Roche Drug Didn't Slow Alzheimer's Symptoms in Trial

 Roche Holding AG said Thursday that its crenezumab drug it is studying for the treatment of Alzheimer's disease didn't slow or prevent cognitive decline in patients in a trial.

The trial was conducted in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer's disease, the Swiss pharma company said.

"The trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function," Roche said.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-Says-Crenezumab-Drug-Didn-t-Slow-Alzheimer-s-Symptoms-in-Trial-40737223/

Investors worry that U.S. profit forecasts are too high

 

Concerns are growing that U.S. corporate earnings are increasingly at risk from dizzying inflation, a strong dollar and rising interest rates, complicating the outlook for investors already reeling from the S&P 500's bear market confirmation earlier this week.

While second-quarter profit growth forecasts have fallen in recent weeks, estimates for the third and fourth quarters and for all of 2022 have held up or risen, according to IBES data from Refinitiv. As of Friday, Wall Street analysts expected S&P 500 earnings to grow by 9.6% in 2022, up from 8.8% at the start of April and from 8.4% on Jan. 1.

Strategists worry those estimates are unlikely to hold up. Many expect more negative outlooks from U.S. companies in the coming weeks and said that guidance will then be reflected in consensus profit growth estimates.

Most S&P 500 companies will report second-quarter earnings after mid-July, and software giant Microsoft and retailer Target have been among the companies issuing dour outlooks in recent weeks.

"Estimates are too high, and you'll see them start to come down as the second-quarter numbers come out and as companies talk about what they're seeing," said Peter Tuz, president of Chase Investment Counsel.

Falling profit expectations could spell more trouble for a market that has been pummeled by worries over how an aggressive Federal Reserve response to surging inflation could hit growth.

The S&P 500 finished Monday more than 20% below its record closing high, confirming the index is in a bear market, according to a commonly used definition. The drop followed stronger-than-expected inflation data last week that ratcheted up expectations for how much the Fed will need to tighten monetary policy in order to tame consumer prices.

The Fed on Wednesday raised rates by 75 basis points, its biggest increase since 1994 and has now increased borrowing costs by a total of 150 basis points this year.

Worries that corporate profits are wavering could bolster the argument that stocks remain richly valued, even after their sharp decline this year. The S&P 500's forward 12-month price-to-earnings ratio stood at 17.1 as of Friday versus 22.1 at the end of December but was still above its long-term average of about 16, Refinitiv data showed.

Challenges facing U.S. companies include a stronger dollar, which was cited by Microsoft when the software-maker cut its fourth-quarter forecast for profit and revenue earlier this month. A stronger greenback typically eats into the profits of companies that have international operations and convert foreign currencies into dollars.

The U.S. currency is up about 9% so far this year and near a two-decade high against a basket of its peers, driven by expectations of higher U.S. rates and heightened geopolitical tensions.

After Microsoft's announcement, investors will be listening for what other software and tech companies like Adobe Inc and IBM have to say about currency issues in upcoming reports, said Daniel Morgan, portfolio manager at Synovus Trust. Adobe is due to release second-quarter results after the bell Thursday.

Also closely watched will be retailers and other consumer discretionary companies, which have struggled under the effects of surging inflation. Shares of Walmart and other big retailers took a hit last week after Target cut its quarterly profit margin forecast and said it would have to offer deeper discounts to clear inventory.

Other challenges include sky-high oil prices and rising interest rates, which have weighed on tech and growth stocks, whose valuations heavily rely on future cash flows. Recent COVID-related lockdowns in China could also take a toll.

"We expect the energy crunch to hit growth and higher labor costs to eat into profits. The problem: Consensus earnings estimates don't appear to reflect this," analysts at Blackrock wrote in a recent note on why they are not "buying the dip" in stocks.

To be sure, while consumer spending is "shifting," it does not seem to be slowing, said Steve DeSanctis, small- and mid-capitalization equity strategist at Jefferies. That may suggest some retailers could benefit from changing consumer habits, even as others feel the pinch.

At the same time, investors may already be pricing in expected hits to earnings given stocks' recent tumble, said Kristina Hooper, chief global market strategist at Invesco.

"The question becomes whether it comes so fast and furious that it really shakes market confidence even further," she said.

https://www.marketscreener.com/quote/stock/ADOBE-INC-4844/news/Analysis-Investors-worry-that-U-S-profit-forecasts-are-too-high-40737011/

Formula production halted at Abbott' Mich. plant in flooding after storms

 The Abbott Laboratories plant in Michigan that was at the center of the nation's baby formula crisis has stopped production again.

Production of its EleCare specialty formula was stopped after severe storms in southwestern Michigan flooded areas of its Sturgis, Michigan plant.

This is the same plant that forced Abbott to issue a recall of some of its formulas in February due to contamination issues.

The closure of the Sturgis facility, the largest in the U.S. and source of leading brands like Similac, exacerbated the industry-wide baby formula shortage. For several months, parents and caregivers have been scrambling as shelves increasingly become more barren. Meanwhile, retailers were forced to put purchasing limits on the product to try and curtail stockpiling.

The company, which has notified the U.S. Food and Drug Administration, said the incident will likely delay production and distribution of the infant formula for a few weeks.

"Abbott has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available," it said in a statement.

Ticker	Security	Last	Change	Change %
ABT	ABBOTT LABORATORIES	104.75	+1.74	+1.69%
Powered By

"Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. In parallel, we will work to restart Similac production at the plant as soon as possible," the statement continued.

US Food and Drug Administration Commissioner Dr. Robert Califf responded to the issue on Twitter Wednesday night writing, "Today, we were made aware of the weather-related situation at Abbott’s Sturgis, Mich. facility. I personally spoke to the CEO tonight and we discussed our shared desire to get the facility up and running again as quickly as possible."

Califf went on to call the situation an "unfortunate setback" and reassure consumers that "the all-of-government work to increase supply means we’ll have more than enough product to meet current demand."

"Abbott has been exceeding the monthly quantity of formula that it produced in 2021 – all while the Sturgis facility is out of production. Other producers also continue to make formula at higher-than-average rates, and we continue to exercise flexibility to import add'l formula," Califf added. "This means that the total amount of formula available, even before the Sturgis plant is back in production, exceeds the demand for formula prior to the recall."

Califf said Abbott will report its progress repairing the plant to the FDA in the coming days. The FDA will then return to the plant to ensure it can restart production safely. 

"Making sure that parents and caregivers have access to both safe and available infant formula remains a top priority for the FDA, and our teams are working night and day to help make that happen," Califf said.

Abbott is only one of four companies, including Gerber, Perrigo and Reckitt, that produce an estimated 90% of U.S. formula.

https://www.foxbusiness.com/lifestyle/abbott-baby-formula-production-halted-michigan-plant-storms

Medicare projections from CBO and the program’s trustees

 The Congressional Budget Office (CBO) and the board of trustees charged with overseeing Medicare’s financial health recently released updated forecasts of the program within days of each other. These latest reports are valuable starting points for examining Medicare’s current status and likely future course.

CBO’s Medicare estimates, released on May 25th, are included in its full reassessment of the national economy and federal budget. The volume provides detailed estimates for all federal tax provisions and spending programs over ten years. It also briefly mentions its updated longer-term forecast, covering the next thirty years (the long-term projections will be discussed in detail in a standalone report the agency is planning to issue in July).

On June 2nd, the Medicare trustees released their statutorily-required annual report, which includes income and cost projections covering 75 years.

Neither of the new forecasts breaks significant ground. Medicare’s income and outgo are expected to track fairly closely with the estimates from last year’s reports. Even so, as is always the case, several data points are worth highlighting.

 

• HI’s Date of Depletion. CBO expects Medicare’s Hospital Insurance (HI) trust fund will be depleted of its reserves in 2030, which is three years later than it projected in July 2021. The Medicare trustees are more pessimistic than CBO, and project HI trust fund exhaustion in 2028.

Both forecasts reveal large cumulative deficits in HI over the coming decade. CBO projects a ten-year HI deficit of $190 billion over the period 2022 to 2031. The Medicare trustees expect a larger deficit, of $380 billion (the trustees forecast covers calendar years, while CBO’s is based on fiscal years).

The trustees note that their projections assume HI spending will continue at the levels specified in current Medicare law even though exhaustion of the trust fund’s reserves would force spending cuts to keep outlays in line with incoming receipts. There is no precedent for how such cuts would be implemented in the unlikely event Congress failed to act to avert insolvency.

• Sources of Spending Growth. Medicare spending is surging as enrollment grows and spending per person escalates with more intensive use of services. The Medicare trustees expect enrollment to add an average of 2.1 percentage points to annual HI spending growth over the next decade, and 2.2 percentage points to Medicare part B. More use of services, and more intensive services per encounter, will add another 2.5 percentage points to HI spending growth, 4.5 percentage points to part B, and 1.5 percentage points to part D.

Overall, both the Medicare trustees and CBO project total program spending growth will average 7.8 percent annually through 2031.

In 2050, CBO projects gross Medicare spending will reach 7.3 percent of GDP, while the trustees expect it to be lower, at 6.2 percent of GDP. In 2021, the ratio of Medicare spending to GDP was 3.9 percent.

• Program Enrollment. As noted, Medicare is under financial pressure in part because of growing program enrollment. As the U.S. populations ages (and the full baby boom generation crosses age 65), both Social Security and Medicare are serving many millions of additional beneficiaries.

In 2021, there were 63 million people enrolled in the HI program. By 2031, CBO expects HI enrollment to reach 76 million, while the trustees forecast an increase to 78 million.

• Medicare Advantage. Both CBO and the trustees expect the trend toward increased enrollment in Medicare Advantage (MA) to continue. By 2031, CBO projections MA enrollment of 43 million, which would be 57 percent of all Medicare participants. The trustees expect MA enrollment to grow to 41 million in 2031, or 53 percent of the full number of Medicare participants.

• Prescription Drug Costs. CBO’s forecast of prescription drug expenses in Medicare part D reveals more rapid growth than is reflected in the report from the Medicare trustees. Over the period 2022 to 2031, CBO projects part D spending growth will average 8.0 percent annually, while the Medicare trustees forecast an average annual rate of 4.8 percent.

• Economic Assumptions. Both CBO and the Medicare trustees based their projections on economic assumptions that already might be out of date. CBO assumes the consumer price index (CPI) will rise 4.7 percent in 2022 and 2.7 percent in 2023, and that the economy will grow in real terms by 3.1 percent in 2022 and 2.2 percent in 2023. The Medicare trustees (using the same assumptions that are also used for the Social Security forecast) expect the CPI to rise by 4.5 percent in 2022 and 2.3 percent in 2023 while the economy would grow in real terms by 3.9 percent in 2022 and 2.8 percent in 2023.

With inflation running above 8 percent through at least May, it will be difficult for the CPI to fall to the levels assumed in CBO’s forecast or the Medicare trustees’ report. Further, it is possible that aggressive monetary tightening in the second half of 2022 will trigger a recession (perhaps in 2023), which would substantially disrupt the forecasts in both reports. In a recession, it is possible that the HI trust fund would run through its remaining reserves rapidly.

Further, high inflation is likely to increase the political pressure in Congress to raise what Medicare pays for hospital and physician services. Under current law, Medicare’s payments will rise at rates that are well below general inflation, which means the providers of these services will experience real reductions in their Medicare receipts. If Congress steps in and provides relief, Medicare’s financial outlook may become even more challenging than is reflected in the recently-issued reports.

 

While both CBO and the Medicare trustees project a modest improvement in their forecasts of the HI trust fund relative to projections from 2021, there is a high degree of uncertainty around the current estimates. Thus, it remains important for Congress to act sooner rather than later to stabilize the program’s finances. Delay will only increase the chances that a change in circumstances will force an abrupt legislative response.

James C. Capretta is a columnist for State of Reform and a senior fellow at the American Enterprise Institute.

https://stateofreform.com/commentary/2022/06/medicare-projections-from-cbo-and-the-programs-trustees/

Every state but Florida pre-ordered COVID-19 vaccines for kids under 5

 Every state has placed an order with the federal government to ensure coronavirus vaccines for young children are delivered as soon as regulators authorize their use — except for one.

 Florida missed a Tuesday deadline to request delivery of COVID-19 pediatric vaccines for children under 5, guaranteeing a delay in access for parents across the state, according to two U.S. government sources. All other 49 states placed pre-orders, which will be delivered in two tranches beginning as early as Monday to thousands of pediatricians’ offices, children’s hospitals, pharmacies and health centers across the country. Those facilities in Florida will not have access during this time and will remain without supply until Florida places an order. 

 Jeremy Redfern, press secretary for the Florida Department of Health, confirmed the department “chose not to participate” in the vaccination program because the state health department is not following federal public health recommendations.

 “The Florida Department of Health has made it clear to the federal government that states do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” Redfern said. 

 “It is also no surprise we chose not to participate in distribution of the COVID-19 vaccine when the Department does not recommend it for all children,” Redfern said. “Doctors can order vaccines if they are in need, and there are currently no orders in the Department’s ordering system for the COVID-19 vaccine for this age group.”

 Florida’s surgeon general and secretary of the state department of health, Joseph Ladapo, has long criticized vaccination requirements for adults. In March, he recommended against vaccinating healthy kids, and the News Service of Florida reported Wednesday that Ladapo would not support inoculating the state’s youngest children either — frustrating pediatricians who say the need for COVID vaccines is clear.

 “I think people like DeSantis and the surgeon general just make it much more difficult for [doctors] to do anything about getting folks to vaccinate their children,” said Dr. Louis St. Petery, a Tallahassee pediatric cardiologist who treats children with some of the highest risks for contracting COVID-19 due to their heart issues. 

Petery said he treated a 4-year-old who was missing one heart chamber. Contracting COVID-19 would cause serious health consequences for that child, as those with heart issues are among those at highest risk for complications from COVID-19. 

“This kid would be a logical candidate to get the 5-and-under vaccine, which [the state] didn’t ask for and we’re not going to be early in getting it,” Petery said. Politics & Policy in the Sunshine State Our weekly newsletter looks at the issues and ideas emerging from the Florida Capitol. 

 HOSPITALS WERE ‘READY TO GO’

 Children under 5 are the last remaining individuals still ineligible for coronavirus vaccines as vaccine manufacturers and regulators have conducted lengthy trials and data reviews. An independent advisory committee for the Food and Drug Administration met over the past two days to review data submitted by Pfizer on its vaccine for children under 5, and by Moderna on its vaccine for those under 6, and endorsed the vaccines for children over six months old. 

A separate advisory panel for the Centers for Disease Control and Prevention will meet on Friday and Saturday to make recommendations for the use of the vaccines. The CDC director could then sign off on distribution as early as this weekend, making shots available as early as Monday.

 “We are prepared to make vaccines readily available for our youngest kids pending FDA and CDC decisions, and we will deploy them as quickly as possible to their distribution channels for administration,” said a U.S. government source.

 “Without Florida ordering vaccines, pediatricians and children’s hospitals will initially be without vaccines, and Florida kids will be severely limited in their ability to get vaccinated.” 

All pre-orders are expected to be delivered in the first week and a half of availability across the rest of the country. Parents in Florida seeking vaccines for their children will still have two options to access the shots. Some community health centers have ordered vaccines directly through the federal government. And federal pharmacy partners will also have supply, although several chains will be prioritizing children ages 3 and up.

 In Florida, 11 retail pharmacies are enrolled in the Federal Retail Pharmacy Program for COVID-19 vaccines, including CVS Health, Walgreens, Publix, Costco and Kroger. Southeastern Grocers — the parent company of Winn-Dixie, Fresco y Mas, and Harveys Supermarket — as well as Walmart, which owns Sam’s Club, are also enrolled. If the new pediatric vaccine gets authorized, Walgreens, Walmart and Southeastern Grocers plan to administer the vaccine to children as young as 3 at select stores in Florida. CVS Health — which owns traditional CVS stores, Navarro Discount Pharmacies and CVS y mas — said it plans to provide the shots to kids as young as 18 months across the country through its 1,100 MinuteClinic locations. Joe DiMaggio Children’s Hospital in Hollywood, part of Memorial Healthcare System, will be one facility heavily affected by a vaccine delay, as the state is its supplier of COVID-19 vaccines.

 “What we plan to do now is have everything operationalized and ready to go for as soon as we have the vaccine in hand and be able to administer it,” said Dr. Ronald Ford, chief medical officer at the children’s hospital. Ford said the hospital’s director of pharmacies did place an order “requesting that when the vaccine was available in the state that we would receive doses.”

 Ford isn’t sure when the hospital would get the newly authorized vaccine for children under 5. Plans are in place to set up small clinics that will accept appointments for children to get the doses as soon as possible.

 “I think there are parents out there who are anxiously awaiting this,” he said.

https://www.miamiherald.com/news/politics-government/article262537502.html

Bubs Australia shares surge on infant formula supply deal with Walmart

 Shares of Bubs Australia jumped on Thursday after the company signed a deal to supply its infant formula products to U.S. retail giant Walmart amid a baby food shortage in the world's largest economy.

Walmart plans to buy a shipment of six Bubs Infant Formula and two Aussie Bubs Toddler Formula products, which would be delivered to about 800 Walmart stores across the United States, Bubs Australia said, adding that the new supply built on its existing online product sales on Walmart.com channel.

Shares of Bubs Australia rose as much as 10.6% to A$0.625 in morning trade, valuing the company at about A$383 million ($268.94 million).

"The addition of Walmart will increase our bricks and mortar exposure in the United States over the coming days and weeks to around 4,800 stores across 35 states," Chief Executive Officer Kristy Carr said.

The 4,800-store footprint includes the first Bubs Australia consignment bought by retailers Kroger and Albertsons.

Bubs Australia recently signed a deal with the U.S. government to supply more than a million tins of infant formula to help the country address the baby food supply crisis.

The crisis was triggered when Abbott Laboratories recalled dozens of its brands in February after consumers complained of infants contracting bacterial infections.

https://finance.yahoo.com/news/bubs-australia-shares-surge-infant-015345854.html

Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants

 Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The antibodies were effective against all SARS-CoV-2 variants of concern tested and could be used alone or in an antibody cocktail to diminish the risk of infection.

Researchers from the Institut Pasteur, Université Paris Cité, and INSERM examined 102 SARS-CoV-2 spike monoclonal antibodies cloned from the B cells of 10 COVID-19 convalescents. They found that the antibodies Cv2.1169 and Cv2.3194 were the only ones to neutralize all SARS-CoV-2 variants, including Omicron BA.1 and BA.2 subtypes. The two antibodies also were fully active against Alpha, Beta, Gamma, and Delta variants. A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

“The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention. Therefore, we are pretty confident that they represent premium candidates for pre-exposure prophylaxis in immunocompromised patients,” says Hugo Mouquet, head of the Laboratory of Humoral Immunology at the Institut Pasteur, who led the study.

Previous research has shown that SARS-CoV-2 spike-specific monoclonal antibodies play a key role in providing in vivo protection and have been used in developing COVID-19 vaccines. However, immunocompromised individuals still lack effective immunity against SARS-CoV-2 infection.

“A key point is that those monoclonals have been engineered for extending their half-lives and therefore have an expected prolonged effect in people but would still require regular injections, possibly every few months, to maintain protective antibody titers,” Mouquet says. The first molecule being developed based on the new research, SPK001, is being studied by the biotech company SpikImm, and clinical trials are expected to start in the middle of this year.

The research has its roots in a task force launched by the Institut Pasteur in the early days of the COVID-19 pandemic. The Mouquet lab focused its efforts on immunotherapeutics because of its ongoing study of human antiviral monoclonal antibodies, including molecules of prophylactic and/or therapeutic potential against HBV and HIV-1.

Notably, one of the two broadly neutralizing antibodies, Cv2.1169, is a type of antibody known as immunoglobulin A that is produced by B cells in the body’s mucosal tissues, such as the respiratory tract, and can be crucial in the early response to respiratory pathogens like SARS-CoV-2.  

“One aspect of our work highlights the role of IgA antibodies for a broad SARS-CoV-2 neutralization. When studying immune responses against pathogens affecting mucosal tissues, we thus consider that IgA-mediated antibody response should be systematically investigated, including in the quest of isolating broadly neutralizing monoclonal antibodies,” Mouquet says.

 

Planchais et al. 2022. J. Exp. Med. https://rupress.org/jem/article-lookup/doi/10.1084/jem.20220638?PR

 

# # #

About Journal of Experimental Medicine

Journal of Experimental Medicine (JEM) publishes peer-reviewed research on immunology, cancer biology, stem cell biology, microbial pathogenesis, vascular biology, and neurobiology. All editorial decisions on research manuscripts are made through collaborative consultation between professional scientific editors and the academic editorial board. Established in 1896, JEM is published by Rockefeller University Press, a department of The Rockefeller University in New York. For more information, visit jem.org.

Visit our Newsroom, and sign up for a weekly preview of articles to be published. Embargoed media alerts are for journalists only.

Follow JEM on Twitter at @JExpMed and @RockUPress.

---

JOURNAL

Journal of Experimental Medicine

DOI

10.1084/jem.20220638 

METHOD OF RESEARCH

Experimental study

SUBJECT OF RESEARCH

Animals

ARTICLE TITLE

Potent human broadly SARS-CoV-2–neutralizing IgA and IgG antibodies effective against Omicron BA.1 and BA.2

ARTICLE PUBLICATION DATE

15-Jun-2022

COI STATEMENT

C. Planchais reported a patent to PCT/EP2022/ 058777 licensed (SpikImm). I. Fern´andez reported a patent to PCT/EP2022/058777 licensed (SpikImm). T. Bruel reported a patent to PCT/EP2022/058777 licensed (SpikImm). G.D. deMelo reported a patent to PCT/EP2022/058777 licensed (SpikImm). P. Charneau reported personal fees from TheraVectys outside the submitted work; in addition, P. Charneau had a patent for seroneutralization pending. S. van der Werf reported a patent for the use of proteins and peptides coded by the genome of a novel strain of SARS-associated coronavirus issued and a patent for SARS-associated coronavirus diagnostics issued. H. Bourhy reported a patent to PCT/EP2022/058777 licensed (SpikImm) and a patent to PCT/IB2021/000314 issued. X. Montagutelli reported a patent to PCT/EP2022/058777 licensed (SpikImm). F.A. Rey reported a patent to PCT/EP2022/058777 licensed (SpikImm). O. Schwartz reported a patent to PCT/EP2022/058777 licensed (SpikImm). H. Mouquet reported grants from SpikImm and personal fees from SpikImm during the conduct of the study; in addition, H. Mouquet had a patent to PCT/EP2022/058777 licensed (SpikImm). No other disclosures were reported.

https://www.eurekalert.org/news-releases/956152