STAT

STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes

In what one U.S. lawmaker described as possibly the “largest tax-dodging scheme” by a pharmaceutical company in history, Pfizer sold $20 billion in medicines to U.S.

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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1 week 13 hours ago

Pharmalot, biotechnology, Pharmaceuticals, policy, STAT+, Taxes

STAT

STAT+: AbbVie, J&J to add proprietary data to AI protein model in bid to accelerate drug discovery

Imagine standing on a vast, dark plain. Without light, you cannot see dips and rolls in the grass or make out hills and valleys. Even if there’s a city off in the distance to your right, it does nothing to illuminate the darkness on your left, unless there are pinpricks of light there which might indicate a mountain or level ground.

So, too, is the vast, unexplored drug-hunting territory of chemical space, waiting to be illuminated by data’s light.

Every AI model trained for biology only can see what’s illuminated by the data points it is trained on. AlphaFold succeeded in predicting protein structures because the 200,000 or so known protein structures in the Protein Data Bank covered enough of the limited ways amino acids can combine that the model was able to understand what almost the entire protein structure space looked like. But ask the PDB for only the structures where proteins are hugging other proteins or — even rarer — interacting with drug-like molecules, and there’s nowhere near enough illumination for AI biology models to understand what the topography of those plains look like, much less make useful predictions for drug discovery.

Life sciences data company Apheris on Thursday announced an effort to boost the capabilities of protein AI models by uniting several pharmaceutical companies’ proprietary data. Apheris’ consortium of pharma companies is partnering with OpenFold3 — Columbia professor Mohammed AlQuraishi’s open-source dupe of AlphaFold3 — to train the model on AbbVie and Johnson & Johnson’s vast stores of structural data. The collaboration will focus on structures relevant to drug discovery, such as small molecule-protein and antibody-antigen interactions. 

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1 week 1 day ago

Biotech, Health Tech, Pharma, Artificial Intelligence, Health Tech, STAT+

STAT

STAT+: Pharmalittle: We’re reading about NIH removing scientific advisers, GSK’s shingles shot, and more

Rise and shine, everyone, another busy day is on the way. We can tell by the parade of motor vehicles passing by the Pharmalot campus and the continuous rumble of commuter trains off in the distance. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is coconut rum, a delicious household favorite. As always, you are invited to join us.

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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1 week 2 days ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Pharmalittle: We’re reading about a new CVS chief, obesity meds cutting overdoses, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We expect to tidy up around the increasingly leafy Pharmalot campus, promenade with the official mascots, and catch up on our reading. We also hope to hold another listening party with Mrs.

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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5 months 2 weeks ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Ron Renaud, biotech’s serial CEO, is ready for a new assignment — and maybe another deal?

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

When it comes to delivering shareholder value through M&A, Ron Renaud is a biotech investor’s best friend. Over the last 10 years, all three of the companies he has helmed were sold to Big Pharma for a combined $16 billion. 

With that track record — and the financial windfall it brings — no one would have begrudged Renaud, 55, had he desired to spend more time with his Cape Cod fishing buddies. But he can’t quit biotech. Weeks after overseeing the close of Cerevel Therapeutics’s $8.7 billion acquisition by AbbVie, Renaud is back as CEO of Kailera Therapeutics, a newly formed company with a pipeline of weight loss drug candidates.

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6 months 2 days ago

Adam's Take, Biotech, biotechnology, Obesity, STAT+

STAT

STAT+: Pharmalittle: We’re reading about a Blue Cross California deal for Humira, Gilead licensing an HIV drug, and more

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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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6 months 3 days ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: $400 million for an obesity drug startup? A new venture is a sign of the times

Atlas Venture and Bain Capital Life Sciences are making their next bet in the buzzy obesity field, launching a new startup led by a chief executive hot off of his third acquisition deal.

Atlas, Bain, and RTW Investments announced Tuesday that they have co-led a $400 million Series A financing for a new Boston-area startup company called Kailera Therapeutics. The investors have also brought in a familiar face: Ron Renaud, who recently oversaw the $8.7 billion acquisition of Cerevel Therapeutics, a spinout of Pfizer assets that Bain helped finance back in 2018. 

Kailera’s series A round total is one of the largest in the biotech industry this year, and speaks to just how much attention weight loss medications have garnered from investors.

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6 months 4 days ago

Biotech, biotechnology, Obesity, STAT+

STAT

STAT+: AbbVie Parkinson’s drug helps improve symptoms in late-stage study

This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. 

This story first appeared in The Readout newsletter. Sign up for The Readout and receive STAT’s award-winning biotech news delivered straight to your inbox. 

AbbVie reported Thursday that its experimental Parkinson’s drug that it got from Cerevel Therapeutics helped alleviate symptoms and improve quality of life in a late-stage study.

In the Phase 3 trial, early-stage Parkinson’s patients on the highest dose of the drug, called tavapadon, experienced a 10.2-point improvement on tests that measured motor symptoms and quality of life, also known as the MDS-UPDRS parts II and III. Meanwhile, those on placebo saw a 1.8-point worsening.

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6 months 1 week ago

Biotech, biotechnology, chronic disease, STAT+

STAT

STAT+: Pharmalittle: We’re reading about an Express Scripts lawsuit against FTC, AMR deaths, and more

Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus.

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.

Continue to STAT+ to read the full story…

6 months 2 weeks ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Pharmalittle: We’re reading about Moderna R&D cuts, Lilly plant investments and more

Rise and shine, everyone, another busy day is on the way. However, this is also shaping up as a beautiful day as well, despite forecasts predicting rising heat. The skies are tranquil, birds are chirping, and the official mascots are chasing creatures on the Pharmalot campus. This calls for celebration with a cup of stimulation, and we are opening a new package of pecan pie for the occasion.

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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6 months 3 weeks ago

Pharmalot, Pharmaceuticals, Research, STAT+

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