Remember, a prescription is not required. So no need to mess with rebates. Our choice today is chocolate raspberry. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, STAT tells us. The move is an early step that could have major ramifications for the pharmaceutical industry, depending on whether and how federal officials actually use the authority. The administration will issue a framework for the U.S. National Institutes of Health to more broadly use march-in rights, a policy that allows it to seize patents from drugmakers whose products rely on federally funded research. The framework will detail when the agency might assert this authority, and endorse using drug prices when deciding.

AbbVie announced plans to purchase Cerevel Therapeutics and its pipeline of experimental neurological and psychiatric medications for $8.7 billion, STAT writes. The deal marks the second billion-dollar acquisition by AbbVie in under a week. Facing the prospect of declining sales from two of its best-selling drugs, the company also acquired Immunogen and its ovarian cancer treatment for $10 billion last week. With this latest deal, AbbVie will acquire several clinical-stage molecules for Parkinson’s, schizophrenia, and epilepsy, among other disorders, many of which previously belonged to one of its biggest rivals.

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The deal marks the second billion-dollar acquisition by AbbVie in under a week. Facing the prospect of declining sales from two of its best-selling drugs, the company also acquired Immunogen and its ovarian cancer treatment for $10 billion last Thursday.

With the buyout, AbbVie will acquire several clinical-stage molecules for Parkinson’s, schizophrenia, and epilepsy, among other disorders, many of which previously belonged to one of the company’s biggest rivals.

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Please feel free to join us. Now, though, the time has come to get cracking. So here is the latest assembly line of items of interest for your enjoyment. We hope you find these useful and have a smashing day. Best of luck and, as always, do stay in touch. …

AbbVie will pay $10 billion for Immunogen, acquiring an approved treatment for ovarian cancer and buying into a burgeoning area of oncology, STAT writes. Under the agreement, AbbVie will pay $31.26 per share in cash, a nearly 100% premium. Central to the deal, which is expected to close in the middle of next year, is Elahere, an Immunogen product that won U.S. Food and Drug Administration approval for advanced ovarian cancer in 2022. Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues.

Novo Nordisk filed lawsuits against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic (see here and here). Testing of compounded drugs from these pharmacies revealed unknown impurities up to 33%, the company claims. To date, Novo Nordisk has filed a total of 12 lawsuits against medical spas, weight loss or medical clinics, and compounding pharmacies, claiming the businesses engaged in false advertising, trademark infringement, and unlawful sales of non-FDA approved compounded products that purportedly contain semaglutide.

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Under the agreement, AbbVie will pay $31.26 per share in cash for Immunogen, a nearly 100% premium to the company’s recent trading price. Central to the deal, expected to close in the middle of next year, is Elahere, an Immunogen product that won Food and Drug Administration approval for advanced ovarian cancer in 2022.

Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues. AbbVie’s acquisition is the latest multibillion-dollar deal in the space, following Merck’s $22 billion agreement with ADC specialist Daiichi Sankyo and Pfizer’s $43 billion buyout of Seagen earlier this year.

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“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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