, said Friday that the Sino-Dutch company’s semiconductors and components containing them were on their way from China to Aumovio’s distribution hub in Hungary.

    Copyright ©2025 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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    Stephen Wilmot

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  • China, Betting It Can Win a Trade War, Is Playing Hardball With Trump

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    In its trade standoff with Washington, Beijing thinks it has found America’s Achilles’ heel: President Trump’s fixation on the stock market.

    China’s leader, Xi Jinping, is betting that the U.S. economy can’t absorb a prolonged trade conflict with the world’s second-largest economy, according to people close to Beijing’s decision-making. China is holding a firm line because of its conviction, the people said, that an escalating trade war will tank markets, as it did in April after Trump announced his so-called Liberation Day tariffs, prompting Beijing to hit back.

    Copyright ©2025 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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    Lingling Wei

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  • Trump Threatens Higher Tariffs on China Citing Restrictions on Rare-Earth Elements

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    President Trump threatened to raise tariffs and impose export controls on China and said there was “no reason” to meet with Chinese leader Xi Jinping after Beijing’s new restrictions on rare-earth materials marked an escalation in tensions between the countries.

    China this week announced new export restrictions on rare earth minerals, which are critical components of products from semiconductors to electric vehicles and jet fighters. China dominates processing capabilities for rare earth minerals, giving it leverage over the U.S. and other nations.

    Copyright ©2025 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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    Gavin Bade

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  • bSerene Debuts Industry-Leading Calming Product Line for Pets

    bSerene Debuts Industry-Leading Calming Product Line for Pets

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    Featuring a comprehensive lineup of on-demand therapies, round-the-clock support and portable solutions for cats and dogs.

    bSereneTM, a trailblazer in pet calming, proudly introduces the most comprehensive lineup of calming solutions for cats and dogs, revolutionizing how pet owners address stressors in their beloved companions. Recognizing that every pet experiences stress differently, bSereneTM offers a groundbreaking calming collection that features a range of targeted and specific products that can be layered and combined to create a customized calming solution that works for your unique furry friend.  

    “As pet owners, we understand that calming solutions, unfortunately, are not one size fits all,” said Michele Crowley, Senior Vice President of Marketing at H&C Animal Health, the owners of bSerene TM. “With our expanded line of calming products, we aim to empower pet owners to support their pets’ emotional health effectively with tailored solutions that address the unique needs of their pets.” 

    Nearly three-quarters of dogs display stress-related behaviors, according to a 2020 study, highlighting the growing need for effective calming solutions. Recognizing this critical need, bSerene TM has emerged as a pioneer in this space. bSerene’s dedication to pet well-being has been recognized by Fear Free®, an organization founded by Dr. Marty Becker that focuses on reducing pets’ fear and anxiety in places like vet offices, shelters, and homes. They’ve named bSerene™ as their official partner for pheromone products, acknowledging the shared mission of making pets’ lives better and calmer. 

    The bSerene TM collection offers targeted solutions for pet owners to find the perfect combination to address their pet’s specific calming needs, whether it’s fear of thunder, separation issues, or general uneasiness. Among the innovative tools in the bSerene TM collection, the Advanced Cat Calming Diffuser Kit uses dual pheromones (Mother Appeasing Pheromone and F3) for multi-cat harmony. 

    Cat Calming Collection: 

    • Advanced Calming Diffuser Kit 
    • Calming Spray 
    • Calming Collar
    • Calming Spot On 
    • Calming Chews 

    Dog Calming Collection: 

    • Calming Diffuser Kit 
    • Calming Spray 
    • Calming Collar 
    • Calming Spot On 
    • Calming Advanced Chews 

    Guided by an unwavering dedication to innovation and quality, bSerene TM is on a mission to consistently pioneer new and effective solutions that not only alleviate stress in pets but also enrich the lives of both pets and their devoted owners. bSerene TM invites pet owners, retailers, and industry professionals attending Global Pet Expo to discover our comprehensive calming collection at booth #1254. 

    Source: H&C Animal Health

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  • Angels’ Eyes Expands Product Line Beyond Tear Stains

    Angels’ Eyes Expands Product Line Beyond Tear Stains

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    Angels’ Eyes Unveils Groundbreaking Expansion, Pioneering a New Era in Tear Stains and Beyond.

    Angels’ Eyes, a trusted name in pet care, is proud to announce a significant expansion of its product line, marking a pivotal moment in the company’s evolution. Renowned for its innovative solutions to pet tear stains, Angels’ Eyes, acquired by H&C Animal Health in 2020 and the brand leader in the tear stain market, is now broadening its focus to cater to a wider range of pet care needs, highlighting its dedication to pet owners’ evolving needs. 

    “If you take care of the pet, the pet takes care of you,” said Chuck Latham, founder of H&C Animal Health. “For many of us, our pets are our constant companions, loyal friends, and even family. That’s why we’re driven to be more than just ‘good enough’ – we’re developing groundbreaking products that address pet health concerns in innovative ways. Our commitment to rigorous research and development ensures each offering effectively supports your furry friend.” 

    The new products from Angels’ Eyes encompass a wide range of categories, including ear care, eye care, seaweed daily dog treats, and the first-ever tear stain-friendly dog treats. This expansion underscores the brand’s dedication to meeting the evolving needs of pet owners and their beloved companions. 

    Angels’ Eyes Sea Sticks Tear Stain Friendly Dog Treats (Available in 3 Sizes: Small, Medium, Large) – The first ever tear stain-friendly dog treat is crafted with a unique blend of brown and red seaweed that can be incorporated into your pet’s daily tear stain regimen. These treats offer a tear stain-friendly way to treat your dog with a unique antioxidant blend of plant-based ingredients that help support your pup’s immune, digestive, and metabolic system while adding a tasty treat to the tear stain-eliminating routine. 

    Angels’ Eyes Gentle Ear Cleansing Wipes, 100 ct.– Soothing, non-irritating ear wipes help to remove the build-up of wax, dirt, debris, and foul odors from your cat or dog’s ears. These convenient and gentle ear wipes feature Aloe Vera and Chamomile to soothe and are free of alcohol, dyes, artificial coloring, and fragrance. 

    Angels’ Eyes Zinc-Otic Ear Relief Treatment – Specially formulated with Natural Boric Acid and Zinc to help combat the symptoms of outer ear infections, such as itching, redness, inflammation, discharge, and unpleasant odors. The non-staining formula contains no steroids or antibiotics, is safe for long-term maintenance, and is an excellent solution for dogs and cats. 

    Angels’ Eyes Sea Sticks Multi-Benefit Daily Dog Treats (Available in 3 Sizes: Small, Medium, Large) – Containing essential vitamins and minerals, our multi-benefit Sea Sticks are not just a delicious daily treat; they are a holistic approach to enhancing your dog’s vitality, ensuring they thrive from the inside out. Our tasty treats also promote better oral hygiene with the power of seaweed and its crunchy ridges to help clean teeth and support a healthy gut. 

    Angels’ Eyes Multi-Purpose Sterile Eye Wash – Provides soothing relief from eye irritation, fights bacteria, and helps remove pollutants such as smog, chlorine, allergies, and debris from your cat or dog’s eyes. Regular use helps to remove tear stains and slow down their development by rinsing away the stain-causing minerals. 

    Angels’ Eyes Multi-Purpose Eye Lubricant – Helps relieve irritation and allergies in your cat or dog’s eyes that cause discharge and excess tears, soothes dry eyes, and may help to reduce tear stains with regular use. Helps to create a protective barrier while moisturizing the eye. 

    Angels’ Eyes invites pet owners, retailers, and industry professionals attending Global Pet Expo to discover the full range of new products and experience the difference firsthand. Stay tuned for more information as Angels’ Eyes continues to roll out these exciting additions to its product portfolio. 

    Source: H&C Animal Health

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  • Disney, Fox and Warner Bros. team up to launch new sports streaming service

    Disney, Fox and Warner Bros. team up to launch new sports streaming service

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    Walt Disney Co.’s ESPN, Fox Corp. and Warner Bros. Discovery Inc. are teaming to create a joint sports streaming service.

    The as-yet unnamed service, which could be available as early as the fall and offer a sort of Hulu model for sports, comes amid an explosion in sports-streaming rights and audiences.

    The service would essentially be a skinny bundle of the companies’ linear channels, including ESPN, ESPN2, ESPNU, SECN, ACCN, ESPNEWS, ABC, Fox, FS1, FS2, BTN, TNT, TBS, truTV, as well as the ESPN+ streaming service.

    “The launch of this new streaming sports service is a significant moment for Disney
    DIS,
    +2.73%

    and ESPN, a major win for sports fans, and an important step forward for the media business,” Disney Chief Executive Bob Iger said in a statement late Tuesday. “This means the full suite of ESPN channels will be available to consumers alongside the sports programming of other industry leaders as part of a differentiated sports-centric service.”

    Added Warner Bros.
    WBD,

    CEO David Zaslav: “This new sports service exemplifies our ability as an industry to drive innovation and provide consumers with more choice, enjoyment and value and we’re thrilled to deliver it to sports fans.”

    Each company will own one-third of the platform, according to Disney, in a deal reminiscent of the original Hulu, which started off as a joint venture between ABC, Fox and NBCUniversal.

    The service will have a new brand with an independent management team, and will be available to bundle with Disney+, Hulu and Max subscriptions.

    “We’re pumped,” Fox
    FOX,
    +0.55%

    CEO Lachlan Murdoch said. “We believe the service will provide passionate fans outside of the traditional bundle an array of amazing sports content all in one place.”

    More details, including pricing, will be announced later.

    Prominently missing from the deal are Comcast Corp.
    CMCSA,
    -1.00%
    ,
    which owns NBCUniversal and its sports lineup that includes NFL football and the Olympics, and Paramount Global
    PARA,
    -0.21%
    ,
    which owns CBS — which carries the NFL and college football, among other sports.

    The new service will showcase thousands of high-profile sporting events and include all four major sports leagues — the NFL, NBA, MLB and NHL — as well as college football and basketball, golf, tennis, cycling, soccer and UFC.

    Shares of Disney were down 1% in extended trading Tuesday, while Fox shares jumped 6% and WBD gained 3%.

    Mike Murphy contributed to this report.

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  • Denim pioneer Levi’s is rolling out ‘tech pants’ and other new offerings this year. But will retailers stock them?

    Denim pioneer Levi’s is rolling out ‘tech pants’ and other new offerings this year. But will retailers stock them?

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    With a rough 2023 in the rearview mirror, Levi Strauss & Co. this year is trying to tackle its problems with new pants.

    That includes pants with lighter-weight denim; pants for women that can be worn as high-rise or low-rise; and even nondenim pants that management, during Levi’s
    LEVI,
    +1.27%

    earnings call on Thursday, referred to as a “tech pant” for men with “moisture control and 360 mobility.” The company also plans to expand its offerings of Performance Cool pants intended to keep the wearer cool and dry on hotter days.

    But as those products roll out, the retailers that account for most of Levi’s sales are still cautious about packing their shelves with new apparel — even though Levi’s executives pointed to slightly better demand from clothing stores during the fourth quarter and holiday period. And as the denim pioneer cuts costs, brings in new leadership and tries to be a bigger e-commerce player, Wall Street will now be digging around for signs of a payoff.

    “Ultimately, the market will be looking for evidence new strategies can drive accelerated growth,” Stifel analyst Jim Duffy said in a research note on Thursday.

    “We continue to believe in brand vitality and opportunities for extension. With product reflective of new direction arriving in the marketplace across 2024, the proof will be in consumer response,” he continued.

    In an interview with MarketWatch on Friday, Duffy said he was optimistic about Levi’s standing as an established brand and stronger demand for its dresses, skirts and other women’s clothing items. But the more products a company rolls out, he suggested, the more it has to invest to make them work — and the more it needs to manage if sales falter.

    “The risk, as I see it, is that more categories means more SKUs and more product that is fashion rather than core basic styles, and more investment and inventory that, if it doesn’t translate to the marketplace, could result in higher markdowns,” he said, referring to the stock-keeping units by which retailers track inventory.

    Levi’s on Thursday said it would lay off between 10% and 15% of its global corporate staff in the first half of this year, a move intended to save $100 million in costs over that period. The layoffs are part of a two-year plan, called Project FUEL, intended to save money and strengthen the part of Levi’s business that sells directly to consumers via its own e-commerce network and its physical stores, as opposed to third-party retail operations.

    The layoff announcement arrived days ahead of Chief Executive Chip Berg’s departure from that role, with Michelle Gass taking over on Jan. 29. As the company tries to be bigger than men’s jeans, Gass, in Levi’s earnings release on Thursday, said she saw an opportunity to grow internationally, make Levi’s own online and bricks-and-mortar sales a greater priority, and turn the brand into a larger “denim apparel lifestyle business.”

    Levi’s shares fell after hours Thursday, after the company’s full-year profit forecast came in below expectations. The stock rebounded 1.3% on Friday but is still down 10.3% over the past 12 months.

    Still, Levi’s direct-to-consumer sales jumped 11% during the fourth quarter, and accounted for 42% of sales overall. Duffy said that the company has pushed deeper into its direct-sales business because it gives executives greater insight into what consumers want, as well as more control over how it markets and sells its clothing. Cutting out other retailers also widens margins on sales, he noted.

    Levi’s operating margins were higher in the fourth quarter. It also declared a dividend of 12 cents per share, payable in cash on Feb. 23.

    But sales in Levi’s wholesale segment — the sales it gets from retailers who buy Levi’s product, then sell it to consumers — fell 2%. Better results in the U.S. and Asia were offset by a drop in Europe, the company said.

    Retailers have spent the past two years trying to clear unwanted clothes from their stockrooms, and cutting prices in the process, after spiking inflation restricted many shoppers’ appetites to basics.

    As Gass prepares to take the reins, she sought to put a positive spin on retail-chain sentiment. “So net-net, overall, as a company, we’re exiting the year on a strong note,” Gass said on the earnings call. “And U.S. wholesale, we’re encouraged. But as it relates to that channel, we’re not declaring victory yet. There’s been a lot of volatility this past year, some in our control, some outside. And so we are taking a cautious approach as we look forward.”

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  • Bluebird Bio Stock Is in Free Fall

    Bluebird Bio Stock Is in Free Fall

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    Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.

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  • AMD Stock Is More Expensive Than Nvidia. That Makes No Sense.

    AMD Stock Is More Expensive Than Nvidia. That Makes No Sense.

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    Advanced Micro Devices is on a roll this week, with its shares marching higher since the chip maker revealed ambitious plans to push into artificial intelligence. Investors looking to dive in best be warned: the stock now looks more expensive than Nvidia.

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  • AMD wins high praise for AI advancements as its stock soars 6%

    AMD wins high praise for AI advancements as its stock soars 6%

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    While Advanced Micro Devices Inc. shares didn’t enjoy a Wednesday bump during the company’s artificial-intelligence event, they were rallying sharply Thursday as analysts reflected on the chip maker’s presentation.

    Chief Executive Lisa Su and her team “put together one of the most impressive new product event/launches by our reckoning in the last decade, perhaps ever,” Rosenblatt Securities analyst Hans Mosesmann wrote in a note to clients.

    The launch of AMD’s
    AMD,
    +7.09%

    MI300X AI/graphics-processing-unit accelerator “was not just a speeds and feeds geek fest (it was that for sure, with AMD claiming superiority in AI inferencing), but an industry movement coalescing around the concept of ‘open’ sourced technologies are preferred (demanded really), to address the insanely fast/accelerating life-changing thing that AI has become,” Mosesmann continued.

    Opinion: AMD’s new products represent the first real threat to Nvidia’s AI dominance

    He was also impressed by the company’s talk of its software platform ROCm, which he thinks is catching up to Nvidia Corp.’s
    NVDA,
    +1.54%

    CUDA.

    “Of course, Nvidia is not going away, and we are quite sure will remain the dominant AI player for years to come but AMD we feel made the case yesterday that they will be an important AI innovator on a secular basis,” Mosesmann noted, as he kept his outperform rating and $200 target price on the stock.

    AMD shares were up 6% in Thursday morning trading.

    Baird’s Tristan Gerra was also impressed.

    “Rapidly unfolding hyperscaler engagements, highly competitive AI architecture specs, along with accelerated new product roadmap, bode well for share gains and continued acceleration in AI-related revenue for AMD beyond 2024, while faster-than-expected rate of adoption so far could potentially drive upside in the AI revenue outlook for 2024, in our view,” he wrote.

    Read: Nvidia and Microsoft CEOs say industrial companies will benefit most from AI. Here are stocks to put on your watch list.

    Gerra also sees the potential for “high-volume deployments,” thanks to the “significant software milestones” AMD is showing. He rates the stock at outperform with a $125 target price.

    TD Cowen’s Matthew Ramsay said that AMD’s event reinforced his belief that the company “is well positioned to meaningfully participate” in the large total addressable market for AI accelerators.

    The company called out Microsoft Corp.
    MSFT,
    -0.01%
    ,
    Meta Platforms Inc.
    META,
    +2.41%

    and Oracle Corp.
    ORCL,
    -0.08%

    as customers, announcements that were “strong” but not “surprising,” in Ramsay’s view.

    “We remain encouraged that AMD is making an impressive case (and is getting customer support) to provide adaptive computing solutions for both training and inference in increasingly large [generative-AI] infrastructure builds,” he wrote. “We believe this signifies a strong AI strategy of delivering a broad portfolio of [central processing unit], GPU, and [field-programmable gate array] assets, with open software that enables easily deployed AI workloads while leveraging the company’s existing partnerships to accelerate its AI ramps at-scale.”

    Ramsay has an outperform rating and $130 target price on AMD shares.

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  • Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

    Roche's Inavolisib Breast Cancer Drug Shows Promise in Late-Stage Study

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    By Mauro Orru

    Roche Holding said its investigational treatment, inavolisib, showed promise in a late-stage study to treat patients with breast cancer.

    The Swiss pharmaceutical company said Tuesday that the phase 3 study met its primary endpoint of progression-free survival, showing that inavolisib, in combination with palbociclib and fulvestrant, delivered a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone.

    While Roche acknowledged that overall survival data were immature at this stage, it said it had observed a clear positive trend. The inavolisib combination was well tolerated.

    The group said inavolisib is an investigational, oral targeted treatment with potential to provide durable disease control.

    Write to Mauro Orru at mauro.orru@wsj.com

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  • LinkedIn hits 1 billion users launches AI chatbot coach | Entrepreneur

    LinkedIn hits 1 billion users launches AI chatbot coach | Entrepreneur

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    Opinions expressed by Entrepreneur contributors are their own.

    This story originally appeared on Readwrite.com

    On November 1, LinkedIn revealed that it has reached over 1 billion members and has introduced an artificial intelligence (AI) chatbot to serve as a “job seeker coach.” Along with the chatbot, the Microsoft-owned company also launched other generative AI tools exclusive to its Premium subscribers. This move is part of LinkedIn’s ongoing commitment to AI-driven solutions, having previously released automated recruiting messages and AI-created job descriptions.

    Related: How to Get High Quality Leads From LinkedIn At No Cost

    Job seeker coach and exclusive AI tools

    The AI chatbot, dubbed the “Job Seeker Coach,” aims to provide personalized career guidance, job search assistance, and tailored recommendations for upgrading skills and improving one’s professional profile. The exclusive generative AI tools for Premium subscribers are designed to enhance networking experiences, optimize content creation, and save time for users by automating various tasks, such as generating pre-populated conversation starters and suggesting relevant articles for sharing.

    The new AI chatbot is based on OpenAI’s GPT-4 and became available to select Premium members. Notably, Microsoft has also invested in OpenAI. To deliver a smooth and interactive chatbot experience, LinkedIn’s engineering team invested significant efforts in decreasing platform latency, says Erran Berger, LinkedIn’s Vice President of Product Engineering. As a result of this collaboration, users can now expect swift and engaging conversations with the chatbot, enhancing their overall LinkedIn experience.

    In a recent conversation with CNBC, Berger emphasized the importance of developing platform features that guarantee fast and effective communication experiences for users. He stated that in today’s fast-paced digital world, users expect seamless, real-time interactions that cater to their needs efficiently. Berger also highlighted that the company’s primary focus is on continuously enhancing these platform features to not only retain their existing user base but also attract new users who value quick and impactful communication.

    Boosting revenue growth and user engagement

    This effort comes as LinkedIn looks to boost revenue growth after eight consecutive quarters of slowed progress. In an attempt to revitalize their platform, LinkedIn is exploring new features and opportunities for user engagement. By implementing innovative strategies, the company hopes to attract more users and advertisers, ultimately driving up revenue and reversing the downward trend.

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    Deanna Ritchie

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  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%

    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%
    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • Ardelyx wins long battle for FDA approval of kidney-disease treatment 

    Ardelyx wins long battle for FDA approval of kidney-disease treatment 

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    Ardelyx Inc.
    ARDX,
    -0.58%

    on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.

    The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.    

    The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April. 

    More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx. 

    High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch. 

    Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said. 

    The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.

    Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.

    Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday. 

    Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis. 

    Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
    SPX
    has gained 13.9%. 

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  • Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result

    Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result

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    By Adria Calatayud

    Novartis said an interim analysis from a phase 3 trial to evaluate its investigational iptacopan drug in patients with kidney disease nephropathy achieved positive results, meeting its primary goal.

    The Swiss pharmaceutical company said Monday that an analysis of study data at nine months showed a clinically meaningful and statistically significant reduction in protein in urine. The company said this demonstrated superiority of iptacopan relative to placebo in reducing protein in urine.

    The safety profile of the drug was consistent with previously reported data, Novartis said.

    Novartis said it plans to review the trial’s interim results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval.

    The study will now continue to assess the iptacopan’s ability to slow disease progression over two years, the company said. Results from the primary goal at the end of the study are expected in 2025.

    Write to Adria Calatayud at adria.calatayud@dowjones.com

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  • Apple says it will fix app software problems blamed for making iPhone 15 models too hot to handle

    Apple says it will fix app software problems blamed for making iPhone 15 models too hot to handle

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    Apple Inc. is blaming a software bug and other issues tied to popular apps such as Instagram and Uber for causing its recently released iPhone 15 models to heat up and spark complaints about becoming too hot to handle.

    The Cupertino, Calif., company
    AAPL,
    +0.30%

    said Saturday that it is working on an update to the iOS17 system that powers the iPhone 15 lineup to prevent the devices from becoming uncomfortably hot and is working with apps that are running in ways “causing them to overload the system.”

    Instagram, owned by Meta Platforms
    META,
    -1.23%
    ,
    modified its social media app earlier this week to prevent it from heating up the device on the latest iPhone operating system.

    Read: The Magnificent Seven could be considered the messy seven after a ‘meh’ third quarter

    Uber
    UBER,
    -0.33%

    and other apps such as the video game Asphalt 9 are still in the process of rolling out their updates, Apple said. It didn’t specify a timeline for when its own software fix would be issued but said no safety issues should prevent iPhone 15 owners from using their devices while awaiting the update.

    “We have identified a few conditions which can cause iPhone to run warmer than expected,” Apple in a short statement provided to The Associated Press after media reports detailed overheating complaints that are peppering online message boards.

    The Wall Street Journal amplified the worries in a story citing the overheating problem in its own testing of the new iPhones, which went on sale a week ago.

    Read: Here’s what Apple’s iPhone 15 says about the world

    It’s not unusual for new iPhones to get uncomfortably warm during the first few days of use or when they are being restored with backup information stored in the cloud — issues that Apple already flags for users. The devices also can get hot when using apps such as video games and augmented reality technology that require a lot of processing power, but the heating issues with the iPhone 15 models have gone beyond those typical situations.

    In its acknowledgement, Apple stressed that the trouble isn’t related to the sleek titanium casing that houses the high-end iPhone 15 Pro and iPhone 15 Pro Max instead of the stainless steel used on older smartphones.

    Apple also dismissed speculation that the overheating problem in the new models might be tied to a shift from its proprietary Lightning charging cable to the more widely used USB-C port that allowed it to comply with a mandate issued by European regulators.

    Although Apple expressed confidence that the overheating issue can be quickly fixed with the upcoming software updates, the problem still could dampen sales of its marquee product at time when the company has faced three consecutive quarters of year-over-year declines in overall sales.

    The downturn has affected iPhone sales, which fell by a combined 4% in the nine months covered by Apple’s past three fiscal quarters compared with a year earlier.

    Apple is trying to pump up its sales in part by raising the starting price for its top-of-the-line iPhone 15 Pro Max to $1,200, an increase of $100, or 9%, from last year’s comparable model.

    Investor worries about Apple’s uncharacteristic sales funk already have wiped out more than $300 billion in shareholder wealth since the company’s market value closed at $3 trillion for the first time in late June.

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  • Apple event: iPhone 15, Apple Watch Series 9 and everything else on the way

    Apple event: iPhone 15, Apple Watch Series 9 and everything else on the way

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    Apple refreshed its iPhone and Apple Watch lineups at a Tuesday event that focused on camera and processing improvements for the phones as well as new gesture controls for the watch.

    Apple
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    kept prices the same on three of its iPhone models, while boosting the starting price of the iPhone 15 Pro Max for the first time when it eliminated what previously was the smallest and cheapest configuration. The least expensive iPhone 15 Pro Max will cost $1,199 for 256GB of storage, which is what that configuration cost a year ago, though at that time there was also a cheaper 128GB option. Apple previously had stuck with a $1,099 base price on the iPhone Pro Max since it rolled out that model in 2019.

    Both the iPhone 15 Pro and the iPhone 15 Pro Max will feature Apple’s custom designed A17 Pro processor, a faster chip that the company says will boost the mobile gaming experience.

    The Pro models are getting slight design enhancements, including new titanium casing and slimmer edges. Apple says that the use of titanium, rather than stainless steel, makes the models lighter than their predecessor.

    Perhaps the best camera upgrade is exclusive to the Pro Max. That phone will have a better telephoto camera supporting up to five-times zoom, compared with three times before, and will be able to capture three-dimensional video that can be viewed with Apple’s soon-to-launch Vision Pro headset.

    See also: Vision Pro could be Apple’s biggest hit since iPhone

    The iPhone 15 and iPhone 15 Plus will receive enhancements, too, including speed boosts via Apple’s A16 processor and camera upgrades that will support better use of portrait mode. The satellite connectivity feature that launched on last year’s iPhones will expand to include roadside assistance as well.

    After facing criticism for the iPhone’s “notch,” Apple turned that space into a Dynamic Island on Pro models last year. Now that technology is coming to the base-level models as well, so users will be able to use that space for more functional means like changing songs.

    iPhone users may be able to throw away their Lightning cables if they get the new models, as all four will charge with the more universal USB-C connectivity, as will other Apple devices such as AirPods Pro. Apple did not spend a lot of time addressing the change from its proprietary “Lightning” connecter, which was forced by new European rules requiring universal connections.

    More on iPhone 15: Apple increases base price on highest-end iPhone for first time

    Apple also detailed the new Apple Watch Series 9 lineup, which includes the second version of the Apple Watch Ultra. The new base Apple Watches will have a new S9 chip that could lead to speed and efficiency improvements and faster load times, the same 18-hour battery life, a new FineWoven fabric band and up to 2000 nit brightness display. The Apple Watch Ultra 2 has features including 36 hours of battery life, an S9 SiP chip, and a 3000-nit brightness display

    The new Apple Watch Series 9 also features a new “double-tap” gesture, which allows people to answer calls and interact with their watch by tapping their index finger and thumb together when their non-watch hand is being previously occupied.

    For more: New Apple Watch Series 9 — cost, new features, and when it comes out

    The new Apple Watch models are set to become available for preorder immediately following the Sept. 12 launch event, and will be available for regular purchase on Friday Sept. 22.

    Apple said the new Apple Watch would be its first fully carbon-neutral device, and dedicated a solid chunk of its hour-and-a-half presentation to discussing environmental sustainability efforts. The company is aiming to be completely carbon-neutral across its operations and supplier operations by 2030.

    Apple also noted that it will no longer use leather in Watch bands, nor any other product. The company also moved up its goal for ditching all plastic packaging — it now expects to accomplish that by the end of 2024.

    See: Apple to drop plastic packaging by end of next year, no leather cases for iPhone15

    Apple added new pink colors to its iPhone and Watch lineup as well. The company also added two new tiers to its iCloud product, which will offer options for 6 and 12 terabytes of remote storage after previously topping out at 2 terabytes.

    Apple stock declined during and after the event, ending the day’s session with a 1.7% drop at $176.30 that helped push the Dow Jones Industrial Average
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    to a slight daily decline. That’s a larger decline than Apple’s average daily performance on iPhone event days historically, but the past has also shown that shares typically rise between the September announcement and the actual launch of the phones.

    Market snapshot: Stocks fall after Apple unveils iPhone 15, with U.S. inflation data looming

    Apple’s stock has increased 35.7% so far this year, easily outpacing the 16.9% increase of the S&P 500 index.
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  • New Apple Watch Series 9: cost, new features, and when it comes out

    New Apple Watch Series 9: cost, new features, and when it comes out

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    Apple’s AAPL keynote event on Tuesday debuted several new products including the iPhone 15, and the much-anticipated Apple Watch Series 9.

    Prices for Apple’s refreshed new watch start at $399 — the same price as the previous watch models when they first debuted.

    Among the new features in the Apple Watch Series 9 is a new S9 chip that could…

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  • The iPhone 15 is coming: Everything to expect from Apple’s big event

    The iPhone 15 is coming: Everything to expect from Apple’s big event

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    For Apple fans, it’s almost that time of year again. 

    The company is expected to launch the iPhone 15 at an event Tuesday, but don’t get too excited about the new phone. This year, the biggest change from Apple
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    could be the iPhone’s price.

    Apple tends to introduce new iPhones every year in the fall, and lately, the company has been keeping prices the same even as it upgrades the technology. That may not be the case this year, though, with some thinking that Apple could boost the price of its Pro-level models by $100 or $200 compared with what an iPhone 14 Pro currently sells for.

    That’s notable because iPhones are already pretty expensive, with the cheapest iPhone 14 Pro option selling for $999 and the priciest iPhone 14 Pro Max configuration going for $1,599.

    “Given the popularity of the iPhone 14 Pro models compared to the iPhone 14 models, Apple may believe consumers will be willing to pay more without much fuss,” Monness, Crespi, Hardt & Co. analyst Brian White wrote in a recent report. “Moreover, Apple may feel a price hike is warranted given the inflationary forces that have disrupted the economy over the past couple of years.”

    Morgan Stanley’s Erik Woodring is less certain that Apple will hike prices broadly. The company could boost the price of its Pro Max phone by $150 to account for an expected new rear-facing periscope lens, but it’s “very un-Apple-like to raise prices across the board in the midst of a smartphone market down 11%,” he wrote. He said he expects the company to keep prices the same on the regular Pro model and its two base-level options.

    One key issue for iPhone enthusiasts — and Apple investors — is when the new phones will be ready for sale. Most of the iPhone models Apple introduced last year hit stores in mid-September, but there are some concerns about potential production delays this year.

    Read: Waiting for the iPhone 15? You might have to hold out longer than you think.

    “The broad availability of the iPhone 15 Pro Max could be October given some manufacturing challenges,” BofA Securities analyst Wamsi Mohan wrote recently.

    iPhone feature updates have become more incremental in recent years, and Apple watchers aren’t expecting anything groundbreaking this time around either. New iPhones always tend to be a little faster than their predecessors, and this year’s models might charge more quickly too. There’s a catch, though, as Apple is expected to switch out its proprietary Lightning cable for the more universal USB-C cord. 

    While the Pro models get a lot of attention, White said that those looking to buy base-level models could see some enhancements. Reports “have highlighted the potential for the iPhone 15 and iPhone 15 Plus to be graced with certain features found on last year’s more expensive Pro models, including the A16 chip, Dynamic Island, and a 48-megapixel camera,” he wrote.

    Why go Pro? Apple could move to a titanium frame from its prior stainless-steel casing and make camera enhancements. Mohan highlighted the potential for a periscope-type telephoto lens on Max versions.

    Apple fans “should also see more casing quality color differentiation between the Pro and regular series to help drive vanity switchers to the higher-priced models,” Jefferies analyst Andrew Uerkwitz wrote recently.

    There could be a dark blue color option for the iPhone Pro line this year, for example, according to 9to5Mac. That said, those content with the base-level model might be enticed by a pink version of that phone, with 9to5Mac noting that that’s one of several rumored pastel color options.

    Read: Here’s why Wall Street may be overreacting about Apple’s China’s challenges

    Apple is also expected to refresh its Apple Watch lineup at Tuesday’s event. Bloomberg News has reported that the Apple Watch Series 9 could feature a faster processor, though it will have the same general design as past models. Apple is also expected to keep the look the same on an upgraded version of its Ultra Watch, and that might come in a black color option.

    The event kicks off at 1 p.m. Eastern time Tuesday and will be available for live viewing on Apple’s site.

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  • The iPhone 15 Can’t Come Soon Enough for Apple

    The iPhone 15 Can’t Come Soon Enough for Apple

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    The new iPhone 15 is coming in September. History says the month is a wash.


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    Not even


     


    Apple was invincible to this tough August. And if investors are pinning their hopes on the iPhone 15 launch in just a couple of weeks, they could very we…

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