The decision is another win for the White House in a bitter legal fight with several drugmakers over the price talks. The ruling also weakens the pharmaceutical industry’s strategy of seeking split decisions in lower courts scattered across the U.S., which could escalate the issue to the Supreme Court.
Medicare drug-price negotiations are a key policy under President Joe Biden’s Inflation Reduction Act that aims to make costly medications more affordable for seniors. In doing so, it could take a bite out of drugmakers’ profits. Final negotiated prices for the first round of drugs subject to the talks, which includes one each from J&J and Bristol Myers, will go into effect in 2026.
J&J and Bristol Myers Squibb did not immediately respond to requests for comment on the ruling.
In separate lawsuits, the drugmakers argued that the negotiations are an unconstitutional confiscation of their drugs by the government and a violation of their right to freedom of speech. They also argued that the talks are an unconstitutional condition to participate in the Medicaid and Medicare programs.
But Judge Zahid Quraishi of the District of New Jersey wrote in a 26-page opinion that participation in the price talks and Medicare and Medicaid markets is voluntary.
The negotiations don’t require drugmakers to “set aside, keep or otherwise reserve any of their drugs” for the use of the government or Medicare beneficiaries, he wrote. Quraishi added the talks don’t force manufacturers to physically transmit or transport drugs at a new negotiated price.
“Selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make [J&J and Bristol Myers Squibb’s] decision to participate any less voluntary,” Quraishi wrote. “For the reasons provided, the Court concludes that the Program does not result in a physical taking nor direct appropriation” of medications from the two drugmakers.
J&J, Bristol Myers Squibb, Novo Nordisk and Novartis presented their oral arguments before Quraishi during the same hearing in March.
That same month, a federal judge in Delaware rejected AstraZeneca’s separate lawsuit challenging the negotiations. In Texas, a third federal judge tossed a separate lawsuit in February.
A federal judge in Ohio also issued a ruling in September denying a preliminary injunction sought by the Chamber of Commerce, one of the largest lobbying groups in the country, which aimed to block the price talks before Oct. 1.
Boxes of Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024.
Hollie Adams | Reuters
Think a friend or colleague should be getting this newsletter? Share this link with them to sign up.
Good afternoon! Drug shortages in the U.S. are at a record high, leaving countless patients in limbo.
A total of 323 drugs were in shortage in the first quarter of this year, up from the previous high of 320 in 2014, according to data published last week by the American Society of Health-System Pharmacists and the University of Utah Drug Information Service. That’s the most medicines since the groups began tracking shortages in 2001.
So, which drugs do the shortfalls affect?
Supplies are low for everything from lower doses of Novo Nordisk’s blockbuster weight loss drug Wegovy, certain doses of Eli Lilly’s popular diabetes injection and weight loss counterpart Zepbound, to key cancer treatments and common antibiotics. Many of them are generic medications, which make up a majority of Americans’ prescriptions.
“All drug classes are vulnerable to shortages,” Paul Abramowitz, CEO of the American Society of Health-System Pharmacists, or ASHP, wrote in a blog post on Thursday.
But he said “some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas.” Ongoing scarcityof ADHD medications “also remain a serious challenge for clinicians and patients,” Abramowitz added.
The drug shortage database maintained by the two organizations is based on voluntary reports from practitioners, patients and others. The figures are confirmed with drugmakers. This list often includes more drugs than the number the Food and Drug Administration considers to be in shortage.
It’s unclear how many patients are impacted by the current drug shortages. But the average shortage from 2016 to 2020 affected at least half a million patients, many of whom are older adults, according to an analysis the Department of Health and Human Services shared with Congress in May.
The shortages can create serious problems.
Margot Wood, an Oregon-based author of the book Fresh, said intermittent shortages of ADHD medications have disrupted her daily life for roughly a year and a half. Wood said she can generally function without the drugs, but noted that every task is “much more complicated and difficult” and “takes three times as long” to do.
“I need them not just for work, but also for my relationships, being a mom, in my hobbies and things and just keeping up with my day-to-day life,” Wood told CNBC.
While patients in some states can scour different pharmacies for the medication they need, Wood said there isn’t much she can do in Oregon. That’s because Oregon considers ADHD medications controlled substances, meaning Wood can only fill her prescription at her designated pharmacy.
When her medication does go back in stock, Wood said she often rations her supply to prepare for potential shortages in the future. She added it is “frustrating” that the reason behind the shortages isn’t clear to patients and even some pharmacists.
JB Reed | Bloomberg | Getty Images
So, what exactly is driving drug shortages? And how can the issue be fixed?
Around 60% of drug manufacturers did not disclose the factors behind the scarcity of medications, according to the new data from ASHP and the University of Utah Drug Information Service.
Some drugmakers said demand has outstripped supply, which has been the case with buzzy weight loss and diabetes medications. Others said manufacturing and quality problems, such as supply chain gaps, played a role.
But the Biden administration has suggested a deeper issue may cause shortages, particularly of generic drugs.
In February, the Federal Trade Commission and HHS said they are examining the role that drug wholesalers and companies that purchase medicines for U.S. health-care providers play in those shortages. The agencies will determine whether those middlemen have misused their market power to cut the prices of generic drugs to the point that manufacturers can’t profit and have to stop production, and rival suppliers are discouraged from competing in the generic drug market.
The Biden administration has taken other steps to tackledrug shortages. Last week, HHS outlined policy recommendations to help prevent supply deficiencies and mitigate vulnerabilities.
That includes collaborations with drugmakers and hospitals that aim to make the drug market more transparent and encourage companies to invest in resilient and diverse drug supply chains.
Abramowitz on Thursday said some of the recommendations align with those of ASHP, but the organization has “serious concerns” about certain parts of the plan. He pointed to a proposal that could penalize hospitals that lack the resources to comply with the recommendations.
“Much work remains to be done at the federal level to fix the root causes of drug shortages,” Abramowitz wrote.
UnitedHealth reveals financial impact of Change Healthcare cyberattack
The corporate logo of the UnitedHealth Group appears on the side of one of their office buildings in Santa Ana, California, U.S., April 13, 2020.
Mike Blake | Reuters
All eyes were on UnitedHealth Group on Tuesday morning as the company reported first-quarter results that gave investors a window into the cost of the Change Healthcare cyberattack.
UnitedHealth said its earnings took a 74 cents per share hit from the breach in the first quarter, and it expects the full-year impact to be between $1.15 and $1.35 per share.
“The core story at UnitedHealth Group remains our colleagues delivering improved experiences for the people we serve and driving balanced growth even while swiftly and effectively addressing the attack on Change Healthcare,” UnitedHealth CEO Andrew Witty said in a release.
UnitedHealth, which owns Change Healthcare, discovered that a cyber threat actor had breached part of the unit’s information technology systems in February. The company had to shut off the affected systems, temporarily leaving many doctors without a way to fill prescriptions or get paid for their services. Many are still contending with the fallout.
Shares of UnitedHealth were up more than 5% as of 11 a.m. ET on Tuesday.
UnitedHealth’s Optum acquired Change Healthcare for $13 billion in 2022. The merger was controversial, as groups like the American Medical Association claimed the union could stifle competition. The Justice Department sued to block the acquisition that year, but the deal eventually went through.
In the company’s quarterly call with investors Tuesday, Witty said UnitedHealth’s ownership of Change Healthcare is “important for the country.” He said the attack likely would have happened either way, but if UnitedHealth did not own the company, Change Healthcare would not have had the resources or support necessary to bring its systems back online.
“We’re going to bring it back much stronger than it was before,” Witty said.
UnitedHealth CFO John Rex said during the call that the company’s insurance unit, UnitedHealthcare, is “pretty much back to normal in terms of claim submission activity” in the wake of the cyberattack. He said claims are flowing as expected.
It is still not clear exactly how the attack happened, or what data was compromised.
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
It might be time to buy gold. The Federal Reserve is poised to cuts interest rates this year and history shows that’s pushed up precious metal prices, according to Bernstein analyst Bob Brackett. “The logic is simple,” Brackett told clients in a note Wednesday. When the expected real interest rates fall, investors buy gold because because owning dollars becomes less attractive, the analyst wrote. Spot gold prices were last trading at $2,052.89 an ounce and were mostly flat in January as traders wait for the central bank’s rate decision and, more importantly, the statement regarding the future outlook, later this afternoon. The pattern of gold rising on lower rates is supported by 50 years of history, with the precious metal rallying in seven of the nine previous rate cut cycles, according to Brackett. The two exceptions to the rule were 1974 and 1981 when the precious metal did not rally after rate cuts, largely because the 10-year Treasury yield didn’t fall, Brackett told clients. “Learning from the last 9 rate cut cycles, especially the 1974 and 1981 cycles, we conclude that rate cut cycle is positive for gold, as long as the Fed successfully brings rates down” for longer-dated Treasurys, Brackett said. “When the Fed fails to bring LT rates down, USD is likely to gain strength (and work against gold prices),” the analyst pointed out. Looking back at the 95 rate cuts since 1971, buying gold delivered weighted average returns of 2.48% in one month and up to 6.53% in a year, according to Brackett. Purchasing the precious metal ahead of a rate cut cycle is correlated with a slightly higher return of 6 basis points, or 0.06%. One major risk to Bernstein’s bullish thesis would come if the U.S. economy continues to show robust growth and low unemployment, Brackett told clients. Traders are already moderating expectations for rate cuts, though gold has held steady so far, Brackett said. Indeed, respondents to CNBC’s recent Fed survey now anticipate the central bank will cut rates fewer times this year and start the cycle later. “In general, the anticipation of more rate cuts often lead to a positive sentiment on gold and mining equities, while the expectation of fewer rate cuts tends to be negative,” Brackett said. Still, it is reasonable to expect that the U.S. economy will slow this year with real rates at the highest level since 2010, which would justify Fed cuts, according to Brackett. “Gold in the long term is generally observed to benefit from rate cuts,” the analyst said. @GC.1 3M mountain April gold futures over the past three months. — CNBC’s Michael Bloom contributed reporting
Every weekday the CNBC Investing Club with Jim Cramer holds a “Morning Meeting” livestream at 10:20 a.m. ET. Here’s a recap of Tuesday’s key moments. 1. U.S. stocks were mixed Tuesday as investors prepared for Big Tech earnings. On deck after the bell are Club names Microsoft and Alphabet . Jim Cramer said investors should watch what Microsoft has to say about the monetization of its generative artificial intelligence offerings. Starbucks , another portfolio name, is also set to release earnings late Tuesday. We expect a shortfall. Looking at the broader market, Jim said investors should watch out for the Fed’s interest rate announcement Wednesday afternoon. “This is a classic day where people are trying to figure out if the Fed is going to screw everybody,” Jim added. 2. Danaher stock was up over 3% in late morning trading, reversing a decline of about that much in the premarket. Management shared a brighter outlook for revenue and said underlying demand for biologic medicines should strengthen. “This is an actual resurrection” for Danaher, Jim said, adding that when the Fed starts cutting rates, spending in the biotech sector should improve. Still, we’re watching out for any destocking headwinds that may impact the company moving forward. Watch your email and texts for our full Danaher quarterly earnings analysis later in the afternoon. 3. Wall Street issued a bullish call around the major U.S. banks. Morgan Stanley analysts said that Basel Endgame — forthcoming regulations that require banks to hold more capital — is less of a concern than when initially proposed. “This opens the door for a significant increase in buybacks, as large-cap banks have the highest excess capital levels ever,” the analysts argued in a new research note. Morgan Stanley analysts increased their Wells Fargo price target as a result. The analysts also mentioned an improved backdrop for capital markets. While they can’t cover themselves, a rebound in IPOs and M & A would likely boost Morgan Stanley’s crucial investment banking segment. (Jim Cramer’s Charitable Trust is long WFC, MS, DHR, MSFT, GOOGL, SBUX. See here for a full list of the stocks.) As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust’s portfolio. If Jim has talked about a stock on CNBC TV, he waits 72 hours after issuing the trade alert before executing the trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB. NO SPECIFIC OUTCOME OR PROFIT IS GUARANTEED.
AbbVie on Wednesday said it will acquire neuroscience drugmaker Cerevel Therapeutics for roughly $8.7 billion.
Under the terms of the deal, AbbVie will pay $45 per share for Cerevel. AbbVie said it expects to complete the acquisition in the middle of 2024.
Shares of Cerevel jumped 16% after the close Wednesday to nearly $43 per share, just below the purchase price. Shares of Abbvie were down less than 1% in extended trading.
The deal is AbbVie’s latest attempt to expand its drug pipeline as its top-selling treatments, such as Humira, face generic competition. Just last week, AbbVie agreed to buy cancer drug developer Immunogen for nearly $10 billion.
Cerevel will specifically beef up AbbVie’s portfolio for psychiatric and neurological disorders “where significant unmet needs remain,” according to a release from AbbVie.
Cerevel will bring over drugs such as Emraclidine, an experimental treatment for both schizophrenia and Alzheimer’s disease psychosis, including symptoms like hallucinations and delusion. That drug is currently in a phase one study in elderly volunteers.
“Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade,” said Richard Gonzalez, CEO and chairman of AbbVie, in a statement. “AbbVie will leverage its deep commercial capabilities, international infrastructure, and regulatory and clinical expertise to deliver substantial shareholder value with multibillion-dollar sales potential across Cerevel’s portfolio of assets.”
AbbVie said it will hold an investor conference call about the deal on Thursday at 8:00 a.m. ET.
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 arenot fine-tuned to provide medical information.” People should never use ChatGPT toprovide 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.
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
The drugmaker observed high rates of adverse side effects, which were mostly mild and gastrointestinal, among patients. A significant share of patients alsostopped 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.
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.
The Gorgon liquefied natural gas (LNG) and carbon capture and storage (CCS) facility, operated by Chevron Corp., on Barrow Island, Australia, on Monday, July 24, 2023.
Bloomberg | Bloomberg | Getty Images
The oil and gas industry needs to let go of the “illusion” that carbon capture technology is a solution to climate change and invest more in clean energy, the head of the International Energy Agency said Thursday.
“The industry needs to commit to genuinely helping the world meet its energy needs and climate goals – which means letting go of the illusion that implausibly large amounts of carbon capture are the solution,” IEA Executive Director Fatih Birol said in a statement ahead of the United Nations Climate Change Conference in Dubai next week.
The technology captures carbon dioxide from industrial operations before emissions enter the atmosphere and stores it underground.
Oil and gas companies face a moment of truth over their role in the clean energy transition, Birol wrote in a an IEA report reviewing the industry’s role in transitioning to an economy with net zero carbon emissions by 2050.
Just 1% of global investment in clean energy has come from oil and gas companies, according to Birol. The industry needs to face the “uncomfortable truth” that a successful clean energy transition will require scaling back oil and gas operations, not expanding them, the IEA chief wrote.
“So while all oil and gas producers needs to reduce emissions from their own operations, including methane leaks and flaring, our call to action is much wider,” Birol wrote.
The industry would need to invest 50% of capital expenditures in clean energy projects by 2030 to meet the goal of limiting climate change to 1.5 degrees Celsius, according to the IEA report. About 2.5% of the industry’s capital spending went toward clean energy in 2022.
One of the major pitfalls in the energy transition is excessive reliance on carbon capture, according to the report. Carbon capture is essential for achieving net zero emissions in some sectors, but it should not be used as a way to retain the status quo, according to the IEA.
An “inconceivable” 32 billion tons of carbon would need to be captured for utilization or storage by 2050 to limit climate change to 1.5 degrees Celsius under current projections for oil and gas consumption, according to the IEA.
The necessary technology would require 26,000 terawatt hours of electricity to operate in 2050, more than total global demand in 2022, according to the IEA.
It would also require $3.5 trillion in annual investment from today through mid-century, which equivalent to the entire oil and gas industry’s annual revenue in recent years, according to the report.
U.S. oil major such as Exxon Mobil and Chevron are investing billions in carbon capture technology and hydrogen, while European majors Shell and BP have focused more on renewables such as solar and wind.
Exxon and Chevron are also doubling down on fossil fuels through mega deals. Exxon is buying Pioneer Resources for nearly $60 billion, while Chevron is purchasing Hess for $53 billion.
Representative Mike Johnson, a Republican from Louisiana, left, speaks with Representative Kat Cammack, a Republican from Florida, outside of a House Republican caucus meeting on Capitol Hill in Washington, DC, US, on Tuesday, Oct. 24, 2023.
Al Drago | Bloomberg | Getty Images
Republican Rep. Mike Johnson of Louisiana was elected speaker of the House of Representatives on Wednesday, ending a three-week leadership crisis that has paralyzed Congress.
Vice chairman of the House Republican conference, Johnson had maintained a low public profile until he was thrust into the spotlight this week after securing the party’s nomination for speaker.
Johnson was elected unanimously by the 220 Republicans who voted, despite being the fourth nominee tapped by the GOP conference in two weeks, as the deeply divided party repeatedly failed to put forward a candidate who had enough support.
Every Democrat who voted Wednesday cast their ballot for Minority Leader Rep. Hakeem Jeffries, D-N.Y.
Johnson managed to rally the GOP conference behind his bid after recalcitrant Republicans rejected the three previous nominees — House Majority Leader Steve Scalise of Louisiana, Rep. Jim Jordan of Ohio and Majority Whip Tom Emmer of Minnesota.
Johnson’s bid received a boost Wednesday from former President Donald Trump, who encouraged Republicans to vote for the Louisianan.
He also consolidated the backing of several moderate New York Republicans who had been reluctant to support some of the more hardline conservatives who sought the top job.
Johnson, who is serving his fourth term in Congress, will wield the gavel as America faces a looming government shutdown, Israel wages war on Hamas, and Ukraine struggles to beat back Russia’s invasion.
The House needs to pass spending legislation by Nov. 17 to keep the government running, and President Joe Biden has called on Congress to approve emergency security assistance for Israel and Ukraine.
Johnson voted against legislation in September that has kept the government running through November, and he has opposed assistance for Kyiv in the past. The Louisiana Republican said earlier this month that the House needs to take all necessary action to help Israel destroy Hamas.
Johnson is a social conservative who served on Trump’s legal team during the former president’s first impeachment. He previously did legal work for the Alliance Defense Freedom, an ultraconservative advocacy group that litigates to restrict abortion access and prohibit same-sex marriage.
Johnson also participated in Republican efforts to overturn Biden’s 2020 election victory.
He filed a legal brief in support of a lawsuit that sought to block the certification of Biden’s victories in Georgia, Pennsylvania, Michigan and Wisconsin. Johnson then supported objections in Congress to the certification Arizona’s and Pennsylvania’s 2020 presidential election results.
This is a developing story. Please check back for updates.
A photo showing the logo of Swiss pharmaceutical giant Roche in Basel.
SEBASTIEN BOZON | AFP | Getty Images
Swiss health care company Roche on Monday announced it would acquire Telavant Holdings in a $7.1 billion transaction.
Telavant produces drugs for people suffering from inflammatory and fibrotic diseases and is in the process of developing a “promising new therapy” for patients with Crohn’s disease, Roche said in a press release.
The terms of the acquisition include a near-term milestone payment of $150 million.
Once given full rights to the RVT-3101 drug — a therapy under development for inflammatory bowel disease, including ulcerative colitis and Crohn’s disease — Roche aims to start global Phase 3 trials, which would involve clinical testing on hundreds to thousands of patients with the target sicknesses.
“Based on the very promising data, we strongly believe in the first-in-class and best-in-disease potential of this late-stage antibody to treat people living with IBD,” Roche Pharmaceuticals CEO Teresa Graham told CNBC in an emailed statement.
“We are eager to develop this antibody further and bring it to market and patients in the US and Japan as soon as possible.”
Telavant is currently owned by Pfizer and Roivant Sciences.
In the Monday announcement, Roche also said it would obtain an option to collaborate with Pfizer on a new inflammatory bowel disease drug.
Two experts see major challenges facing the adoption of new obesity drugs.
Dr. Kavita Patel, a physician and NBC News medical contributor, believes fresh data from Novo Nordisk on Ozempic’s ability to delay the progression of chronic kidney disease is among the strongest supporting evidence for secondary uses of the drug.
However, she considers data supporting the use of obesity drugs for other conditions including Alzheimer’s and alcohol addiction as underdeveloped.
“Those trials … are nowhere near as robust as the data we have on [Novo Nordisk trial] FLOW, on sleep apnea, cardiovascular risks, on diabetes control — double-blind placebo, randomized controlled trials that are incredible,” she told CNBC’s “Fast Money” on Wednesday. “We have a long way to go for that. I’ve seen a lot of miracle drugs before.”
Novo Nordisk halted FLOW on Tuesday. According to the company’s press release, it happened more than a year after an interim analysis showed that Ozempic could treat chronic kidney disease in Type 2 diabetic patients.
As of Friday’s close, Novo Nordisk is up 9.82%since itsannouncement. Its obesity drug maker competitor Eli Lilly is up 5.16% in the same period.
Patel believes efficacy is just one of the major hurdles the medication needs to clear before it can be approved for uses outside of diabetes management.
“We know this drug works really well in diabetics. But there are so many barriers to getting there —including cost, adherence, prescriber rate,” said Patel, who also served as a White House Health Policy Director under President Obama.
Patients opting to use GLP-1 drugs — a group of medications initially designed to control diabetes — for weight management often must pay out-of-pocket.
“Right now, we are seeing active employers, entire states that are declining to cover on the weight loss indication,” Patel said.
If the U.S. Food and Drug Administration approves Ozempic for use in Type 2 diabetics with chronic kidney disease, which Patel believes will happen, it could force the hand of insurance companies to expand their coverage of the drug.
“We’ll see a final package of data that will just be so compelling, that it would be wrong not to cover this, because it should be superior to what we have available to us,” she noted. “That is something that I think the insurance companies will have a difficult time [with].”
Mizuho Health Care Sector Strategist Jared Holz also expects challenges related to insurance coverage as more patients begin taking GLP-1 drugs, which could limit overall adoption.
“The payers, at some point, are going to be saying, ‘We get it, but we cannot pay for these at this volume without seeing the benefit, which may be 10 years from now, 20 years from now, 30.’ We have no idea when the offset is going to be,”he also told CNBC’s “Fast Money.”
Holz also pointed out the divide emerging in the health care sector between Novo Nordisk, Eli Lilly and their pharmaceutical peers.
“We haven’t seen this kind of valuation disconnect between the peer group, maybe in the history of the sector,” he said.
The growth trend may not be sustainable for Novo Nordisk and Eli Lilly, based on current supply constraints that have left patients unable to secure dosages.
“The companies can’t make enough, I don’t think, to actually put out revenue that’s going to appease investors, given where the stocks are trading,” said Holz.
A Novo Nordisk spokesperson did not offer a comment due to the company’s quiet period ahead of earnings. Eli Lilly did not immediately respond to a request for comment.
Novartis said in August that it plans to spin off its generics unit Sandoz to sharpen its focus on its patented prescription medicines.
Bloomberg | Bloomberg | Getty Images
Novartis on Wednesday completed the spinoff of its generics and biosimilars business Sandoz, whose shares began trading at 24 Swiss francs in the early minutes of the company’s debut on the SIX Swiss Exchange.
The Swiss drugmaker initially announced intentions to spin off the business in August, offering stakeholders one Sandoz share for every five Novartis shares via a dividend-in-kind distribution.
Narasimhan told CNBC that the company had accelerated its efforts over the last six years to “focus Novartis as a pure play innovative medicines company.”
Pure play companies refer to entities that target a single product or industry sector.
“Over the last six years, we’ve done over $100 billion of transactions. We exited consumer health to create one of the largest consumer health companies, exited Alcon in the largest public market spin in European capital markets, we exited our Roche stake,” Narasimhan told CNBC’s Julianna Tatelbaum.
“Now we spin [off] Sandoz, and what is left now is really where I think Novartis is best suited to succeed in the long run — a pure play innovative medicines company focused on bringing R&D efforts and the new medicines we create to markets around the world.”
Novartis shares climbed more than 3% in early trade in Zurich to lead the pan-European Stoxx 600 index.
Novartis also reiterated its full-year guidance, with sales expected to grow in a high single-digit percentage and with core operating income set to grow in the low double digits to mid-teens.
In a statement alongside the Wednesday announcement, Narasimhan said this was a “truly historic moment for Novartis and Sandoz” as they begin life as independent companies.
“With several consecutive quarters of sales growth, Sandoz starts out from a position of strength as a global leader in Generics and Biosimilars, and I am confident they are poised to deepen their impact on patients and society,” he added.
Jefferies analysts have valued the Sandoz listing at between $12.3 billion and $16.2 billion, when the company begins trading on Wednesday.
Sandoz CEO Richard Saynor also on Wednesday told CNBC that the spinoff would help his company focus its own strategy, which includes a pipeline of 25 biologics projects, with five more set to launch over the next two years.
“Ultimately, it’s about focus. Sandoz is the world’s largest generics and biosimilars company, and now, by becoming an independent company, we can focus on how we grow that business, how we bring more products to patients, and really continue to build on the momentum that we’ve created over the last couple of years,” Saynor told CNBC on Wednesday.
Saynor said the company’s broad aims are to continue to build on the sales momentum of the last seven quarters, expanding the profit margin over the next few years and driving free cash flows.
Around half of Sandoz revenues come from Europe, which Saynor said gives the company a “huge platform to grow.”
“We’ve invested heavily in our biologics pipeline, so, as we sit here today, we have 25 projects in our pipeline, and we’re in the process of launching about five over the next two years,” Saynor said.
“We’ve guided [that] around $3 billion of sales will come from our new pipeline, which is more than twice what we’ve seen over the previous five years, and we’re expecting half to come from biosimilars and half of the growth in total will now come from North America, so we’ll see the U.S. business starting to accelerate over the next few years.”
Judge Michael Newman of the Southern District of Ohio issued a ruling denying a preliminary injunction sought by the Chamber of Commerce, one of the largest lobbying groups in the country, which aimed to block the price talks before Oct. 1.
That date is the deadline for manufacturers of the first 10 drugs selected for negotiations to agree to participate in the talks.
But Newman, a nominee of former president Donald Trump, also declined to grant the Biden administration’s motion to dismiss the case entirely.
Instead, he asked the Chamber to amend its complaint by Oct. 13 to clarify certain details in the case.
Newman also gave the Biden administration until Oct. 27 to renew its motion to dismiss the case.
He said “a final determination on standing issues will be made following a short (60-day) discovery period and—assuming they are filed—renewed motions to dismiss.”
The ruling from Newman is a blow to the pharmaceutical industry, which views the process as a threat to its revenue growth, profits and drug innovation.
President Joe Biden’s Inflation Reduction Act, which passed in a party-line vote last year, gave Medicare the power to directly hash out drug prices with manufacturers for the first time in the federal program’s nearly 60-year history
The Chamber, which represents some companies in the industry, and drugmakers like Merck and Johnson & Johnson filed at least eight separate lawsuits in recent months seeking to declare the negotiations unconstitutional. But the Chamber’s suit was the only one seeking a preliminary injunction.
Michael Newman, U.S. District Court Judge Ohio
Source: U.S. District Court
The Chamber’s lawsuit argues that the program violates drugmakers’ due process rights under the Fifth Amendment by giving the government the power to effectively dictate prices for their medicines.
The Chamber said an appeals court established a precedent that when the government sets prices, it must provide procedural safeguards to ensure a company receives a reasonable rate and fair return on investment. Itstems from the 2001 case Michigan Bell Telephone Co. v. Engler, according to the Chamber.
The Medicare negotiations do not provide these safeguards and impose price caps that are well below a drug’s market value, the Chamber argued.
“There is a very, very high risk, maybe a guarantee, but certainly a very, very high risk, that this regime will result in prices that are unfair,” Jeffrey Bucholtz, an attorney for the Chamber, told judge Newman during a hearing earlier this month.
He added that drugmakers either must agree to theprice the government sets, or face an excise tax of up to 1,900% of U.S. sales of the drug.
But lawyers for the DOJ said during the hearing that the program was far from compulsory. Drugmakers can choose the alternative to those two options: Withdraw their voluntary participation in the Medicare and Medicaid programs, according to attorney Brian Netter.
“The measure of relief here is for manufacturers to decide whether they want to stay in the program under the terms that are on offer,” Netter said. “If they choose not to, that’s their prerogative.”
The other suits are scattered in federal courts around the U.S.
Legal experts say the pharmaceutical industry hopes to obtain conflicting rulings from federal appellate courts, which could fast-track the issue to the Supreme Court.
Medicare covers roughly 66 million people in the U.S., according to health policy research organization KFF. The drug price talks are expected to save the insurance program an estimated $98.5 billion over a decade, the Congressional Budget Office said.
In August, the Biden administration unveiled the 10 drugs that will be subject to the first round of price talks, officially kicking off a lengthy negotiation process that will end in August 2024. The reduced prices for those initial medications won’t go into effect until January 2026.
That includes blood thinners from Bristol-Myers Squibb and J&J, and diabetes drugs from Merck and AstraZeneca. It also includes a blood cancer drug from AbbVie, one of the companies represented by the Chamber of Commerce.
Covid-19 home test kits are pictured in a store window during the Covid-19 pandemic in the Manhattan borough of New York City, Jan. 19, 2022.
Carlo Allegri | Reuters
The Biden administration on Wednesday said it will resume offering free at-home Covid tests to American households Monday as the virus gains a stronger foothold nationwide.
Americans will soon be able to use COVIDtests.gov to request four free tests, the administration said in a release.
The government had offered free test kits through that website since January 2022, but the site stopped taking orders June 1 of this year to conserve supplies of the tests.
The government is relaunching the program in time for the fall and winter when the virus typically spreads at higher levels. Covid hospitalizations have already increased for eight straight weeks — an uptick primarily driven by newer strains of the virus.
But the Biden administration noted that the at-home tests set to be delivered will detect currently circulating Covid variants. The kits are intended for use through the end of 2023 and will come with instructions for how people can verify if a test’s expiration date has been extended, the administration added.
Testing is a critical tool for protection as Covid infections climb again.But lab PCR tests — the traditional method of detecting Covid — have become more expensive and less accessible for some Americans since the U.S. government ended the public health emergency in May.
The end of that declaration also changed how public and private insurers cover at-home tests, potentially leaving some people unable to get those tests for free through their plans.But certain local health clinicsand community sites still offer at-home tests to the public at no cost.
Also on Wednesday, the Biden administration said it will provide $600 million to strengthen manufacturing capacity at 12 Covid test manufacturers across the country. The administration expects to secure about 200 million tests from those companies.
“These critical investments will strengthen our nation’s production levels of domestic at-home COVID-19 rapid tests and help mitigate the spread of the virus,” Health and Human Services Secretary Xavier Becerra said in a statement.
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 inthe 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.
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.
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 orapp, 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.
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.
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.
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.
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.
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.
J.M. Smucker ‘s plan to buy Twinkies -maker Hostess Brands is a risky move, if Morgan Stanley’s latest research is correct. The firm revisited its August call that a new class of weight loss medications would hamper growth at some food and beverage companies . This time it backed up its thesis with additional demographic data about grocery shoppers from Numerator Insights as well as data from the Centers for Disease Control and Prevention. The results aren’t rosy for Ding Dongs. “Our analysis reinforces the view that snacking companies such as TWNK are likely to be most adversely affected by GLP-1 adoption, while weight management food companies like SMPL and BRBR could benefit,” Morgan Stanley analyst Pamela Kaufman wrote in a note to clients on Monday. BellRing makes protein shakes and powders and owns the PowerBar brand. Its stock is up a whopping 60% year to date. But Simply Good , which owns brands like Atkins and Quest that make ready-to-drink shakes, snacks and frozen meals, has seen its stock fall nearly 15% over the same time period. In August, Morgan Stanley analysts said they expect increased adoption of GLP-1 medications like Novo Nordisk’s Wegovy will lead to a 1.3% drop in calorie consumption in the U.S. by 2035. The estimate was based on the idea that patients taking the weight loss drugs typically reduce their daily calorie intake by 20% to 30% as they cut back on daily meals by 20% and snacks by 40%, the analysts said. They also assumed at the time that these same consumers were more likely to buy indulgent snacks and packaged foods sold by brands like Smucker, Hostess and others. The new report backs this up. “Across our coverage, Numerator Insights data highlight that most center-store packaged food companies slightly over-index to consumers with obesity,” Kaufman said. Also, these same foods are the types of items that consumers are likely to cut back on when they are getting serious about losing weight, she said. The analysis showed Hostess was the most exposed to shoppers with obesity and type 2 diabetes. People with both conditions are also most likely to qualify for anti-obesity medication, the analysts said. On Monday, Smucker’s stock was down about 7%, and at one point hit a 52-week low of $129.00, after it said it would pay $5.6 billion to buy Hostess in a stock-and-cash deal. Hostess stock soared 19% on the news. Other food stocks with higher exposure to customers with obesity include Conagra , Kraft Heinz and Smucker, the report said, citing the Numerator data. “Importantly, BRBR and SMPL over-index to consumers who are addressing their obesity through lifestyle changes and prescription drugs, reinforcing their complementary qualities and potential category tailwinds from GLP-1 drugs,” the report said. In Morgan Stanley’s original report, the analysts also emphasized that food and beverage companies could ease the impact of the trend by reformulating products to have fewer calories and sugar or by shifting product mix to healthier items. —CNBC’s Michael Bloom contributed to this report.
Smoke pours from the Twin Towers of the World Trade Center after they were hit by two hijacked airliners in a terrorist attack in New York City, Sept. 11, 2001.
Robert Giroux | Getty Images
Two victims who perished in the World Trade Center have been identified more than two decades after the Sept. 11, 2001, terrorist attacks, New York City’s chief medical examiner said Friday.
The names of the victims, a man and a woman, are being withheld at the request of their families, officials said. They are the 1,648th and 1,649th victims whose remains have been identified since 2001.
The remains of 1,104 victims, or 40% of those who died in the attacks, still have not been found nearly 22 years after al-Qaida terrorists hijacked commercial airlines and crashed them into the Twin Towers in lower Manhattan.
The towers were destroyed in the attacks, leaving more than 2,700 people dead.
Dr. Jason Graham, New York City’s chief medical examiner, described the painstaking effort to identify the victims’ remains as “the largest and most complex forensic investigation” in U.S. history.
Investigators have spent decades using DNA testing to identify tens of thousands of remains recovered from the Ground Zero disaster site. More than 30% of the remains recovered are still unidentified, according to the medical examiner’s office.
CNBC Politics
Read more of CNBC’s politics coverage:
Graham said in a statement Friday that the medical examiner’s office has made a “solemn pledge” to return the remains of those who perished to their loved ones.
The identification of the man was confirmed through DNA testing of remains recovered in 2001. The woman was identified through the testing of remains recovered in 2001, 2006 and 2013.
The announcement that two victims were identified comes three days before the anniversary of the attacks. The man and the woman are the first new identifications since September 2021.
Less than an hour after the attacks on the Twin Towers, al-Qaida terrorists crashed a third commercial airliner into the Pentagon, killing 184 people.
Passengers in a fourth hijacked airliner heading for the nation’s capital fought for control of the plane. United Airlines Flight 93 crashed in a field outside Shanksville, Pennsylvania, killing all 40 people on board.
In the wake of the attacks, the U.S. went to war in Afghanistan, where the leader of al-Qaida, Osama bin Laden, was sheltered by the Taliban. The Bush administration subsequently invaded Iraq to overthrow Saddam Hussein, who had no connection to the attacks.
More than 6,700 U.S. troops died in those wars.
Bin Laden was killed by U.S. forces during a raid in Pakistan in 2011. The Biden administration withdrew the U.S. military from Afghanistan in 2021 and the Taliban returned to power after the collapse of the U.S.-backed government in Kabul.
Weight loss drugs are being assessed for their ability to treat conditions like dementia and addiction after a landmark study showed that Wegovy helped reduce the risk of heart attacks and strokes.
Bloomberg | Bloomberg | Getty Images
LONDON — Scientists have begun investigating whether so-called miracle obesity drugs could be used to treat conditions such as dementia and alcohol addiction after recent trials pointed to the drugs’ efficacy in treating serious health issues.
Late-stage trial data released last month by Novo Nordisk indicated that its Wegovy weight loss injection led to “large reductions” in heart failure-related symptoms among at-risk patients.
It comes weeks after the Danish pharmaceutical company published the results of its much anticipated “SELECT” study, which showed the drug’s role in reducing the risk of major cardiovascular events such as heart attacks or strokes.
The findings mark a major milestone as the company seeks to broaden perceptions of its product — dubbed by some a “vanity drug” — and researchers are hopeful they spell positive news for the drugs’ other applications.
“The results show that this medication can have health benefits above and beyond the short-term,” Christian Hendershot, director of the clinical and translational addiction research program at the University of North Carolina at Chapel Hill, told CNBC via Zoom.
Hendershot is one researcher investigating whether the appetite-regulating mechanisms at play in weight loss drugs could be used to treat other conditions such as alcohol and drug addiction.
Novo Nordisk’s Wegovy and Eli Lilly‘s Mounjaro work by imitating a naturally occurring gut hormone that helps regulate appetite in the brain, ultimately leading to weight loss. For that, they rely on active ingredients called semaglutide and liraglutide, respectively, which belong to a group of drugs called GLP-1 receptor agonists.
Pre-clinical trial data has for several years pointed to the efficacy of GLP-1 medication in reducing drug and alcohol intake among animals. Hendershot is now testing Ozempic — Wegovy’s predecessor used to treat type 2 diabetes — to see whether those trends apply to humans, too.
If those two studies both readout … it’s hard to overstate the effect this will have on the field.
Kyle Simmons
rofessor of pharmacology and physiology at Oklahoma State University
“There is reason for optimism, particularly given the reports. Now it’s our job to do the research to validate those findings with clinical data,” said Hendershot, who expects to publish early findings next year.
If broader applications of the drugs are proven to be effective, the implications could be vast, according to Kyle Simmons, professor of pharmacology and physiology at Oklahoma State University, who cited early indications of the drugs’ efficacy in reducing cocaine, amphetamine and opioid cravings.
Simmons is currently leading the Semaglutide Therapy for Alcohol Reduction (STAR) trial, a 12-week double-blind, placebo-controlled study, which is running in tandem with a separate but similar study at the University of Baltimore.
“If those two studies both read out, and they’re both positive, it’s hard to overstate the effect this will have on the field,” he said.
Some researchers are hopeful the drugs could also have use cases in the treatment of dementia and other cognitive disorders.
Already, there is evidence to suggest that GLP-1 drugs can reduce the build-up of amyloid and tau on the brain — two proteins thought to be responsible for Alzheimer’s disease, the most common type of dementia.
Now, a trial underway at the University of Oxford will test patients at risk of developing dementia — i.e. those with high levels of amyloid on the brain — to see whether the drugs lead to a reduction in tau accumulation and brain inflammation.
“We want to see if these drugs are interfering with the core Alzheimer’s disease pathology,” said Ivan Koychev, a senior clinical researcher, who is leading the study.
Elsewhere, others think the drugs could have potential applications in the treatment of polycystic ovary syndrome (PCOS), a disorder that can cause irregular periods, hormone imbalances and fertility issues.
“If women with PCOS exhibit positive outcomes in terms of irregular periods and hirsutism [excess hair growth] despite modest weight loss, it could underscore the medication’s broader therapeutic potential,” said Harshal Deshmukh, a consultant endocrinologist and senior clinical lecturer at the University of Hull, who is currently conducting one such trial.
Additional possible use cases for weight loss drugs could exacerbate the hurdles already faced by patients using them, however: high costs and supply shortages.
Earlier this month, Novo Nordisk extended restrictions on starter doses of Wegovy due to production constraints, while Eli Lilly warned of continued delays in Mounjaro output for the same reason.
Hendershot said his study was not currently being impacted by shortages, but Simmons described it as a “significant concern.”
Meantime, concerns have been raised about the possible adverse effects of the drugs after some patients reported thoughts of suicide or self-harm.
Is this medication … turning down the gain on reward-signaling
Kyle Simmons
rofessor of pharmacology and physiology at Oklahoma State University
Novo Nordisk CEO Lars Fruergaard Jorgensen told a Reuters Newsmaker event last month that the number of suspected cases remained minimal relative to the wide reach of the drug. “When you have medicine that’s used in millions of patients, and many different types of patients, then you can come across different events,” he said.
However, Simmons said that more research is still needed to understand the impact of such drugs on reward signaling in the brain. His own research will test for such signals by monitoring participants’ reward responses in a virtual reality simulation.
“Is this medication, because of its effects maybe on the mesolimbic dopamine system, just turning down the gain on reward signaling in such a way that could promote anhedonia?” Simmons said. Anhedonia is a term used to describe a reduced ability to experience pleasure.
“If this drug is used by more and more people, if it starts to promote a loss of interest in pleasure more generally, that might not be a great thing, for example, for people who have a history of major depressive disorder,” he added.
