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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In any event, there is work to be done, so as always, we have assembled a few items of interest for you. After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. Postcards and telegrams are still accepted. …

Novartis is losing its chief commercial officer and president of its innovative medicines group as Marie-France Tschudin is leaving to take up another position elsewhere, Pharmaphorum writes. Tschudin, who has been seen as a rising star in her almost seven years at Novartis, was named chief commercial officer last year as part of chief executive officer Vas Narasimhan’s effort to streamline the company. She also headed the innovative medicines businesses outside the U.S. Patrick Horber, currently head of immunology at AbbVie, will take over later this year, reporting directly to Narasimhan.

The recently approved RSV vaccines have been celebrated as key public health tools, but some vaccine experts have lamented one aspect of the clinical trials that led to their approval — namely, that older adults were largely left out of them, STAT tells us. Among adults, RSV poses the biggest threat to the oldest seniors and people with certain preexisting health conditions. But the trials for the vaccines, which have been approved for adults 60 and older, included few participants 80 and older. People who are immunocompromised and those who live in nursing homes were also not included.

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Our choice today is salted caramel mocha, a touch of the Jersey Shore. Please feel free to join us. Meanwhile, we have assembled a few items of interest for you to peruse as you being your journey. We hope all goes well and that you conquer the world. And of course, do keep in touch. …

The three companies that recently left the Pharmaceutical Research & Manufacturers of America, the industry trade group, all spent less on lobbying following their departures, STAT reports, citing newly released federal disclosures. AbbVie, Teva Pharmaceutical, and AstraZeneca left over a span of five months following the passage of the drug-pricing reform law pushed by Democrats last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt its bottom line.

Drug companies are systematically funding grassroots patient groups that lobby the U.K. cost-effectiveness watchdog to approve the rollout of their drugs, The Guardian reveals. Of 173 drug appraisals conducted by the National Institute for Health and Care Excellence since April 2021, 138 involved patient groups with a financial link to the maker of the drug being assessed, or have since received funding. Financial interests were often not clearly disclosed in NICE documents. Many of the groups that received payments later made impassioned pleas to NICE for treatments to be approved. Others made submissions appealing NICE decisions when drugs were refused for being too expensive.

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The reasons can vary, from quality control failures at manufacturing plants to surging demand, including significant interest that has at times squelched availability of drugs taken for weight loss.

But the problem is not easily fixed. Most active pharmaceutical ingredients are made in China, and boosting production in the U.S. is not like flipping a switch. Many of the drugs in short supply are generics made in India, where regulators often find serious production lapses. So what to do? Along with a colleague, Marta Wosińska, a senior fellow in economic studies at The Brookings Institution, has three ideas to alleviate shortages of generic sterile injectable medicines, in particular. They suggest the U.S. government should provide incentives to upgrade facilities and create a buffer inventory. But they also argue hospital purchasing is in need of an overhaul. We discussed the possibilities; our conversation has been lightly edited. 

I’ve been writing about drug shortages on and off for many years, but the problem never goes away. And now, it seems even worse. Obviously, something has to change. But what exactly has been lacking with our policies to date?

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Speaking of which, we have gathered the latest bushel for your perusal if you scroll down a wee bit. Of course, all of this means that it is time to get cracking. So here we go. We hope you have a smashing day and conquer the world. And as always, please do stay in touch …

Eisai announced that Ivan Cheung, who ran its global Alzheimer’s drug program, will retire at the end of the month and be replaced by the son of Eisai chief executive officer Haruo Naito, STAT writes. The move comes after Cheung led the push for U.S. approval of the breakthrough medicine Leqembi. Keisuke Naito, 34, a senior vice president and chief strategy and planning officer, will become acting global Alzheimer’s officer. Cheung’s resignation comes less than a week after Eisai and Biogen were granted full approval for Leqembi in the U.S. The drug is the first medicine shown to slow progression of the disease, which afflicts some 6 million Americans.

Express Scripts will add three biosimilar versions of AbbVie’s blockbuster arthritis treatment Humira to its list of preferred drugs, Reuters notes. The biosimilars include branded and unbranded versions from Sandoz, the generic unit of Novartis, as well as one from Boehringer Ingelheim. Express Scripts, the pharmacy benefits manager owned by Cigna, said the biosimilars would be included as preferred brands on its formulary. The drugs, launched this month, add to competition for Humira in the U.S. that started in January with the launch of a biosimilar by Amgen that is already on Express Scripts formulary.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Reata Pharmaceuticals hired Rajiv Patni as executive vice president, chief R&D officer. Previously, he worked at Global Blood Therapeutics, where he was chief medical officer.

But all work and no play can make for a dull chief medical officer.

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