ReportWire

Tag: Pfizer Inc.

  • Trump unveils deal to expand coverage and lower costs on obesity drugs

    WASHINGTON (AP) — President Donald Trump unveiled a deal Thursday with drugmakers Eli Lilly and Novo Nordisk to expand coverage and reduce prices for the popular obesity treatments Zepbound and Wegovy.

    Known as GLP-1 receptor agonists, the drugs have soared in popularity in recent years, but patient access has been a consistent problem because of their cost — around $500 a month for higher doses — and insurance coverage has been spotty. More than 100 million American adults are obese, according to federal estimates.

    Coverage of the drugs for obesity will expand to Medicare patients starting next year, according to the administration, which said some lower prices also will be phased in for patients without coverage. Starting doses of new, pill versions of the treatments also will cost $149 a month if they are approved.

    “(It) will save lives, improve the health of millions and millions of Americans,” said Trump, in an Oval Office announcement in which he referred to GLP-1s as a “fat drug.”

    Thursday’s announcement is the latest attempt by the Trump administration to rein in soaring drug prices in its efforts to address cost-of-living concerns among voters. Pfizer and AstraZeneca recently agreed to lower the cost of prescription drugs for Medicaid after an executive order in May set a deadline for drugmakers to electively lower prices or face new limits on what the government will pay.

    As with the other deals, it’s not clear how much the price drop will be felt by consumers. Drug prices can vary based on the competition for treatments and insurance coverage.

    Obesity drugs are popular, but costly

    The obesity drugs work by targeting hormones in the gut and brain that affect appetite and feelings of fullness. In clinical trials, they helped people shed 15% to 22% of their body weight — up to 50 pounds or more in many cases.

    Patients usually start on smaller doses and then work up to larger amounts, depending on their needs. They need to stay on the the treatments indefinitely or risk regaining weight, experts say.

    The medications have proven especially lucrative for Lilly and Novo. Lilly said recently that sales of Zepbound have tripled so far this year to more than $9 billion.

    But for many Americans, their cost has made them out of reach.

    Medicare, the federally funded coverage program mainly for people ages 65 and over, now covers the cost of the drugs for conditions such as type 2 diabetes and cardiovascular disease, but not for weight loss alone. Trump’s predecessor, Joe Biden, proposed a rule last November that would have changed that, but the Trump administration nixed it.

    Few state and federally funded Medicaid programs, for people with low incomes, offer coverage. And employers and insurers that provide commercial coverage are wary of paying for these drugs in part because so many people might use them.

    The $500 monthly price for higher doses of the treatments also makes them unaffordable for those without insurance, doctors say.

    Trump tries to show he is in touch with cost-of-living concerns

    Thursday’s announcement comes as the White House is looking to demonstrate that Trump is in touch with Americans’ frustrations with rising costs for food, housing, health care and other necessities.

    “Trump is the friend of the forgotten American,” said Health and Human Services Secretary Robert F. Kennedy, Jr. at Thursday’s announcement. “Obesity is a disease of poverty. And overwhelmingly, these drugs have only been available for people who have wealth.”

    (Obesity rates actually are slightly higher for middle-income Americans than they are for those with the lowest and highest incomes, according to 2017-2020 data collected by the U.S. Centers for Disease Control and Prevention.)

    Kennedy had previously expressed skepticism about GLP-1s, but he was full of praise for Trump for pushing to help a broader segment of Americans have access to the drug.

    Trump, who has a history of commenting on people’s appearance, asked the officials who joined him in the Oval Office whether they had used the weight-loss medications.

    “Do you take any of this stuff, Howard?” Trump asked Commerce Secretary Howard Lutnick. “Not yet,” Lutnick replied. “He’s taking it,” the president said of Steven Cheung, who is the White House director of communications.

    The drug-pricing announcement came days after Democrats swept elections in races across the country. Economic worries were the dominant concern for those casting their ballots, according to findings from the AP voter poll.

    Plan calls for phased-in price reductions

    The White House sought to diminish price-reduction efforts by the previous Democratic administration as a gift to the pharmaceutical industry.

    Trump, instead, consummated a deal that ensures Americans aren’t unfairly financing the pharmaceutical industry’s innovation, claimed a senior administration official, who briefed reporters ahead of Thursday’s Oval Office announcement.

    Another senior administration official said coverage of the drugs will expand to Medicare patients starting next year. The program will start covering the treatments for people who have severe obesity and others who are overweight or obese and have serious health problems, the official said. Those who qualify will pay $50 copays for the medicine.

    Lower prices also will be phased in for people without coverage through the administration’s TrumpRx program, which will allow people to buy drugs directly from manufacturers, starting in January.

    Administration officials said the average price of the drugs sold on TrumpRx will start at around $350 and then drop to $245 over the next two years.

    A Novo Nordisk spokesperson declined to provide details on their pricing changes.

    Lilly said it will sell a starter dose of Zepbound for $299 a month and additional doses at up to $449. Both represent $50 reductions from current prices for doses it sells directly to patients.

    Administration officials said lower prices also will be provided for state and federally funded Medicaid programs. And starting doses of new, pill versions of the obesity treatments will cost $149 a month if they are approved.

    U.S. health regulators on Thursday separately agreed to dramatically expedite review of Lilly’s obesity pill, orforglipron. An FDA decision on Novo Nordisk’s Wegovy pill is expected later this year.

    Doctors who treat patients for obesity say help is needed to improve access. Dr. Leslie Golden says she has roughly 600 patients taking one of these treatments, and at least 75% struggle to afford them. Even with coverage, some face $150 copayments for refills.

    “Every visit it’s, ‘How long can we continue to do this? What’s the plan if I can’t continue?’” said Golden, an obesity medicine specialist in Watertown, Wisconsin. “Some of them are working additional jobs or delaying retirement so they can continue to pay for it.”

    ___

    AP Health Writer Matthew Perrone contributed to this report.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

    Source link

  • Trump says the US has secured $17 trillion in new investments. The real number is likely much less

    WASHINGTON (AP) — The economic boom promised by President Donald Trump centers on a single number: $17 trillion.

    That’s the sum of new investments that Trump claims to have generated with his tariffs, income tax cuts and aggressive salesmanship of CEOs, financiers, tech titans, prime ministers, presidents and other rulers. The $17 trillion is supposed to fund new factories, new technologies, more jobs, higher incomes and faster economic growth.

    “Under eight months of Trump, we’ve already secured commitments of $17 trillion coming in,” the president said in a speech last month. “There’s never been any country that’s done anything like that.”

    But based on statements from various companies, foreign countries and the White House’s own website, that figure appears to be exaggerated, highly speculative and far higher than the actual sum. The White House website lists total investments at $8.8 trillion, though that figure appears to be padded with some investment commitments made during Joe Biden’s presidency.

    The White House didn’t lay out the math after multiple requests as to how Trump calculated $17 trillion in investment commitments. But the issue goes beyond Trump’s hyperbolic talk to his belief that the brute force of tariffs and shaming of companies can deliver economic results, a strategy that could go sideways for him politically if the tough talk fails to translate into more jobs and higher incomes.

    Just 37% of U.S. adults approve of Trump’s handling of the economy, according to a September poll by The Associated Press-NORC Center for Public Affairs. That’s down from a peak of 56% in early 2020 during Trump’s first term — a memory he relied upon when courting voters in last year’s election.

    Adam Posen, president of the Peterson Institute of International Economics, said the public commitments announced by Trump do represent a “meaningful increase” — but one that amounts to hundreds of billions of dollars, not trillions. Even then, that comes with long-term costs as countries might be less inclined to invest with the U.S. after being threatened to do so.

    “It is a national security mistake because you’re turning allies into colonies of a sort — you’re forcibly extracting from them things that they don’t see as entirely in their interest,” Posen said. “Twisting the arms of governments to then twist the arms of their own businesses is not going to get you the payoff you want.”

    Trump banking on foreign countries making good on promises

    The Trump administration is betting that tariffs are an effective tool to prod other countries and international companies to invest in the United States, a big stick that other administrations failed to wield. Trump’s pitch to voters is that he will play a role in directly managing the investment commitments made by foreign countries — and that the allocation of that money starting next year will revive what has been a flagging job market.

    “The difference between hypothetical investments and ground being broken on new factories and facilities is good leadership and sound policy,” said White House spokesman Kush Desai.

    The White House said that Japan will invest $1 trillion, largely at Trump’s direction. The European Union will commit $600 billion. The United Arab Emirates made commitments of $1.4 trillion over 10 years. Qatar pledged $1.2 trillion. Saudi Arabia intends to pony up $600 billion, India $500 billion and South Korea $450 billion, among others.

    The challenge is the precise terms of those investments have yet to be fully codified and released to the public, and some numbers are under dispute, potentially fuzzy math or, in the case of Qatar, more than five times the annual gross domestic product of the entire country. The White House maintains that Qatar is good for the money because it produces oil.

    South Korea already has misgivings about its investment commitment, which is $100 billion lower than what the White House claims, after immigration agents raided a Hyundai plant under construction in Georgia and arrested Korean citizens. There are also concerns that an investment that large without a better way to exchange currencies with the U.S. could hurt South Korea’s economy.

    “From what I’ve seen, these commitments are worth about as much as the paper they’re not written down on,” said Jared Bernstein, who was the chairman of the Council of Economic Advisers in the Biden White House.

    As for the $600 billion committed by European companies, that’s based on those businesses having “expressed interest” and having stated “intentions” to do so through 2029 rather than an overt concession, according to European Union documents.

    Still too soon to see any investment impact in overall economy

    So far, there has yet to be a notable boost in business investment as a percentage of U.S. gross domestic product. As a share of the overall economy, business investment during the first six months of Trump’s presidency has been consistently bouncing around 14%, just as it was before the pandemic.

    But economists also note that Trump is double-counting and relying on investments that were initially announced during the Biden administration or investments that were already likely to occur because of the artificial intelligence build out.

    For example, the White House lists a $16 billion investment by computer chipmaker Global Foundries. But of that sum, more than $13 billion was announced during the Biden administration and supported by $1.6 billion in grants by the 2022 CHIPS and Science Act, as well as other state and federal incentives.

    Similarly, the White House is banking on $200 billion being invested by the chipmaker Micron, but at least $120 billion of that was announced during the Biden era.

    ‘The tariffs played a big role’

    For their part, White House officials largely credit Trump’s tariffs — like those imposed on Oct. 1 on kitchen cabinets, large trucks and pharmaceutical drugs — for forcing companies to make investments in the U.S., saying that the risk of additional import taxes if countries and companies fail to deliver on their promises will ensure that the promised cash comes into the economy.

    On Tuesday, Pfizer CEO Albert Bourla endorsed this approach after his pharmaceutical drug company received a three-year grace period on tariffs and announced $70 billion in investments in the U.S.

    “The president was absolutely right,” Bourla said. “Tariffs is the most powerful tool to motivate behaviors.”

    “The tariffs played a big role,” Trump added.

    Source link

  • These high-dividend-yielding stocks could see a rebound as rates decline, BMO says

    These high-dividend-yielding stocks could see a rebound as rates decline, BMO says

    Source link

  • Jim Cramer: Merck is a buy after the drugmaker’s post-earnings dip — here’s why

    Jim Cramer: Merck is a buy after the drugmaker’s post-earnings dip — here’s why

    Source link

  • Cramer's week ahead: Earnings season kicks off after JPMorgan Healthcare Conference

    Cramer's week ahead: Earnings season kicks off after JPMorgan Healthcare Conference

    CNBC’s Jim Cramer on Friday told investors what to watch for on Wall Street next week, highlighting JPMorgan‘s market-moving health-care conference in San Francisco. Taking place from Monday to Thursday, the conference is one of the year’s largest gatherings of major industry CEOs where they reveal earnings guidance and updates on clinical trial research.

    “The new year has started with a redistribution of cash out of the ‘Magnificent Seven’ and on to the sidelines,” Cramer said, pointing to health-care stocks as a particularly notable group that will likely be “propelled by what people expect to hear from the JPMorgan Healthcare Conference.”

    Cramer will interview several CEOs at the conference, starting with Walgreens CEO Tim Wentworth on Monday. Cramer said he’s interested to hear how the company plans to get its groove back after cutting its dividend nearly in half this week. Cramer will also speak with leadership from Amgen and Medtronic, as well as the new CEO of Bristol Myers, Chris Boerner, whom he’ll ask about the company’s rigorous biotech acquisition plans.

    On Tuesday and Wednesday, Cramer will continue to interview the CEOs of major industry names, including Eli Lilly CEO David Ricks. Cramer said he’s particularly interested in the company’s diabetes and weight loss drug as well as its Alzheimer’s initiative. He’ll also speak with CVS Health CEO Karen S. Lynch to discuss the company’s ongoing transition from drug store to health-care provider. Cramer will also hear from the CEOs of Pfizer, Regeneron, Novartis, Abbott Labs and Cencora.

    Thursday brings the consumer price index for December. Cramer said he thinks those hoping for soft figures will be disappointed. Cramer will also be tuning into CES, the Consumer Electronics Show, next week. The tech event will include commentary by leadership from Nvidia and Dell.

    Earnings season kicks off Friday with reports from major banks including JPMorgan, Bank of America and Wells Fargo. BlackRock will also report, and Cramer said he thinks the company’s earnings could give investors a solid overview of the financial industry. He’ll also be paying attention to Friday reports from UnitedHealth Group and Delta.

    Jim Cramer talks what's ahead for the markets next week

    Jim Cramer’s Guide to Investing

    Sign up now for the CNBC Investing Club to follow Jim Cramer’s every move in the market.

    Disclaimer The CNBC Investing Club Charitable Trust holds shares of Eli Lilly.

    Questions for Cramer?
    Call Cramer: 1-800-743-CNBC

    Want to take a deep dive into Cramer’s world? Hit him up!
    Mad Money TwitterJim Cramer TwitterFacebookInstagram

    Questions, comments, suggestions for the “Mad Money” website? madcap@cnbc.com

    Source link

  • Single-stock ETFs tap into the market’s ‘gambling mindset,’ expert says. What investors need to know

    Single-stock ETFs tap into the market’s ‘gambling mindset,’ expert says. What investors need to know

    Traders work on the floor of the New York Stock Exchange.

    Brendan McDermid | Reuters

    More than a year after single-stock exchange-traded funds hit the U.S. market, risk-seeking investors continue to dive in.

    Single-stock ETFs were first introduced in Europe in 2018. There are now nearly four dozen single-stock ETFs in the U.S., many of which track the so-called “Magnificent Seven” stocks — Apple, Microsoft, Alphabet, Nvidia, Amazon, Tesla and Meta. Other names on Morningstar’s list of single-stock ETFs include Coinbase and Alibaba.

    Collectively, single-stock ETFs have about $3.3 billion of net assets, according to Morningstar. 

    The growth of these single-stock ETFs, which are leveraged, is not particularly surprising, given that the Nasdaq is up more than 40% this year and big-tech stocks in particular are soaring. But they’ve likely earned a long-term spot in the market.

    Single-stock ETFs “are here to stay,” said Bryan Armour, director of passive strategies research for North America at Morningstar. The strategy “taps into some of the gambling mindset that exists in markets,” he said.

    More from ETF Strategist

    Here’s a look at other stories offering insight on ETFs for investors.

    Here’s what investors need to know about the growth of the single-stock ETF market and where it could be heading. 

    Where the single-stock ETF action is, starting with Tesla

    There are 45 single-stock ETFs in total, according to Morningstar, from a handful of providers including Direxion, AXS, GraniteShares and YieldMax. These ETFs follow bull, bear or option income strategies.

    The largest by asset size is the Direxion Daily TSLA Bull 1.5X Shares, which tracks Tesla. In July, it became the first of its kind in the U.S. to surpass the $1 billion asset mark. 

    The second-largest single-stock ETF by asset size is the YieldMax TSLA Option Income Strategy ETF, which had around $841 million of assets at the end of November, according to Morningstar.

    In third place by asset size is the GraniteShares 1.5x Long NVDA Daily ETF, which tracks Nvidia and has soared in a year dominated by artificial intelligence optimism and the gains for chipmakers. It had about $245 million in assets at the end of November, Morningstar data shows.

    To achieve their stated returns, leveraged and inverse ETPs often use a range of investment strategies. This can include swaps, futures and other derivatives as well as long or short positions, according to a FINRA explainer.

    Expect more high-risk ETFs to hit the market

    Rich Lee, head of program and ETF trading at Robert W. Baird & Co., expects to see more single-stock ETFs with an options overlay strategy and income component. YieldMax offers several of these ETFs that seek to generate monthly income by selling/writing call options on single company stock exposures.

    There is continuous appetite for single-stock ETFs, and there will continue to be innovation, combining themes and exposures under the ETF wrapper, Lee said. “It’s a way to get quick exposure with leverage.”

    While the number and assets within these ETFs has mushroomed, there have been duds. Single-stock ETFs tracking Nike and Pfizer — the former whose shares are close to flat this year and the latter whose shares are down 45% — among a few others, closed down. Some stocks are too bland to get investors riled up one way or another, Armour said. If an ETF can’t get enough traction, investment managers have to decide where to focus their resources, he said. It’s something for investors to keep in mind: What’s on the market today may not be in a few months.

    Using single-stock ETFs is not a long-term strategy

    Performance is all over the map. The Direxion Daily TSLA Bull 1.5X, for instance, had a total one-year return of about 12% through November, but it’s up about 148% year to date through Dec. 15, according to Morningstar. The GraniteShares 1.5x Long COIN Daily ETF, which tracks Coinbase, had a one-year return through November of about 206% and returned about 488% year to date through Dec. 15, according to Morningstar.

    Not surprisingly, single-stock ETFs that take a bear strategy have seen negative returns of late.

    But performance over time isn’t really the point.

    The market for these vehicles is mostly traders and individual investors with an extremely high risk tolerance. There are other ways to gain leverage, without needing to pay fees in the 1% range, but for some more sophisticated retail investors who don’t have experience with leverage, a single-stock ETF can be a safer option, Armour said. “It’s just not a smart long-term strategy. It’s a very costly way to gamble in the stock market.”

    The SEC’s warning to retail investors

    These vehicles are appropriate for sophisticated retail investors and professionals that are willing to take a short-term view and are willing to monitor their positions daily, said Ed Egilinsky, head of sales and distribution and alternatives at Direxion.

    “These are not buy-and-hold products,” he said. “If someone is looking to buy something and not pay attention to it, this is not the vehicle.”

    The U.S. Securities and Exchange Commission issued an investor warning in August, reiterating the extra risks inherent to single-stock ETFs. “Because leveraged single-stock ETFs in particular amplify the effect of price movements of the underlying individual stocks, investors holding these funds will experience even greater volatility and risk than investors who hold the underlying stock itself,” the SEC said.

    “You definitely have to understand what investing or hedging investment you’re trying to achieve with these products,” Lee said. “For a lot of these leveraged products, people are using it to get intraday exposure or use it for some sort of hedging.”

    Which stocks could be targeted for the next hotly traded single-stock ETF?

    Success is determined in part by assets, daily volume and scale, said Egilinsky. While he declined to be specific about where Direxion is next looking to add to its single-stock ETF lineup, he did say AI is a hot area. “We’re going to let this play out over time. It’s still in its infancy stages and we’ll continue to look for single stocks that make sense for us to bring to the market.”

    Source link

  • Free ChatGPT may incorrectly answer drug questions, study says

    Free ChatGPT may incorrectly answer drug questions, study says

    Harun Ozalp | Anadolu | Getty Images

    The free version of ChatGPT may provide inaccurate or incomplete responses — or no answer at all — to questions related to medications, which could potentially endanger patients who use OpenAI’s viral chatbot, a new study released Tuesday suggests.

    Pharmacists at Long Island University who posed 39 questions to the free ChatGPT in May deemed that only 10 of the chatbot’s responses were “satisfactory” based on criteria they established. ChatGPT’s responses to the 29 other drug-related questions did not directly address the question asked, or were inaccurate, incomplete or both, the study said. 

    The study indicates that patients and health-care professionals should be cautious about relying on ChatGPT for drug information and verify any of the responses from the chatbot with trusted sources, according to lead author Sara Grossman, an associate professor of pharmacy practice at LIU. 

    For patients, that can be their doctor or a government-based medication information website such as the National Institutes of Health’s MedlinePlus, she said.

    An OpenAI spokesperson said the company guides ChatGPT to inform users that they “should not rely on its responses as a substitute for professional medical advice or traditional care.”

    The spokesperson also shared a section of OpenAI’s usage policy, which states that the company’s “models are not fine-tuned to provide medical information.” People should never use ChatGPT to provide diagnostic or treatment services for serious medical conditions, the usage policy said.

    ChatGPT was widely seen as the fastest-growing consumer internet app of all time following its launch roughly a year ago, which ushered in a breakout year for artificial intelligence. But along the way, the chatbot has also raised concerns about issues including fraud, intellectual property, discrimination and misinformation. 

    Several studies have highlighted similar instances of erroneous responses from ChatGPT, and the Federal Trade Commission in July opened an investigation into the chatbot’s accuracy and consumer protections. 

    In October, ChatGPT drew around 1.7 billion visits worldwide, according to one analysis. There is no data on how many users ask medical questions of the chatbot.

    Notably, the free version of ChatGPT is limited to using data sets through September 2021 — meaning it could lack significant information in the rapidly changing medical landscape. It’s unclear how accurately the paid versions of ChatGPT, which began to use real-time internet browsing earlier this year, can now answer medication-related questions.  

    Grossman acknowledged there’s a chance that a paid version of ChatGPT would have produced better study results. But she said that the research focused on the free version of the chatbot to replicate what more of the general population uses and can access. 

    She added that the study provided only “one snapshot” of the chatbot’s performance from earlier this year. It’s possible that the free version of ChatGPT has improved and may produce better results if the researchers conducted a similar study now, she added.

    Grossman noted that the research, which was presented at the American Society of Health-System Pharmacists’ annual meeting on Tuesday, did not require any funding. ASHP represents pharmacists across the U.S. in a variety of health-care settings.

    ChatGPT study results

    The study used real questions posed to Long Island University’s College of Pharmacy drug information service from January 2022 to April of this year. 

    In May, pharmacists researched and answered 45 questions, which were then reviewed by a second researcher and used as the standard for accuracy against ChatGPT. Researchers excluded six questions because there was no literature available to provide a data-driven response. 

    ChatGPT did not directly address 11 questions, according to the study. The chatbot also gave inaccurate responses to 10 questions, and wrong or incomplete answers to another 12. 

    For each question, researchers asked ChatGPT to provide references in its response so that the information provided could be verified. However, the chatbot provided references in only eight responses, and each included sources that don’t exist.

    One question asked ChatGPT about whether a drug interaction — or when one medication interferes with the effect of another when taken together — exists between Pfizer‘s Covid antiviral pill Paxlovid and the blood-pressure-lowering medication verapamil.

    ChatGPT indicated that no interactions had been reported for that combination of drugs. In reality, those medications have the potential to excessively lower blood pressure when taken together.  

    “Without knowledge of this interaction, a patient may suffer from an unwanted and preventable side effect,” Grossman said. 

    Grossman noted that U.S. regulators first authorized Paxlovid in December 2021. That’s a few months before the September 2021 data cutoff for the free version of ChatGPT, which means the chatbot has access to limited information on the drug. 

    Still, Grossman called that a concern. Many Paxlovid users may not know the data is out of date, which leaves them vulnerable to receiving inaccurate information from ChatGPT. 

    Another question asked ChatGPT how to convert doses between two different forms of the drug baclofen, which can treat muscle spasms. The first form was intrathecal, or when medication is injected directly into the spine, and the second form was oral. 

    Grossman said her team found that there is no established conversion between the two forms of the drug and it differed in the various published cases they examined. She said it is “not a simple question.” 

    But ChatGPT provided only one method for the dose conversion in response, which was not supported by evidence, along with an example of how to that conversion. Grossman said the example had a serious error: ChatGPT incorrectly displayed the intrathecal dose in milligrams instead of micrograms

    Any health-care professional who follows that example to determine an appropriate dose conversion “would end up with a dose that’s 1,000 times less than it should be,” Grossman said. 

    She added that patients who receive a far smaller dose of the medicine than they should be getting could experience a withdrawal effect, which can involve hallucinations and seizures

    Source link

  • Pfizer to discontinue twice-daily weight loss pill due to high rates of adverse side effects

    Pfizer to discontinue twice-daily weight loss pill due to high rates of adverse side effects

    Pfizer on Friday said it would stop developing the twice-daily version of its experimental weight loss pill after obese patients taking the drug lost significant weight but had trouble tolerating the drug in a mid-stage clinical study

    The drugmaker observed high rates of adverse side effects, which were mostly mild and gastrointestinal, among patients. A significant share of patients also stopped taking the drug.

    “At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies,” the company said.

    But Pfizer said it still plans to release phase two trial data on a once-a-day version of the drug in the first half of 2024, which will “inform a path forward.” The pharmaceutical giant will wait to see that data before deciding whether to start a phase three study on the once-daily pill, which Wall Street views as the more competitive form of the treatment.

    Shares of Pfizer fell 4% in premarket trading Friday after it announced the trial results.

    Still, the data on the twice-daily drug is a blow to Pfizer’s hopes to win a $10 billion slice of the booming weight loss drug market, which CEO Albert Bourla has said could grow to $90 billion. The company is betting on a successful weight loss pill to help it rebound from plummeting demand for its Covid products and a roughly 40% share price drop this year. 

    But investors have been pessimistic about Pfizer’s potential in the weight loss drug space since the company scrapped a different once-daily pill in June and proceeded with the less attractive danuglipron. Now, Friday’s data puts Pfizer even further behind the dominant players in the weight loss drug market, Eli Lilly and Novo Nordisk, which are racing to develop more convenient pill versions of their blockbuster weight loss and diabetes injections. 

    Pfizer’s phase two trial on its twice-daily pill followed around 600 obese adults who did not have Type 2 diabetes. The trial examined the drug’s effect on weight loss after 26 or 32 weeks, at different dosage amounts ranging from 40 milligrams to 200 milligrams.

    Like Novo Nordisk’s Wegovy and Ozempic, Pfizer’s pill works by mimicking a hormone produced in the gut called GLP-1, which signals to the brain when a person is full.

    Pfizer said the trial on danuglipron met the primary goal of demonstrating “statistically significant” reductions in body weight.

    Patients who took the pill twice a day lost 6.9% to 11.7% of their body weight on average at 32 weeks, and from 4.8% to 9.4% at 26 weeks.

    Meanwhile, patients on a placebo gained 1.4% of their body weight at 32 weeks and 0.17% at 26 weeks.

    When adjusting for the difference between the weight gain observed in patients who took the placebo, Pfizer’s twice-daily pill caused 8% to 13% weight loss on average at 32 weeks and 5% to 9.5% at 26 weeks.

    The company said high rates of adverse events were observed among patients in the study, with up to 73% experiencing nausea, up to 47% vomiting and up to 25% experiencing diarrhea. More than 50% of patients across all dose sizes stopped taking the pill, compared to roughly 40% among those on the placebo, according to Pfizer.

    No new safety issues were observed, and danuglipron was not associated with increased liver enzymes like Pfizer’s other discontinued weight loss pill.

    Data from the phase two trial will be presented at a future scientific conference or published in a peer-reviewed journal.

    Wall Street’s expectations

    The tolerability issues align with some analysts’ predictions ahead of the data release. 

    Leerink Partners analyst David Risinger wrote in a Monday note that the proportion of patients who discontinue treatment with Pfizer’s twice-daily danuglipron in the phase two trial would likely be higher than those who stopped taking a once-daily pill from Eli Lilly.

    By comparison, 10% to 21% of patients who took Eli Lilly’s pill, orforglipron, in a mid-stage trial discontinued the treatment at 32 weeks due to adverse side effects, he noted.

    Risinger said that’s likely because danuglipron’s total daily dose is far higher, which may cause more adverse effects. Patients on the highest dose size of Pfizer’s pill took 400 milligrams each day, while those on the highest dosage of Eli Lilly’s drug took 45 milligrams a day.

    Pfizer’s phase-two trial also didn’t allow downtitration, or decreasing the dose of a drug over time once a specific response has been achieved. Eli Lilly’s mid-stage trial on its pill did. 

    There is hope that patients will better tolerate the once-daily version of danuglipron compared to the twice-daily form. Pfizer appears to believe a once-daily version of the drug could lessen gastrointestinal side effects, according to some analysts.

    They pointed to Pfizer’s second-quarter earnings call, when the company’s chief scientific officer, Mikael Dolsten, suggested that a once-daily version may improve a patient’s tolerability of the drug, which could lessen the gastrointestinal side effects “that have been seen as limiting” danuglipron.

    But the effects will be unclear until the mid-stage trial data is released next year.

    Notably, the weight loss caused by twice-daily danuglipron appeared to fall short of analysts’ expectations. 

    Ahead of the data release, several analysts said Pfizer’s twice-daily pill has to be about as effective as Eli Lilly’s once-a-day pill to be competitive. That means at least a 14% to 15% weight loss, Cantor Fitzgerald analyst Louise Chen told CNBC earlier this month.

    Risinger also wrote in October that Pfizer’s danuglipron needs to show weight reduction in the “mid-teens” percentages to be considered competitive with Eli Lilly’s pill. 

    Obese or overweight patients who took 45 milligrams of Eli Lilly’s pill once a day lost up to 14.7% of their body weight, or 34 pounds, after 36 weeks, according to the company’s phase-two trial results.

    Eli Lilly’s results appear consistent with the weight reduction caused by a high-dose oral version of Novo Nordisk’s semaglutide – the active ingredient used in the diabetes drug Ozempic and weight loss treatment Wegovy – but came over a shorter trial period.

    More than 2 in 5 adults have obesity, according to the National Institutes of Health. About 1 in 11 adults have severe obesity.

    Clarification: This story was updated to reflect that some weight-loss data was adjusted to include results from the placebo group.

    Source link

  • CNBC Daily Open: Are things about to get more difficult?

    CNBC Daily Open: Are things about to get more difficult?

    Up from No. 13 in 2022, Minneapolis, Minnesota ranked as the No. 2 most neighborly city in America.

    S. Greg Panosian | E+ | Getty Images

    This report is from today’s CNBC Daily Open, our new, international markets newsletter. CNBC Daily Open brings investors up to speed on everything they need to know, no matter where they are. Like what you see? You can subscribe here.

    What you need to know today

    S&P 500 in correction
    The
    S&P 500 index slipped into correction territory on Friday amid fears of a recession, closing 10.3% lower from this year’s peak on July 31. The Dow Jones Industrial Average closed 1.12% lower, and the Nasdaq Composite held 0.38% higher. Asia-Pacific markets kicked off the week on a mixed note ahead of key economic readings from the region. Japan’s Nikkei 225 fell 1.03% while the Kospi in South Korea was up 0.35%.

    Hey, Big Spender  
    Inflation in September rose but consumer spending came in even stronger than economists expected, numbers from the Commerce Department showed on Friday. The core personal consumption expenditures price index, the Fed’s key inflation measure, was 0.3% higher for the month, which was in line with the Dow Jones estimate. Even though prices picked up, personal spending continued, rising 0.7%, which was better than the 0.5% forecast.

    A potential pause?
    The Federal Reserve is widely seen leaving interest rates unchanged at the end of its two-day policy meeting this week, even as its preferred inflation indicator remains well above its 2% target. Earlier this month, Fed Chair Jerome Powell said “inflation is still too high,” raising expectations that another rate hike may not be entirely out of the picture.

    HSBC’s bumper profit
    HSBC reported quarterly profit after tax of $6.26 billion, up a whopping 235% compared to the $2.66 billion from a year ago quarter. Profit before tax, for the three months ended September, rose by $4.5 billion to $7.7 billion, due to a higher interest rate environment.

    [PRO] This under-the-radar stock is set for an AI boost
    Investors have piled into the likes of NvidiaBaidu and Alibaba as such tech companies have leveraged the use of artificial intelligence. But one portfolio manager says there’s one lesser-known stock that stands out.

    The bottom line

    Markets survived another brutal week and are looking to wrap up an even more tumultuous month, which saw the S&P 500 and Nasdaq indexes slip into correction territory.

    A correction is when an index falls more than 10% (but less than 20%) from its most recent closing high. It’s called a correction because historically the drop often “corrects” and returns prices to their longer-term trend.

    Investors have had to tackle everything from multi-year high Treasury yields, a busy earnings season to multiple inflation readings. A reading on personal consumption expenditures on Friday served as the latest evidence that American consumer spending remained healthy.

    Core PCE rose 0.3% in September and 3.7% year over year, matching estimates from economists polled by Dow Jones. Personal spending increased 0.7%, however, surpassing estimates of 0.5%. PCE is the Federal Reserve’s most preferred inflation metric.

    The reading came ahead of the Fed’s two-day policy meeting this week, at the end of which the U.S. central bank is widely expected to pause on hiking rates.

    Morningstar’s chief U.S. market strategist Dave Sekera says the Fed is done hiking, and forecasts the central bank will start to cut the federal funds rate in the first half of 2024. 

    “As we forecast the rate of economic growth to slow and inflation to moderate, this allows the Fed to move to increasingly more accommodative language in early 2024 to prepare the market in advance for when they decide to begin cutting rates,” Sekera wrote.

    A Fed meeting was by no means the only market-moving event investors were looking at. About 30% of the S&P 500 is scheduled to report earnings this week, among which Apple, McDonald’s and Pfizer will deliver quarterly results.

    And if that wasn’t packed enough, market players will also be chasing the October jobs report due on Friday. It’s expected to show the U.S. economy added 175,000 jobs last month, according to consensus estimates from FactSet. That will follow a blowout 336,000 job additions from the prior month. 

    [ad_2]
    Source link

  • CNBC Daily Open: The perfect storm

    CNBC Daily Open: The perfect storm

    NEW YORK, NEW YORK – JUNE 03: People walk by the New York Stock Exchange (NYSE) at the start of the trading day on June 03, 2022 in New York City. A new jobs report released by the Labor Department this morning shows employers added 390,000 jobs in May. Stocks pointed lower ahead of the opening bell on Friday, putting indexes back into the red for the week. (Photo by Spencer Platt/Getty Images)

    Spencer Platt | Getty Images News | Getty Images

    This report is from today’s CNBC Daily Open, our new, international markets newsletter. CNBC Daily Open brings investors up to speed on everything they need to know, no matter where they are. Like what you see? You can subscribe here.

    What you need to know today

    S&P 500 in correction
    The benchmark 
    S&P 500 index slipped into correction territory on Friday on fears of a recession, closing 10.3% lower from this year’s peak on July 31. The Dow Jones Industrial Average closed 1.12% lower, while the Nasdaq Composite held 0.38% higher. European stocks also ended lower, with the benchmark Stoxx 600 closing down 0.8%.

    Hey, Big Spender  
    Inflation in September rose but consumer spending came in even stronger than economists expected, numbers from the Commerce Department showed on Friday. The core personal consumption expenditures price index, the Fed’s key inflation measure, was 0.3% higher for the month, which was in line with the Dow Jones estimate. Even though prices picked up, personal spending continued, rising 0.7%, which was better than the 0.5% forecast.

    A potential pause?
    The Federal Reserve is widely seen leaving interest rates unchanged at the end of its two-day policy meeting this week, even as its preferred inflation indicator remains well above its 2% target. Earlier this month, Fed Chair Jerome Powell said “inflation is still too high,” raising expectations that another rate hike may not be entirely out of the picture.

    One million share sale
    JPMorgan Chase CEO Jamie Dimon is set to sell one million shares of the bank in 2024. The plan raised concerns that Dimon could be contemplating retirement. Still, a spokesperson for the country’s biggest lender said the move wasn’t related to a succession plan, and that Dimon has “no current plans” for another sale.

    [PRO] The S&P 500 correction is good news
    The stock market tumbled into correction territory this week, sparking fears of more turmoil is ahead. But for disciples of Warren Buffett, a 10% drawdown for the the S&P 500 shouldn’t matter.   

    The bottom line

    Markets survived another brutal week and are looking to wrap up an even more tumultuous month, which saw the S&P 500 and Nasdaq indexes slip into correction territory.

    A correction is when an index falls more than 10% (but less than 20%) from its most recent closing high. It’s called a correction because historically the drop often “corrects” and returns prices to their longer-term trend.

    Investors have had to tackle everything from multi-year high Treasury yields, a busy earnings season to multiple inflation readings. A reading on personal consumption expenditures on Friday served as the latest evidence that American consumer spending remained healthy.

    Core PCE rose 0.3% in September and 3.7% year over year, matching estimates from economists polled by Dow Jones. Personal spending increased 0.7%, however, surpassing estimates of 0.5%. PCE is the Federal Reserve’s most preferred inflation metric.

    The reading came ahead of the Fed’s two-day policy meeting this week, at the end of which the U.S. central bank is widely expected to pause on hiking rates.

    Morningstar’s chief U.S. market strategist Dave Sekera says the Fed is done hiking, and forecasts the central bank will start to cut the federal funds rate in the first half of 2024. 

    “As we forecast the rate of economic growth to slow and inflation to moderate, this allows the Fed to move to increasingly more accommodative language in early 2024 to prepare the market in advance for when they decide to begin cutting rates,” Sekera wrote.

    A Fed meeting was by no means the only market-moving event investors were looking at. About 30% of the S&P 500 is scheduled to report earnings this week, among which Apple, McDonald’s and Pfizer will deliver quarterly results.

    And if that wasn’t packed enough, market players will also be chasing the October jobs report due on Friday. It’s expected to show the U.S. economy added 175,000 jobs last month, according to consensus estimates from FactSet. That will follow a blowout 336,000 job additions from the prior month. 

    [ad_2]
    Source link

  • Jamie Dimon’s stock-moving trades show why investors should track CEOs’ buying and selling

    Jamie Dimon’s stock-moving trades show why investors should track CEOs’ buying and selling

    Jamie Dimon, chairman and chief executive officer of JPMorgan Chase & Co. says the new U.K. government should be “given the benefit of the doubt.”

    Al Drago | Bloomberg | Getty Images

    For the first time in nearly two decades running JPMorgan Chase, CEO Jamie Dimon will voluntarily sell stock in the bank.

    The disclosure, in a securities filing Friday, detailed next year’s planned sales — pressuring JPMorgan (JPM) shares and the Dow Jones Industrial Average and highlighting why tracking trades made by executives involving the companies they lead should be an important part of every investor’s homework.

    Dimon is setting up the trades through a predetermined plan that executives at publicly traded companies use to protect against insider trading accusations. It will mark the first time that the 67-year-old CEO has offloaded shares of JPMorgan for non-technical reasons, such as exercising options.  

    The planned sales – amounting to roughly 12% of the JPMorgan stock owned by Dimon and his family – are being done for tax planning and personal wealth diversification reasons, the bank said. Both are common reasons for executives to sell stock in their firms. The bank also said Dimon continues to believe JPMorgan’s prospects are “very strong,” and his planned trades are not related in any way to succession. Such sales are often seen when CEOs get close to retirement.

    As you can see, making sense of insider transactions can sometimes be a tall task.

    When they buy, it’s generally seen as an encouraging sign by Wall Street — and there is, perhaps, no better example of this than another move by Dimon in 2016, when he purchased JPMorgan stock.

    Fears of a weakening global economy sent stocks into a tailspin in early 2016, driving shares of JPMorgan down nearly 20% and the S&P 500 down more than 10% at their lows.

    But that weakness didn’t last long.

    The trajectory of the market changed just six weeks into the new year. That’s when Dimon disclosed — after the closing bell on Feb. 11, 2016 — that he bought 500,000 shares of the bank, worth about $26 million at the time.

    Dimon’s stock purchase, intended to show confidence in the financial sector, has become legendary on Wall Street. It ultimately coincided with — or perhaps was the reason for — the closing lows for not only shares of JPMorgan in 2016 but also the S&P 500 overall.

    Jim Cramer has since dubbed Feb. 11, 2016: “The Jamie Dimon Bottom.” JPMorgan finished up 30% that year, while the S&P 500 ended more than 9% higher — both huge turnarounds.

    While executive stock sales — such as Dimon’s planned transactions next year — are not universally red flags, they can get complicated.

    Source link

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

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

    Pfizer Inc.
    PFE,
    -1.73%

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

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

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

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

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

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

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

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

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

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

    Source link

  • 5 things to know about the new COVID-19 vaccine

    5 things to know about the new COVID-19 vaccine

    It may be time to get your COVID-19 vaccine again.

    There’s a new booster that’s coming out to guard against the virus. The Centers for Disease Control and Prevention said Tuesday that it was recommending the vaccine, which is being produced in versions by Moderna
    MRNA,
    +3.18%

    and Pfizer
    PFE,
    -0.20%

    -BioNTech
    BNTX,
    -2.06%
    ,
    for people 6 months of age and older.

    Here are answers to some common questions about the shot — and what you may need to know before you receive it.

    Why are we seeing another booster?

    Boosters are all about maintaining protection against the virus as new COVID-19 variants emerge. The CDC said: “The updated vaccines should work well against currently circulating variants of COVID-19, including BA.2.86, and continue to be the best way to protect yourself against severe disease.” The CDC also noted that “protection from COVID-19 vaccines and infection decline over time. An updated COVID-19 vaccine provides enhanced protection against the variants currently responsible for most hospitalizations in the United States.”

    So, everyone who is 6 months or older should receive it?

    That’s the CDC’s recommendation, but not everyone sees this booster as a firm requirement, depending on various medical and other factors.

    Dr. Paul A. Offit, a pediatrician with the Children’s Hospital of Philadelphia who specializes in infectious diseases, told MarketWatch that the new vaccine is a must for some who are at higher risk for developing serious illness, such as people who are over 75, people who have certain health problems (including diabetes, obesity or chronic lung or heart disease) and people who are immune compromised.

    And what about the others? Offit said it can be a case of “low risk, low reward.” Meaning there’s little harm in getting the booster and it may buy “a few months protection against mild disease,” Offit said. But he stops short of saying the booster is an absolute necessity for such people.

    Still, CDC director Dr. Mandy K. Cohen counters such an argument. In a column for the New York Times, Cohen noted that all the members of her family, including her 9- and 11-year-old daughters, would be getting the booster. “Some viruses…change over time. This coronavirus is one of them. It finds ways to evade our immune systems by constantly evolving. That’s why our vaccines need to be updated to match the changed virus,” Cohen explained.

    What if you recently had COVID? Or have just gotten the previous COVID booster?

    Offit said you should wait at least two months — and possibly as long as four months — before receiving the new vaccine.

    The CDC said, “You should get a COVID-19 vaccine even if you already had COVID-19,” adding “you may consider delaying your next vaccine by 3 months from when your [COVID] symptoms started or, if you had no symptoms, when you received a positive test.”

    When and where can you get the new booster?

    The CDC said the vaccine “will be available by the end of this week at most places you would normally go to get your vaccines.”

    How much will it cost?

    The new shots are expected to have list prices of $110 to $130, but the CDC said, “Most Americans can still get a COVID-19 vaccine for free.” That is, most health-insurance plans will cover the cost.

    As for those without insurance, the CDC said there are still plenty of free options, including programs run by local health centers and health departments as well as pharmacies participating in the CDC’s Bridge Access Program. For more information about where to get the booster, go to Vaccines.gov.

    Source link

  • New Covid vaccines could reach Americans as soon as Thursday – here’s what you need to know

    New Covid vaccines could reach Americans as soon as Thursday – here’s what you need to know

    A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine’s Southern Cooking in Chatham, Illinois, Dec. 30, 2021.

    Brian Cassella | Tribune News Service | Getty Images

    A new round of Covid vaccines is finally here in the U.S.

    The Centers for Disease Control and Prevention cleared single-strain shots from Pfizer and Moderna on Tuesday, following approvals from the Food and Drug Administration on Monday. Those mRNA vaccines are designed to target a relatively new omicron subvariant called XBB.1.5. 

    The first doses of the new shots will be available at some pharmacies and other vaccine distribution locations within 48 hours of the CDC’s recommendation, agency staff said Tuesday during a meeting of independent advisors to the CDC. That means jabs could reach Americans as soon as Thursday.

    Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up. 

    The debut of the new shots comes after Covid hospitalizations increased for the seventh straight week in the U.S., hitting 17,418 as of the week ending Aug. 26, according to the latest data from the CDC. That number remains below the surge the nation saw in the summer of 2022. 

    But the recent uptick is raising concerns about how much traction Covid will gain in the coming fall and winter months, when respiratory viruses typically spread at higher levels and people spend more time indoors. 

    Public health officials and health experts hope the arrival of new vaccines will help the U.S. avoid another severe Covid wave and “tripledemic” of Covid, the flu and respiratory syncytial virus, which inundated hospitals last winter. The Biden administration said last month that it will encourage eligible Americans to receive an updated Covid vaccine alongside an annual flu shot and an RSV jab approved for older adults or mothers. 

    Roughly 42% of Americans surveyed by the CDC in August said they “definitely will” or “probably will” get a Covid vaccine this fall, Dr. Megan Wallace, a CDC epidemiologist, said during the advisory meeting.

    Here’s everything you need to know about the updated Covid vaccines, from where to find them, whether you can get them for free and when to get them.

    Who should get the updated shots?

    The CDC on Tuesday recommended that all Americans ages six months and older get the new shots. The agency’s website outlines more specific guidelines for staying up to date on Covid vaccines, which differ depending on age group and risk level.

    The CDC said that everyone ages 6 and older should get at least one dose of an updated mRNA vaccine this year, regardless of whether they’ve received any of the original Covid shots.

    People ages 65 years and older may get an additional dose of an new Covid vaccine four or more months after their first new shot.

    Children 6 months through 5 years of age who are getting their vaccines for the first time should complete their primary series with two doses of an updated Moderna shot or three doses of a new Pfizer jab, according to the CDC. If children previously received prior vaccines, the CDC has different recommendations for how many updated doses to get.

    People who are moderately or severely immunocompromised should get one or more doses of a new shot, depending on their vaccination history. Those patients are at higher risk of getting severely sick from Covid, according to the CDC.

    Where can you get a new shot? 

    A sign advertises COVID-19 (coronavirus) vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, August 14, 2023.

    Brian Snyder | Reuters

    The updated shots will soon be available to eligible people at pharmacies, health clinics and community centers, among other vaccine distribution sites. Those locations will stop offering last year’s bivalent boosters, which are no longer authorized for use in the U.S.

    Several retail pharmacy chains told CNBC that they will start offering appointments for the new shots shortly after the CDC recommendation: 

    • Walgreens will allow people to schedule appointments for the new shots within 24 hours after the CDC recommendation, “with available appointments starting that week,” a company spokesperson said. People can schedule those appointments through the Walgreens website or app, or by calling 1-800-WALGREENS. The company will add more appointments on a rolling basis. 
    • CVS Pharmacy locations will start receiving supply of the updated vaccines “later this week,” a company spokesperson said. Pharmacies will receive more doses on a rolling basis and appointments will be available to schedule on the CVS website and CVS Pharmacy app. 
    • Albertsons expects its 1,700 pharmacies to begin administering the updated shots “as early as Friday,” a spokesperson said. The company’s pharmacies span stores like Safeway, Vons, Jewel-Osco, Shaw’s, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Amigos and Market Street. People can view and schedule appointments on the Albertsons website or app.
    • Kroger will allow people to walk in or schedule appointments to get the new Covid vaccine at the company’s pharmacies or clinics. 

    Americans will soon be able to use the federal website vaccines.gov to find other locations offering the updated Covid shots, according to a CDC spokesperson. The agency is still “unsure of the exact timing” for when the site will be updated to include a search filter for the new vaccines, the spokesperson added.

    Later this week, uninsured and underinsured people will also be able to use the site to find locations offering the new vaccines for free through the Bridge Access Program. Around 85% of uninsured Americans live within five miles of a location participating in that program, according to the CDC’s Twentyman.

    Will the updated shots be free? 

    There are slight changes to how Covid vaccines are covered in the U.S this year. But the federal government aims to ensure all people can still receive them for free.

    The U.S. Covid public health emergency ended in May, which means the federal government is shifting vaccine distribution to the private market this fall. 

    Manufacturers will sell their updated shots directly to health-care providers at more than $120 per dose. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free. 

    All three vaccine manufacturers shared the list prices of their new vaccines during the advisory meeting on Tuesday: Moderna’s shot is $129 per dose, Pfizer’s is $120 per dose and Novavax’s jab is $130 per dose.

    Private insurers will provide the vaccines to beneficiaries at no cost. Government payers such as Medicare and Medicaid will also cover the new shots with no co-payments.

    For the estimated 30 million uninsured Americans, the Biden administration aims to offer shots for free through its “Bridge Access Program” at health centers, clinics and pharmacies across the U.S.

    “We’re setting up the Bridge Access Program as a temporary solution to maintain access to Covid-19 vaccines, specifically in the short term,” said Dr. Evelyn Twentyman, a CDC medical officer, during the advisory meeting on Tuesday.

    The program will begin as soon as vaccines have reached participating providers, which include CVS and Walgreens, according to Twentyman. Free vaccines through the program will not be available after December 2024.

    The CDC’s Vaccines For Children program will also provide free Covid shots to children whose families or caretakers can’t afford them after the shots move to the commercial market.

    How should you time your new Covid vaccine?

    People should talk to their doctors about when to get an updated shot because it largely depends on individual risk levels and situations, health experts told CNBC.

    Individuals at higher risk of getting severely ill from Covid, including older adults and those who are immunocompromised, should get a new vaccine as soon as they can, according to Dr. Taison Bell, an associate professor of medicine at the University of Virginia Health.

    Younger, healthy adults can choose to wait so that immunity from the vaccine kicks in around the winter holidays or a specific event where they may be more exposed to Covid, Bell added. 

    He said Covid vaccines take around two weeks to produce an immune response against the virus, and that protection tends to last for a few months. So if a patient has upcoming travel or a large gathering to attend in mid-October, they could plan to get the new shot at the beginning of that month. 

    People recently vaccinated should wait two months before getting an updated vaccine, according to the CDC’s Wallace. Spacing out shots will allow people to maximize the protection they get from each shot.

    Those who have been recently infected can wait three months, but they can also get it “as soon as they’re feeling better,” Wallace added.

    “You have the option to wait for three months, but it is not a requirement,” she said during the advisory meeting.

    How effective are the updated shots? 

    The new shots from Pfizer, Moderna and Novavax are designed to target XBB.1.5, which has since been overtaken in prevalence by other, related strains. It only accounted for around 3% of all U.S. cases as of Sept. 2, according to the latest data from the CDC. 

    All three companies said that their updated vaccines produced robust immune responses against the now-dominant EG.5, or “Eris,” variant in trials. That omicron strain is closely related to XBB.1.5 and accounted for 21.5% of all U.S. cases as of Sept. 2, according to the CDC.

    They also presented preliminary trial data in June indicating that their jabs will protect against all other XBB strains. Collectively, those variants make up more than 90% of all cases in the U.S., according to CDC microbiologist Dr. Natalie Thornburg.

    “So the take-home message is that currently, almost all circulating lineages of viruses are XBB variants,” Thornburg said during the advisory meeting Tuesday.

    Both Pfizer and Moderna have also released initial trial data indicating that their new shots were effective against another omicron variant called BA.2.86. Novavax on Monday said it was still testing its vaccine against that strain.

    BA.2.86 has been detected in small numbers across the U.S., but health officials worldwide are watching it closely due to its high number of mutations. 

    Following the approvals on Monday, the FDA said the “extent” of protection provided by the updated shots from Pfizer and Moderna against currently circulating variants like EG.5 and BA.2.86 “appears to be of a similar magnitude” to the protection provided by previous Covid vaccines against prior variants of the virus. 

    “This suggests that the vaccines are a good match for protecting against the currently circulating Covid-19 variants,” the agency said in a release

    The FDA also said it is confident in the safety of the updated vaccines, noting that the benefits of the shots for people 6 months and older outweigh their risks.

    Source link

  • CDC recommends updated COVID shots for people 6 months of age and older

    CDC recommends updated COVID shots for people 6 months of age and older

    The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.

    Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc.
    MRNA,
    -0.53%

    and Pfizer Inc.
    PFE,
    +0.62%

    -BioNTech
    BNTX,
    -1.97%

    should become available later this week.

    “We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

    The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.

    The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.

    The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines. 

    The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.

    Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.

    Under the Bridge Access program, CVS Health Corp.
    CVS,
    +2.57%

    will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc.
    WBA,
    +1.35%

    will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.

    Source link

  • FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

    FDA approves updated Covid vaccines from Pfizer and Moderna as hospitalizations rise

    A health-care worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, Jan. 26, 2022.

    Vanessa Leroy | Bloomberg | Getty Images

    The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna, putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise.

    The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for children 6 months through 11 years old, according to an FDA release.

    The updated vaccines from Pfizer and Moderna won’t be available to Americans just yet.

    A CDC advisory panel is scheduled to meet Tuesday to vote on a recommendation on the use of those jabs. After the CDC director signs off on those recommendations, the shots can be administered at pharmacies, health clinics and other vaccine distribution sites.

    The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September

    The FDA did not announce a decision Monday on an updated Covid shot from Novavax, but the company said in a statement that the agency is still reviewing its vaccine. Shares of Novavax closed nearly 13% lower Monday following the approval of the other updated jabs.

    Novavax’s vaccine uses protein-based technology, a decades-old method deployed in routine vaccinations against hepatitis B and shingles. Meanwhile, Pfizer’s and Moderna’s shots use messenger RNA, which teaches cells how to make proteins that trigger an immune response against Covid.

    The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations.

    While the shots do not target the variants dominant now, the vaccine makers have said the shots will still offer protection against those strains as children return to school and the weather gets cooler.

    “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities,” Pfizer CEO Albert Bourla said in a release following the approval.

    Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.

    Hospitalizations have increased for seven straight weeks, and rose more than 15% for the week ending Aug. 26, to 17,418, according to the latest data from the CDC. But that number remains below the surge the nation saw in summer 2022, when hospitalizations climbed to more than 40,000.

    The uptick is fueled by newer — but closely related to XBB.1.5 — strains of the virus such as EG.5, or Eris. That omicron strain accounted for 21.5% of all cases as of Sept. 2, according to the CDC. 

    Meanwhile, XBB.1.5 is declining in the U.S., the CDC said. 

    A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pennsylvania, U.S, on Tuesday, Apr. 5, 2022.

    Hannah Beier | Bloomberg | Getty Images

    Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris.

    Both Pfizer and Moderna have also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are watching closely.

    “The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA said in the release Monday.

    The agency noted that last year’s Covid boosters from Pfizer and Moderna are no longer authorized in the U.S.

    The upcoming vaccine rollout will be the first since the end of the U.S. Covid public health emergency, which expired in May. 

    The end of that declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated shots directly to health-care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free. 

    Private insurers and government payers such as Medicare, which cover the vast majority of Americans, are expected to provide the vaccines to people for no fee. Federal efforts such as the Biden administration’s Bridge Access Program aim to provide free Covid shots to uninsured people.

    The Biden administration will urge Americans to receive an updated Covid shot this fall, White House press secretary Karine Jean-Pierre said last week.

    “Vaccinations against Covid-19 remains the safest protection for avoiding hospitalization, long-term health outcomes, and death,” Jean-Pierre said during a briefing.

    But it’s unclear how many Americans will actually roll up their sleeves to get another shot in the coming months.

    Only around 17% of the U.S. population — around 56 million people — have received Pfizer’s and Moderna’s latest boosters since they were approved in September 2022, according to the CDC. 

    Source link

  • As the new Eris Covid variant spreads across the world, here’s what we know so far

    As the new Eris Covid variant spreads across the world, here’s what we know so far

    An illustrative image of a person holding a medical syringe and a vaccine vial in front of the Pfizer logo displayed on a screen.

    Nurphoto | Nurphoto | Getty Images

    The World Health Organization is monitoring a new strain of Covid-19 called EG.5, or “Eris,” that accounts for a growing share of cases in countries including China and the United States.

    The WHO has designated it a “variant of interest,” meaning it will be monitored for mutations that could make it more severe.

    Based on current evidence, the WHO says it presents a low public health risk at a global level, in-line with other variants currently in circulation. In May, the WHO more broadly said Covid-19 was now “an established and ongoing health issue which no longer constitutes a public health emergency of international concern.”

    Symptoms and spread

    Based on sequencing information submitted to the Global Initiative on Sharing All Influenza Data (GISAID) as of Aug. 7, the largest portion of EG.5 cases were identified in China, followed by the U.S., South Korea, Japan and Canada.

    It was also identified in Australia, Singapore, the U.K., France, Portugal and Spain.

    According to the Centers for Disease Control and Prevention, EG.5 is now the dominant strain in the U.S., accounting for 17.3% of cases as of the week ending Aug. 5.

    Vaccine reformulations

    Source link

  • Earnings playbook: How to trade some of the biggest reports this week, including Apple

    Earnings playbook: How to trade some of the biggest reports this week, including Apple

    Source link

  • Stocks making the biggest moves premarket: Intel, Roku, Procter & Gamble and more

    Stocks making the biggest moves premarket: Intel, Roku, Procter & Gamble and more

    Signage outside Intel headquarters in Santa Clara, California, on Monday, Jan. 30, 2023.

    David Paul Morris | Bloomberg | Getty Images

    Check out the companies making headlines before the bell.

    Intel — Shares popped 6.7% after the chipmaker posted better-than-expected second-quarter results and a return to profitability after two consecutive losing periods. Intel’s forecast for the third quarter also came in above analyst expectations. The company reported adjusted earnings of 13 cents a share on revenues of $12.95 billion.

    Roku — The streaming stock rallied nearly 10% after reporting a narrower-than-expected loss for the second quarter. Roku reported a loss of 76 cents a share and revenues of $847 million. Analysts polled by Refinitiv had anticipated a loss of $1.26 per share and $775 million in revenue.

    Biogen — Biogen shares moved slightly lower after the biotechnology company said it’s acquiring Reata Pharmaceuticals for $172.50 per share, in a cash deal valued at about $7.3 billion. Shares of Reata soared more than 51% on the news.

    Procter & Gamble — The consumer giant saw shares rise more than 1% in premarket trading after the company reported quarterly earnings and revenue that beat analysts’ expectations. However, P&G released a gloomy outlook for its fiscal 2024 sales that fell short of Wall Street’s estimates.

    Exxon Mobil — Shares moved slightly lower after the oil stock posted mixed second-quarter results. The company reported earnings of $1.94 a share, excluding items, that fell short of the $2.01 expected by analysts, per Refinitiv. Revenues came in at $82.91 billion, above the expected $80.19 billion.

    Chevron — The oil stock lost nearly 1% even after reporting a beat on the top and bottom lines for the second quarter. Earnings fell from a year ago due to a drop in oil prices.

    First Solar – Shares soared 12% after the solar company posted earnings per share of $1.59 on revenue of $811 million for the second quarter. Those results beat Wall Street expectations of 96 cents per share on revenue of $721 million, according to Refinitiv. The company also announced plans to invest up to $1.1 billion to build a fifth manufacturing facility in the United States.

    Enphase Energy – Shares of Enphase dropped more than 15% after the company posted second-quarter revenue Thursday of $711 million that fell short of analyst estimates of $722 million, according to Refinitiv. The stock also faced a wave of downgrades Friday morning from Deutsche Bank, Wells Fargo and Roth MKM.

    Sweetgreen – Shares of the salad chain slid more than 13% after the company posted weak sales that missed Wall Street expectations in the second quarter and a net loss of $27.3 million, or 24 cents per share. Sweetgreen did say it’s aiming to turn a profit for the first time by 2024.

    Ford Motor – The automaker said adoption of electric vehicles is going more slowly than the company forecast and that it expects to lose $4.5 billion on the EV business this year, widening losses from roughly $3 billion a year earlier. Otherwise, Ford posted strong quarterly earnings that beat Wall Street expectations and raised its full-year guidance. Shares were flat in premarket trading.

    Juniper Networks — Shares of the technology company fell 8% after Juniper’s third-quarter guidance came in lighter than expected. The company said it expects earnings per share between 49 cents and 59 cents, with revenue between $1.34 billion and $1.44 billion. Analysts had penciled in 62 cents per share and $1.48 billion of revenue. The company’s second-quarter results did come in slightly above expectations.

    AstraZeneca — U.S. listed shares of the drugmaker added more than 5% before the bell. The U.K.-based company reported second-quarter earnings of $2.15 per share on $11.42 billion in revenue. That surpassed the EPS of $1.95 expected by analysts polled by Refinitiv on revenues of $11.03 billion. AstraZeneca also said it would buy a portfolio of preclinical rare disease gene therapies from Pfizer for up to $1 billion.

    Xpeng — The Chinese electric vehicle stock jumped more than 6% in the premarket. Jefferies upgraded shares to a buy from a hold, citing Xpeng’s joint development plan with Volkswagen

    New York Community Bancorp — The regional bank stock rose about 2% before the bell after JPMorgan upgraded New York Community Bancorp to an overweight rating from neutral. The Wall Street firm called the company a “massive market share taker” in its upgrade.

    Mondelez International — Mondelez International added 2.7% before the bell on strong second-quarter results. The snack maker on Thursday reported earnings of 76 cents a share, excluding items, on $8.51 billion in revenue. Analysts polled by Refinitiv had estimated EPS of 69 cents and revenues of $8.21 billion.

    — CNBC’s Tanaya Macheel, Yun Li and Jesse Pound contributed reporting

    Source link

  • Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024

    Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024

    A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, on Wednesday, Jan. 26, 2022.

    Vanessa Leroy | Bloomberg | Getty Images

    The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government’s supply of shots runs out this fall.

    Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments.

    The Health and Human Services Department also is hoping that vaccine makers will donate shots to pharmacies as part of the program.

    There are between 25 to 30 million uninsured adults in the United States and other Americans whose insurance will not cover free Covid products this fall, according to the federal Centers for Disease Control and Prevention.

    Currently, the government has an inventory of vaccines purchased from three manufacturers, Pfizer, Moderna and Novavax, and those companies do not sell the shots to health-care providers.

    In the fall, the companies will begin selling shots directly to health providers, and the government’s supply is expected to run out.

    The Health and Human Services Department in April first announced the Bridge Access Program, but had not said when the program would stop providing shots for free to the uninsured until Thursday.

     The program reflects a broad shift on the pandemic’s effects worldwide. As Covid cases and deaths have dropped to new lows, governments have rolled back stringent health mandates like masking and social distancing, and the rate at which people get Covid vaccines has slowed to a crawl over the past year.

    Earlier this year, the World Health Organization declared an end to the global Covid public health emergency earlier this year. In May, HHS declared an end to the emergency in the United States.

    Source link