Pharmalot and the rotation will likely include this, this, this, and this. And what about you? With holidays unfolding, you could head to your local temple of consumption and give the economy a boost. You could also plan an end-of-year getaway or, perhaps, you might soak in the great outdoors with a ride in the country or a walk in the park. Well, whatever you do, have a grand time. And be safe. Enjoy, and see you soon. …

After months of deliberation, the Biden administration disclosed plans to sidestep patents in order to lower costs for some pricey medicines that were discovered with taxpayer money. But the move, which must still be finalized by an inter-agency working group, is already causing uncertainty over the extent to which drugmakers may lose valuable monopolies and consumers will save money, STAT explains. This reflects the seemingly contradictory approach the administration has taken toward the controversial concept, as well as open-ended language in the proposal. As a result, there is a mix of fear and doubt as the pharmaceutical industry and patients try to envision the eventual terms.

The $32,000 cost of a crucial drug to treat severe lead poisoning drew ire from U.S. Sen. Amy Klobuchar (D-Minn.), who wrote a letter to Rising Pharmaceuticals seeking answers on how the company reached its price, CNN says. The drug costs almost 10 times more than an imported version of the medicine from France, which the U.S. Food and Drug Administration had allowed to be used in the U.S. while the drug was in shortage. Toxicologists says the price can make it difficult for hospitals to stock the medicine, called calcium disodium EDTA, potentially leading to delays of days when patients need urgent treatment. EDTA is used for the most severe cases of lead poisoning.

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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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With 10 days to go, only one company has responded to a demand by the U.S. Federal Trade Commission for several brand-name drugmakers to delist dozens of patents that were improperly or inaccurately listed in a government registry, according to a source familiar with the matter.

As a result, the agency is readying plans to file lawsuits against the other companies, some of which are among the biggest drugmakers in the world, such as AbbVie, AstraZeneca, and GSK. The FTC notified the companies on Nov. 7 that they must withdraw or amend the patent listings, or an individual must certify under penalty of perjury that the listings comply with federal law and regulations.

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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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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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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 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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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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