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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Meanwhile, our ever-growing to-do list requires attention. Sound familiar? So, here are some items of interest. Have a great day and hope you conquer the world, everyone …

Coherus BioSciences agreed to resolve a dispute over its plans to launch a lower-priced version of AbbVie’s Humira rheumatoid arthritis drug, Reuters writes. Earlier this month, Coherus said it will launch a biosimilar version of the drug at an 85% discount to the $6,922 list price and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27. AbbVie alleged it breached an older deal granting Coherus a non-exclusive license to commercialize a biosimilar version in the U.S. as of July 1. AbbVie will not terminate the initial licensing deal based on its notice. It would have to serve another notice and give Coherus time to resolve the breach if it chooses to end the deal.

Expanded access to the Alzheimer’s drug from Eisai and Biogen is unlikely to happen quickly even if the Food and Drug Administration decides follow-up studies confirm the drug helps slow the disease, Bloomberg News explains. Medicare said that “broader” coverage would begin “on the same day the FDA grants traditional approval.” But patients, doctors, and analysts are all doubtful, citing the limited information publicized by the agency on how the registry will work. For the registry to succeed, it must be easy for prescribers to use, they argue. Researchers and others also will need real-time data to show whether the drug is beneficial and safe, they added.

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The agreement  —which involves Teva Pharmaceuticals; Allergan, a unit of AbbVie; CVS; and Walgreens — is the latest involving several major players blamed for the crisis. Last year, dozens of states and thousands of local communities reached a global settlement worth $26 billion with three largest pharmaceutical wholesalers as well as Johnson & Johnson to resolve civil lawsuits.

As part of the deal, Teva agreed not to market opioids and will provide its generic version of Narcan, the overdose reversal medication, which it has valued at $1.2 billion. Allergan is required to stop selling opioids for the next 10 years, while CVS and Walgreens have agreed to monitor, report, and share data about suspicious activity related to opioid prescriptions.

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