Raphael Stevens

Novo Nordisk asked the Food and Drug Administration to prevent compounding pharmacies from making cheaper versions of its popular weight loss injection Wegovy and diabetes treatment Ozempic.
The Danish drugmaker contends the medications are too complex for those manufacturers to make safely. 
The FDA still has to make a final decision on whether to bar those unapproved versions of semaglutide, the active ingredient in Ozempic and Wegovy.

Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy.
Hollie Adams | Reuters

Novo Nordisk on Tuesday asked the Food and Drug Administration to prevent compounding pharmacies from making unapproved and often cheaper versions of its popular weight loss injection Wegovy and diabetes treatment Ozempic, arguing that the medications are too complex for those manufacturers to make safely. 
The FDA still has to make a final decision on whether to bar compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. In a statement, the agency said it is reviewing the petition and will respond directly to Novo Nordisk.

The move is Novo Nordisk’s latest attempt to crack down on potentially harmful copies of semaglutide after it filed 50 lawsuits against several clinics, compounding pharmacies and other manufacturers over the last year. It comes as the Danish drugmaker tries to ramp up the supply of semaglutide to meet unprecedented demand in the U.S.
Patients have turned to compounded versions of semaglutide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per month before insurance and other rebates. Many health plans don’t cover semaglutide for weight loss, making compounded versions a more affordable alternative.
Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet FDA requirements. 
The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. The lowest dose of Wegovy is currently in short supply, but all other doses of the drug and Ozempic are listed as available, according to the FDA’s drug shortage database. 
But Novo Nordisk late Tuesday nominated semaglutide to the FDA’s “Demonstrable Difficulties for Compounding” lists, which include complex drugs that compounders are not allowed to make, even during shortages, because they could potentially pose safety risks. 

“Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them,” Novo Nordisk said in a statement. 
The Danish drugmaker cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and instances where a compounded product contained no semaglutide at all. 
“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk said in a statement. The company said its “aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide products.”
The FDA has previously warned about the risks of using compounded versions of so-called GLP-1s such as semaglutide. That refers to a buzzy class of medications that mimic hormones produced in the gut to tamp down a person’s appetite and regulate their blood sugar. 
Earlier this month, the FDA said compounded versions of semaglutide and similar drugs can be risky for patients because they are unapproved, meaning the agency does not review their safety, effectiveness and quality before they are put out in the market. 
The FDA in August also said it had received reports of patients overdosing on compounded semaglutide due to errors such as patients self-administering incorrect amounts of a treatment. 
Both Wegovy and Ozempic are under patent protection in the U.S. and abroad, and Novo Nordisk and its rival Eli Lilly do not supply the active ingredients in their drugs to outside groups. The companies say that raises questions about what some manufacturers are selling and marketing to consumers.
Tirzepatide is the active ingredient in Eli Lilly’s weight loss injection Zepbound and diabetes treatment Mounjaro. 
Like Novo Nordisk, Eli Lilly has sued several weight loss clinics, medical spas and compounding pharmacies across the U.S. over the past year. 
Notably, the FDA took tirzepatide off its shortage list earlier in October after more than a year, even as some pharmacies say they are still struggling to stock up on the branded versions of that drug. A trade group representing some compounders sued the FDA, which led the agency to say it will reconsider its decision to remove tirzepatide from its shortage list.

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The median price of an existing home sold in September was $404,500, an increase of 3% year over year.
Inventory rose 1.5% month to month to 1.39 million homes for sale at the end of September.

Sales of previously owned homes fell 1% in September compared with August, to a seasonally adjusted, annualized rate of 3.84 million units, the slowest pace since October 2010, according to the National Association of Realtors.
Sales were 3.5% lower than in September 2023. Sales fell in three out of four U.S. regions, with just the West region seeing a gain.

This count is based on closings, representing contracts signed likely in July and August. Mortgage rates started July near 7% on the 30-year fixed and then fell slowly through August to just below 6.5%. Rates are now more than a full percentage point lower than they were a year ago.
“Home sales have been essentially stuck at around a four-million-unit pace for the past 12 months, but factors usually associated with higher home sales are developing,” said Lawrence Yun, chief economist for the National Association of Realtors.

A “For Rent, For Sale” sign is seen outside of a home in Washington, U.S., July 7, 2022. 
Sarah Silbiger | Reuters

Inventory rose 1.5% month to month to 1.39 million homes for sale at the end of September. That represents a 4.3-month supply at the current sales pace. Inventory was 23% higher from September 2023.
“More inventory is certainly good news for home buyers as it gives consumers more properties to view before making a decision,” Yun said. “However, the inventory of distressed properties is minimal because the mortgage delinquency rate remains very low. Distressed property sales accounted for only 2% of all transactions in September.”
The pressure of still low inventory continues to push prices higher. The median price of an existing home sold in September was $404,500, an increase of 3% year over year and the 15th consecutive month of annual price gains.

Cash continues to be king in this market, making up 30% of September sales. Pre-Covid, cash buyers made up about 20% of sales. Yun noted that it is not just investors using cash, as investors actually pulled back slightly in September to just 16% of sales, down from 19% in August.
Homes are sitting longer, an average of 28 days compared with just 21 days a year ago. First-time buyers pulled back again, making up just 26% of September sales. That matches the all-time low from August.  More

Coca-Cola posted earnings and revenue that topped expectations.
Higher prices helped to offset sluggish demand for beverages.
Coke said it now expects organic revenue growth of about 10% this year, the high end of its previous range.

Coca-Cola on Wednesday reported quarterly earnings and revenue that topped analysts’ expectations, thanks to a boost from higher prices that offset sluggish demand.
Shares of the company fell 2% in premarket trading.

Here’s what the company reported compared with what Wall Street was expecting, based on a survey of analysts by LSEG:

Earnings per share: 77 cents adjusted vs. 74 cents expected
Revenue: $11.95 billion adjusted vs. $11.60 billion expected

Coke reported third-quarter net income attributable to shareholders of $2.85 billion, or 66 cents per share, down from $3.09 billion, or 71 cents per share, a year earlier.
Excluding items, the company earned 77 cents per share.
Adjusted net sales of $11.95 billion were roughly flat from a year earlier. Coke’s organic revenue, which strips out the impact of acquisitions, divestitures and currency, climbed 9% during the quarter.
Unit case volume fell 1% in the quarter, driven by weakening demand in some international markets. The metric strips out the impact of pricing and foreign currency to reflect demand. Consumer companies, including Coke, have reported in recent months that customers are more price sensitive, leading to sluggish demand for its products as prices remain high.

Even so, Coke in recent quarters has been besting rival PepsiCo, which has been dealing with the fallout from Quaker Foods recalls, in addition to a U.S. consumer who has been snacking and drinking less. Pepsi said volume for its North American beverage business fell 3% in its third quarter, fueled by weakening demand for energy drinks.
Coke’s unit case volume in North America was flat for the quarter, as shrinking demand for its water, sports, coffee and tea products offset growth in its namesake soda, juice, dairy, plant-based beverages and sparkling flavors.
But unit case volume fell 2% in both the company’s Europe, Middle East and Africa and Asia-Pacific regions. The company called out volume declines in China and Turkey specifically. Like North America, Latin America reported flat volume.
Globally, volume for Coke’s sparkling soft drinks, like Sprite, and for its namesake soda were both flat for the quarter. The company’s juice, dairy and plant-based beverages division reported a 3% decline in volume. Its water, sports, coffee and tea segment saw volume fall 4%, fueled by a 6% drop in bottled water.
Coke said its pricing rose 10%. Roughly 4% of that increase comes from markets experiencing intense inflation, like Argentina, while the rest is the result of price hikes and customers trading up to pricier options.
For 2024, Coke now expects organic revenue growth of roughly 10%, on the high end of its prior range of 9% to 10%. The company reiterated its projection that comparable earnings per share will rise 5% to 6%.
Coke will provide its full 2025 outlook when it reports fourth-quarter earnings, but the company is already expecting currency to hurt its results next year. Coke is projecting a low-single-digit headwind for comparable revenue and a mid-single-digit headwind for earnings per share.

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Boeing’s new CEO Kelly Ortberg said the company must focus on its core business ahead of his first earnings call since taking the top job in August.
Boeing’s more than 32,000 striking machinists will also vote on a new contract proposal on Wednesday that could end a more than five-week work stoppage.
The manufacturer is bleeding cash and is preparing to raise billions in equity or debt after lost more than $6 billion in the last quarter.

Workers picket outside the Boeing Co. manufacturing facility during a strike in Renton, Washington, US, on Thursday, Oct. 3, 2024. 
David Ryder | Bloomberg | Getty Images

Boeing’s new CEO Kelly Ortberg said the company needs to become leaner and improve quality, a vision he laid out for the troubled plane manufacturer ahead of his first quarterly call with analysts on Wednesday. At the same time, thousands of striking Boeing machinists will vote on a new labor contract, and Ortberg said he was hopeful for a deal.
Boeing reported a more than $6 billion loss for the third quarter, its largest since 2020 when the pandemic halted most aircraft demand and its best-selling airplane was grounded after two crashes.

Boeing had released preliminary third-quarter results earlier this month, showing revenue of $17.8 billion, down less than 2% from a year earlier, as well as a loss of $9.97 a share and an operating cash outflow of $1.3 billion. It disclosed charges of more than $5 billion across its commercial and defense units and said it ended the third quarter with $10.5 billion in cash and marketable securities.
Its commercial airplane unit’s losses swelled to more than $4 billion from a $678 million loss a year before. The charges were related to the additional delay of the debut of its 777X wide-body aircraft to 2026 and another delay tied to the 767. Boeing plans to end production of the 767 when orders are fulfilled in 2027.
Its defense unit lost $2.4 billion in the third quarter from $924 million in the same period of 2023, with charges tied to several programs, including the KC-46 tanker and the troubled Starliner. The Starliner capsule returned empty from the International Space Station this summer, without the two NASA astronauts it originally carried to space.
Here’s what the company reported versus what Wall Street analysts surveyed by LSEG, formerly known as Refinitiv, expected:

Loss per share: $10.44 adjusted. That may not compare with an adjusted loss of $10.52 expected by LSEG.
Revenue: $17.84 billion vs $17.82 billion expected

Ortberg, a former CEO of Rockwell Collins, took the helm of Boeing in August, tasked with restoring the company’s reputation and stamping out quality problems on aircraft and in other programs. In January, a door plug blew out minutes into an Alaska Airlines flight on a 737 Max 9 after key bolts weren’t reinstalled before the plane left Boeing’s factory. The near-catastrophe reignited safety concerns from regulators and customers.

“We need to know what’s going on, not only with our products, but with our people,” Ortberg said Wednesday. “And most importantly, we need to prevent the festering of issues and work better together to identify, fix, and understand root cause.”
Ortberg acknowledged that it will take some time to turn the ship.
“We have employees who are thirsty to get back to the iconic company they know, setting the standards for the products that we deliver,” he said.
Ortberg earlier this month said Boeing will slash 10% of its global workforce of about 170,000 people, hinting at a slimmer manufacturer. He is expected to face questions on the call about which units or projects the company will consider shedding.
“We need to reset priorities and create a leaner, more focused organization,” he said in his prepared remarks.

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The most pressing issue for Boeing this week is ending a costly labor strike that has hobbled its factories in the Seattle area, where most of its aircraft are produced. More than 32,000 machinists walked off the job early Sept. 13, about two weeks before the quarter ended, after overwhelmingly voting down a contract that included 25% raises, among other changes. A new proposal, unveiled Saturday, included 35% raises over four years, a higher signing bonus and 401(k) contributions, and other improvements.
The strike costs Boeing $1 billion a month, according to S&P Global Ratings, and getting to a speedy conclusion is crucial for the fragile aerospace supply chain, where furloughs are already beginning.
“We have been feverishly working to find a solution that works for the company and meets our employees’ needs,” Ortberg said.
The deal includes a commitment from Boeing to build its next aircraft in the Pacific Northwest. That has been a sore spot for unionized machinists after Boeing moved its 787 Dreamliner production to a non-union facility in South Carolina.
“Boeing is an airplane company and at the right time in the future we need to develop a new airplane. But we have a lot of work to do before then,” Ortberg said Wednesday.
Analysts are optimistic that the deal will pass. Results of the labor vote are expected late Wednesday night. More