customers six years ago, but did not report any profits from those sales on its 2019 tax returns because all of the income was supposedly earned offshore, according to an investigation by the Democratic staff of the Senate Finance Committee.

As a result, the company was able to avoid paying billions of dollars in federal income taxes and, in fact, also did not report any taxable income in the U.S. for 2018 and 2020. To accomplish this, Pfizer used what was described as an “egregious tax gimmick” called “round-tripping,” a tax avoidance scheme that involves making sales to U.S. customers, but treating the profits as foreign income for tax purposes.

Often, round-tripping refers to offshoring manufacturing to a foreign subsidiary located in another country or jurisdiction with lower tax rates. The list includes Puerto Rico and Ireland, where Pfizer has various operations. Another tactic is to shift intellectual property rights to such havens or engage in transfer pricing, which involves a company selling itself products at artificially high prices.

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After all, the neurons could use all the help they can get, would you not agree? Meanwhile, here are a few items of interest for you to digest as you embark on your own journey today, which we hope is meaningful and satisfying. On that note, time to hustle. Best of luck, and do keep in touch. …

Prominent outside scientists who help the U.S. National Institutes of Health evaluate its internal research programs are being abruptly removed, according to five advisers whose positions were terminated and a recording of an internal meeting obtained by STAT. The motivations behind the removals from the agency boards of scientific counselors remain unclear. But among those being terminated are non-U.S. citizens, women, scientists from underrepresented racial and ethnic groups, and individuals whose research focus or other work touches on areas the new administration considers taboo, such as diversity and equity. The removals come amid a broader attempt by the Trump administration to align health agencies with the president’s views on DEI, gender, immigration, and other issues, by terminating grants mentioning words like “diversity” or focused on environmental justice, while explicitly targeting such employees for removal.

GSK has teamed up with two research organizations in the U.K. to explore a possible link between its shingles vaccine Shingrix and a reduced risk of dementia, Pharmaphorum says. The tantalizing hypothesis — drawn from observational and retrospective studies — is that vaccination against shingles can help protect against dementia in the following years. To test it prospectively, GSK will work with the UK Dementia Research Institute and Health Data Research UK to use de-identified, population-level electronic health data from the National Health Service to look at the impact of shingles vaccination on dementia risk. Their study will look at real-world data from around 1.4 million people aged 65 and 66 at the time that the U.K. expanded its shingles national immunization program in 2023. Research has already shown that vaccines against shingles potentially reduce the risk of dementia, but past studies only identified associations, not causality.

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Pharmalot and the rotation will likely include this, this, this, this and this. And what about you? Once again, we maintain there is no better time to enjoy the great outdoors. And as seasonal festivities approach, you could start searching for the great pumpkin or, if you are particularly ambitious and visit the correct locales, you could hunt down your own turkey. For those inclined to hang around Gotham, there are always museums and moving picture shows to take in. Or you could hide indoors with a good book. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

CVS Health is naming longtime executive David Joyner as its new chief, succeeding Karen Lynch at the helm of the struggling health care giant, The Wall Street Journal writes. Joyner has been president of CVS Caremark, the company’s pharmacy benefit manager, as well as an executive vice president of CVS. He is set to take over as president and chief executive on Friday. CVS is making the changes after repeatedly cutting its forecasts for this year’s financial performance, moves that led to a 19% decline in its share price this year, a push for changes by a major hedge fund, and a board review of strategy that included the option of breaking up the company. Joyner will face a difficult task. Not only must he turn around CVS’s Aetna health insurance business, but he must also contend with U.S. Federal Trade Commission scrutiny of pharmacy benefit giants including Caremark. CVS also faces longstanding challenges in the retail pharmacy business. 

Donald Trump has backed off his ambitious plans to slash U.S. drug prices and repeal the Affordable Care Act, leaving something of a vacuum in his health policy agenda. One former Trump White House official says the policy ideas are there — but enacting them could take messy fights, STAT tells us. The official, Joe Grogan, said Republicans will need to repeal or revisit President Biden’s signature drug pricing law and expanded Affordable Care Act subsidies, should Trump take office. Trump had previously proposed tying U.S. drug prices to a basket of payments made by similarly wealthy countries, but has retreated from that approach. Grogan said this is because Biden’s plan to let Medicare negotiate drug prices directly with pharmaceutical companies, passed in the Inflation Reduction Act, changed the landscape. As the provisions go into effect, this has raised premiums, which Grogan forecasted could cause a “death spiral” in Medicare Part D, the program’s prescription drug benefit.

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So grab that cup of stimulation and get started. Our flavor today is tiramisu, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

A major California health insurer is set to offer one of the world’s top-selling drugs for free in a bid to show the medicine can reach Americans affordably without going through the middlemen that typically control its flow, The Los Angeles Times says. Blue Shield of California struck an unusual deal to buy a lower-cost version of Humira directly from a manufacturer, bypassing the giant pharmacy benefit managers that normally determine which maker’s drug will go to tens of millions of Americans. AbbVie’s Humira has been a prime example of how drug prices can stay high even after drugmakers lose patent protection. Sales of Humira, at one point the world’s top-selling drug, were $14 billion last year even after low-cost versions hit the market. Blue Shield of California currently spends more than $100 million a year on Humira, more than any other drug. The new lower prices and lack of fees for middlemen should result in a savings of $20 million over three years, executives said, adding that the figure might be a low estimate.

In response to increased criticism of its pricing, Gilead Sciences has reached voluntary licensing deals with companies to make generic versions of its twice-yearly HIV medicine, lenacapavir, in 120 mostly low- and lower-middle-income countries, STAT reports. The move comes after a pair of late-stage clinical trials found the injectable medicine was highly effective in preventing HIV, paving the way for the company to seek regulatory approval for pre-exposure prophylaxis, or PrEP. The results generated considerable excitement since a daily pill is nearly 100% effective but compliance is spotty and there is a stigma attached to regularly taking a drug for HIV. But its impact on addressing an epidemic that, as of 2022, still led to more than 1 million new infections each year is uncertain. And the reason is pricing. Lenacapavir is already approved for treating HIV but has a hefty price tag of $42,250. So patient advocates have been urging the company to reach a licensing deal but also lower its price. The criticism was heightened after a recent analysis found that the medicine could be made for as little as $26 to $40 a year. As a result, Gilead is hoping its licensing plan will appease critics.  

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We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is orange cream, for those tracking our habits. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

Express Scripts, which is one of the largest pharmacy benefit managers in the U.S., filed a lawsuit demanding that a recent Federal Trade Commission report accusing the industry middlemen of raising drug prices should be vacated, STAT tells us. In scathing language, the company argued the report was “seventy-four pages of unsupported innuendo leveled … under a false and defamatory headline.” The lawsuit also alleged the FTC “followed prejudice and politics, not evidence or sound economics, and wrongly concluded that PBMs inflate drug costs and harm independent pharmacies.” FTC Chair Lina Khan was also accused of “anti-PBM bias.”

Antimicrobial-resistant bacterial infections directly caused more than 1 million deaths worldwide annually from 1990 to 2021, and that number is projected to increase by almost 70% over the next 25 years, MedPage Today writes, citing an analysis in The Lancet. In 2021, 1.14 million deaths that were attributable to bacterial antimicrobial resistance occurred across the globe, slightly higher than the 1.06 million AMR-attributable deaths in 1990. Bacterial AMR was also associated with an estimated 4.71 million deaths in 2021, about the same as in 1990. By 2050, the researchers forecast that an estimated 1.91 million AMR-attributable deaths and 8.22 million AMR-associated deaths could occur every year worldwide. From 2025 to 2050, a cumulative 39.1 million deaths attributable to AMR could occur.

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What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …

Moderna plans to cut its annual spending on research and development by 23%, or $1.1 billion, between 2024 and 2027 in a concession to investors who have viewed the company’s outlays following its pandemic-era windfall as profligate, STAT writes. In a press release issued ahead of an investor meeting today, the company also said it plans to break even by 2028, when it expects it will reach annual sales of $6 billion. Moderna shares have fallen 29% so far this year and are down more than 82% from their highs during the pandemic — when its ability to rapidly develop a Covid-19 vaccine stood as a proof-of-concept for its technology and left it flush with revenue. Now Moderna, which still has a market capitalization of $30 billion, faces the challenge of moving forward quickly on its many research products.

Shares in Roche dropped to a two-month low on Thursday after an experimental weight-loss pill that carries high market hopes was linked to an elevated rate of temporary side effects in its initial test phase on humans, Reuters points out. The stock was trading 3.5% down in morning trading, after the company presented details on the trial with its once-daily pill CT-996 late on Wednesday. A brief summary in July of the study’s promising results had boosted its share price. According to a presentation at the European Association for the Study of Diabetes in Madrid, all 25 trial participants experienced mild or moderate side effects, including those that only received an ineffective placebo. Side effects were mostly gastrointestinal, like those associated with similar drugs.

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The U.S. Food and Drug Administration has scolded AbbVie for making false and misleading claims in a TV ad about a migraine pill that features Serena Williams, the third time this year the agency has taken a major pharmaceutical company to task for its marketing.

The agency is upset with Abbvie for a couple of reasons. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated,” according to an Aug. 29 letter that was posted on Wednesday on the FDA website.

Moreover, the regulator also chastised the company for using a “celebrity athlete,” which is problematic in this instance because the ad “amplifies the misleading representations and suggestions made and increases the potential for audiences to find the misleading promotional communication more believable due to the perceived credibility of the source.”

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So grab that cup of stimulation and get started. Our flavor today is crème brulée, for those tracking our habits. Now, though, the time has come to get busy. So please grab your own cup and dig in to the items of interest assembled below. We hope you have a wonderful day, and please do keep in touch. …

Novo Nordisk’s older weight-loss drug Saxenda helped children between the ages of 6 and under 12 reduce their body mass index by 7.4% in a 56-week trial, but the findings also raise questions about whether obesity medications, some of which are currently approved for teenagers, should also be given to children at such a young age, STAT notes. The Novo-sponsored study was the first to examine the safety and efficacy of once daily injections of Saxenda, known chemically as liraglutide, in young children. No medications are currently approved for the treatment of obesity in children under age 12, though Saxenda was approved for adolescents in 2020 and for adults in 2014. Novo said it has applied with U.S. and European regulators to expand the approval to include the ages involved in this study.

An experimental vaccine from GSK for combating herpes failed in an early-stage trial, halting an effort to bring the first shot for the condition to market, Bloomberg News tells us. While there were no safety concerns, the trial for a therapeutic vaccine to treat the herpes simplex virus failed to meet its efficacy objective. There are currently no approved vaccines for the virus, which causes genital herpes, although there is a shot for the herpes virus that causes chickenpox. The failure is not expected to impact the company’s outlook for the short to medium term as sales of the shot had not yet been baked into revenue projections. Still, this is a blow for GSK, which has zeroed in on vaccine development and been buoyed by its success with its vaccine for a common respiratory illness.

Continue to STAT+ to read the full story…

We hope you have a wonderful day and please do keep in touch. Once again, we will note that our settings have changed to accept postcards and telegrams…

The U.S. House of Representatives passed a bill by 306 to 81 votes to make drug companies stop doing business with some Chinese biotechs within eight years if they want to remain in good standing with the federal government, STAT reports. The BIOSECURE Act would prohibit the U.S. government from contracting with, or providing grants to, companies that do business with a “biotechnology company of concern.” It specifically names five Chinese companies: BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and Wuxi Biologics. The bill would likely need to hitch a ride with a larger legislative vehicle, such as the annual defense bill or government funding legislation, during the lame duck session between the elections and when newly elected officials take office.

Amid calls to expand access to medicines in low- and middle-income countries, a new analysis finds that most of the world’s 20 largest pharmaceutical companies have taken steps to reach patients, but many efforts are yielding decidedly mixed results, STAT tells us. On the one hand, 19 companies have established methods for providing treatments to these countries — but only nine of the drugmakers created comprehensive plans. Moreover, there is no consensus on how to calculate the number of patients being reached, so the approach taken varies widely among products and countries. In addition, most of the companies rely on sales volume to measure access goals, but this can be an imperfect benchmark because it does not ensure that medicines actually reached patients.

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Our choice today is salted caramel, a touch of the Jersey Shore as we say around the Pharmalot campus. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck and do keep in touch…

The largest U.S. pharmaceutical industry trade group and several drug companies lost a bid to block a Maryland law requiring the companies to offer discounts on medicines dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations, Reuters notes. U.S. District Judge Matthew Maddox refused to issue a preliminary order blocking the law while he hears a challenge to it by the Pharmaceutical Research and Manufacturers of America, Novartis, AbbVie and AstraZeneca. The case is among numerous similar challenges to state laws around the country dealing with obligations under the 340B program, a federal program under which hospitals and clinics serving low-income populations can receive discounts on prescription drugs. Drugmakers must participate in the 340B program in order to receive funds from government health insurance programs like Medicare and Medicaid.

On Sunday, a small biotech company called Summit Therapeutics won a remarkable victory, saying its experimental drug outperformed Merck’s Keytruda, the world’s best-selling drug, in non-small cell lung cancer, the disease that represents the biggest market for the Merck drug, STAT tells us. By itself, Summit’s victory would be a dramatic story, although not an unheard of one in the unpredictable world of biotechnology. But it’s just the start. Because at the center of it is one of the industry’s most iconoclastic figures: Robert “Bob” Duggan, who became a billionaire after he bought up shares of another biotech company, Pharmacyclics, that was a on the brink of failure, developed a breakthrough cancer drug, and sold the company to AbbVie for $21 billion.

Continue to STAT+ to read the full story…