Pfizer, Johnson & Johnson, Walmart, Ozempic

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Good morning, I highly encourage you to read this study that STAT published today about a research project at Mount Sinai where doctors took biopsies of the brains of living patients, raising alarm at the FDA.

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What you need to know this morning

• Pfizer reports this profit for the first quarter and slightly raised its profit outlook for the rest of the year. Sales expectations remained unchanged.
• Johnson & Johnson offered one new proposal to pay $6.5 billion to settle thousands of lawsuits alleging that baby powder and other talc-containing products caused ovarian cancer.

FTC is cracking down on Ozempic’s ‘junk’ patents

The Federal Trade Commission is expanding its campaign to curb alleged patent abuse by the pharmaceutical industry, challenging more than 300 patent citations for 20 drugs, including Novo Nordisk’s successful diabetes drug Ozempic.

Drug manufacturers are increasingly accused of filing inappropriate or inaccurate patents to make it harder for generic companies to sell cheaper alternatives, expanding their monopolies. Under current rules, if a brand-name company sues a generic rival for patent infringement, the FDA is automatically barred from approving the generic for 30 months. Branded companies thus have an incentive to list more patents, whether they are valid or not.

A study published two months ago had suggested that the FTC may want to investigate the patents listed for the injector pens that Ozempic comes in. said the study authors.

Read more from STAT’s Ed Silverman about what other drugs and devices the FTC targeted.

Dark days for a once-hyped video game treatment

Akili Interactive made waves in 2020 for gaining approval to sell a video game to treat ADHD, but the treatment saw sluggish sales as it failed to gain traction with insurers and patients.

The company is now laying off 46% of its staff and evaluating strategic alternatives, it said yesterday. This comes after another round of major layoffs implemented by Akili last year, reducing its workforce by 40%.

It’s been a bleak period for digital therapeutics companies. Earlier this year, Better Therapeutics, which made an app to treat type 2 diabetes, shut down operations. And almost exactly a year ago, Pear Therapeutics sold its assets at a bankruptcy auction.

Read more from STAT’s Mario Aguilar about the company’s fate.

Starting age for mammography lowered to 40 years

The U.S. Preventive Services Task Force has lowered the recommended age for all women to start breast cancer screening from 50 to 40, in part because breast cancer rates are rising among younger women.

Cancer screening recommendations are difficult because they must weigh the benefits of detecting cancer early against the potential harm. Such harms include unnecessary biopsies for false-positive cases and overdiagnoses (diagnoses of tumors that grow so slowly that they would not have harmed or killed the patient). More screening, such as expanding the age range eligible for screening, often helps save lives, but comes at the cost of additional harm.

In this case, task force members believed that lowering the screening age to 40 was well worth the trade-off. They predict that this measure could save an additional 1.3 lives per 1,000 people.

Read more from STAT’s Angus Chen about why the task force made this change and what other experts think.

‘Skinny labels’ have saved Medicare a lot of money

Skinny labeling occurs when drug manufacturers receive approval for a generic or biosimilar drug for a specific use and not for any other proprietary use for which the brand-name drug is prescribed.

This practice can be traced back to a decades-old law intended to bring cheaper generic drugs to the market, and it appears that the law has achieved the desired effect. A new analysis shows that the use of skinny labeling saved Medicare Part D $15 billion on just fifteen medications between 2015 and 2021.

Researchers found that the generic drugs with skinny labels were more likely to generate competition than if they had not been available, and that the use of these generics was higher than what would otherwise have occurred without skinny label alternatives.

Read more from Ed about the details of the new research.

Read more

• In a major reversal, Walmart closed medical clinics and online care, STAT
• Bristol Myers, Johnson & Johnson appeals conspiracy after US judge dismisses IRA lawsuits Fierce pharmacy
• The Justice Department will move to reclassify marijuana in a historic shift, AP sources say
• Opinion: Creating the next wave of antibody therapies requires innovative collaboration, STAT