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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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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In the meantime, here as always are some tidbits to get your day started. If you hear anything interesting out there, do let us know. …

Coherus BioSciences plans to sell a biosimilar version of Humira at a steep discount, STAT reports, and the company will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Coherus’ version of Humira, one of the world’s best-selling medicines, will carry a $995 list price for a carton of two autoinjectors, which is an 85% discount from the $6,922 that AbbVie charges for the branded product. Coherus will also sell its drug at a discount to the Mark Cuban Cost Plus Drug company, which will market the treatment for about $579.

The U.S. Food and Drug Administration approved a second vaccine to protect older adults against RSV, STAT tells us, licensing Pfizer’s Abrysvo for adults 60 and older. The decision comes about a month after the agency approved GSK’s Arexvy, the first-ever vaccine against respiratory syncytial virus, or RSV. Neither vaccine is currently available for use. The Centers for Disease Control and Prevention must recommend the vaccines before they can be sold, a process expected to conclude later this month.

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The rotation will likely include this, this, this and this. And what about you? Once again, this is a wonderful time to enjoy the great outdoors — beaches, woods, and lakes are beckoning. Or you could putter about your castle — a little spring cleaning is a good thing. And if mom is around, remember to say hi. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers, but it failed to pass an ambitious reform despite strong bipartisan support, STAT explains. The committee passed, 18 to 3, a bill that would ban pharmacy benefit managers from using spread pricing. The bill would also require that pharmacy benefit managers disclose rebates, fees, and other payments they receive and pass them on to the insurers for whom they negotiate the concessions. Lawmakers did not vote on a bill that would ban pharmacy benefit managers from charging administrative fees based on a percentage of a drug’s list price.

Pfizer chief executive officer Albert Bourla indicated that pharmaceutical companies will likely take legal action against Medicare drug price negotiations, CNBC tells us. Bourla referred to a provision in the Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. Bourla called the plan “negotiation with a gun to your head.” The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the plan, but noted he is “not optimistic” about that happening.

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Pharmalot — the rotation will include this, this and this. And what about you? Given the spate of tumultuous news these past few days, perhaps spending time by calming ocean waters or in the solitude of a woodsy area is in order. Or you could zone out and binge-watch something fanciful on the telly. Or perhaps this is an opportunity to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing, STAT reports. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab. The findings come after the university newspaper reported former Genentech employees claimed an internal review uncovered falsified data and that the neuroscientist tried to keep that information quiet.

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As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …

A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.

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Our choice today is mocha marshmallow. No prescription is required, so no rebates must be paid or tracked. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Postcards and telegrams are welcomed. …

The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices, STAT notes. Pfizer had the most drugs on the list of any manufacturer, with five. AbbVie’s blockbuster rheumatoid arthritis drug, Humira, is on the list. Gilead Sciences, Endo International, Leadiant Biosciences, and Kamada had two drugs each. The fines are some of the first major changes to the U.S. drug pricing landscape since the Inflation Reduction Act became law. But White House officials said they intend to delay actual invoices for the price hikes until 2025.

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