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    FDA withdraws Covid antibody treatment Evusheld because it’s not effective against 93% of subvariants

    The FDA pulled Evusheld from the market because it is not effective against more than 90% of the Covid subvariants that are currently circulating in the U.S.
    People with compromised immune systems, such as cancer chemotherapy and organ-transplant patients, are some of the groups most vulnerable to severe disease from Covid.
    Many take Evusheld as an additional layer of protection because the vaccines do not trigger a strong immune response for them.

    Evusheld (tixagevimab and cilgavimab) injection, a new COVID-19 treatment that people can take before becoming symptomatic. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images)
    Chris Sweda | Tribune News Service | Getty Images

    The Food and Drug Administration on Thursday pulled its authorization for AstraZeneca’s Evusheld, an antibody injection that people with weak immune systems relied on for additional protection against Covid-19.
    The FDA pulled Evusheld from the market because it is not effective against more than 90% of the Covid subvariants that are currently circulating in the U.S.

    The omicron XBB.1.5 subvariant, which is adept at evading antibodies that block infection, has quickly risen in the U.S. and is now causing 49% of new cases, according to data from the Centers for Disease Control and Prevention.
    Evusheld is also not effective against the BQ.1, BQ.1.1 and XBB subvariants. Taken together with XBB.1.5, versions of Covid that are resistant to Evusheld now represent nearly 93% of new cases in the U.S.
    “Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA said in a statement Thursday.
    People with compromised immune systems, such as cancer chemotherapy and organ-transplant patients, are some of the groups most vulnerable to severe disease from Covid. Many take Evusheld as an additional layer of protection because the vaccines do not trigger a strong immune response for them.
    The decision to pull Evusheld comes more than a month after the FDA withdrew an antibody treatment called bebtelovimab because it was not effective against the BQ.1 and BQ.1.1 subvariants.

    Evusheld is taken as a preventive measure before exposure to Covid. It is a combination of antibodies, cilgavimab and tixagevimab, taken as two injections every six months.
    Just over one million doses of Evusheld have been distributed in the U.S. since the FDA authorized the injections in December 2021, according to data from the Health and Human Services Department. About 720,000 of those doses have actually been administered to patients.
    More than 7 million adults in the U.S. have a compromised immune system. They represented about 12% of Covid hospitalizations, despite making up just 3% of the population, according to a study from the CDC that looked at data from 10 states.
    There is currently no replacement for Evusheld. Dr. Ashish Jha, head of the White House Covid task force, has blamed Congress for the dwindling number of treatments. He said lawmakers’ failure to pass additional Covid funding means there isn’t money to invest in new antibodies.
    “We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters in October. “Because of lack of congressional funding, that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
    President Joe Biden told people with compromised immune systems to consult with a doctor.
    “New variants may make some existing protections ineffective for the immunocompromised,” the president said in October. “Sadly, this means you may be at a special risk this winter. I urge you to consult your doctors on the right steps to protect yourself, take extra precautions.”

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    Here’s where mainland Chinese traveled overseas for the Lunar New Year

    Hong Kong and Macao were the most popular spots, said Trip.com, citing flight bookings on its platform for the first four days of the Lunar New Year.
    The seven-day holiday kicked off on Saturday, and marks the first leisure travel period after Beijing relaxed its Covid-related border controls..

    BEIJING — Travelers from mainland China stuck close to home in Asia during the Lunar New Year, the first holiday after Beijing relaxed its Covid-related border controls.
    Hong Kong and Macao were the most popular spots, said Trip.com, citing flight bookings on its platform for the first four days of the Lunar New Year. The seven-day holiday kicked off on Saturday.

    Here are the next three most popular overseas destinations for mainland travelers, according to Trip.com:
    3. Bangkok
    4. Singapore
    5. Phuket, Thailand
    Flight bookings for travel from the mainland to overseas destinations during the first four days of the holiday quadrupled from a year ago, Trip.com said.

    In late December, Beijing announced that beginning Jan. 8 travelers would no longer need to quarantine upon arrival on the mainland, and that Chinese citizens could start to resume leisure travel abroad. The change ended nearly three years of border controls.
    However, Japan and South Korea — both popular among Chinese tourists — subsequently imposed temporary restrictions on travelers from China, including limits on visas and quarantining Covid-positive individuals.

    Singapore has not announced any changes, while Thailand scrapped its plan to require international visitors to show proof of Covid vaccination, just days after announcing it.
    China has seen a wave of Covid infections after Beijing ended most domestic Covid controls in early December. A negative Covid test is still required for travel to the mainland.
    In 2019, Chinese outbound tourists spent $54.7 billion on shopping, according to Euromonitor International. More

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    Audi’s new EV is a luxury SUV with augmented reality that doubles as a pickup

    The rear glass of the Audi “Activesphere” vehicle can slide forward, opening the flat trunk of the SUV and creating an open-air space for hauling objects.
    Augmented reality glasses are used to view the gauges, controls and other elements that would typically be displayed via screens.
    Automakers routinely use concept vehicles to gauge customer interest or show the future direction of a vehicle or brand. The vehicles are not meant to be sold to consumers.

    Audi Activesphere EV concept

    Audi’s new concept vehicle is an all-electric luxury SUV that uses augmented reality glasses and can double as a small pickup truck, signaling potential future technologies for the Volkswagen luxury brand.
    The rear glass of the “Activesphere” vehicle can slide forward, opening the flatbed trunk of the SUV and creating an open-air space for hauling objects. Audi’s calling the modular open cargo bed an “active back,” but consumers shouldn’t necessarily expect to see a production vehicle with the unique feature anytime soon.

    “It’s a completely new range and a new possibility it affords to us,” Philipp Gündert, Audi brand strategy, said during a media briefing. “We at Audi are well known for trying out new things with cars … there’s also an Audi tradition to say, ‘Never say never.’ Although there’s no concrete plans, yet.”

    Audi Activesphere EV concept

    Automakers routinely use concept vehicles to gauge customer interest or show the future direction of a vehicle or brand. The vehicles are not meant to be sold to consumers.
    The augmented reality glasses are used to view the gauges, controls and other elements that would typically be displayed via screens. With no screens, the dashboard is clean and unobstructed, allowing occupants to focus on their external surroundings or design elements of the vehicle.  
    Audi describes the controls as an “invisible” or “digital” layer of vehicle controls and information. The displays, which it’s calling “Audi Dimensions,” change based on where the driver is looking as well as their expected needs. Everything can be controlled with hand gestures.

    Audi Activesphere EV concept

    The glasses could hypothetically be used inside the vehicle as well as during activities such as golf or hiking for distances, navigation and other things. Augmented reality glasses layer things over actual things as opposed to virtual reality, which is an all-encompassing separate environment.

    Like the “active back,” the augmented reality glasses are a concept of what could be in future vehicles but aren’t necessarily meant for production vehicles anytime soon.
    Audi emphasized that it has no plans to make its own augmented reality glasses. Instead, it would work with partners to integrate the technology with the vehicle.
    The vehicle features a retractable steering wheel for human driving that would stow away when the vehicle is in self-driving mode, a technology included in all of Audi’s “sphere” concept vehicles.

    Audi Activesphere EV concept

    The term “sphere” is meant to symbolize the interior space of the vehicles for drivers and passengers, according to Audi, essentially turning vehicles into another personal experience or living space. This is its fourth “sphere” concept since 2021.
    Previous vehicles were the Skysphere roadster in 2021, followed by the Grandsphere sedan and Urbansphere in April 2022. All the vehicles share futuristic design elements and are all modular.
    Gündert said there are elements of all the concept vehicles that will make it into production but signaled things such as lights and design. He said the performance Grandsphere is the one closest to a production vehicle.

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    Cramer’s lightning round: I say thumbs up to MP Materials

    Monday – Friday, 6:00 – 7:00 PM ET

    It’s that time again! “Mad Money” host Jim Cramer rings the lightning round bell, which means he’s giving his answers to callers’ stock questions at rapid speed.

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    MP Materials Corp: “I say, thumbs up, MP Materials.”

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    2 hours ago

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    RPC Inc: “I want you to hold [onto] it.”

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    Marvell Technology Inc: “You don’t want to buy until it reports. After it reports, we’re going to take a solid look at it. … If you do own it now, you’ll do just fine.”

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    Li Auto Inc: “Listen to [Tesla CEO] Elon Musk on the conference call. He likes the Chinese automakers. Who am I to go against the smartest man in the world?”

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    Jim Cramer credits strong earnings from Tesla and United Rentals for helping lift the market

    Monday – Friday, 6:00 – 7:00 PM ET

    CNBC’s Jim Cramer said that Thursday’s rally is thanks to a batch of strong company earnings.
    He went over several examples of corporate news and earnings reports that fueled Thursday’s gains, including Chevron, Tesla and United Rentals.

    CNBC’s Jim Cramer said that Thursday’s rally is thanks to a batch of strong company earnings.
    “I’ve said over and over again that during earnings season, what matters is companies and the CEOs with the smarts to direct them,” he said.

    Stocks rose on Thursday as investors digested the latest batch of earnings and new gross domestic product data showing the U.S. economy grew by a higher-than-expected 2.9% in the fourth quarter.
    Cramer said that contrary to what many might believe, the economic data didn’t drive the trading session’s rallies.
    “That’s a classic misdirection play — just totally wrong. It’s stale. It doesn’t count. We’re in earnings season, for heaven’s sake,” he said, adding, “Stocks did well today because many of them delivered good numbers.”
    He went over several examples of corporate news and earnings reports that fueled Thursday’s gains:

    “It’s very confusing if you’re on permanent negative autopilot because you only pay attention to the [Federal Reserve]. If you watched the individual companies, these moves would be a lot less surprising,” Cramer said.

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    FDA advisors recommend replacing original Covid vaccine with bivalent omicron shots for all doses

    The 21 members of the FDA committee unanimously backed the proposal, agreeing that it would simplify the U.S. Covid vaccination program.
    Currently, Pfizer’s and Moderna’s omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain.

    The new COVID-19 booster which includes protection for Omicron at AltaMed Health Services in South Gate on Thursday, October 6, 2022.
    Sarah Reingewirtz | MediaNews Group | Los Angeles Daily News via Getty Images

    The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first two immunizations with the new bivalent omicron shots.
    If the FDA accepts the advisors’ recommendation, the U.S. would likely phase out the companies’ vaccines developed in 2020 against the original Covid-19 strain that emerged in Wuhan, China.

    Instead, the drugmakers’ bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series.
    Currently, Pfizer’s and Moderna’s omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain.
    The committee’s 21 members unanimously backed the proposal, agreeing that it would simplify the U.S. Covid vaccination program.
    “This is absolutely the right thing to do for the program. It will make things simpler,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases, a division of the Centers for Disease Control and Prevention.
    The proposed change would only affect people who have not yet received their two-dose primary vaccination series. No timeline was provided on when this switch might occur if the FDA accepts the panel’s nonbinding recommendation.

    The recommendation to adopt a single formulation across all doses comes as the FDA is trying to streamline Covid vaccination so that the system is easier for the public and health-care workers to understand.
    “The overall thought here is that getting towards one vaccine composition for everyone will ultimately be much, much more helpful,” said Dr. Peter Marks, who heads the FDA’s vaccine division.
    The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter. That formulation would be used by all manufacturers for all doses.
    Under the proposal, most people who have been exposed to the Covid spike protein twice, either through vaccination or infection, would only receive one Covid shot a year moving forward. Older adults and people with compromised immune systems may need two shots because they don’t mount as strong of an immune response.
    Marks said the goal is to roll out updated Covid and flu vaccines at the same time in the fall to make it easy for people to get their shots in one visit. This could help boost vaccine coverage and reduce the burden on hospitals as they simultaneously confront circulation of Covid, flu and respiratory syncytial virus, he said.
    “The advantage of this also is if we can see the influenza vaccine and the Covid-19 vaccine occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected and reducing the amount of disease we see,” Marks told the committee members.
    But committee member Dr. Cody Meissner, a pediatrician at the Geisel School of Medicine, said it is too early to say whether annual vaccination for Covid is needed.
    Panel member Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said flu and Covid differ in important ways when it comes to vaccination.
    If the flu vaccine doesn’t match the dominant variant, you don’t have much protection, Offit said. But the Covid vaccines are still protecting well against severe illness, he said.
    “I think we need to define what we want from this vaccine,” said Offit, who has repeatedly emphasized the prevention of severe disease rather than mild illness.

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    Hasbro warns of weak holiday quarter results, cuts 15% of its workforce

    Hasbro will cut 1,000 employee positions, around 15% of its total workforce.
    The toymaker warned of weak holiday quarter results.
    Wizards of the Coast, which includes Dungeons and Dragons, will remain a bright spot, the company said.

    Game maker Hasbro
    Justin Sullivan | Getty Images

    Hasbro said Thursday it would eliminate around 1,000 employee positions and warned of weak holiday-quarter results.
    Shares of the toy maker fell more than 6% in extended trading.

    “Despite strong growth in Wizards of the Coast and Digital Gaming, Hasbro Pulse, and our licensing business, our Consumer Products business underperformed in the fourth quarter against the backdrop of a challenging holiday consumer environment,” said Hasbro CEO Chris Cocks.
    The layoff of around 15% of its global workforce comes as the company seeks to save between $250 million and $300 million annually by the end of 2025.
    Hasbro said it expects fourth-quarter revenue, which includes the holiday season, to reach $1.68 billion, down 17% compared to the year-earlier period. Estimates had called for Hasbro to reach $1.92 billion during the quarter, according to data from Refinitiv.
    For the full year, the company foresees revenue hitting $5.86 billion, down 9% compared to 2021.
    “While the full year 2022, and particularly the fourth quarter, represented a challenging moment for Hasbro, we are confident in our Blueprint 2.0 strategy, unveiled in October, which includes a focus on fewer, bigger brands; gaming; digital; and our rapidly growing direct to consumer and licensing businesses,” Cocks said.

    The company has faced revenue woes in recent quarters, as it contends with tough comparisons with pandemic-fueled toy sales, inflation weighing on consumers wallets and high levels of inventory.
    Wizards of the Coast, which includes Dungeons and Dragons, Magic: The Gathering and digital gaming, will remain a bright spot, the toymaker said. The company expects the division to have generated $339 million in revenue during the fourth quarter, up 22% compared to last year, and reach $1.33 billion in revenue for the full year, up 3% from 2021.
    The division recently came under fire from fans after Hasbro attempted to rewrite a two-decade-old open game license for Dungeons and Dragons in order to boost revenue. Earlier this month, the Rhode Island-based toymaker postponed its update of its licensing terms in order to address mounting concern from the D&D community, which largely viewed the proposed changes as overreaching and unfair to third-party content creators.
    Hasbro said it still intends to create a new open game license, or OGL, but that it will not include a royalty structure or give itself access to intellectual property made by third-party content creators.
    The company is set to report its fourth-quarter earnings Feb. 16.

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    Luxury retailer LVMH is optimistic as it sees Chinese shoppers and tourists returning

    Luxury giant LVMH said China’s wealthy consumers have started returning to stores after the country’s reopening.
    LVMH reported its second straight year of record sales and profits, with 2022 revenue up 23%.
    The company’s cautious optimism echoes positive comments earlier this month from Burberry and Swatch.

    Bernard Arnault, Chairman and CEO of LVMH Moet Hennessy Louis Vuitton, attends a news conference to present the 2022 annual results of LVMH in Paris, France, January 26, 2023.
    Gonzalo Fuentes | Reuters

    Luxury giant LVMH said China’s wealthy consumers have started returning to stores after the country’s reopening and it remains optimistic about the year ahead.
    “We have every reason to be confident, indeed optimistic on China,” LVMH CEO Bernard Arnault said during the company’s earnings presentation. “In Macao, where the Chinese can now travel, the change is quite spectacular. The stores are full and it’s really come back very strong.”

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    Arnault added that if the “green shoots” the company sees in China continue to grow, “it will be an excellent year.”
    LVMH reported its second straight year of record sales and profits, with 2022 revenue up 23% to 79.2 billion euros, or about $86.2 billion. Profits grew 17% to 14 billion euros, or about $15.2 billion.
    The return of the Chinese luxury consumer is the key question for the global luxury industry in 2023, as the U.S. and European economies slow. Shares of LVMH, Richemont, Kering and other big luxury names have soared this month on hopes for a rapid bounce back in China’s luxury spending, which accounted for a third of all luxury sales before the pandemic shifted consumer spending habits.
    LVMH Chief Financial Officer Jean-Jacques Guiony cautioned that while the rebound has been strong in January, “we’re not back to the levels of 2019. We’re a long way from that.”
    Yet LVMH’s cautious optimism echoes positive comments earlier this month from Burberry and Swatch.

    Burberry cited “very promising signs in China” after a difficult December, while Swatch said its “sales growth in January in China reinforces the Group’s expectation to aim for a record year in 2023.”
    Some analysts say China’s reopening could mark a “big bang” moment for luxury — driving sales in the country as well as in Europe, as Chinese tourists return to Paris, Milan and London this summer and shop for luxury goods.
    “If they resume travel and they head for the countries that attract them, they will probably come to France, and we are ready to receive them,” Arnault said.
    Bain & Co estimates that global luxury sales grew 22% in 2022, to over $380 billion, with the U.S. replacing China as the top market. Even if China rebounds, growth in luxury sales is likely to be slower this year. Bain estimates global sales could grow between 3% and 8% in 2023, depending on China’s reopening and the U.S.
    There are already signs that the U.S. market is slowing. LVMH said revenue grew 7% in the U.S. during the fourth quarter, a sharp deceleration from growth of 26% and 22% in the first two quarters of the year.
    Guiony, however, said the declines are largely due to favorable comparisons in the first two quarters and the surge in Americans taking advantage of a strong dollar to buy luxury goods in Europe over the summer. He said sales at Sephora — the beauty retailer owned by LVMH — showed no signs of consumer weakness in the U.S. and had “high growth in the fourth quarter.”
    “We’re not concerned,” Guiony said.

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