A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Good afternoon! Wegovy, the blockbuster weight loss treatment from Novo Nordisk, tops the list of drugs that could soon become part of the second round of price negotiations between manufacturers and Medicare. 

That’s according to a paper published last week in the Journal of Managed Care & Specialty Pharmacy. By February, the government will unveil the next 15 costliest Medicare Part D drugs that will be subject to the talks, for price changes that will go into effect in 2027. 

The Biden administration last month announced new negotiated prices for the first 10 Medicare Part D drugs selected for the talks. Those prices will take effect in 2026. 

Medications containing the same active ingredient and manufactured by the same company will be considered a single drug for the talks, according to guidance from the Centers for Medicare & Medicaid Services. The researchers said that’s why they expect all of Novo Nordisk’s three branded drugs containing semaglutide – Wegovy, the diabetes injection Ozempic and an older diabetes pill called Rybelsus – to be selected for the talks as a single product.

That may be a big deal for older adults who use those treatments, which each carry price tags of around $1,000 per month before insurance. However, it’s still unclear how much Medicare could negotiate down those costs — and how much patient costs would fall after insurance and rebates. 

The Biden administration, lawmakers and patient advocates have long criticized the Danish drugmaker for the high list prices of its obesity and diabetes drugs. Novo Nordisk’s CEO Lars Fruergaard Jørgensen faced a Senate grilling on Tuesday over those prices. 

While Jørgensen did not commit to lowering prices of Wegovy and Ozempic, he vowed to “collaborate” with pharmacy benefit managers “on anything that helps patients get access and affordability.” He also pushed back on Medicare price negotiations when asked about the potential selection of Wegovy and Ozempic, calling the talks “price-setting” that will have negative consequences for drug innovation.

Medicare Part D doesn’t cover weight loss treatments unless they are approved and prescribed for another health condition. But Wegovy could make the list for negotiations because it is now approved to reduce the risk of major cardiovascular complications, making it likely that some Part D plans have started covering the treatment, according to the researchers. 

Under CMS guidance, drugs must be on the market for at least seven years without generic competitors before Medicare can select them for price talks. Semaglutide will have been on the market for seven years and one month by February and does not have any generic equivalents.

Other researchers and Wall Street analysts have said they expect Ozempic to be subject to negotiations because of how much Medicare Part D spends on the treatment. 

The program spent more than $5.6 billion on semaglutide drugs in 2022, which only reflects spending on Ozempic and Rybelsus since Wegovy was not covered at the time, the paper said. Researchers also projected that Medicare Part D spent nearly $7.5 billion on Ozempic and Rybelsus in 2023, which is $3 billion higher than spending for the second-highest eligible drug. 

They noted they likely “underestimated” their projected spending figures for semaglutide

The other drugs expected to be subject to price talks include GSK‘s Trelegy Ellipta, a prescription inhaler used to treat asthma and chronic obstructive pulmonary disease, and Xtandi, a rheumatoid arthritis medication from Astellas Pharma. 

Still, researchers said the final list of drugs selected will depend on whether generic versions launch before February. 

We’ll be following the next round of Medicare drug price negotiations closely, so stay tuned for our coverage. 

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Data startup Particle Health on Monday filed an antitrust lawsuit against Epic Systems, a software vendor that houses medical records for around 280 million patients in the U.S.

Particle alleges that Epic is using its dominance in the electronic health records space to stifle competition in other markets that use this data. The suit was filed in the Southern District of New York. 

Oracle and Meditech are other prominent companies in the electronic health records segment, and patients often have data stored across multiple vendors. Even so, Epic is a formidable competitor. The company commands the most acute care market share in the U.S., covering more than half all acute care multispecialty beds, according to a report from KLAS Research. Additionally, Epic was the only vendor that saw a net increase in this market share in 2023, the report said.  

Particle’s lawsuit comes after the two companies clashed over data-sharing practices earlier this year. Epic and Particle both belong to an interoperability network called Carequality, which helps facilitate a large-scale exchange of patient information.

Epic filed a formal dispute with Carequality in March, citing concerns that Particle and its participant organizations “might be inaccurately representing the purpose associated with their record retrievals.” To join the Carequality network, organizations must be approved and abide by “Permitted Purposes,” generally having to do with treatment, for the exchange of patient records.

In its 81-page complaint, Particle said Epic’s dispute was “manufactured” and that Epic asserted some Particle customers, not Particle itself, were obtaining records improperly. Particle said Epic used its “outsized influence” over Carequality to get a favorable outcome, and argues that it has suffered damages because of Epic’s conduct.

“Absent repercussions, Epic will be incentivized to run this playbook again the next time a competitor emerges,” Particle said in a release Monday.

Epic said it will “vigorously defend itself against Particle’s meritless claims,” and that it will continue to protect patients’ privacy.

“Particle’s claims are baseless. This lawsuit attempts to divert attention from the real issue: Particle’s unlawful actions on the Carequality health information exchange network violated HIPAA privacy regulations,” an Epic spokesperson told CNBC in a statement Tuesday. “Particle’s complaint mischaracterizes Carequality’s decision, which in fact proposes banning Particle customers that were accessing patient data for impermissible purposes.” 

It will likely be a while before there’s a definitive ruling, as antitrust cases often move slowly. Google, for instance, lost an antitrust case last month that was originally filed in 2020. A federal U.S. judge ruled that the company illegally held a monopoly over text advertising and search.

You can read the full Particle complaint against Epic here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

Moderna on Thursday said it plans to cut around $1.1 billion in expenses by 2027 and win approvals for several new products as it charts a path forward after the rapid decline of its Covid business. 

The biotech company said it expects 10 new product approvals through 2027. But Moderna said it will also pause work on some products in its pipeline and scrap others, as it aims to “pace ourselves” in new research and development spending. 

The company aims to trim R&D spending to a range of $3.6 billion to $3.8 billion in 2027, down from an expected $4.8 billion at the end of this year, according to a release.

“You’re going to start seeing things come down because there are some studies that we are going to basically sunset and we’re not going to start,” Moderna CEO Stephane Bancel told CNBC, adding that the company is putting its latent product portfolio “on hold.” That refers to a category of viruses that linger inside patients for prolonged periods without causing any symptoms but can reactivate and cause serious health complications later in their lives. 

Still, shares of Moderna fell more than 15% on Thursday.

Leerink Partners analyst Mani Foroohar said in an email Thursday that the company’s updates “put to rest key elements of the bull thesis” for its stock and “reflect a worsening financial position.”

“R&D reductions are too far out chronologically to be credible from a management team that we think has proven serially unable to project the performance of their business,” Foroohar said.

In a research note Thursday, Jefferies analyst Michael Yee said that the bulk of the cost savings won’t be achieved until 2027, which “now delays profitability until 2028.”

Moderna said it plans to “break even” on an operating cash cost basis with $6 billion in revenue in 2028. The company previously said it expects to break even and return to growth in 2026.

The company expects 2025 revenue to come in at $2.5 billion to $3.5 billion. From 2026 to 2028, Moderna expects a compounded annual growth rate of more than 25% as new products launch. 

While Moderna expects some product approvals in 2025, the company is “not expecting meaningful revenue contributions until the year after,” Moderna CFO Jamey Mock told investors during the event.

Also on Thursday, Moderna announced positive late-stage trial results for its vaccine against respiratory syncytial virus in high-risk adults ages 18 to 59, with plans to file for approval for that age group this year. It also announced positive data on its experimental stand-alone flu shot for adults ages 65 and older. 

The company unveiled those updates during its annual research and development day investor event in New York on Thursday, which focuses on its product pipeline and long-term business updates. It comes around four months after U.S. regulators cleared Moderna’s RSV vaccine for seniors, its second commercially available product after its Covid vaccine. 

The company said it now has five respiratory shots with positive phase three results and expects to submit three of those jabs for approval this year. That includes Moderna’s combination shot targeting Covid and the flu, which it expects to file for approval in the U.S. this year, along with a new and more effective version of its Covid shot. 

Moderna also has five nonrespiratory products across cancer, latent viruses and rare diseases that could be approved by 2027, according to the company’s release. 

The company expects 2025 revenue to come in at $2.5 billion to $3.5 billion. From 2026 to 2028, Moderna expects a compounded annual growth rate of more than 25% as new products launch. 

“That’s really a remarkable achievement that the team has accomplished, leaving us with a lot of drugs that are working, which is why we need to pace ourselves in terms of R&D investment,” he told CNBC. 

Moderna presented new data on its RSV vaccine, mRESVIA, which is cleared in the U.S. and European Union for adults 60 and above. 

The company said the shot met all of the main efficacy goals in an ongoing phase three study on adults ages 18 to 59 who are at increased risk of getting severely sick from the virus. There were no safety concerns observed, Moderna added.

There are currently no RSV shots approved worldwide for younger, high-risk adults, such as those with weakened immune systems or underlying chronic conditions like asthma and diabetes. Moderna’s main rivals in the RSV space, Pfizer and GSK, are also seeking an expanded approval for the age group. 

Bancel said the company plans to use a “priority review voucher” when it files for approval for people ages 18 to 59, which would reduce the amount of time it takes for the Food and Drug Administration to review the product to six months instead of 10 months. Moderna hopes the agency will clear mRESVIA for that age group in time for the RSV season in 2025. 

“It’s in the millions of people who could benefit. … We are also doing so just to be competitive in the marketplace because if you are a large retail pharmacy, you want your product to be available for all of your customers that show up,” Bancel said. 

But the company is also discontinuing development of its RSV vaccine for infants under 2 years old based on “emerging clinical data.” 

Moderna said its experimental stand-alone flu vaccine, mRNA-1010, produced a higher immune response against the virus compared with an existing flu shot in a recent phase three trial. The shot has also demonstrated “consistently acceptable safety and tolerability” across three late-stage trials, the company added.

Meanwhile, Moderna said it plans to move its shot against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea, to a phase three trial “imminently.” Bancel said he believes the company could finish the study within a year and file for approval immediately after if the data is positive. 

“This could be a product that is two years away from launch, which is great because there’s nothing today to treat norovirus,” he said. “A lot of health-care professionals get infected by their patients.”

Moderna is also partnering with Merck to develop a personalized cancer vaccine, which is being studied in combination with Keytruda in patients with different forms of the disease. 

The companies are studying the shot in a phase three trial in patients with a deadly skin cancer and discussing an approval with regulators based on data from a mid-stage study on the jab.

But Moderna said the FDA has “not been supportive” of a so-called accelerated approval of the shot based on its existing data. That refers to an FDA designation that clears drugs faster if they fill an unmet medical need for serious conditions.

Bancel said, “we’re going to keep having discussions” with regulators, and “we’re also generating more data.”

— CNBC’s Angelica Peebles contributed to this report.