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Federal regulators are confronting a new twist in drug development: manufacturers that include software with the medicine to prod patients to take pills as directed, manage side effects or track how well a treatment works.

Why it matters: The apps could boost the drugs' clinical value and provide a more personalized approach to managing chronic conditions such as depression or obesity.

• But the combinations are blurring the line between drugs and devices and putting the FDA on the hook for making sure the software doesn't pose an increased risk to patient safety.

The big picture: The FDA is fine-tuning guardrails that would allow software that guides treatment to be prescribed at the same time and appear on the same labels as drugs they accompany.

• Prescription drug use-related software, or PDURS, has been on the agency's radar since 2017, when it rolled out a digital health plan to better address mobile medical apps, fitness trackers and software that aids clinical decisions.
• Guidance released last fall that's due to be finalized soon lays out benchmarks for new products and what existing software may face reviews and potentially need to be upgraded.

Zoom in: In April, the FDA approved an app from Click Therapeutics and Otsuka Pharmaceutical that's meant to be used in tandem with drugs over six weeks to help treat major depressive disorder.

• It's just one example of how the worlds of drugs and digital health are converging, Click Therapeutics CEO David Klein told Axios. "Software solutions can fill some very important gaps," Klein said.
• In the case of GLP-1 drugs like Wegovy or Zepbound, it could reduce the odds of patients stopping the meds early due to side effects, and help them reduce muscle loss.

Between the lines: But there are thorny questions, such as when would software be considered promotional labeling?

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Novo Nordisk and Eli Lilly are asking the FDA to block compounders from making copies of their blockbuster weight-loss drugs, arguing that such versions could be unsafe.

Why it matters: This could slow a medical revolution that promises to reshape America's economy — and Americans themselves.

• It also may mean tighter margins for telehealth companies like Ro and Hims & Hers, although both also sell branded versions of GLP-1 drugs.

Driving the news: Novo last week nominated semaglutide — the active ingredient in Ozempic and Wegovy — to join a list of drugs that the FDA considers too complex to be made by compounders.

• This came after a similar (albeit more redacted) filing from Eli Lilly over tirzepatide, the active ingredient in its Mounjaro and Zepbound.

The big picture: This is just part of a multi-pronged legal approach by the pharma giants, which claim to be protecting patients. Compounders, on the other hand, argue that the moves are to protect profits.

• Many compounders produce the drugs for around $100 a month, whereas the list price for Novo's Wegovy is more than $1,300.

Zoom in: Beyond safety, there also is a question of shortages.

• Semaglutide injections remain on the FDA's shortages list, which initially enabled compounding.
• Tirzepatide injections were removed from the list earlier this month, before the FDA decided to reevaluate that decision after being sued by the compounders.

Look ahead: If the FDA entertains the safety filings, the subsequent process could take upward of a year.

The bottom line: We've previously discussed the parallels between GLP-1 drugs and LLM-fueled artificial intelligence.

• Let's add another: Incumbent calls for more safety guardrails.

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Employers worried about lawsuits from workers charging they're not spending their health care dollars wisely are increasingly casting a more critical eye on the middlemen that help manage their drug costs.

Why it matters: While the Biden administration and Congress turn up the heat on pharmacy benefit managers, corporate discontent could have a far bigger impact on the industry if the employers find alternate benefit arrangements.

Driving the news: More than half of 188 companies polled in September and October are considering a change to their PBM in one to three years, per a new survey from the National Alliance of Healthcare Purchasers.

• Those weighing a change said they want more transparent contracts and pricing, including the ability to see how much of the negotiated savings on a drug is shared with the employer.
• It tracks with sentiment from other employer groups like the Business Group on Health, which found one-third of its 40 members have begun to switch or are considering switching PBMs.

The other side: Some of the largest PBMs dispute these characterizations, saying they've been transparent and are guarding against drugmaker price-gouging.

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The median annual price of a new drug to market soared to $300K in 2023.

Yet four in five Express Scripts by Evernorth patients paid $250/yr out-of-pocket for ALL their medications.

Learn how Express Scripts is advocating to make medications more affordable.

The threat of a U.S. crackdown on some Chinese biotech firms isn't deterring pharmaceutical companies from signing deals with WuXi AppTec, one of the targeted companies that's also a linchpin in global drug development.

The big picture: The contract research company on Monday said it had signed 800 new customers in the first three quarters of the year — which is 300 more than it signed in the first half of 2024, Endpoints News reported.

Yes, but: Its year-to-date U.S. revenues fell 9% to $2.47 billion, compared with the same period last year.

Catch up quick: Congress still is considering whether to pass the Biosecure Act, which would end U.S. contracting with select Chinese firms deemed a threat to national security by 2032, effectively locking them out of the market.

• Bill supporters are concerned about biopharma's increasing reliance on Chinese companies for production and research, and the prospect of the Beijing regime having control over critical ingredients and medicines. WuXi AppTec denies it poses any risk.
• There's still concern that the bill, as written, would unfairly single out some companies and could bring higher drug prices — or more shortages if key ingredients get scarce and supply chains are squeezed.

What's ahead: Regardless of whether Congress acts, drugmakers see advantages to maintaining contracts with WuXi for as long as possible because Chinese firms have more competitive prices, per Endpoints.