“Surprisingly fine,” said Conway-Anderson, a 36-year-old agroforestry professor at the University of Missouri. There was an 11-millimeter precancerous polyp that the doctors had discovered, but they’d snipped it out of her colon and recommended surveillance every three years. “Obviously, it’s big news to hear, but grateful this seems to be manageable. I’ll do it,” she said. “Then the bill came.”

She was being charged nearly $12,000 for the procedure after insurance. Conway-Anderson’s head spun. She couldn’t understand how it could cost so much, especially when she thought the colonoscopy was preventative for cancer and thus covered. “I was floored,” she said. “I was like I can’t pay this. I don’t know what you want me to do.”

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To help you along, we have assembled another laundry list of items of interest for you to peruse. Meanwhile, do keep us in mind if you hear anything interesting. We continue to accept — at absolutely no charge to you — postcards and telegrams. And of course, we hope you have a smashing day. …

Making good on a recent threat, the U.S. Federal Trade Commission is challenging more than 100 patents on brand-name medicines that it says were improperly or inaccurately listed by some of the world’s biggest drug companies in a key government registry, STAT writes. The agency notified 10 companies that listings for dozens of patents on such medicines as asthma inhalers and epinephrine autoinjectors are being disputed. The companies that received warning notices included AbbVie, AstraZeneca, and subsidiaries of GSK and Teva Pharmaceutical. The companies have 30 days to withdraw or amend their patent listings, or certify under penalty of perjury the listings comply with federal law.

Activist investor Elliott Investment Management has built a stake in BioMarin Pharmaceutical and and held discussions with the company for months about its future, according to Reuters. The hedge fund, which oversees some $60 billion in assets, has spent over $1 billion on the stake in BioMarin, which focuses on rare genetic disorders and is valued at about $16 billion. BioMarin is trying to find its footing amid a change in chief executives and slow progress in the launch of its drug Roctavian to treat hemophilia. Analysts noted that BioMarin’s hard-to-manufacture therapies and the fact that its entire portfolio is excluded from Medicare prescription drug price negotiations could appeal to buyers.

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The agency notified 10 companies that listings for dozens of patents on such medicines as asthma inhalers and epinephrine autoinjectors are being disputed. The companies that received warning notices included AbbVie, AstraZeneca, Mylan Specialty, Boehringer Ingelheim, and subsidiaries of GSK and Teva Pharmaceutical. The companies have 30 days to withdraw or amend their patent listings, or certify under penalty of perjury that the listings comply with federal law and regulations.

The move comes two months after the FTC issued a policy statement noting some drug companies have failed to follow requirements for listing patents in the Food and Drug Administration’s Orange Book in hopes of thwarting competition from lower-cost generic medicines. This registry is used to put generic companies on notice about certain types of patents that a brand-name company claims cover its drug.

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People who almost certainly had Alzheimer’s were also included in the study, but in this group, a placebo outperformed Cassava’s drug.

The conclusion, of course, is obvious: Simufilam is inactive. It’s an inert compound no more effective than a placebo. Cassava’s assertion that simufilam is showing “disease-modifying activity” falls apart given its study was opened to people who should have been ineligible because they were misdiagnosed with Alzheimer’s. Whether that was done intentionally or unwittingly isn’t known, but it’s certainly troubling and makes the case for immediate, regulatory intervention even stronger.

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One can never be too sweet, yes? Meanwhile, here is the latest grab bag of interesting items for you to peruse. We hope your day is productive and meaningful. And please do stay in touch. We appreciate the insights and tips. …

The U.S. Food and Drug Administration disclosed some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing methods used to evaluate a risk of inadvertently making unwanted changes to patient DNA, STAT explains. None of the concerns suggest the agency is reluctant to approve the treatment, which was developed by Vertex Pharmaceuticals and CRISPR Therapeutics. FDA staff said the type of gene editing raises concerns about “off-target” unintended genomic alterations. The small genetic sample size used in a lab analysis may not be sufficient for safety assessment because it did not capture the diversity of the entire U.S. population for the disease.

The FDA warned consumers to not purchase or use certain eye drops from several brands because they may cause eye infection and in some cases possible vision loss, Reuters writes. The agency recommended against the use of 26 over-the-counter eye drop products mainly used to treat symptoms of dry eyes and provide relief against eye irritation. The eye drops are marketed by CVS Health, Rite Aid, and Cardinal Health, among others. The FDA also asked the manufacturer to recall all lots of the product after its investigators found insanitary conditions in the manufacturing facility.

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The most obvious partner would be Mass General Brigham, the large, not-for-profit system that operates the Boston hospital where Dana-Farber’s doctors currently treat cancer patients. But after seven years of negotiations with MGB’s top brass — including about 30 meetings in the past 10 months alone — she said it became clear that they weren’t interested.

“It would have been easier if MGB would have said, ‘Yes, we can do that with you,’” Glimcher told The Boston Globe’s editorial board on Tuesday. “That would have been the easiest path. But they refused over and over and over again.”

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The findings stemmed from a multi-state investigation of seven sepsis cases transmitted during blood transfusions. Samples collected between 2018 and 2022 led researchers to platelet collection products made by the company at a plant in Puerto Rico. Ultimately, the facility was the “most probable” source of the cases, according to the report in the CDC’s Emerging Infectious Diseases journal.

Bacterial contamination of platelet components commonly occurs during blood collection and typically involves a single identified species of bacteria. But “multiple episodes” of different bacteria contamination “with identical bacterial species in platelet components across different states is exceedingly rare, suggesting a possible common source of contamination,” the researchers wrote.

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Nonetheless, we are giving it a go. Hopefully, you will be a beneficiary, since we have assembled a few items of interest to help you start your own day. On that note, we hope that all goes well and that you conquer the world. And of course, do keep in touch. …

All the drugmakers that make the 10 prescription medicines subject to the first-ever price negotiations for the U.S. Medicare health program said they signed on to participate in the talks by the Oct. 1 deadline, Reuters notes. The penalties for not doing so would have been steep: Drugmakers would have to pay 65% to 95% taxes on their drug’s Medicare sales or withdraw all of their products from the Medicare and Medicaid programs, which together provide health benefits to 158 million Americans. At least seven of the drugmakers have sued the U.S. Department of Health and Human Services, which oversees the Medicare agency, calling the process unconstitutional price-setting.

AstraZeneca agreed to pay $425 million to settle U.S. product liability lawsuits related to the heartburn and stomach acid treatments Nexium and Prilosec, which some users said caused kidney damage, Bloomberg News says. The settlement resolves litigation in New Jersey and Delaware courts. A single case is still pending in Louisiana, with a trial set for next year. AstraZeneca said it continues to believe the claims are without merit and admits no wrongdoing, but settled to avoid costly legal procedures. Heartburn medications have been the subject of a range of concerns in recent years. In June, GSK settled litigation with a man who claimed its Zantac treatment caused his cancer.

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Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

The organization looked at four blockbuster drugs — Humira, Avastin, Rituxan, and Lantus — that had biosimilars launched between 2019 and 2023. On average, each of the drugs in the analysis earned three times the revenue during the patent extension period as they did during the original patent protection period, which gave them an average 13.2 years of unchallenged market presence.

Overall, the drugs made 56% of their overall revenue in the years after the end of the initial patent. In the first 20 years, they made $126 billion of the total $284 billion they earned up until competitors entered the market.

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This was supposed to be the year the biotech industry recovered from its ongoing slump, but that simply hasn’t happened, STAT tells us. The industry remains locked in a slowdown that began in late 2021, with investors saying that despite the profit prospects of weight-loss drugs made by Big Pharma, they’ve soured on the sector at large. That could change if the Federal Reserve lowers interest rates and if more biotechs successfully go public in 2024, according to cautiously optimistic observers.

Japan’s health ministry has approved Leqembi, an Alzheimer’s drug developed by Eisai and Biogen, Reuters explains. Eisai, a Japanese pharma firm, spearheaded work on the drug, which clinical trials found modestly slowed the progression of Alzheimer’s. Eisai must now win reimbursement approval from the country’s national health system, after which the company has said it will begin marketing the drug in Japan within two months.

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