Johnson & Johnson On Monday, it said it plans to reduce its stake by at least 80% in Kenvue, the consumer health company it founded as an independent company earlier this year, via a stock exchange offering.

J&J owns 89.6% of the common shares of Kenvue, which amounts to more than 1.72 billion shares.

The exchange offer, also known as a split, will allow J&J shareholders to swap all or a portion of their shares for Kenvue common stock at a 7% discount. It is expected to be tax deductible, J&J said in a statement.

The company indicated that the split is voluntary for investors and is scheduled to close on the third of August. 18, which is much earlier than expected.

J&J said it received a waiver denying the stock lock period associated with Kenvue’s initial public offering in May. This lockout agreement required J&J to wait 180 days to sell any of its stock.

“We believe now is the right time to distribute Kenvue shares, and we are confident that the split is the appropriate path forward to create value for our shareholders,” J&J CEO Joaquín Duato said in a statement.

Duato added that the split will increase J&J’s focus on its pharmaceutical and medical technology businesses — both of which helped the company beat second-quarter revenue and adjusted earnings last week.

J&J first announced its intention to launch a swap offering in its second-quarter earnings report Thursday, but the company provided few details on the plan. Kenvue shares tumbled after that announcement, despite second-quarter results that also beat Wall Street estimates.

When asked about J&J’s planned swap offering Thursday, Kenvue CEO Thibaut Mongon told CNBC’s “Squawk on the Street” that the company is “pleased with the way shareholders have been received for the IPO.”

“We see a great deal of alignment among our new investors in seeing Kenvue’s potential, but I can tell you we’re absolutely ready to leave as a completely independent company,” he said.

Most consumers have cut back on spending because inflation is squeezing their wallets, but they haven’t stopped paying for brand-name health and personal care products, said Kenvue CEO Thibaut Mongon.

Mongon told CNBC on Thursday that consumers are still willing to spend on the company’s branded products — even if they cut discretionary spending at retail stores and cut back on some essential items by changing their usual purchase size or switching brands at lower prices.

the Johnson & Johnson pop-up consumer Kenvue beat second-quarter revenue and adjusted earnings estimates on Thursday, helped by resilient demand for the company’s wealth from widely recognized brands like Band-Aid, Tylenol, Listerine, Neutrogena and Aveeno.

However, the company’s share price fell after J&J announced that it would launch an exchange bid to reduce its stake in Kenvue much earlier than expected.

Kenvo also noted that “private label” penetration into the consumer health products market was stable during the quarter. Private label refers to products that are manufactured and sold under a specific retailer’s name and are sold at a lower price and are intended to compete with branded products such as Kenvue.

These spending trends could bode well not only for Kenvue, but also for other companies in the consumer health, beauty, and beverage industries that may not see consumers turning to cheaper products as often despite higher prices.

“We are now living in a volatile environment with continued consumer uncertainty and continued inflationary pressures,” Mongon told CNBC. “But I think people are very focused on their health and well-being right now.”

“They want to make sure they are doing what it takes to improve their health,” he said. “They’re looking for reliable, scientifically backed, and effective solutions to take better care of their health, and that’s what we and our brands do. It’s what we’ve been doing for a long time.”

Kenvue expects continued strong demand in the coming quarters. The company expects 2023 sales to increase between 4.5% and 5.5% over last year.

RBC Capital analyst Nick Moody expressed confidence in Kenvue’s ability to “maintain its momentum,” highlighting consumer confidence in the company’s brands, health and personal care products in general.

He noted that trade reduction pressures have increased for some companies, based on their market share changes over the past few months. Meanwhile, Kenvue has gained market share, and will likely continue to do so despite the broader environment.

“If we were going to see a decline in trade with them, we would have started to see it already,” Modi said.

Like Kenvue, some beauty and beverage companies may not see the same kind of trade declines as some core consumer sectors during the current period of macroeconomic uncertainty, according to Modi.

He said beauty products such as makeup are increasingly seen as an “affordable luxury” even as inflation squeezes consumers’ budgets.

“They don’t want to feel bad about their situation and buy cheaper makeup,” Modi said.

companies like Hollandwhich sells cosmetics, skin and hair care, and other beauty products, has benefited from the flexibility of the beauty category.

Earlier this year, Ulta said its 2022 revenue exceeded $10 billion, while annual net income exceeded $1 billion — both company records. Ulta also reported first-quarter earnings that beat expectations in May, largely driven by demand for its beauty products.

Oddity Tech, a beauty and wellness company that uses artificial intelligence to develop cosmetics, also appeared to be harnessing the power of the beauty category when it made its public market debut on Wednesday. Shares of the direct consumer platform rose 35%.

Beverage companies are also well positioned, Modi said, noting that big brand names such as Coca-Cola are not at great risk of private label penetration.

Coca-Cola’s first-quarter earnings beat expectations for higher demand for its beverages. But price increases for its products, which were implemented to mitigate the impact of inflation, also helped support results.

Monjon said consumers are turning to brands and products they “know and trust” during tough economic times.

The behavior — and a growing focus on health and well-being — is fueling demand for Kenvue products, which have been “in homes for years, decades, sometimes generations,” he said.

Modi agreed, adding that the Covid-19 pandemic has greatly increased consumers’ attachment to brands, especially those that help people take care of their health.

For example, demand for Tylenol soared and outpaced other pain relievers during the pandemic as people scrambled to stock up on essential health products.

“During the time frame of Covid, you were looking to save your family or get your kids through a difficult period of time with certain medicines and products, and I think that kind of emotional connection and sharing helped sustain the brand,” Modi told CNBC.

“Consumers tend to trust these brands during the most traumatic moments in their lives, so I think that’s why we’re seeing brands like Kinview remain so resilient despite the overall pressure,” he said.

The pandemic has made consumers more able to “take their health into their own hands at home,” added Navan Tai, an analyst at BNP Paribas Ixan.

This shift is likely to benefit Kenvue and others in the consumer health field, she said, and is “an additional differentiation from other consumer categories.”

I’ve noted that Kenvue isn’t “totally immune” from decline and private-label competition. But she said product recommendations by healthcare professionals offer “some protection”.

Third-party surveys of some healthcare practitioners in the United States from 2020 to 2022 found that Tylenol was the top adult pain medication recommended by physicians nationwide, according to an April Kenvue IPO filing.

Those surveys also found that neutrogena was the leading sunscreen and acne treatment brand in the united states, while listerine was the top dentist-recommended mouthwash.

Mongon noted during the company’s earnings call that these recommendations “ultimately foster a lifetime of loyalty to our brands, loyalty that is passed down from generation to generation.”

Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the service is “reasonable and necessary” for a diagnosis.

Chiquita Brooks-LaSure, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” A CMS spokesperson said a final decision could come within 90 days.

Positron emission tomography scans are an important diagnostic tool that detects the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare generally pay 20% of the cost of a PET scan after the deductible is met. The cost of a one-time scan would be about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

doctor. It’s possible for regional contractors to come to different coverage decisions for PET scans, said Sean Tunis, CMS’ former chief medical officer. But these organizations generally work together on key issues and there’s no reason to think their policies on PET scans will differ widely across the United States, said Tunis, now a consultant at Rubix Health.

Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also in development, and some are already in use, but not yet widely deployed.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanimab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

The first over-the-counter birth control pill in the United States can remain out of reach for some women and girls because health insurance plans are not required to cover the drug in its over-the-counter form.

The U.S. Food and Drug Administration on Thursday approved Opill oral contraceptives for sale without a prescription, a landmark decision that would make the pill easier to obtain by eliminating the need to visit a doctor’s office and refill prescriptions.

A third of adult women who have tried to obtain prescription contraceptives encountered barriers to accessing them, according to a survey published in the Journal of Women’s Health in 2016.

Opel manufacturer perego It expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in two months before the pill hits stores, Perrigo CEO Fredrik Welgren said during a call with reporters Thursday.

Welgren said the company is committed to ensuring that Opel is affordable. Perrigo sets up a program to help patients, so the cost of birth control pills isn’t a barrier for women struggling to make ends meet.

But some women and girls still face obstacles in obtaining an Opel. The Affordable Care Act does not require private health insurance to cover the cost of birth control pills when used without a prescription. Most health insurance companies are required to offer birth control for free when a doctor prescribes it.

State Medicaid programs are generally not required to cover over-the-counter drugs, according to the federal Centers for Medicare and Medicaid Services.

Welgren said Perego is enlisting private insurance programs and state health care programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needs to be amended to ensure that health insurance pays for over-the-counter birth control.

It’s unclear whether insurance coverage for Opel will be in place when the pill is available in stores early next year, Welgren said. “We have some work to do to make that happen. It will take some time,” she said.

Congressional Democrats and President Joe Biden are pushing to expand access to birth control.

senator. Patty Murray, D-WA, reintroduced legislation called Accessible Affordability in the Senate in May that would require health insurance companies to offer over-the-counter oral contraceptives for free.

Biden ordered the US Department of Health and Human Services in June to ensure that all contraceptives approved by the Food and Drug Administration are available without out-of-pocket costs.

An agency spokesperson said Friday that CMS encourages health insurance to cover over-the-counter birth control products for free. The spokeswoman said the agency is working on ways to ensure that contraceptives approved by the Food and Drug Administration are available for over-the-counter use without sharing costs.

Opill is 93% effective in preventing pregnancy. It is the most effective form of over-the-counter birth control in the United States, and must be taken at the same time each day to ensure its effectiveness.

Welgren said that 15 million women in the United States who are sexually active and do not want to become pregnant use a method of contraception less effective than Opal or no method of contraception at all.

Nearly half of the 6 million pregnancies in the United States each year are unintended, according to the Food and Drug Administration. According to the agency, unintended pregnancies are associated with premature birth, which can lead to poor health outcomes for newborn babies.

Uninsured Americans pay an average of nearly $98 for a bottle Eli Lillygeneric insulin, even after the company pledged to lower the product’s list price to $25 per vial, according to a report released Thursday by the senator. Elizabeth Warren.

Eli Lilly pledged earlier this year to lower the list price of the generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the largest insulin manufacturers in the world.

The Massachusetts senator’s report surveyed more than 300 pharmacy chains and independents in the United States between June 9 and 28 to determine whether the price reduction announced by Eli Lilly “translated into real patient relief.”

The survey found that a third of pharmacies charge uninsured patients $164 or more for a bottle of Eli Lilly’s Lispro.

Seven pharmacies charged $200 per bottle or more, and two sold the product for more than $300.

Chain pharmacies charged uninsured customers an average of $123 per vial for generic insulin, compared to an average of $63 at independent pharmacies.

Eli Lilly did not immediately respond to CNBC’s request for comment on the poll.

The study findings indicate that “Eli Lilly’s promises of affordable insulin have not been delivered to uninsured patients across the country,” Warren said in a statement.

She said the data also shows that Congress needs to take more steps to rein in excessive pricing, such as capping insulin fees at $35 per month for all patients, regardless of their insurance status.

President Joe Biden’s Inflation Reduction Act currently sets co-insulin amounts at $35 per month for people covered by Medicare.

“My new report confirms that far too many uninsured Americans do not have access or cannot afford to pay astronomical prices for life-saving universal insulin — lawmakers need to step up and take action,” Warren said in a press release.

Insured Americans usually pay a fraction of the list price of insulin. But uninsured people often have to pay the full cost, which could force them to ration or stop taking a life-saving diabetes treatment.

Nearly 30% of uninsured diabetics reported skipping insulin doses, taking less than prescribed or delaying purchases within the past year, Warren said, citing a 2022 study conducted by researchers from Harvard University and other institutions.

“No American should ever be forced to choose between life-saving medications, such as insulin, and their ability to pay for food, shelter, and their daily needs,” Warren said.

Earlier this year, Eli Lilly, Sanofi And Novo Nordisk is committed to reducing the list prices of the most commonly prescribed types of insulin by at least 70% later in 2023.

Eli Lilly and Sanofi also set monthly insulin costs at $35 for people with private insurance.

The three companies together control 90% of the global insulin market.

Their commitments were met with praise from lawmakers and Biden, who was pleased that the companies were finally heeding the calls to help make diabetes care more affordable in the United States.

But the Warren poll raises questions about the effectiveness of cost-cutting efforts.

About 37 million people in the United States, or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.

The American Diabetes Association said nearly 8.4 million people with diabetes are insulin dependent.

Medicare has agreed to pay for Leqembi’s treatment for Alzheimer’s disease, a major turning point for patients diagnosed with the early stages of the disease.

Leqembi is the only drug on the market now that has been shown to slow the progression of early-stage Alzheimer’s disease in a clinical trial. The monoclonal antibody, given twice monthly through an IV, slowed cognitive decline by 27% over the course of 18 months in the trial.

Leqembi is made by the Japanese pharmaceutical company Eisai and its partner Biogenheadquartered in Cambridge, Massachusetts.

Medicare’s decision to cover Leqembi, which came moments after the US Food and Drug Administration approved the drug Thursday, promises to make treatment more accessible to patients.

Medicare coverage is critical for most patients to have any hope of being able to afford Leqembi. Eisai priced Leqembi at $26,500 a year before insurance coverage, which is too expensive for Medicare patients, whose average income is about $30,000.

Medicare foots the majority of the bill, though many patients will still face several thousand dollars out of their own pockets.

Patients on traditional Medicare will pay 20% of Leqembi’s bill, according to the federal Centers for Medicare and Medicaid Services. That means those patients could see an annual bill of more than $5,000, according to an estimate from KFF, a nonprofit group that researches healthcare issues.

People with Medicare Advantage plans typically pay 20% more for drugs like Leqembi, up to the out-of-pocket limit, which was about $5,000 on average for in-network services, according to the KFF.

Patients with supplemental insurance such as Medigap or Medicaid may pay less, according to the KFF.

People with modest means may not be able to afford an out-of-pocket Leqembi even with Medicare coverage, said Tricia Newman, a Medicare expert at KFF.

Newman said this is particularly worrisome because blacks and Hispanics are more likely to develop Alzheimer’s disease but are likely to have lower incomes.

If demand for Leqembi is high, there are also concerns that patients could face long waiting times to see specialists and receive injections.

Medicare has certain conditions that must be met for patients to be eligible for Leqembi coverage.

To be diagnosed with Alzheimer’s disease or mild cognitive impairment, patients should undergo a cognitive assessment and undergo a positron emission tomography scan or a spinal tap to detect the amyloid protein associated with the disease. PET scans are the most common way to detect amyloid because they are less invasive.

Medicare currently covers one PET scan per age for amyloid detection. A spokesperson for the agency said CMS is reconsidering this policy and plans to release a proposed rule soon.

The requirement for clinicians to enter patient information into the registration system is controversial. The Alzheimer’s Association and some members of Congress are concerned that the requirement to collect data creates unnecessary red tape for patients to receive treatment.

The federal Centers for Medicare and Medicaid Services has created a nationwide portal that is supposed to make it easier for doctors to enter required information about their patients. CMS has released a video showing clinicians how to navigate the system:

Doctors can access free registration on this website.

doctor. The record is simple and unlikely to be burdensome for patients and doctors, said David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota.

Patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease need to talk to their doctor about whether Leqembi’s benefits outweigh the risks, according to CMS.

Although Leqembi slightly slowed cognitive decline in clinical trials, the treatment also carries serious risks of brain swelling and bleeding. In the trial, 13% of patients given Leqembi had swelling and 14% had bleeding.

Swelling and bleeding were usually mild, with no obvious symptoms, but these episodes can be fatal, according to an independent Food and Drug Administration review of clinical trial data. When symptoms do appear, they include headache, confusion, dizziness, vision changes, and nausea.

People who have two copies of a gene mutation called APOE4 are at increased risk of swelling and bleeding and patients should be tested to confirm if they have the mutation before taking Leqembi, according to the US Food and Drug Administration. A CMS spokesperson said Medicare covers testing for the APOE4 mutation.

And according to the Food and Drug Administration, patients who take anticoagulants appear to be more likely to have bleeding in the brain.

Three patients who received Leqembi died in the trial, although the Food and Drug Administration could not determine if these deaths were related to the treatment.

Patients who have been appropriately diagnosed and informed should be able to decide for themselves whether they want to take Leqembi after weighing the benefits of the treatment against the risks of potentially serious side effects, Knopman said.

The Food and Drug Administration on Thursday fully approved the Alzheimer’s treatment Leqembi, a pivotal decision that would expand access to the expensive drug for older Americans.

Medicare announced shortly after the US Food and Drug Administration (FDA) approval that it now covers antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first antibody treatment for Alzheimer’s disease to receive full approval from the Food and Drug Administration. It is also the first such drug to gain broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early-onset Alzheimer’s disease by 27% over the course of 18 months during the Eisai clinical trial. The antibody, which is given twice a month by intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Medicare coverage is a critical step in helping older Americans with early-onset Alzheimer’s disease pay for treatment. With a median income of about $30,000, most people on Medicare can’t afford Leqembi’s $26,500 annual rate set by Eisai without insurance coverage.

Medicare had previously agreed to cover Leqembi only for patients participating in clinical trials after the treatment received urgent approval in January. This policy has severely restricted access to the drug.

To be eligible for coverage, patients must be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a physician participate in a data collection system set up by the federal government to monitor treatment benefits and risks.

Joanna Pike, president of the Alzheimer’s Association, a lobby group that advocates for people living with the disease, said that while Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, manage their daily lives and spend more time with their families.

“This gives people months to get to know their spouses, children and grandchildren,” Paik said in a statement Thursday. “It also means more time for the person to drive safely, accurately, and quickly to take care of family finances and to participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in the Esay study died. FDA scientists said it’s unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the United States, according to the Food and Drug Administration.

doctor. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly showed a benefit for patients in the Eisai trial, though he cautioned that the treatment’s efficacy was modest.

Adequately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly injections, Knopman said.

To receive coverage, Medicare requires patients to find a healthcare provider who participates in a scoring system that collects factual data about the drug’s benefits and risks. The system is controversial. The Alzheimer’s Association and some members of Congress worry that this requirement will create barriers to treatment.

There are concerns that the number of healthcare providers participating in such registries will be limited, and that people in rural towns and other disadvantaged communities will have to travel many hours to find such a provider.

The Centers for Medicare and Medicaid Services has created a nationwide portal to make it easier for healthcare providers to provide required data on patients receiving Leqembi. The free-to-use portal went into effect moments after the FDA’s decision on Thursday.

representative. Anna Echo of California, ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Bargan, D-Calif., raised concerns in a letter to CMS last month that patients might struggle to find a physician involved in the system.

Alzheimer’s disease is usually diagnosed with the help of a positron emission tomography (PET) scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently covers one PET scan per age for dementia. It is not clear if the program plans to change that policy.

There is also concern that there may be too few specialist doctors and sites to administer the injection if Leqembi is widely adopted as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to years over the next decade depending on demand.

Thomas Phillipson, who advised the FDA commissioner and CMS official during the second Bush administration, said registration is an unnecessary hurdle and Medicare should drop it, but he doesn’t think the requirement will create an insurmountable barrier for patients arriving at Lekembe.

If Leqembi is in high demand, said Phillipson, an expert in health care economics at the University of Chicago, doctors will have an incentive to participate in the enrollment and drug companies will want to help.

He said how high the demand for Leqembi would be was uncertain. He said families concerned about serious side effects may choose not to take the treatment, while others will decide the benefits outweigh those risks.

Leqembi’s price and treatment benefit-risk profile are controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet the Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental medical coverage or other secondary insurance, depending on the agency.

Patients can face up to $6,600 in annual costs for Leqembi even with Medicare coverage, according to a study published in JAMA Internal Medicine. The study estimated that the treatment could cost Medicare up to $5 billion a year depending on how many people get the injections.

senator. Bernie Sanders, chairman of the Senate Health Committee, called Leqembi’s price “unreasonable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said the patient’s out-of-pocket costs for Leqembi would amount to one-sixth of seniors’ total annual income, and he noted that the higher cost of treatment could increase premiums for everyone on Medicare.

Leqembi’s annual list price of $26,500 is lower than the company’s estimate of $37,600 for the total value of the treatment per patient, Eisai says. The Institute for Clinical and Economic Review, a nonprofit organization that analyzes healthcare costs, estimated in April that it should be between $8,900 and $21,500 a year.

Although Leqembi could be costly for Medicare, Philipson said delaying treatment coverage would dramatically increase health care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to more serious illness requiring nursing home care. Expensive.

Phillipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of antibody therapies for Alzheimer’s disease by a year would lead to $6.8 billion in spending increases. By 2040, healthcare spending will increase by $248 billion.

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June to support the drug’s clinical benefit for patients. The committee was unusually small because some members had recused themselves due to conflicts of interest.

The American Academy of Neurology said in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial for Leqembi was well designed and that the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, have strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory committee that the evidence of the drug’s benefit did not outweigh the significant risks of brain swelling and bleeding.

Representatives from the National Center for Health Research and Physicians of America, also nonprofits, told the panel that the Eisai clinical trial did not include enough black patients, who are at a higher risk of developing Alzheimer’s disease.

Leqembi has been technically approved for the US market since January, when the US Food and Drug Administration (FDA) cleared the treatment under an accelerated course. The US Food and Drug Administration (FDA) uses accelerated approvals to save time and get drugs to critically ill patients faster.

But Medicare refused to cover Leqembi at the time, asking for more evidence that the expensive treatment had real clinical benefit for patients who outweigh the risks.

The program’s cautious coverage policy stems from the controversial Food and Drug Administration (FDA) approval in 2021 of another antibody treatment for Alzheimer’s disease called Aduhelm, which was also introduced by Eisai and Biogen.

An advisory committee for the US Food and Drug Administration (FDA) declined to approve Aduhelm because the data did not support a clinical benefit for patients. Three counselors resigned after the agency decided to approve the treatment anyway.

Knopman is one of the advisors who resigned because of the FDA’s decision on Adholm. He said that a date for Kimbe is different. Knopman said Esay ran a clean trial that showed the antibody had modest clinical benefit for patients.

A congressional investigation later found that the FDA’s approval of Adholm was “riddled with irregularities.”

In his letter to Becerra, Sanders said the FDA “has a special responsibility to restore the public’s trust following its inappropriate relationship with Biogen during the agency’s review of a previous Alzheimer’s disease drug, Aduhelm.”

Medicare said Friday it would allow drug companies to publicly discuss historical drug price negotiations for the program, ignoring a confidentiality requirement that the industry has argued violates the First Amendment in lawsuits filed this month.

In initial guidance issued in March, Medicare prohibited the industry from publicly disclosing information about the low price the federal government initially offered for targeted drugs under the program, as well as the government’s reasons for choosing that price point.

Medicare also prohibited the companies from disclosing any oral conversations during the negotiation period. It also requires companies to destroy any information within 30 days if the property is no longer selected for negotiations.

In revised guidance issued Friday, Medicare said the company “may choose to publicly disclose information related to ongoing negotiations at its discretion.”

The Inflation Reduction Act, passed last year, allowed Medicare to negotiate prices directly with drug companies for the first time. The program is a mainstay of the Biden administration’s efforts to control rising drug prices in the United States

merckAmerican Chamber of Commerce, Bristol-Myers Squibb The drug industry lobby group Pharmaceutical Research and Manufacturers in America asked federal courts this month to declare drug price negotiations unconstitutional.

Merck, Chamber, and Bristol Myers Squibb argued in their lawsuits that Medicare had imposed a gag order effectively banning companies from publicly disagreeing with the federal government’s position in violation of the First Amendment.

However, the industry lawsuits also focus on broader allegations that the software violates due process and expropriation of private property without fair compensation under the Fifth Amendment to the US Constitution.

Health and Human Services Secretary Xavier Becerra pledged on Friday to press ahead with negotiations despite lawsuits from the drug industry.

“Pharmaceutical companies have achieved record profits for decades,” Becerra said in a statement. “They are now lining up to block the work of this administration to negotiate better drug prices for our families.

“We will not back down,” Becerra said.

HHS will release a list of 10 high-cost drugs it has selected for negotiation by September. The companies have to decide whether to participate in the negotiations in the following month.

Drug makers who choose not to participate face severe financial penalties. They can avoid these penalties by ending their participation in Medicare and Medicaid drug discount programs.

The companies have argued that opting out of rebate programs is not a feasible alternative because the programs account for nearly half of the state’s annual spending on prescription drugs.

Pfizer On Monday, it said it would stop development of an experimental obesity and diabetes pill, called lutigliprone, because of elevated liver enzymes in patients who took the drug once daily in clinical studies.

These elevated enzymes often indicate damage to liver cells, but the pharmaceutical giant said no patients experienced liver-related symptoms or side effects.

Pfizer shares closed down 3.6 percent on Monday.

New York-based Pfizer said it would instead focus on its other oral obesity drug, danoglipron, which is in fully registered phase II clinical trials.

That study found that body weight decreased after patients with type 2 diabetes took high doses of danuglipron twice daily for 16 weeks, according to Pfizer results released last month.

The company expects to complete plans for a Phase 3 clinical trial program for danuglipron by the end of 2023. Pfizer added that it is also developing a version of danuglipron that patients take once a day instead of twice.

“We look forward to analyzing danuglipron’s Phase 2 results and selecting the dose and titration schedule that will maximize therapeutic benefits, safety, and tolerability,” William Sessa, Pfizer’s chief scientific officer for internal medicine, said in a press release.

Pfizer CEO Albert Bourla said the obesity pill could eventually bring in $10 billion each year for the company.

Lotiglipron, danuglipron, and Novo NordiskThe popular weight loss injections Ozempic and Wegovy are part of a class of medications called glucagon-like peptide-1 agonists.

They mimic a hormone produced in the gut called GLP-1, which sends signals to the brain when a person is full.

Medications can also help people manage type 2 diabetes because they stimulate the release of insulin from the pancreas, which lowers blood sugar levels.

Oral medications such as danuglipron from Pfizer can offer an advantage over frequent injections. Novo Nordisk and Eli Lilly They are also developing their own experimental pills for obesity and diabetes.

The new class of obesity drugs is sparking public interest and causing the weight-loss industry to go gold. But there is still uncertainty about its accessibility, and questions remain about how long patients need to take the drugs to shed unwanted weight.

Some people who stop taking medications complain of a return of weight that is difficult to control.

More than 2 in 5 adults are obese, according to the National Institutes of Health. About 1 in 11 adults is obese.

Analysts believe Eli Lilly’s pill has an edge over Pfizer’s danuglipron.

Pfizer’s decision to compete in the oral weight-loss drug space with danuglipron will be challenging given the strong data on Eli Lilly’s experimental pill orforglipron, Wells Fargo analyst Mohit Bansal said in a research note Monday.

Overweight or obese patients who took orforglipron once a day lost 14.7% of their body weight after 36 weeks, according to clinical trial results released by the company on Friday.

Bansal added that doctors generally prefer a one-a-day pill such as orforglipron over twice-daily danuglipron: “Depending on convenience, tolerability, and volume of weight loss, Forglipron is likely to be the factor to overcome,” Bansal added.

An advisory panel for the Centers for Disease Control and Prevention recommended Wednesday that adults 60 and older, after consultation with their physicians, receive a single dose of RSV vaccines from Pfizer And GSK.

The panel said older people should use “joint clinical decision making,” which involves working with their healthcare provider to determine how much they can benefit from a shot.

Outgoing CDC Director Rochelle Walensky will decide whether to finalize the recommendation.

The committee’s decision brings one step closer to making punches against respiratory syncytial virus available to the public this fall, when the disease usually begins to spread at higher levels.

The recommendation also comes weeks after the Food and Drug Administration approved both vaccines, making them the world’s first authorized shots against respiratory syncytial virus.

The virus is a common respiratory infection that usually causes mild cold-like symptoms, but causes more severe cases in the elderly and children. Each year, RSV kills between 6,000 and 10,000 older adults and a few hundred children under 5 years old, according to the CDC.

Pfizer and GSK on Wednesday submitted new clinical trial data to the panel, which provided the first glimpse of the picks’ durability after one season of RSV. The season usually lasts from October to March in the northern hemisphere.

A single dose of Pfizer’s shot was 78.6% effective in preventing lower respiratory tract infections with three or more symptoms during the middle of the second RSV season, according to new clinical trial results presented Wednesday. This is down from over 85% at the end of the first season in seniors.

Pfizer said efficacy dropped to 48.9% in the “mid-season 2” for less severe forms of the disease in that age group, down from about 66%.

The company said Wednesday that a single dose of the GSK shot was 78.8% effective against severe RSV disease after two seasons, compared to 94% after one season. Severe illness refers to conditions that prevent normal daily activities.

For less severe RSV disease, efficacy decreased to 67.2% during two seasons from 82% after one season.

doctor. Michael Melgar, the CDC medical officer who evaluated the data on both shots, noted during a public meeting that both Pfizer and GSK still lacked efficacy data for subgroups of the elderly population at high risk for RSV infection.

Melgar said adults age 75 and older with an underlying medical condition are underrepresented in Phase 3 clinical trials from both companies. He said that elderly people with weakened immune systems were excluded from the trials altogether.

Both companies said studies on this population are ongoing.

It’s still not clear how much the footage will cost. GSK said it would price its vaccine between $200 and $295. Pfizer said it will price it between $180 and $270.

The companies refused to guarantee pricing.

The picks will help the US battle the RSV season coming into the fall after an unusually intense RSV season last year.

Hospitals across the country have been overwhelmed by cases of the virus in children and the elderly, in large part because the public has stopped practicing Covid-sanitary measures that have helped keep the spread of RSV down.