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Broadening the Scope of Clinical Trials: The Changing Role of Real-World Evidence

The role that real-world evidence, and the data that feeds into it, play in the clinical trials arena is changing. For many years, drug developers and…

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The role that real-world evidence, and the data that feeds into it, play in the clinical trials arena is changing. For many years, drug developers and regulators have collected real-world data (RWD) on adverse events linked to newly approved medicines. However, this data has not played a significant role in developing or executing pre-approval clinical trials.

The situation is now changing. “There’s always been a need to look at how drugs that are coming out of clinical trials behave in the real world,” Gracy Crane, International Regulatory Policy Lead for RWD at Roche in the U.K., told Inside Precision Medicine.

“A lot of the safety monitoring has actually been done using RWD. But recently, there’s been a step change in that RWD has moved now from the safety space into more of an efficacy and effectiveness space.”

There are several reasons for this change. To begin with, there is simply more RWD available than there has ever been before and there are easier ways of collecting it. For example, advances in digitalization have made it possible to use electronic health record data, as well as claims data from insurance companies.

Other technological advances, such as the development of easily accessible and affordable wearable health devices have also contributed to this trend, and advances in artificial intelligence and machine learning are simplifying the analysis of big data.

“A lot of data is being collected in the real world, but also there are more opportunities to use advanced analytics in order to be able to interrogate that data,” commented Crane. “There’s no use just having tons of data, you have to be able to have a tool to be able to make sense of the data… It’s a perfect storm, all coming together in order to be able to deliver what we need.”

Another reason for the current interest in real-world evidence (RWE), created through the analysis of RWD, is a frustration with the way traditional clinical trials are carried out. While no one denies that randomized controlled trials are the gold standard for showing effectiveness of new therapies, they also have problems, such as high costs and a historical lack of diversity among participants, among other issues.

Warren Whyte, vice president of Scientific Partnerships and head of the Engaging Research to Achieve Cancer Care Equity program at ConcertAI

“Effective clinical trials are very critical for the advancement of health because they enable us to introduce new therapeutics into the market to help address cancer and other diseases. And yet, only 10% of cancer patients participate in a clinical trial and that percentage is even lower for minority and underrepresented groups,” noted Warren Whyte, vice president of scientific partnerships and head of the Engaging Research to Achieve Cancer Care Equity program at ConcertAI, a company using RWD and AI to help improve clinical trials in oncology.

In 2016, the U.S. government passed the 21st Century Cures Act, which aimed to streamline drug and device development and bring treatments to patients faster. Recognizing the potential of RWE to support regulatory decision making, including approval of new indications for approved drugs, Congress added a clause stating that the U.S. FDA should create a framework to evaluate the potential for RWE to support new drug indications, or to satisfy post-approval study requirements.

Amy Abernethy
Amy Abernethy, president, Clinical Studies Platforms at Verily Life Sciences

“RWD has been around for some time, but it’s particularly top of mind right now as the FDA issued a series of guidelines last year that point to its future use for drug approvals,” explained Amy Abernethy, former FDA principal deputy commissioner and current president, clinical studies platforms, at Verily Life Sciences.

“In these, the FDA highlights what they’ll be looking for as they consider the RWD in submissions, including things like data quality, methods for linking between different datasets, and statistically robust methods for analyzing RWD.”

Using Real-World Data to Implement Precision Medicine

Although randomized controlled clinical trials are the gold standard that drug developers aspire to achieve, sometimes it is not possible or even ethical to randomize patients into a trial. This can be especially relevant for pediatric, rare or orphan diseases where patients are hard to find and often critically ill.

Marjorie Zettler
Marjorie Zettler, executive director of clinical science at Regor Pharmaceuticals

Marjorie Zettler is a cancer specialist and executive director of clinical science at Regor Pharmaceuticals. She explained that the use of RWE to support cancer drug approvals, for example, as an external control, is becoming more common.

Expanded access or ‘compassionate use’ is a route for very sick individuals to be treated with investigational drugs that have not yet reached the market. Data from these patients is collected and is increasingly being used to support drug approvals.

For example, in 2016, blinatumomab was approved for acute lymphoblastic leukemia in children, partly supported by data collected from individuals under the age of 18 in a single-arm, open label, expanded access study.

“For childhood cancers, there’s such an unmet need there and the trials can be so difficult to do. In my own research, I found that expanded access data to support efficacy or safety of the product was the predominant type of RWD that’s been used to support pediatric approvals,” said Zettler.

For many rare diseases, recruiting to randomized trials can be a challenge. There are low numbers of people affected and the health status of the patients can be critical and time sensitive, meaning many simply cannot afford to miss out on a potential treatment opportunity.

There is a chance to improve trials in rare diseases by bringing in an external RWD control to what might otherwise be a single-arm trial and this is something Roche has made use of in the past. “Risdiplam [for treatment of spinal muscular atrophy] is a great example where we have utilized RWD to better understand the natural history of the disease and also as an external control for our trials,” said Crane.

A problem with many randomized controlled trials is they have (at least historically) been carried out largely in White, male populations. This can create a distorted view of certain diseases, such as cancer. For example, for many cancers, Black patients are diagnosed later, with more advanced disease, compared with patients of other races or ethnicities, notes Zettler.

In April 2022, the FDA released draft guidance for industry to improve enrollment of participants from underrepresented racial and ethnic populations. While this is only a guidance document, it is at least a step in the right direction.

“We can use real-world data to understand our patient population better so that we can design more inclusive trials,” explained Zettler. “Real-world data can also help us choose our clinical trial sites. There was a really simple but elegant study a few years ago, where the authors used Medicare claims data to map the zip codes of African American and Asian American patients with lung cancer… They put those on a map and when we see them side by side, we can see the obvious conclusion was that there’s a major disconnect between U.S. lung cancer clinical trials, site placement and where diverse patient populations live.”

Whyte says he thinks RWD can help diversify trials in three ways. First, by helping organizations better understand why some people may not be participating in clinical trials. Second, by evaluating old approaches, identifying challenges and using them to find new solutions. Finally, by identifying new sites, neighborhoods and communities where trials have not been conducted in the past.

“We understand that there are certain challenges that may prevent people from going to sites where trials are being conducted,” said Whyte.  “If we could find ways to identify community centers that have the infrastructure and the resources to conduct clinical trials, and they’re right in these people’s backyards, then we owe it to them to invest in the infrastructure and whatever is necessary to have that clinical trial be conducted in their neighborhoods. That way, it makes it far easier for people to enroll.”

Neureka Uses Data toSolve the Mystery of SUDEP infographic

Real-World Data Challenges

The use of RWD and RWE in clinical trials is increasing, but some experts have reservations about how useful it can be.

Louise Bowman
Louise Bowman, professor in the clinical trials service unit at the University of Oxford

“Without randomized evidence, one can’t necessarily be certain as to whether a treatment is actually safe and effective or not,” Louise Bowman, a professor in the clinical trials service unit at the University of Oxford, told Inside Precision Medicine. “Our worry is that inappropriate use of real-world data may not be giving us the right answers when it comes to the management of patients.”

Virginia Nido, global head, industry collaborations at Roche, agrees that using RWD effectively can be difficult. “I think the real question is, is it possible to actually change it into evidence that could be used to show whether or not a drug or a device is safe and effective for human use? I think in some cases, it’s possible to do that. But it’s hard.”

Nido advocates instead for the sharing of collected clinical trial data to be used for new trials, either in the design or implementation stage.

“There’s quite a lot of products that companies might have been working on, that we’re just no longer interested in pursuing. That data is sitting on a shelf somewhere… we’re finished with them and we won’t be further analyzing that data. So why not share it,” she emphasized. “RWD is very easy to get and very difficult to use and clinical trial data is very hard to get and much easier to use.”

Reliability of data can be a problem in the RWD and RWE space. If information such as that stored in electronic health records or collected by health insurance companies is not collected to be used in a clinical trial it may not be truly applicable to a research question. Other problems can include missing data, such as tests never ordered in clinical practice and tests ordered but not done, or patients moving from one unconnected medical system to another.

John Concato
John Concato, associate director for real-world evidence analytics in the Office of Medical Policy at the Center for Drug Evaluation and Research, FDA

“Many clinical trials evaluate changes in outcome measurements over time, perhaps based on standardized assessments to generate uniform data. If these latter types of outcomes are not used in clinical care or are not recorded consistently, they can be challenging to measure using RWD,” explained John Concato, associate director for real-world evidence analytics in the Office of Medical Policy at the Center for Drug Evaluation and Research, FDA.

Data linkage, where several data sets are combined and then the gaps between sets are filled in, is one way to address missing information in RWD. “This means you have to deal with the data quality challenges that come from combining datasets such as data conflicts from multiple source datasets representing the same variable, which is something we’re working to advance as an industry,” said Abernethy.

Nancy Dreyer
Nancy Dreyer, epidemiologist and chief scientific officer emerita at life science analytics company Iqvia

Nancy Dreyer, epidemiologist and chief scientific officer emerita at life science analytics company Iqvia, has worked on RWD and RWE for many years. She helped develop the Good Research for Comparative Effectiveness (GRACE) guidelines, now used by researchers and regulators around the world, to help judge whether real world studies assessing comparative effectiveness are rigorous enough to be used for assessing medical treatments and technologies.

She agreed with Abernethy about data linkage. “One of the trends we’re starting to see is the value of data linkage in clinical trials. You can take your very strong clinical information and extrapolate it to a larger population… it allows you to do follow up beyond the end of the trial, and it also allows you to understand a lot more about the path to diagnosis.”

Creating Next Generation Clinical Trials

Randomized controlled trials are still the goal for most therapeutic product developers. While it can be complicated to use, it seems clear that RWD is here to stay. Even those skeptical of RWE use for assessing the efficacy of medicines and other therapeutic products agree that RWD can be invaluable for improving trial design, running clinical trials and assessing post marketing safety.

“We should be using these data to do trials better and more efficiently. I think RWD has a really valuable potential, if used correctly, and if not over interpreted,” said Bowman.

Developments in precision medicine, technology and data analysis; the COVID-19 pandemic; and concerns about the lack of diversity, long duration, and high cost of traditional clinical trials are all driving change in the field.

Precision medicine concepts are increasingly being used to design basket trials, which assess therapies for diseases sharing a common genetic mutation such as different types of cancer, and umbrella trials, evaluating multiple therapies for different molecular subgroups of the same disease or condition. The pandemic has contributed to an increase in decentralized trials, where patients are monitored or treated using telemedicine or medical services close to their home, which seems set to continue.

RWD is being incorporated into new trials as external controls, when appropriate clinical trial data is not available. In November 2022, the FDA announced it would be doing a large trial with the National Cancer Institute, two pharmaceutical companies and an academic cooperative trials group called ‘Project Pragmatica,’ a large pragmatic trial of a combination therapy for advanced non-small cell lung cancer.

Pragmatic trials—where inclusion and exclusion criteria mirror the real world and follow-up is done in clinical practice—are also embracing real-world principles. The widely cited RECOVERY trial, set up in the U.K. to find therapies for COVID-19 is a good example of a successful pragmatic trial.

“With pragmatic trials, there is an opportunity to bring in the randomization part. That’s why this is attractive to health authorities because you’re preserving the randomization. But you also have the potential benefit of having a trial from clinical practice,” explained Crane.

“One of the key challenges is the operationalization of these types of trials, because obviously by loosening up the inclusion/exclusion criteria, there’ll be challenges with assessing the efficacy. We have to be able to understand better how we, by having those loose inclusion exclusion criteria, evaluate efficacy in those scenarios.”

Concato thinks that combinations of the new trial types could be key to improving design and costs of clinical trials. “Real-world data tend to contain data on diverse study populations, providing potential opportunities for addressing health disparities. Specifically, decentralized trials and trials involving real-world data have the potential to reduce costs & increase study diversity while generating robust evidence.”

 

References

  1. 21st Century Cures Act
  2. FDA Medical Review – blinatumomab
  3. American Cancer Society’s report on the status of cancer disparities in the United States, 2021. Islami et al. CA Cancer J Clin. 2022 Mar;72(2):112-143.
  4. Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry
  5. Geographic relationship between lung cancer clinical trial sites and patient prevalence and demographics in the Medicare Fee-for-service program. Roy et al. Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2): Abstract D081.
  6. The GRACE Checklist: A Validated Assessment Tool for High Quality Observational Studies of Comparative Effectiveness
  7. Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable. Dreyer, N. Ther Innov Regul Sci. 2018 May;52(3):362-368.
  8. FDA, NCI study will serve as prototype for streamlined pragmatic trials
  9. RECOVERY trial website recoverytrial.net
  10. Real-World Evidence — Where Are We Now? Concato J. and Corrigan-Curay J.  N Engl J Med 2022; 386:1680-1682.

The post Broadening the Scope of Clinical Trials: The Changing Role of Real-World Evidence appeared first on Inside Precision Medicine.

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Shakira’s net worth

After 12 albums, a tax evasion case, and now a towering bronze idol sculpted in her image, how much is Shakira worth more than 4 decades into her care…

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March 14, 2024

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Shakira’s considerable net worth is no surprise, given her massive popularity in Latin America, the U.S., and elsewhere. 

In fact, the belly-dancing contralto queen is the second-wealthiest Latin-America-born pop singer of all time after Gloria Estefan. (Interestingly, Estefan actually helped a young Shakira translate her breakout album “Laundry Service” into English, hugely propelling her stateside success.)

Since releasing her first record at age 13, Shakira has spent decades recording albums in both Spanish and English and performing all over the world. Over the course of her 40+ year career, she helped thrust Latin pop music into the American mainstream, paving the way for the subsequent success of massively popular modern acts like Karol G and Bad Bunny.

In late 2023, a 21-foot-tall bronze sculpture of Shakira, the barefoot belly dancer of Barranquilla, was unveiled at the city's waterfront. The statue was commissioned by the city's former mayor and other leadership.

Photo by STR/AFP via Getty Images

In December 2023, a 21-foot-tall beachside bronze statue of the “Hips Don’t Lie” singer was unveiled in her Colombian hometown of Barranquilla, making her a permanent fixture in the city’s skyline and cementing her legacy as one of Latin America’s most influential entertainers.

After 12 albums, a plethora of film and television appearances, a highly publicized tax evasion case, and now a towering bronze idol sculpted in her image, how much is Shakira worth? What does her income look like? And how does she spend her money?

Related: Dwayne 'The Rock' Johnson's net worth: How the new TKO Board Member built his wealth from $7

How much is Shakira worth?

In late 2023, Spanish sports and lifestyle publication Marca reported Shakira’s net worth at $400 million, citing Forbes as the figure’s source (although Forbes’ profile page for Shakira does not list a net worth — and didn’t when that article was published).

Most other sources list the singer’s wealth at an estimated $300 million, and almost all of these point to Celebrity Net Worth — a popular but dubious celebrity wealth estimation site — as the source for the figure.

A $300 million net worth would make Shakira the third-richest Latina pop star after Gloria Estefan ($500 million) and Jennifer Lopez ($400 million), and the second-richest Latin-America-born pop singer after Estefan (JLo is Puerto Rican but was born in New York).

Shakira’s income: How much does she make annually?

Entertainers like Shakira don’t have predictable paychecks like ordinary salaried professionals. Instead, annual take-home earnings vary quite a bit depending on each year’s album sales, royalties, film and television appearances, streaming revenue, and other sources of income. As one might expect, Shakira’s earnings have fluctuated quite a bit over the years.

From June 2018 to June 2019, for instance, Shakira was the 10th highest-earning female musician, grossing $35 million, according to Forbes. This wasn’t her first time gracing the top 10, though — back in 2012, she also landed the #10 spot, bringing in $20 million, according to Billboard.

In 2023, Billboard listed Shakira as the 16th-highest-grossing Latin artist of all time.

Shakira performed alongside producer Bizarrap during the 2023 Latin Grammy Awards Gala in Seville.

Photo By Maria Jose Lopez/Europa Press via Getty Images

How much does Shakira make from her concerts and tours?

A large part of Shakira’s wealth comes from her world tours, during which she sometimes sells out massive stadiums and arenas full of passionate fans eager to see her dance and sing live.

According to a 2020 report by Pollstar, she sold over 2.7 million tickets across 190 shows that grossed over $189 million between 2000 and 2020. This landed her the 19th spot on a list of female musicians ranked by touring revenue during that period. In 2023, Billboard reported a more modest touring revenue figure of $108.1 million across 120 shows.

In 2003, Shakira reportedly generated over $4 million from a single show on Valentine’s Day at Foro Sol in Mexico City. 15 years later, in 2018, Shakira grossed around $76.5 million from her El Dorado World Tour, according to Touring Data.

Related: RuPaul's net worth: Everything to know about the cultural icon and force behind 'Drag Race'

How much has Shakira made from her album sales?

According to a 2023 profile in Variety, Shakira has sold over 100 million records throughout her career. “Laundry Service,” the pop icon’s fifth studio album, was her most successful, selling over 13 million copies worldwide, according to TheRichest.

Exactly how much money Shakira has taken home from her album sales is unclear, but in 2008, it was widely reported that she signed a 10-year contract with LiveNation to the tune of between $70 and $100 million to release her subsequent albums and manage her tours.

Shakira and JLo co-headlined the 2020 Super Bowl Halftime Show in Florida.

Photo by Kevin Winter/Getty Images)

How much did Shakira make from her Super Bowl and World Cup performances?

Shakira co-wrote one of her biggest hits, “Waka Waka (This Time for Africa),” after FIFA selected her to create the official anthem for the 2010 World Cup in South Africa. She performed the song, along with several of her existing fan-favorite tracks, during the event’s opening ceremonies. TheThings reported in 2023 that the song generated $1.4 million in revenue, citing Popnable for the figure.

A decade later, 2020’s Superbowl halftime show featured Shakira and Jennifer Lopez as co-headliners with guest performances by Bad Bunny and J Balvin. The 14-minute performance was widely praised as a high-energy celebration of Latin music and dance, but as is typical for Super Bowl shows, neither Shakira nor JLo was compensated beyond expenses and production costs.

The exposure value that comes with performing in the Super Bowl Halftime Show, though, is significant. It is typically the most-watched television event in the U.S. each year, and in 2020, a 30-second Super Bowl ad spot cost between $5 and $6 million.

How much did Shakira make as a coach on “The Voice?”

Shakira served as a team coach on the popular singing competition program “The Voice” during the show’s fourth and sixth seasons. On the show, celebrity musicians coach up-and-coming amateurs in a team-based competition that eventually results in a single winner. In 2012, The Hollywood Reporter wrote that Shakira’s salary as a coach on “The Voice” was $12 million.

Related: John Cena's net worth: The wrestler-turned-actor's investments, businesses, and more

How does Shakira spend her money?

Shakira doesn’t just make a lot of money — she spends it, too. Like many wealthy entertainers, she’s purchased her share of luxuries, but Barranquilla’s barefoot belly dancer is also a prolific philanthropist, having donated tens of millions to charitable causes throughout her career.

Private island

Back in 2006, she teamed up with Roger Waters of Pink Floyd fame and Spanish singer Alejandro Sanz to purchase Bonds Cay, a 550-acre island in the Bahamas, which was listed for $16 million at the time.

Along with her two partners in the purchase, Shakira planned to develop the island to feature housing, hotels, and an artists’ retreat designed to host a revolving cast of artists-in-residence. This plan didn’t come to fruition, though, and as of this article’s last update, the island was once again for sale on Vladi Private Islands.

Real estate and vehicles

Like most wealthy celebs, Shakira’s portfolio of high-end playthings also features an array of luxury properties and vehicles, including a home in Barcelona, a villa in Cyprus, a Miami mansion, and a rotating cast of Mercedes-Benz vehicles.

Philanthropy and charity

Shakira doesn’t just spend her massive wealth on herself; the “Queen of Latin Music” is also a dedicated philanthropist and regularly donates portions of her earnings to the Fundación Pies Descalzos, or “Barefoot Foundation,” a charity she founded in 1997 to “improve the education and social development of children in Colombia, which has suffered decades of conflict.” The foundation focuses on providing meals for children and building and improving educational infrastructure in Shakira’s hometown of Barranquilla as well as four other Colombian communities.

In addition to her efforts with the Fundación Pies Descalzos, Shakira has made a number of other notable donations over the years. In 2007, she diverted a whopping $40 million of her wealth to help rebuild community infrastructure in Peru and Nicaragua in the wake of a devastating 8.0 magnitude earthquake. Later, during the COVID-19 pandemic in 2020, Shakira donated a large supply of N95 masks for healthcare workers and ventilators for hospital patients to her hometown of Barranquilla.

Back in 2010, the UN honored Shakira with a medal to recognize her dedication to social justice, at which time the Director General of the International Labour Organization described her as a “true ambassador for children and young people.”

On November 20, 2023 (which was supposed to be her first day of trial), Shakira reached a deal with the prosecution that resulted in a three-year suspended sentence and around $8 million in fines.

Photo by Adria Puig/Anadolu via Getty Images

Shakira’s tax fraud scandal: How much did she pay?

In 2018, prosecutors in Spain initiated a tax evasion case against Shakira, alleging she lived primarily in Spain from 2012 to 2014 and therefore failed to pay around $14.4 million in taxes to the Spanish government. Spanish law requires anyone who is “domiciled” (i.e., living primarily) in Spain for more than half of the year to pay income taxes.

During the period in question, Shakira listed the Bahamas as her primary residence but did spend some time in Spain, as she was dating Gerard Piqué, a professional footballer and Spanish citizen. The couple’s first son, Milan, was also born in Barcelona during this period. 

Shakira maintained that she spent far fewer than 183 days per year in Spain during each of the years in question. In an interview with Elle Magazine, the pop star opined that “Spanish tax authorities saw that I was dating a Spanish citizen and started to salivate. It's clear they wanted to go after that money no matter what."

Prosecutors in the case sought a fine of almost $26 million and a possible eight-year prison stint, but in November of 2023, Shakira took a deal to close the case, accepting a fine of around $8 million and a three-year suspended sentence to avoid going to trial. In reference to her decision to take the deal, Shakira stated, "While I was determined to defend my innocence in a trial that my lawyers were confident would have ruled in my favour [had the trial proceeded], I have made the decision to finally resolve this matter with the best interest of my kids at heart who do not want to see their mom sacrifice her personal well-being in this fight."

How much did the Shakira statue in Barranquilla cost?

In late 2023, a 21-foot-tall bronze likeness of Shakira was unveiled on a waterfront promenade in Barranquilla. The city’s then-mayor, Jaime Pumarejo, commissioned Colombian sculptor Yino Márquez to create the statue of the city’s treasured pop icon, along with a sculpture of the city’s coat of arms.

According to the New York Times, the two sculptures cost the city the equivalent of around $180,000. A plaque at the statue’s base reads, “A heart that composes, hips that don’t lie, an unmatched talent, a voice that moves the masses and bare feet that march for the good of children and humanity.” 

Related: Taylor Swift net worth: The most successful entertainer joins the billionaire's club

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Delta Air Lines adds a new route travelers have been asking for

The new Delta seasonal flight to the popular destination will run daily on a Boeing 767-300.

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March 14, 2024

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Those who have tried to book a flight from North America to Europe in the summer of 2023 know just how high travel demand to the continent has spiked.

At 2.93 billion, visitors to the countries making up the European Union had finally reached pre-pandemic levels last year while North Americans in particular were booking trips to both large metropolises such as Paris and Milan as well as smaller cities growing increasingly popular among tourists.

Related: A popular European city is introducing the highest 'tourist tax' yet

As a result, U.S.-based airlines have been re-evaluating their networks to add more direct routes to smaller European destinations that most travelers would have previously needed to reach by train or transfer flight with a local airline.

The new flight will take place on a Boeing 767-300.

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Delta Air Lines: ‘Glad to offer customers increased choice…’

By the end of March, Delta Air Lines  (DAL)  will be restarting its route between New York’s JFK and Marco Polo International Airport in Venice as well as launching two new flights to Venice from Atlanta. One will start running this month while the other will be added during peak demand in the summer.

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“As one of the most beautiful cities in the world, Venice is hugely popular with U.S. travelers, and our flights bring valuable tourism and trade opportunities to the city and the region as well as unrivalled opportunities for Venetians looking to explore destinations across the Americas,” Delta’s SVP for Europe Matteo Curcio said in a statement. “We’re glad to offer customers increased choice this summer with flights from New York and additional service from Atlanta.”

The JFK-Venice flight will run on a Boeing 767-300  (BA)  and have 216 seats including higher classes such as Delta One, Delta Premium Select and Delta Comfort Plus.

Delta offers these features on the new flight

Both the New York and Atlanta flights are seasonal routes that will be pulled out of service in October. Both will run daily while the first route will depart New York at 8:55 p.m. and arrive in Venice at 10:15 a.m. local time on the way there, while leaving Venice at 12:15 p.m. to arrive at JFK at 5:05 p.m. on the way back.

According to Delta, this will bring its service to 17 flights from different U.S. cities to Venice during the peak summer period. As with most Delta flights at this point, passengers in all fare classes will have access to free Wi-Fi during the flight.

Those flying in Delta’s highest class or with access through airline status or a credit card will also be able to use the new Delta lounge that is part of the airline’s $12 billion terminal renovation and is slated to open to travelers in the coming months. The space will take up more than 40,000 square feet and have an outdoor terrace.

“Delta One customers can stretch out in a lie-flat seat and enjoy premium amenities like plush bedding made from recycled plastic bottles, more beverage options, and a seasonal chef-curated four-course meal,” Delta said of the new route. “[…] All customers can enjoy a wide selection of in-flight entertainment options and stay connected with Wi-Fi and enjoy free mobile messaging.”

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Stock Market Today: Stocks turn lower as factory inflation spikes, retail sales miss target

Stocks will navigate the last major data releases prior to next week’s Fed rate meeting in Washington.

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March 14, 2024

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Check back for updates throughout the trading day

U.S. stocks edged lower Thursday following a trio of key economic releases that have added to the current inflation puzzle as investors shift focus to the Federal Reserve's March policy meeting next week in Washington.

Updated at 9:59 AM EDT

Red start

Stocks are now falling sharply following the PPI inflation data and retail sales miss, with the S&P 500 marked 18 points lower, or 0.36%, in the opening half hour of trading.

The Dow, meanwhile, was marked 92 points lower while the Nasdaq slipped 67 points.

Treasury yields are also on the move, with 2-year notes rising 5 basis points on the session to 4.679% and 10-year notes pegged 7 basis points higher at 4.271%.

Updated at 9:44 AM EDT

Under Water

Under Armour  (UAA)  shares slumped firmly lower in early trading following the sportswear group's decision to bring back founder Kevin Plank as CEO, replacing the outgoing Stephanie Linnartz.

Plank, who founded Under Armour in 1996, left the group in May of 2021 just weeks before the group revealed that it was co-operating with investigations from both the Securities and Exchange Commission and the U.S. Department of Justice into the company's revenue recognition accounting.

Under Armour shares were marked 10.6% lower in early trading to change hands at $7.21 each.

Source: Under Armour Investor Relations

Updated at 9:22 AM EDT

Steely resolve

U.S. Steel  (X)  shares extended their two-day decline Thursday, falling 5.75% in pre-market trading following multiple reports that suggest President Joe Biden will push to prevent Japan's Nippon Steel from buying the Pittsburgh-based group.

Both Reuters and the Associated Press have said Biden will express his views to Prime Minister Kishida Yuko ahead of a planned State Visit next month at the White House. 

Related: US Steel soars on $15 billion Nippon Steel takeover; United Steelworkers slams deal

Updated at 8:52 AM EDT

Clear as mud

Retail sales rebounded last month, but the overall tally of $700.7 billion missed Street forecasts and suggests the recent uptick in inflation could be holding back discretionary spending.

A separate reading of factory inflation, meanwhile, showed prices spiking by 1.6%, on the year, and 0.6% on the month, amid a jump in goods prices.

U.S. stocks held earlier gains following the data release, with futures tied to the S&P 500 indicating an opening bell gain of 10 points, while the Dow was called 140 points higher. The Nasdaq, meanwhile, is looking at a more modest 40 point gain.

Benchmark 10-year Treasury note yields edged 3 basis points lower to 4.213% while two-year notes were little-changed at 4.626%.

Stock Market Today

Stocks finished lower last night, with the S&P 500 ending modestly in the red and the Nasdaq falling around 0.5%. The declines came amid an uptick in Treasury yields tied to concern that inflation pressures have failed to ease over the opening months of the year.

A better-than-expected auction of $22 billion in 30-year bonds, drawing the strongest overall demand since last June, steadied the overall market, but stocks still slipped into the close with an eye towards today's dataset.

The Commerce Department will publish its February reading of factory-gate inflation at 8:30 am Eastern Time. Analysts are expecting a slowdown in the key core reading, which feeds into the Fed's favored PCE price index.

Retail sales figures for the month are also set for an 8:30 am release as investors search for clues on consumer strength, tied to a resilient job market. Those factors could give the Fed more justification to wait until the summer months to begin the first of its three projected rate cuts.

"The case for a gradual but sustained slowdown in growth in consumers’ spending from 2023’s robust pace is persuasive," said Ian Shepherdson of Pantheon Macroeconomics. 

"Most households have run down the excess savings accumulated during the pandemic, while the cost of credit has jumped and last year’s plunge in home sales has depressed demand housing-related retail items like furniture and appliances," he added.

Benchmark 10-year Treasury yields are holding steady at 4.196% heading into the start of the New York trading session, while 2-year notes were pegged at 4.628%.

With Fed officials in a quiet period, requiring no public comments ahead of next week's meeting in Washington, the U.S. dollar index is trading in a narrow range against its global peers and was last marked 0.06% higher at 102.852.

On Wall Street, futures tied to the S&P 500 are indicating an opening bell gain of around 19 points, with the Dow Jones Industrial Average indicating a 140-point advance.

The tech-focused Nasdaq, which is up 7.77% for the year, is priced for a gain of around 95 points, with Tesla  (TSLA)  once again sliding into the red after ending the Wednesday session at a 10-month low.

In Europe, the regionwide Stoxx 600 was marked 0.35% higher in early Frankfurt trading, while Britain's FTSE 100 slipped 0.09% in London.

Overnight in Asia, the Nikkei 225 gained 0.29% as investors looked to a key series of wage negotiation figures from key unions that are likely to see the biggest year-on-year pay increases in three decades.

The broader MSCI ex-Japan benchmark, meanwhile, rose 0.18% into the close of trading. 

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