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    Paramount shares jump after reports of takeover interest

    Paramount shares surged following reports that RedBird and Skydance were exploring a potential takeover.
    Paramount’s controlling shareholder, Shari Redstone, has been in the market for a deal.

    The Paramount logo is seen on a building in Los Angeles on Nov. 13, 2023.
    Nurphoto| Getty Images

    Paramount Global shares surged Friday following reports from Deadline and Puck News that Skydance and RedBird Capital were exploring potentially taking over the media giant.
    Paramount shares closed up more than 12% Friday. The company has a market cap of about $10.4 billion and its year to date share price is virtually flat, lagging the S&P 500’s 20% gain.

    Paramount’s controlling shareholder, Shari Redstone, has been open to making big deals, especially as the company weathers the storms of declining revenue and streaming losses.
    RedBird, controlled by longtime former Goldman Sachs partner Gerry Cardinale, is invested in a variety of media and sports assets, including David Ellison’s Skydance, which helped produce Paramount’s 2022 blockbuster “Top Gun: Maverick,” among other hits.
    Paramount has a long-term debt load of $15.6 billion, and investors have speculated about how the company will be able to forge a path in 2024. TV ad revenue was also a weak spot for the company in its most recent quarterly report.
    Meanwhile, the company is reportedly considering bundling its Paramount+ streaming service with Apple TV+.
    Paramount, RedBird Capital and Skydance did not immediately respond to CNBC’s requests for comment.

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    Paramount Global’s year-to-date stock performance

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    U.S. approves first gene-editing treatment, Casgevy, for sickle cell disease

    The U.S. Food and Drug Administration has approved Casgevy, the first gene-editing treatment to be marketed in the country.
    Casgevy uses Nobel Prize-winning technology CRISPR to treat sickle cell disease, a blood disorder that affects about 100,000 Americans.
    Vertex Pharmaceuticals and CRISPR Therapeutics co-developed the one-time treatment that will cost $2.2 million per patient.

    The U.S. Food and Drug Administration on Friday approved the country’s first gene-editing treatment, Casgevy, for use in patients with sickle cell disease.The approval comes about a decade after the discovery of CRISPR technology for editing human DNA, representing a significant scientific advancement. Yet reaching the tens of thousands of people who could benefit from the treatment could be challenging given the potential hurdles — including cost, at $2.2 million per patient — of administering the complex therapy.
    Casgevy, co-developed by Vertex Pharmaceuticals and CRISPR Therapeutics, uses Nobel Prize-winning technology CRISPR to edit a person’s genes to treat disease. The treatment was approved by U.K. regulators last month.

    Shares of Vertex fell 1% Friday, while shares of CRISPR fell 8%.
    Sickle cell, an inherited blood disorder, causes red blood cells to become misshapen half moons that get stuck inside blood vessels, restricting blood flow and causing what are known as pain crises. About 100,000 Americans are estimated to have the disease.

    This microscope photo provided on Oct. 25, 2023, by the Centers for Disease Control and Prevention shows crescent-shaped red blood cells from a sickle cell disease patient in 1972. Britain’s medicines regulator has authorized the world’s first gene therapy treatment for sickle cell disease, in a move that could offer relief to thousands of people with the crippling disease in the U.K.
    Dr. F. Gilbert/CDC via AP, File

    Casgevy uses CRISPR to make an edit to a person’s DNA that turns on fetal hemoglobin, a protein that normally shuts off shortly after birth, to help red blood cells keep their healthy full-moon shape. In clinical trials, Casgevy eliminated pain crises in most patients.
    The FDA approved the treatment for people 12 years and older.
    “Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field especially for individuals whose lives have been severely disrupted by the disease,” said Dr. Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, in a statement.

    “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited,” Verdun added.
    While the treatment itself is administered only once, the whole process takes months. Blood stem cells are extracted and isolated before being sent to Vertex’s lab, where they’re genetically modified. Once ready, patients receive chemotherapy for a few days to clear out the old cells and make room for the new ones. After the new cells are infused, recipients spend weeks in the hospital recovering. 
    Vertex will take the lead on launching the drug and estimates about 16,000 people with severe cases of sickle cell will be eligible.
    Even among the people who could benefit the most, analysts worry few will clamor for a treatment that takes months to complete, carries the risk of infertility and could be cost prohibitive. Vertex said in a regulatory filing Friday it will charge $2.2 million per patient for the treatment.
    “We believe the price of medicine to reflect the value that it brings, and the value that this brings is a one-time therapy for potentially a lifetime of cure,” Vertex CEO Dr. Reshma Kewalramani said Friday in an interview with CNBC.
    Vertex is seeing “unanimous enthusiasm” from payers, patients and physicians, because people with sickle cell have been marginalized, Kewalramani said, and the field hasn’t seen much innovation.
    Because the procedure is so complex, it will be limited to certain health facilities like academic medical centers. Nine health-care facilities are ready to start administering Casgevy, Vertex said in a release, with more facilities added in the coming weeks.

    Bluebird’s Lyfgenia 

    The FDA also on Friday approved a separate gene therapy by Bluebird Bio, called Lyfgenia that works differently than Casgevy but is administered similarly and is also intended to eliminate pain crises. That therapy was similarly approved for the treatment of sickle cell disease in people 12 years and older.
    Bluebird will charge $3.1 million per patient for Lyfgenia. Shares of that company, which has a market value of just about $300 million, fell 40% Friday.
    Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, estimated during a call with reporters Friday that across the two therapies approved Friday, close to 20,000 patients will be eligible for treatment.
    But the FDA included a black-box warning – the strongest safety warning label –  to Bluebird Bio’s Lyfgenia, noting that in rare cases the therapy can cause certain blood cancers. 
    The FDA added that warning after two patients who received Lyfgenia in a clinical trial died from a form of leukemia, Verdun told reporters Friday. 
    The agency said it’s still unclear whether Lyfgenia itself or another part of the treatment process, such as the chemotherapy, caused the cancer.
    But Marks said that the FDA wants patients to be aware of all potential side effects of the entire treatment process: “It’s about the totality of the therapy that’s given,” he told reporters.
    Vertex did not see similar blood cancer cases in its clinical trial, which is why it did not receive a black-box warning on its label, Verdun noted.
    Both Bluebird Bio and Vertex will follow patients who receive the treatments for 15 years as part of a post-approval study. The FDA has encouraged the companies to specifically monitor for malignancies, or the presence of cancerous cells that can spread to other sites of the body. More

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    Starbucks tells union it wants to resume contract talks in January

    Starbucks said it wants to resume contract talks with the union representing its baristas, starting in January.
    No locations have reached a contract with the company in the nearly two years since the first company-owned cafes unionized in the U.S.
    The potential restart of talks opens a window to resolving a stalemate between Starbucks and the union.

    Members and supporters of Starbucks Workers United protest outside of a Starbucks store in Dupont Circle in Washington, D.C., on Nov. 16, 2023.
    Kevin Dietsch | Getty Images

    Starbucks said it wants to resume contract talks with the union representing its baristas, starting in January.
    Saturday marks the two-year anniversary of the first unionization of company-owned Starbucks cafes in the U.S. Since then, more than 360 locations have voted to unionize, representing about 4% of the company’s total U.S. company-owned footprint.

    No locations have yet reached a contract with the company. The potential restart of talks could open a window to resolve a stalemate in one of the most high-profile labor disputes in the U.S. in recent years.
    The employees have pushed Starbucks to raise pay and fix what they call understaffing at cafes, among other demands.
    Labor laws don’t require that the employer and union reach a collective bargaining agreement, only that both bargain in good faith. After a year, workers who lose faith in the union can petition to decertify, putting a ticking clock on negotiations. At least 19 locations have filed petitions to decertify with the National Labor Relations Board, but seven have been dismissed related to rulings that Starbucks broke federal labor law.
    Starbucks and the union, Starbucks Workers United, began talks more than year ago, but negotiations have been fraught. Both parties have accused the opposing side of failing to bargain in good faith.
    Starbucks has insisted on face-to-face negotiations, with no representatives appearing via Zoom. The union has accused Starbucks of using that excuse as a stalling tactic.

    “We collectively agree, the current impasse should not be acceptable to either of us,” Sara Kelly, Starbucks’ chief partner officer, wrote in a letter addressed to Workers United International President Lynne Fox, which was obtained by CNBC. “It has not helped Starbucks, Workers United or, most importantly, our partners. In this spirit, we are asking for your support and agreement to restart bargaining.”
    In the letter, Kelly also outlines several conditions to resume negotiations, including no audio or video recording or feeds.
    If Workers United agrees, Starbucks hopes to begin talks again in January with a representative set of stores.
    The union said it received the letter, is reviewing it and plans to respond.
    “We’ve never said no to meeting with Starbucks. Anything that moves bargaining forward in a positive way is most welcome,” Fox said in a statement to CNBC.
    In November, Starbucks workers conducted their largest-ever labor action, walking out at more than 200 stores on Red Cup Day, one of the chain’s busiest days of the year. Starbucks Workers United said the strike resulted in one big change that baristas asked for: the ability to turn off mobile orders during busy promotion days. Starbucks said the change to its mobile ordering system was already in the works before the demonstration.Don’t miss these stories from CNBC PRO: More

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    PGA Tour star Jon Rahm signs on to join Saudi-backed LIV Golf

    Golf superstar Jon Rahm officially signed on with the Saudi-backed LIV Golf league Thursday in a shocking departure from the PGA Tour.
    It’s interesting timing, given the proposed deal to combine the two leagues, which faces a Dec. 31 deadline.
    Rahm, who won the Masters earlier this year, would be the latest star to be poached by LIV.

    Jon Rahm of Spain celebrates making a putt for birdie on the 18th green during the final round of the 2021 U.S. Open at Torrey Pines Golf Course (South Course) on June 20, 2021 in San Diego, California.
    Sean M. Haffey | Getty Images Sport | Getty Images

    Golf superstar Jon Rahm officially signed on with the Saudi-backed LIV Golf league Thursday in an industry-shocking departure from the PGA Tour. The announcement follows numerous reports that indicated Rahm was gearing up to sign off on the deal.
    Rahm, who won the Masters in April and is ranked No. 3 in the world, told Fox New’s Brett Baier on Thursday, “The growth that LIV Golf has brought to the game is something with a ton of potential and something I’m really excited about.”

    “I can’t comment on that, private business,” Rahm added in response to speculation regarding the reported price tag of the deal.
    The move is the latest blockbuster development in the long and tumultuous saga of the PGA Tour and LIV Golf. The two leagues face a Dec. 31 deadline to decide the fate of their proposed combination.
    The golf world is rife with speculation that the deal with Rahm could be part of a strategy by LIV to pressure the PGA Tour into signing off on the merger.
    When asked for comment, LIV Golf referred CNBC to the announcement made Thursday.
    ESPN reported Thursday that the deal with Rahm could extend beyond three years and is worth more than $300 million. By comparison, former PGA golfer Phil Mickelson inked a deal with LIV in 2022 for $200 million. Rahm could also be getting an ownership stake in a new team on the league as LIV recruits additional PGA Tour players, ESPN added.

    Last month, PGA announced that its league members would get the opportunity to take an ownership stake in the new company formed after the completion of the PGA-LIV Golf merger.
    LIV has repeatedly poached PGA players, creating a particular point of contention for other golfers in the sport. Rory McIlroy, the world’s No. 2 player, said in July that he would retire if LIV Golf was “the last place to play golf on earth.”
    The PGA Tour declined to comment on news of a deal with Rahm. An agency that has represented Rahm also declined to comment. Another firm representing Rahm didn’t immediately respond to a request.
    The Wall Street Journal first reported that Rahm was working on a deal with LIV. More

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    Lululemon shares fall as retailer gives tepid holiday outlook despite strong start to shopping season

    Lululemon posted sales growth in North America and its international markets in the third quarter, but its holiday guidance fell short of Wall Street estimates.
    The athletic apparel retailer, best known for its yoga pants and belt bags, beat Wall Street’s third-quarter sales expectations.

    Black Friday shoppers at a Lululemon store at the Garden State Plaza in New Jersey.
    Mike Calia | CNBC

    Lululemon on Thursday said it saw strong third-quarter demand and a positive start to the holiday shopping season, but the retailer’s shares fell in extended trading after it gave a tepid fourth-quarter outlook.
    Here’s how the company did in its third fiscal quarter:

    Earnings per share: $2.53, adjusted. It wasn’t immediately clear if the figures were comparable with what Wall Street was anticipating, based on a survey of analysts by LSEG, formerly known as Refinitiv.
    Revenue: $2.20 billion vs. $2.19 billion expected

    The company’s reported net income for the three-month period that ended Oct. 29 was $249 million, or $1.96 per share, compared with $255 million, or $2 per share, a year earlier. 
    Sales rose to $2.2 billion, up about 19% from $1.86 billion a year earlier.
    During the quarter, sales jumped 12% in North America and 49% internationally, but the retailer’s holiday guidance came in light of expectations. Lululemon said it’s expecting sales to be between $3.14 billion and $3.17 billion for the fourth quarter, which is shy of the $3.18 billion analysts had expected, according to LSEG.
    Lululemon expects earnings to be between $4.85 and $4.93 per share, compared to estimates of $4.80 to $5.19, according to LSEG. For the full year, Lululemon expects sales to be between $9.55 billion and $9.58 billion, compared to estimates of between $8.11 billion and $9.90 billion, according to LSEG.
    “We’re pleased with the trends we’ve seen at the start of the holiday season. That being said, the majority of the quarter remains in front of us,” finance chief Meghan Frank said on a call with analysts. “We remain aware of the uncertainties in the macro environment, and we continue to plan a business for multiple scenarios.”

    Shares fell about 3% in extended trading.
    On a call with analysts, CEO Calvin McDonald said Black Friday this year was the “single biggest day” in the company’s history. He added that Lululemon is “encouraged” by the trends it has seen at the start of the holiday season.
    “As we enter the holiday season, we are pleased with our early performance and are well-positioned to deliver for our guests in the fourth quarter,” McDonald said in a news release. “I am energized by the significant opportunities ahead.”
    During Lululemon’s third quarter, total comparable sales were up 13%, higher than the 12.4% jump analysts had expected, according to StreetAccount. Comparable sales at the retailer’s stores came in at 9%, lower than the 11.7% Wall Street expected.
    But comparable direct-to-consumer sales spiked 18%, higher than the 16.9% analysts had expected, according to StreetAccount.
    Lululemon incurred $72.1 million in impairment charges related to Mirror, the connected fitness company it acquired for $500 million during the Covid-19 pandemic that it’s now winding down. Those costs add to the $443 million in impairment charges the company reported earlier this year for the equipment.
    As part of a new partnership with former rival Peloton, Lululemon will no longer sell the Mirror device or produce content for its Studio app. Instead, Peloton will provide all the content for Lululemon’s app and in turn, the retailer will become Peloton’s primary athletic apparel partner.Don’t miss these stories from CNBC PRO: More

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    Retail lobby group’s retraction of key crime claim shows how hard it is to track theft

    The National Retail Federation has walked back its claim that organized retail crime accounted for nearly half of all shrink losses because the analysis was incorrect and based on flawed data. 
    The retraction underscores just how difficult it is for the industry to accurately measure the impact and source of inventory losses, even as they use those data points to lobby lawmakers.
    The NRF retracted the claim after an investigation from RetailDive published at the end of November revealed the discrepancy.

    Visitors enter the venue at The NRF 2020 Vision: Retail’s Big Show, held in New York, the United States, Jan. 12, 2020.
    Wang Ying | Xinhua News Agency | Getty Images

    The leading retail lobbying group has walked back a key claim about shrink, or inventory losses from various sources, after a news investigation revealed that the analysis was incorrect.
    The Friday retraction from the National Retail Federation underscores just how difficult it is for the industry to accurately measure the impact and source of inventory losses, even as it uses that data to lobby lawmakers to pass stricter laws that crack down on theft. 

    In April, the NRF published a report about organized retail crime in conjunction with private security firm K2 Integrity that claimed “nearly half” of the estimated $94.5 billion that retailers said they lost to shrink in 2021 “was attributable” to ORC. 
    That claim contradicted the NRF’s own annual shrink survey that showed all external theft – not just incidents related to organized groups – accounted for just 37% of those losses in 2021.
    Typically, organized retail crime refers to incidents that involve coordinated groups of people who shoplift from stores and then resell the items either online or in informal street and flea markets. Retailers often point to it as one of the biggest issues affecting their stores, associates and profitability, and are mounting a concerted lobbying campaign to convince state and federal lawmakers to pass laws that would bring harsher penalties for organized theft offenses. 
    External theft, on the other hand, includes any goods stolen by someone who doesn’t work for the retailer. It includes petty shoplifting incidents, which retailers usually say they are not as concerned about. 
    The NRF retracted the claim after an investigation from Retail Dive published at the end of November revealed the discrepancy. NRF spokesperson Mary McGinty told CNBC it was based on U.S. Senate testimony given in 2021 by Ben Dugan, a current asset protection executive at CVS Health and the former president of advocacy group the Coalition of Law Enforcement and Retail. 

    In his testimony, Dugan said that ORC accounted for $45 billion in annual losses for retailers, according to the coalition’s estimates. 
    “The statement that ‘nearly half of… [shrink] was attributed to ORC’ was a mistaken inference made by the K2 analyst linking the results of the NRF NRSS survey from 2021 and an assertion by Ben Dugan from CLEAR in 2021 Senate testimony,” McGinty told CNBC.
    The NRF modified the report and removed the claim, McGinty said. Dugan directed CNBC to CLEAR for a response.
    She added that the NRF “stand[s] behind the widely understood fact that organized retail crime is a serious problem impacting retailers of all sizes and communities across our nation,” but acknowledged how difficult it is to gather data on theft. 
    “At the same time, we recognize the challenges the retail industry and law enforcement have with gathering and analyzing an accurate and agreed-upon set of data to measure the number of incidents in communities across the country,” McGinty said. “The reality is retailers and law enforcement agencies continue to experience daily incidents of theft, partner in large-scale investigations and report recoveries of stolen retail goods into the millions of dollars.”
    The NRF’s studies are the best guess the industry can make about how shrink affects companies. The media widely reports on them, and lawmakers use them as evidence when they call for stricter laws and regulations.
    But the flawed data reinforces skepticism about the claims that retailers and their powerful trade associations make about organized retail crime, because even the industry’s own data is difficult to trust.
    The NRF’s retraction isn’t the first time the firm published data that later ended up incorrect. 
    In a previous NRF shrink survey, it reported that retailers saw $94.5 billion in inventory losses in 2021. It calculated that by applying the average shrink rate of 1.4% to preliminary retail sales data reported to the U.S. Census Bureau that year. 
    When the U.S. Census later published its final retail sales number for the year, those figures were lower than estimates, making shrink losses about $600 million less than what the NRF originally reported.
    When CNBC brought this discrepancy to the NRF’s attention earlier this year, the firm didn’t revise the data point in its survey. It did use the correct figure in its 2022 report when it compared that year’s losses with the prior years.
    McGinty noted that the Census “revises and then revises again and again,” but the firm doesn’t revise its published numbers “because it is a ‘point in time’ number.”
    “It’s not flawed data,” McGinty said. “It’s data based on the best available information at the time.”
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    Ferrari’s $400,000 Purosangue is a dream to drive. Just don’t call it an SUV

    Don’t call the Ferrari Purosangue an SUV.
    For one, the company doesn’t, omitting the moniker from its launch materials and press announcements, dubbing it instead “the first four-door, four-seater Ferrari.”

    Ferrari’s mystique is built on racing and rarity. Slapping the famed prancing horse on just another SUV would be contrary to its carefully crafted image and exclusivity. And, Ferrari is fairly late to the segment and wants to distinguish the Purosangue from the SUVs of its luxury rivals. Porsche launched the Cayenne more than 20 years ago, Lamborghini has been making the Urus for more than five years and Aston Martin rolled out the DBX in 2020.
    Yet, the biggest reason to avoid those three letters: From behind the wheel, the Purosangue is no SUV.

    The Ferrari Purosangue.
    Bradley Howard | CNBC

    The Purosangue, its name meaning “pure blood” or “thoroughbred” in Italian, comes with a 7.5 liter, V-12 engine. The vehicle starts at $400,000, but with additional options, most buyers will end up paying more than $500,000.
    Driving it was unlike anything I’d experienced before. It’s not an SUV, but it is unquestionably a Ferrari.
    It starts with the exterior. In pictures, the Purosangue looks bulbous, pedestrian, even a little boring — especially compared to the Urus, with its space-age winglets and angles. But in person, the Purosangue is perfectly proportioned, more like a crouching tiger than racehorse.

    The car’s vents, air buttresses, spoilers and diffusers can only be appreciated up close and were the result of hundreds of hours in the wind tunnel.

    The Ferrari Purosangue.
    Adam Jeffery | CNBC

    The Purosangue is big, weighing over 2 tons, and measuring 16 feet long and 6½ feet wide.
    The two rear passenger seats aren’t token “sports car seats” for toddlers, but they are fully adjustable individual seats that comfortably fit even those passengers over 6 feet tall.

    Suicide doors on the Ferrari Purosangue.
    Adam Jeffery | CNBC

    Sliding into any seat of the Purosangue is blissfully un-Ferrari-like. No crouching or spinal origami required to climb in. The rear doors, called “welcome doors,” are rear-hinged similar to a Rolls-Royce, and glide open with the tap of a button.
    The cargo space can easily handle a large grocery run and, with the rear seats folded back, a bicycle or larger gear.

    Trunk storage in the Ferrari Purosangue.
    Adam Jeffery | CNBC

    All of that sounds like an SUV but wait until you start up the engine and press the accelerator.
    Perhaps to compensate for the naysayers who said Ferrari would denigrate the brand with a truck, Ferrari chose to power the Purosangue with its most celebrated engine: a naturally aspirated, V-12. It’s old-school, raw power and generates 715 horsepower with 528 pound-feet of torque.

    The Ferrari Purosangue.
    Bradley Howard | CNBC

    It’s also midfront mounted, with the gearbox at the rear, so the car has a 49:51 weight distribution, more akin to a sports car than an SUV.
    Roaring down the highway or through windy country roads, the Purosangue sounds and feels like a more nimble car.
    It’s not the same as a Ferrari sports car, let’s not kid ourselves. Yet, the steering is sharp and light (almost too light until you get used to it), the brakes are firm and the power is instant and gratifying.

    The Ferrari Purosangue.
    Adam Jeffery | CNBC

    When you drive the Purosangue, you may not squeal or scream like you might in any other Ferrari. But you will undoubtedly smile at what the engineers at Maranello have managed to create.
    Ferrari’s other big innovation for the Purosangue is the suspension. The supercar maker created a new active suspension system that includes a “True Active Spool Valve System,” which combines an electric motor with a hydraulic damper to shift force at high speeds.
    The result is less body roll and incredible cornering. Throwing the Ferrari around high-speed turns feels effortless and evenly balanced.

    Detail of carbon fiber materials in the Ferrari Purosangue.
    Adam Jeffery | CNBC

    The Purosangue is not perfect, of course.
    Some long-time Ferrari owners who have driven the car told me they were disappointed with the interior, which they said looks “too basic” — especially at a price tag of up to $500,000.
    The cabin is simple, and Ferrari was proud of using recycled, environmentally friendly materials for the Alcantara upholstery. Yet, competing with luxury SUVs, the Purosangue interior could use a bit more luxury.

    A view of the backseat interior of the Ferrari Purosangue.
    Adam Jeffery | CNBC

    Some Ferrari owners and dealers also griped about the engine sound, which they said was too muted for their liking. As one Ferrari collector told me, “For a Ferrari V-12, the engine just doesn’t sound right.”
    To my ears, it sounded glorious, full of all the usual Ferrari rumbles at the low end and whines at higher RPMs, yet not so aggressive that it would annoy your neighbors in the cul-de-sac.
    As important as the engine sound has traditionally been for Ferrari owners, it may not be as critical to customers interested in a four-door.
    One dealer told me that about a third of the buyers of the Purosangue are new to the Ferrari brand, which means Ferrari has succeeded in building a car to expand its market.
    Is it a “pure blood” Ferrari? Is it an SUV? Ferrari purists can debate what to call it. The proof is in the sales. The Purosangue is sold out for more than two years and the only available slots are for 2026.
    I call it a success.

    The Ferrari Purosangue.
    Adam Jeffery | CNBC

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    Biden administration asserts power to seize drug patents in move to slash high prices

    The Biden administration asserted its authority to seize the patents of certain costly medications.
    The effort marks a new push to slash high drug prices and promote more competition in the pharmaceutical industry in the U.S.
    The administration unveiled a new framework outlining the factors federal agencies should consider in determining whether to use a controversial policy known as march-in rights

    President Joe Biden speaks about protecting Social Security, Medicare, and lowering prescription drug costs, during a visit to OB Johnson Park and Community Center, in Hallandale Beach, Florida, on Nov. 1, 2022.
    Kevin Lamarque | Reuters

    The Biden administration on Thursday opened the door to seizing the patents of certain costly medications from drugmakers in a new push to slash high drug prices and promote more pharmaceutical competition.
    The administration unveiled a framework outlining the factors federal agencies should consider in deciding whether to use a controversial policy, known as march-in rights, to take patents for drugs developed with taxpayer funds and share them with other pharmaceutical companies if the public cannot “reasonably” access the medications. Doing so could lead to the development of lower-priced generic alternatives, which could cut into key drug companies’ profits and reduce costs for patients.

    For the first time, officials can now factor in a medication’s price in deciding to break a patent.
    It is unclear whether and how federal agencies will use march-in rights under the new framework. Notably, “no agency to date” has exercised the policy, which came about under the Bayh-Dole Act of 1980, a senior administration official said during a call with reporters Wednesday. 
    But the administration will “make it clear that when drug companies won’t sell taxpayer-funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less,” Lael Brainard, White House national economic advisor, told reporters. 
    The framework will be open to public comment for 60 days.
    The administration’s announcement follows a nearly nine-month review of the federal government’s march-in rights, which aimed to update the framework for using the policy.

    It also comes as President Joe Biden makes lowering U.S. drug prices a key pillar of his health-care agenda and reelection platform for 2024. 
    Political pressure has pushed health-care companies to launch their own efforts to lower drug prices. CVS on Tuesday unveiled a new prescription drug pricing model, which could potentially cut costs for patients at the pharmacy counter.
    Nearly 3 in 10 Americans struggle to pay for the drugs they need, according to a July survey from health policy research organization KFF. And some research suggests that U.S. patients spend about $1,200 more per person on prescription medications than those in any other nation.
    Yet taxpayers have spent tens of billions of dollars to fund hundreds of drugs in the last decade — which the Biden administration believes could justify more government action to cut prices.
    The administration’s new push to use march-in rights could eventually have major ramifications for the pharmaceutical industry, which has long argued that the policy discourages research and development of new drugs.

    Activists protest the price of prescription drug costs in front of the U.S. Department of Health and Human Services (HHS) building on October 06, 2022 in Washington, DC.
    Anna Moneymaker | Getty Images

    Drugmakers have argued that seizing the patent for a medication makes that treatment vulnerable to competition, which can reduce a company’s revenue and limit how much it can reinvest into drug development.
    That pushback has made the federal government reluctant to use march-in rights in the past, which has frustrated progressives on Capitol Hill. 
    On Thursday, Sen. Elizabeth Warren told CNBC that the Biden administration’s new framework “is using the right approach overall, which is use every tool in the toolbox to bring down drug prices.”
    “When there’s no competition in a market, then that falls hard on people who need that drug,” the Massachusetts Democrat said. “It also falls hard on taxpayers who end up paying for it through other government programs.”
    She added that march-in rights have existed in the law for a long time. But that power hasn’t been “picked up and used very aggressively,” so she is glad to see the administration “move in this direction.”
    Meanwhile, the pharmaceutical industry’s largest lobbying group slammed the Biden administration’s push to exercise march-in rights in a statement. 
    “This would be yet another loss for American patients who rely on public-private sector collaboration to advance new treatments and cures,” said a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents drugmakers such as Pfizer, Eli Lilly and Johnson & Johnson. “The Administration is sending us back to a time when government research sat on a shelf, not benefitting anyone.”
    The White House feigned disappointment about the lobbying group’s stance in a post on X, formerly known as Twitter.
    “Oh no. We’ve upset Big Pharma again,” the White House said.
    Both the Obama and Trump administrations had rejected march-in requests from lawmakers and patient advocates. The Trump administration even proposed a rule that would prevent the government from exercising the policy based on the high price of a drug alone. 
    The Biden administration chose not to finalize that proposal earlier this year, according to a release from the White House on Thursday. 
    But the Biden administration has also shied away from using march-in rights up until now. In March, the administration declined to break the patent of the costly prostate cancer drug Xtandi from Astellas Pharma and Pfizer. 
    The drugmakers charge more than $150,000 a year for Xtandi in the U.S. before insurance and other rebates, but charge a fraction of that price in other developed countries.
    The Biden administration has attempted to lower drug prices in other ways, such as giving Medicare the power to negotiate drug prices for the first time in the federal program’s 60-year history as part of the Inflation Reduction Act. 
    But Xtandi was excluded from the first 10 medications the government selected for negotiations, which prompted Astellas Pharma to drop a lawsuit it filed to halt the price talks.
    Also on Thursday, the Biden administration unveiled efforts that aim to counter allegedly anti-competitive practices by big health-care companies.
    Some target private equity firms, which have been buying up physician practices, nursing homes and other health-care providers. Private equity ownership in the health-care industry has ballooned, with approximately $750 billion in deals between 2010 and 2020, according to a report from the American Antitrust Institute.
    The administration is concerned that corporate owners are “maximizing their profits at the expense of patients’ health and safety, while increasing costs for patients and taxpayers alike,” according to a White House fact sheet.
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