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Technology

In Japan, pet fish playing Nintendo Switch run up bill on owner’s credit card

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CNN
 — 

Here’s something you don’t see everyday. Pet fish playing a video game in Japan managed to log on to the Nintendo Switch store, change their owner’s avatar, set up a Pay Pal account and rack up a credit card bill.

And it was all seemingly livestreamed, in real time, on the internet.

The fish in question belong to a YouTuber known as Mutekimaru, whose channel is popular with the gaming community for its videos featuring groups of tetra fish that “play” video games.

Mutekimaru had previously installed sophisticated motion detection tracking software in fish tanks, enabling the fish to remotely control a Nintendo Switch console.

But the technology, and the fishes’ apparent mastery of it, led to an unexpected turn of events earlier this month while Mutekimaru was live-streaming a game of Pokémon.

Mutekimaru had stepped away for a break when the game crashed due to a system error and the console returned to the home screen.

But the fish carried on swimming, like fish tend to do, and seemingly continued to control the console remotely from their tank.

During the next seven hours, the fish reportedly managed to change the name of their owner’s Switch account before twice logging into the Nintendo store, where users can purchase games and other downloadable content.

They also managed to “check” legal terms and conditions, downloaded a new avatar and even set up a PayPal account from the Switch – sending an email out to their owner in the process, video from the livestream appeared to show.

But things didn’t end there. The fish were also seen adding 500 yen ($4) to Mutekimaru’s Switch account from his credit card during the livestream – exposing his credit card details in the process, the YouTuber revealed in a follow-up video about the episode.

By this point, thousands of comments were streaming in as viewers watched the unintended takeover being livestreamed on the channel, and the incident went viral on Twitter, where thousands of Japanese users shared their amusement.

Mutekimaru later said that he had contacted Nintendo to explain what happened and asked for a refund of his 500 yen.

Nintendo declined to comment to CNN, citing customer confidentiality.



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Business

Some auto insurers are refusing to cover some Hyundai and Kia models

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CNN
 — 

Progressive and State Farm, two of America’s largest auto insurers, are refusing to write policies in certain cities for some older Hyundai and Kia models that have been deemed too easy to steal, according to the companies.

Several reports say the companies have stopped offering insurance on these vehicles in cities that include Denver, Colorado and St. Louis, Missouri. The insurance companies did not tell CNN which cities or states were involved.

The Highway Loss Data Institute released insurance claims data last September that confirmed what various social media accounts had been saying: Some 2015 through 2019 Hyundai and Kia models are roughly twice as likely to be stolen as other vehicles of similar age, because many of them lack some of the basic auto theft prevention technology included in most other vehicles in those years, according to the HLDI.

Specifically, these SUVs and cars don’t have electronic immobilizers, which rely on a computer chip in the car and another in the key that communicate to confirm that the key really belongs to that vehicle. Without the right key, an immobilizer should do just that – stop the car from moving.

Immobilizers were standard equipment on 96% of vehicles sold for the 2015-2019 model years, according the HLDI, but only 26% of Hyundais and Kias had them at that time. Vehicles that have push-button start systems, rather than relying on metal keys that must be inserted and turned, have immobilizers, but not all models with turn-key ignitions do.

Stealing these vehicles became a social media trend in 2021, according to HLDI, as car thieves began posting videos of their thefts and joyrides and even videos explaining how to steal the cars. In Wisconsin, where the crimes first became prevalent, theft claims of Hyundais and Kias spiked to more than 30 times 2019 levels in dollar terms.

“State Farm has temporarily stopped writing new business in some states for certain model years and trim levels of Hyundai and Kia vehicles because theft losses for these vehicles have increased dramatically,” the insurer said in a statement provided to CNN. “This is a serious problem impacting our customers and the entire auto insurance industry.”

Progressive is also cutting back on insuring these cars in some markets, spokesman Jeff Sibel said in an emailed statement.

“During the past year we’ve seen theft rates for certain Hyundai and Kia vehicles more than triple and in some markets these vehicles are almost 20 times more likely to be stolen than other vehicles,” he wrote. “Given that we price our policies based on the level of risk they represent, this explosive increase in thefts in many cases makes these vehicles extremely challenging for us to insure. In response, in some geographic areas we have increased our rates and limited our sale of new insurance policies on some of these models.”

Progressive continues to insure those who already have policies with the company, he said. Progressive is also providing them with advice on how to protect their vehicles from theft.

Michael Barry, a spokesman for the Insurance Information Institute, said it was very unusual for auto insurers to simply stop writing new policies on a given make or model of vehicle.

“They generally want to expand their market share depending on where they’re doing business,” he said.

Hyundai and Kia operate as separate companies in the United States, but Hyundai Motor Group owns a large stake in Kia and various Hyundai and Kia models share much of their engineering.

Engine immobilizers are now standard on all Kia vehicles, according to a statement by the automaker and the company says it has been developing and testing security software for vehicles not originally equipped with an immobilize. Kia said it has begun notifying owners of the availability of this software, which is being provided at no charge.

Hyundai said it is providing free steering wheel locks to some police departments around the country to give local residents who have easily stolen Hyundai models. Hyundai dealers are also installing free security kits for the vehicles, the company said.

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Business

Gautam Adani’s business loses $50 billion in market value after short seller report

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New Delhi
CNN
 — 

The value of Gautam Adani’s business empire has crashed by more than $50 billion this week since Hindenburg Research, a US firm that makes money from short selling, published a blistering report accusing it of fraud.

India’s Adani Group has denounced Hindenburg’s allegations as “baseless” and “malicious,” and it is considering legal action. But the sharp sell-off in shares, which began Wednesday, accelerated Friday after US hedge fund billionaire Bill Ackman said he found the short seller’s report credible.

Hindenburg Research published an investigation on Adani’s conglomerate late on Tuesday, accusing it of “brazen stock manipulation and accounting fraud scheme over the course of decades.” It said it had taken a short position in Adani Group companies, meaning it would benefit from a drop in their value.

Shares of those companies — some of which had surged over 500% in the last few years — plunged when India’s stock market opened Wednesday. The rout resumed Friday when trading resumed following a market holiday on Thursday.

Shares of Adani Transmission, Adani Total Gas and Adani Green Energy — three of the group’s seven listed companies — were down 20% each on Friday, while shares of Adani Enterprises, the conglomerate’s flagship company, fell 18%. Friday’s losses wiped out almost $39 billion in market value.

According to the Bloomberg Billionaires Index, Adani is still Asia’s richest man with a personal fortune worth $113 billion, $30 billion more than fellow Indian entrepreneur Mukesh Ambani. Friday’s losses will reduce that gap.

Hindenburg said Thursday that it stood fully by its report and believed any legal action would be “meritless.”

“If Adani is serious, it should also file suit in the US where we operate. We have a long list of documents we would demand in a legal discovery process,” the short seller said in a post on Twitter.

Hindenburg isn’t the first research firm to express concern about the finances of Adani’s sprawling empire, which has borrowed $30 billion to become established in industries ranging from logistics to mining, and is aggressively growing in diverse sectors such as media, data centers, airports and cement.

Ackman weighed into the debate on Twitter Thursday, saying he found the Hindenburg investigation “highly credible and extremely well researched.”

“We are not invested long or short in any of the Adani companies … nor have we done our own independent research,” Ackman added.

Hindenburg’s claims come at a sensitive time. Adani Enterprises is aiming to raise 200 billion rupees ($2.5 billion) by issuing new shares this month. The offer will close on Tuesday.

A college dropout and a self-made industrialist, Adani is the world’s fourth richest man, ahead of Bill Gates and Warren Buffet. He is also seen as a close ally of India’s prime minister, Narendra Modi.

The 60-year old tycoon founded the Adani group over 30 years ago.



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Business

Gautam Adani slams short-seller Hindenburg’s claims as ‘baseless’ and ‘malicious’

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New Delhi
CNN
 — 

India’s Adani Group on Wednesday denounced allegations of fraud made by US-based short seller Hindenburg Research as “baseless” and a “malicious combination of selective misinformation.”

Hindenburg Research published an investigation on billionaire Gautam Adani’s sprawling conglomerate on Tuesday, accusing it of “brazen stock manipulation and accounting fraud scheme over the course of decades.”

Hindenburg said it has taken a short position in companies in the Adani Group “through U.S.-traded bonds and non-Indian-traded derivative instruments.” Short sellers aim to make money by betting that the stock price of the companies they target will fall.

Adani’s business empire contains seven listed companies — in sectors ranging from ports to power stations — and shares in most of them fell by between 3% and more than 8% on Wednesday.

The plunge had an immediate impact on the billionaire’s net worth. According to Bloomberg’s Billionaires Index, Adani lost nearly $6 billion on Wednesday. He is currently worth $113 billion.

In its investigation, which Hindenburg said took two years to compile, the research firm questioned the “sky-high valuations” of Adani firms and said their “substantial debt” puts the entire group “on a precarious financial footing.”

The research firm concluded its report with 88 questions for the Adani Group. These range from asking for details on Adani’s offshore entities, to why it has “such a convoluted, interlinked corporate structure.”

CNN has not verified the claims in the report, and India’s stock market regulator did not immediately respond to a request for comment.

Shares of Adani’s companies have surged in the last few years, making him Asia’s richest man.

In a statement released a few hours after Hindenburg published its report, the Adani Group’s chief financial officer Jugeshinder Singh said that Hindenburg did not make “any attempt to contact us or verify the factual matrix,” adding that the allegations made by the short seller are “stale, baseless and discredited.”

The conglomerate has faced scrutiny from Indian authorities in the past. In 2021, shares in Adani’s companies tumbled after The Economic Times newspaper said that foreign funds that hold stakes worth billions of dollars were frozen by the country’s National Securities Depository. The Adani Group called that report “blatantly erroneous.”

Nate Anderson, who founded Hindenburg Research, has made a name for himself in the past few years by targeting companies that he thinks are overvalued and have suspect financials. Anderson is best known for going after electric truck company Nikola in 2020, calling it an “intricate fraud,” and causing the firm’s stock to plunge sharply. In 2022, Nikola’s founder was convicted by a US jury of fraud in a case alleging he lied to investors about the company’s technology.

But some have accused Hindenburg of trying to push stocks lower with its research reports in order to make a profit.

Its report on the Adani Group comes at a sensitive time. Later this week, Adani Enterprises, the conglomerate’s flagship company, is aiming to raise 200 billion rupees ($2.5 billion) by issuing new shares.

Singh said that the “timing of the report’s publication clearly betrays a brazen, mala fide intention to undermine the Adani Group’s reputation with the principal objective of damaging the upcoming follow-on public offering.”

The conglomerate is also considering taking five new businesses to the stock market in the next two to five years.

A college dropout and a self-made industrialist, Adani is the world’s fourth richest man, ahead of Bill Gates and Warren Buffet, according to Bloomberg’s Billionaires Index. He is also seen as a close ally of India’s current prime minister, Narendra Modi.

The 60-year-old tycoon founded the Adani group over 30 years ago. It now has established businesses in industries ranging from logistics to mining, and is aggressively growing in diverse sectors such as media, data centers, airports, and cement.

But this is not the first time analysts have expressed fear that the rapid expansion of his business comes with a huge risk. Adani’s juggernaut has been fueled by a $30 billion borrowing binge, making his business one of the most indebted in the country.

Last year, CreditSights, a research firm owned by Fitch Group, published a report about Adani Group titled “Deeply Overleveraged” in which it expressed strong concerns about its debt-funded growth plans.

Adani Group responded to CreditSights with a 15-page report, saying that the “leverage ratios” of its companies “continue to be healthy and are in line with the industry benchmarks in the respective sectors” and that they “have consistently de-levered” in the last nine years.

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World

Nearly 220 million people in Pakistan without power after countrywide outage

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Islamabad, Pakistan
CNN
 — 

A nationwide power outage in Pakistan left nearly 220 million people without electricity on Monday, threatening to cause havoc in the South Asian nation already grappling with fuel shortages in the winter months.

The country’s Ministry of Energy said in a statement the country’s National Grid went down at 7.34 a.m local time, “causing a widespread breakdown in the power system,” according to initial reports.

“System maintenance work is progressing rapidly,” the statement added.

A “limited number of grids” in the capital Islamabad and the city of Peshawar have had power restored, the ministry said.

It is unclear how long the outage will last and efforts are underway to restore power to various parts of the country.

In the city of Quetta, in Pakistan’s northern Balochistan province, the outage has affected all aspwects of daily life, including hospitals, markets and households.

“Due to unavailability of generators, services are affected in health centers in suburbs of Quetta city,” the director of Balochistan’s health department, Dr. Imran Zarkoon, told CNN.

Zaheer, the owner of a clothing ship in Quetta, said they have no backup and have been waiting for the electricity to be restored for hours.

“The whole market of Jinnah road is practically shut, as without electricity customers do not turn to shops,” he said.

The outage comes as the country’s fragile economy continues to struggle with multiple challenges, including a severe energy crisis.

Earlier this month, Prime Minister Shehbaz Sharif ordered all federal departments to reduce their energy consumption by 30%, while his government ordered all markets to close by 8.30 p.m. and restaurants by 10 p.m.

The decision to reduce energy usage came as Pakistan announced its foreign exchange reserves had dwindled to alarmingly low levels. In December, the country’s total liquid foreign exchange reserves stood at $11.7 billion, which is half the amount it held at the start of last year, according to the central bank.

Monday’s power outage is Pakistan’s most widespread power shutdown since 2021, when the nation plunged into darkness for hours after a “sudden plunge in the frequency in the power transmission system.”

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US

Women living in states with abortion bans suffer greater economic insecurity

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New York
CNN
 — 

Women living in states that restrict or ban abortion face greater economic insecurity than those living in states where they have access, new research finds.

Since the nearly seven months since the Supreme Court overturned Roe v. Wade, half of all states – 26 in total – have implemented new abortion restrictions or all-out bans.

In nearly all 26 states, there are lower minimum wages, unionization levels, access to Medicaid and unemployment benefits, as well as higher rates of incarceration than states with more lenient abortion policies, according to new research by the Economic Policy Institute.

“These economic policies all compound on each other. And you add to that an abortion ban, it just compounds this financial stress, this economic insecurity,” said Asha Banerjee, an economic analyst with the institute and the author of the report.

Last year, Treasury Secretary Janet Yellen made a similar argument to the Financial Oversight Council.

“I believe that eliminating the right of women to make decisions about when and whether to have children would have very damaging effects on the economy and would set women back decades,” Yellen told lawmakers in May.

The lack of abortion access has the greatest economic impact on women of color, especially those already in dire financial conditions, according to Banerjee.

“In many of these states, especially the states which have banned abortion, many of the women who are facing economic challenges already are also women of color,” she said.

Raising the minimum wage is a powerful tool that has been known to have significant impact on closing racial income gaps. But nearly two-thirds of abortion restrictive states have a $7.25 minimum wage, the lowest legal hourly wage for most workers in the United States.

The average minimum wage across the 26 states is $8.17, lower than the average $11.92 for states with no restrictions. (Many of those states also have a higher cost of living, however.)

“If the person denied an abortion is also working a minimum wage job, the negative economic effect is compounded,” the report states.

Many of those low-wage jobs also do not offer benefits like health care, which is why access to Medicaid is critical.

“Medicaid is a lifeline for low-income families and low-income women when jobs might not offer adequate healthcare. Medicaid in the immediate postpartum period is especially important,” said Banerjee.

Just 12 states have not expanded Medicaid benefits since the 2010 Obamacare law, and all of them have restrictive abortion policies.

However, some states with total abortion bans, with few exceptions, have expanded Medicaid, including Missouri. And in five other abortion restrictive states (Idaho, Missouri, Nebraska, Oklahoma and South Dakota later this year) residents voted to expand the benefit.

Access to unemployment insurance is another key indicator of a state’s commitment to economic support for residents. Forty-two percent of residents have access to unemployment benefits in states that have abortion protections. Compare that to 30% in states with abortion restrictions.

Even if unemployment is accessible, the amount differs from state to state. For example, in Mississippi, a state with a total abortion ban with limited exceptions, weekly unemployment checks average $217. Meanwhile in Massachusetts, which has a more protective 24-week abortion ban – checks average $556 weekly.

“When you have unemployment insurance it helps create financial stability. These states which have abortion bans also have really terrible unemployment insurance systems with really low benefits which do not help one support oneself,” said Banerjee.

Although women make up a smaller percentage of those incarcerated than men, it is the economic category with the greatest difference between abortion protected and abortion-restricted states. The rate of incarceration in states with restrictive or total bans on abortion is more than one and a half times higher than the rate of incarceration for states with abortion protections.

“It’s very much a racial justice issue because Black and Hispanic women are very disproportionately incarcerated. And that has huge economic impacts on future earnings and the ability to get a job,” said Banerjee.

In some states with abortion restrictions and higher rates of incarceration – legislation has suggested also criminalizing women, doctors or anyone aiding a woman in seeking an abortion.

“The incarceration argument is especially important because in these states where abortion bans have come into play, there’s a huge criminalization aspect,” said Banerjee.

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US

California storm: 90% of residents are under flood watches as another storm threatens mudslides, power outages and deadly inundation

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CNN
 — 

Much of California can’t soak up another drop of rain. Yet the state is getting pummeled again with torrential downpours and ferocious winds, causing power outages and treacherous travel conditions.

More than 34 million Californians were under a flood watch Monday – about 90% of the state’s population and 10% of the US population.

Parts of the central California coast got walloped with 1 to 1.25 inches of rainfall per hour, the Weather Prediction Center said. Extensive rainfall there Monday triggered significant flooding, mudslides, debris flows and closed roadways.

Widespread rainfall totals of 3 to 6 inches have been observed from just south of San Francisco to just north of Los Angeles. Isolated amounts of 6 to more than 10 inches have been observed in the higher terrain near the coast.

As the rain shifted slowly to the south Monday toward Los Angeles, the National Weather Service there warned of the risk of flooding, debris flow in land scarred by recent wildfires and an increased risk of rock and mudslides in mountains and on canyon roads.

And hurricane-force wind gusts topping 74 mph thrashed states across the western US. More than 37 million people were under wind alerts Monday in California, Nevada, Oregon, Washington, Utah, Arizona and Wyoming.

A 132-mph wind gust lashed Oroville, California. Residents in Washoe City, Nevada, were hit with a 98-mph gust, the Weather Prediction Center said.

TRACK THE STORMS

“Expect widespread power outages, downed trees and difficult driving conditions,” the National Weather Service in Sacramento tweeted. “Now is the time to prepare if you have not already!”

Almost 92,000 homes, businesses and other power customers had no electricity Monday evening, according to PowerOutage.us.

And the central California coast could be at risk of a tornado, CNN Meteorologist Dave Hennen said.

The severe weather is part of a relentless parade of atmospheric rivers slamming the West Coast.

California is now extremely vulnerable to flooding because much of the state has been scarred by historic drought or devastating wildfires – meaning the land can’t soak up much rainfall.

And after an onslaught of storms since late December led to deadly flooding, Gov. Gavin Newsom warned Sunday: “We expect to see the worst of it still in front of us.”

Two bouts of major rainfall are expected to hammer the West Coast over the next few days – without much of a break between events for the water to recede.

The system is part of an atmospheric river – a long, narrow region in the atmosphere that can transport moisture thousands of miles, like a fire hose in the sky.

The atmospheric river slamming California on Monday could result in a 1-in-50 year or 1-in-100 year rainfall event near Fresno, the Weather Prediction Center said.

A moderate risk – level 3 of 4 – of excessive rainfall covers over 26 million people in California, including in San Francisco, Sacramento, Los Angeles and Fresno, where rain could fall at 1 inch per hour.

The San Lorenzo River in Santa Cruz County has risen 14 feet in just over four hours and is in major flood stage. Parts of the county will experience “widespread flooding at shallow depths,” and the city of Santa Cruz will have serious flooding, according to data from the National Oceanic and Atmospheric Administration and US Geological Survey.

The threat will shift further south Tuesday, with a level 3 of 4 risk centered over Los Angeles.

“While some of the forecast rain totals are impressive alone, it is important to note that what really sets this event apart are the antecedent conditions,” the National Weather Service office in San Francisco said.

“Multiple systems over the past week have saturated soil, increased flow in rivers and streams, and truly set the stage for this to become a high impact event.”

In Sacramento County, officials warned “flooding is imminent” and issued evacuation orders for the Wilton community near the Cosumnes River before roads become impassable.

Wilton residents also had to evacuate during last week’s storm, when exit routes flooded quickly, officials said.

El Dorado, Monterey, Santa Cruz and Santa Clara and Alameda counties have issued evacuation warnings or recommendations for some areas due to possible flooding and other safety risks as forecasters warned of swelling rivers.

Residents in all areas of Montecito, the city of Santa Barbara and parts of Carpinteria and Summerland are being ordered to evacuate immediately due to the threat of the ongoing storm, the Santa Barbara County Incident Management Team said on Monday evening.

“LEAVE NOW! This is a rapidly evolving situation,” the team said in a release.

Montecito is a haven for the rich and famous, including Prince Harry and his wife, Meghan, Duchess of Sussex; Oprah Winfrey and Ellen Degeneres. Monday marks exactly five years since heavy rains in the area caused deadly mud- and landslides.

Santa Barbara County authorities are advising residents to “be prepared to sustain yourself and your household for multiple days if you choose not to evacuate, as you may not be able to leave the area and emergency responders may not be able to access your property in the event of road damage, flooding, or a debris flow.”

Newsom on Sunday asked the White House for an emergency declaration to support response and recovery efforts.

“We are in the middle of a deadly barrage of winter storms – and California is using every resource at its disposal to protect lives and limit damage,” Newsom said in a statement. “We are taking the threat from these storms seriously, and want to make sure that Californians stay vigilant as more storms head our way.”

San Francisco Mayor London Breed on Monday issued a Local Proclamation of Emergency due to the ongoing series of winter storms that began New Year’s Eve, according to a news release from his office.

This storm system arrives on the heels of a powerful cyclone that flooded roads, toppled trees and knocked out power last week to much of California. Earlier, a New Year’s weekend storm system produced deadly flooding.

At least 12 Californians have died from “storm-related impacts” such as flooding since late December, the governor’s office said.

In San Luis Obispo County, dive teams from the sheriff’s office and Cal Fire rescuers were searching Monday for a 5-year-old child reported to have been swept away in flood waters near the Salinas River in San Miguel.

“Floods kill more individuals than any other natural disaster,” California Emergency Services Director Nancy Ward said Sunday. “We’ve already had more deaths in this flood storm since December 31 than we had in the last two fire seasons of the highest fire acreage burned in California.”

Flood-related deaths can happen when drivers attempt to cross standing water.

“Just a foot of water and your car’s floating. Half a foot of water, you’re off your feet. Half foot of water, you’re losing control of your vehicle,” Newsom said.

“We’re seeing people go around these detours because they don’t see any obstacles – they think everything is fine, and putting their lives at risk or putting first responders lives at risk.”

For anyone who doesn’t need to travel during the peak of this storm, “please don’t,” California Secretary of Natural Resources Wade Crowfoot said. “Be prepared for power outages and other interruptions. Have those flashlights, the candles, batteries, charge cell phones at the ready.”

Already, flooded roads, toppled trees and downed power lines are making travel difficult, California Highway Patrol said. Some fallen trees crushed cars and homes over the weekend. On Monday, portions of the Pacific Coast Highway – US 101, a major north-south highway, were closed.

The Santa Barbara Airport, a tri-county regional airport, is closed because of flooding airport officials said Monday.

California is experiencing “weather whiplash,” going from intense drought conditions to now contending with its fifth atmospheric river, Newsom said.

Much of the state has already seen 5 to 8 inches of rain over the last week. Two to 4 more inches of rain are expected across the coasts and valleys – and even more in mountains and foothills through Tuesday.

Rising from swelling rivers could spill over and inundate communities.

The rainfall over the weekend brought renewed flood concerns for streams, creeks and rivers. The Colgan Creek, Berryessa Creek, Mark West Creek, Green Valley Creek and the Cosumnes River all have gauges that are either above flood stage or expected to be in the next few days.

“The cumulative effect of successive heavy rainfall events will lead to additional instances of flooding. This includes rapid water rises, mudslides, and the potential for major river flooding,” the National Weather Service said Monday.

The moisture is expected to sink southward Monday night, making flooding “increasing likely” over the Southern California coastal ranges Tuesday, the weather service said. Fierce winds are expected to accompany the storm as it pushes inland.

“Valley areas will likely see gusts as high as 45-50 mph, with gusts greater than 60 mph possible in wind prone areas,” the National Weather Service in Reno said. The Sierra Ridge could receive peak gusts between 130 to 150 mph Monday.

For those at higher elevations, intense snow and ferocious winds will be the biggest concerns.

Parts of the higher elevations in the Sierra Nevada have gotten more than 100” – or 8.3 feet – of snow in just the past few weeks, the Weather Prediction Center said.

Now, another 6 feet of snow is expected in some parts of the Sierra.

As the storm pushes inland, more than 5 feet of snow could fall along the Sierra Crest west of Lake Tahoe, the weather service said.

The heavy snow and strong winds could lead to near whiteout conditions on roads.



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Business

Alzheimer’s drug lecanemab receives accelerated FDA approval amid safety concerns

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CNN
 — 

The US Food and Drug Administration granted accelerated approval Friday for the Alzheimer’s disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline.

“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.”

Lecanemab will be marketed as Leqembi, the FDA statement said. It has shown “potential” as an Alzheimer’s disease treatment by appearing to slow progression, according to Phase 3 trial results, but it has raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.

In July, the FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company. The accelerated approval program allows for earlier approval of medications that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger and longer trials.

If those trials confirm that the drug provides a clinical benefit, the FDA could grant traditional approval. But if the confirmatory trial does not show benefit, the FDA has the regulatory procedures that could lead to taking the drug off the market.

Lecanemab, a monoclonal antibody, is not a cure but works by binding to amyloid beta, a hallmark of Alzheimer’s disease. In late November, results from an 18-month Phase 3 clinical trial published in The New England Journal of Medicine showed that lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events.”

The results also showed that about 6.9% of the trial participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group.

The most common adverse events in the lecanemab group were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.

Some people who get ARIA may not have symptoms, but it can occasionally lead to hospitalization or lasting impairment. And the frequency of ARIA appeared to be higher in people who had a gene called APOE4, which can raise the risk of Alzheimer’s disease or other dementias. ARIA “were numerically less common” among APOE4 noncarriers, the study showed.

The drug’s prescribing information carries a warning about ARIA, the FDA says.

The trial results also showed that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group.

The Alzheimer’s Association welcomed Friday’s decision.

“By slowing progression of the disease when taken in the early stages of Alzheimer’s, individuals will have more time to participate in daily life and live independently,” President and CEO Joanne Pike said. “This could mean more months of recognizing their spouse, children and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”

More than 6.5 million people in the United States live with Alzheimer’s disease, according to the Alzheimer’s Association, and that number is expected to grow to 13.8 million by 2060.

Lecanemab will carry a wholesale price of $26,500 per patient per year, the drug’s manufacturers announced Friday.

Biogen and Eisai have listed the drug slightly below the reduced price of the Alzheimer’s medication Aduhelm, which now costs an average patient about $28,200. The companies had to lower the cost of Aduhelm – originally set at $56,000 per patient per year – after insurers balked at covering it.

In justifying the cost of Leqembi, the companies said in a news release that based on the estimated quality of life gained by people who take it, the value of the medication to society is around $37,000 a year, but they chose to go lower “aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability.”

The wholesale cost of a drug is akin to a car’s sticker price. It isn’t necessarily what patients will pay after insurance or other discounts are factored in.

Insurance coverage for this medication is not a given, however. Medicare restricted its coverage of lecanemab’s sister drug, Aduhelm, after clinical trials showed questionable benefits to patients. The agency agreed to cover the drug only for people enrolled in registered clinical trials, which limited access to the medication.

Center for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure said after the FDA’s decision Friday that her office would quickly review Leqembi, but for now, because of its accelerated approval, it will be covered the same way Aduhelm is covered.

“At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes,” Brooks-LaSure said in a statement.

Last month, the Alzheimer’s Association filed a formal request asking CMS to provide “full and unrestricted coverage” Alzheimer’s treatments approved by the FDA.

“What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong,” Pike said in a statement Friday.

“The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug’s evidence. CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer’s. Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months – memories, skills and independence. They’re losing time.”

CMS told CNN that it will review and respond to the association’s request. The agency also noted that it continues to stay informed about ongoing clinical trials, including the most recent lecanemab results published in the New England Journal of Medicine. Also, it has met with drugmakers to learn about their efforts since CMS’s coverage decision was announced.

The FDA approved Aduhelm for early phases of Alzheimer’s disease in 2021 – but that decision has been shrouded in controversy as a congressional investigation found last week that the FDA’s “atypical collaboration” to approve the high-priced drug was “rife with irregularities.”

Before Aduhelm, the FDA had not approved a novel therapy for the condition since 2003.

Aduhelm’s FDA approval and initial hefty price tag hit Medicare’s Part B premiums, driving up the 2022 standard monthly payments by 14.5% to $170.10.

About $10 of the premium spike – or just under half the amount – was due to Aduhelm, a CMS official told CNN in late 2021.

The premium increase was set before Medicare announced its limited coverage of the drug, but its actuaries had to make sure that the program had sufficient funding in case Aduhelm was covered.

Medicare’s decision, as well as Biogen’s slashing of the drug’s cost, prompted a decline in monthly premiums for 2023 to $164.90.

The FDA’s accelerated approval of lecanemab was expected, said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine.

Isaacson said lecanemab can be “another tool” in his toolbox to fight Alzheimer’s disease.

“I will prescribe this drug in the right person, at the right dose and in a very carefully monitored way, but this drug is not for everyone,” he said.

“I would do genetic testing for APOE4 first. I would have a frank discussion with my patients,” he said. “If someone is having side effects, if someone is on a blood-thinning medication, if someone has a problem, they need to discuss this with the treating physician, and they need to seek medical attention immediately.”

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Business

Jack Ma to relinquish control of Ant group

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CNN
 — 

Chinese billionaire Jack Ma will no longer control Ant Group after the fintech giant’s shareholders agreed to reshape its shareholding structure, according to a statement released by the company on Saturday.

After the adjustment, Ma’s voting rights will fall to 6.2%, according to the statement and CNN calculations.

Before the restructure, Ma held 50.52% of voting rights at Ant via Hangzhou Yunbo and two other entities, according to its IPO prospectus filed with stock exchanges in 2020.

Ant added in the statement that the voting rights adjustment, a move to make the company’s shareholder structure “more transparent and diversified,” will not result in any change to the economic interests of any shareholders.

Ant said its 10 major shareholders, including Ma, had agreed to no longer act in concert when exercising their voting rights, and would only vote independently, and thus no shareholder would have “sole or joint control over Ant Group.”

The voting rights overhaul came after Chinese regulators pulled the plug on Ant’s $37 billion IPO in November 2020, and ordered the company to restructure its business.

As part of the company’s restructuring, Ant’s consumer finance unit applied for an expansion of its registered capital from $1.2 billion to $2.7 billion. The China Banking and Insurance Regulatory Commission recently approved the application, according to a government notice issued late last week.

After the fund-raising drive, Ant will control half of its key consumer finance unit, while an entity controlled by the Hangzhou city government will own a 10% stake. Hangzhou is where Alibaba and Ant have been headquartered since their inceptions.

Ant Group is a fintech affiliate of Alibaba, both of which were founded by Ma.

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Business

SEC closes insider trading probe into former Republican senator

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CNN
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The US Securities and Exchange Commission has closed its insider trading investigation into stock trades made by then-Sen. Richard Burr and his brother-in-law at the outset of the pandemic, the former senator announced Friday.

“This week, the SEC informed me that they have concluded their investigation with no action. I am glad to have this matter in the rearview mirror as I begin my retirement from the Senate following nearly three decades of public service,” Burr, a North Carolina Republican, said in a statement.

The announcement comes nearly two years after the Justice Department closed its own review of the matter, which was launched in March 2020, soon after questionably timed trades by Burr and other lawmakers became publicly known.

Burr sold $1.65 million in stock on February 13, 2020, previous court filings by the SEC revealed. The sales included tens of thousands of dollars in stock in the hospitality industry, which was particularly hard hit in coronavirus outbreak.

The SEC declined CNN’s request for comment.

The trades made by Burr and his brother-in-law first attracted scrutiny because of Burr’s position on Senate committees overseeing health policy and US intelligence. The Intelligence Committee, which Burr chaired at the time, had received periodic briefings on the coronavirus as the outbreak began to spread but it did not receive such a briefing the week of the trades.

The SEC previously said Burr possessed “material nonpublic information concerning Covid-19 and its potential impact on the U.S. and global economies.”

In the DOJ’s probe of the stock trade, Burr turned over his official Senate phone to the FBI after a warrant was served, an official confirmed to CNN at the time. Use of the warrant had been signed off at the highest levels of the Justice Department, as is protocol, according to the source.

The Senate-issued cellphone was Burr’s primary device and investigators had asked Apple for information from Burr’s iCloud backup, a person familiar with the investigation previously said.

Burr had consistently denied any wrongdoing, saying he made the trades based solely on public information, not information he received from the committee.

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