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.

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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.

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With any luck, we will also find time for another listening party, where the rotation is likely to include this, this, this, this and this. And what about you? Summer is rapidly nearing an end, but there is still time to enjoy the great outdoors. Remember, beaches, lakes, and hiking trails are beckoning. This may also be an opportunity to sample new eateries or catch up on your reading, or perhaps, simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you on Tuesday, since this is a holiday weekend on this side of the pond. …

Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment, STAT writes. Researchers combined data on nearly 4,000 patients across four trials who had heart failure with reduced ejection fraction (or HFpEF) and found that 5.4% of those treated with Wegovy experienced cardiovascular-related death or heart failure events, compared with 7.5% of those who received placebo. This translated to a 31% risk reduction. On heart failure events, defined as hospitalizations or urgent care visits, Wegovy cut the risk by 41%. On cardiovascular-related deaths, it reduced the rate by 18%, but this result was not statistically significant.

Meanwhile, Wegovy demonstrated still another benefit to patients in a study that found, compared to placebo, the medicine cut the chances of dying from Covid-19 by roughly a third, STAT notes. Given that obesity is a major risk factor for severe Covid outcomes, it perhaps seems obvious that a medicine that helps people lose weight also helps protect them from the worst tolls of a SARS-CoV-2 infection. But researchers say it might not be as straightforward as that. “All of that just means somebody is in a better state when they get hit by a medical disaster like a severe Covid infection,” said Benjamin Scirica, a cardiovascular medicine specialist at Brigham and Women’s Hospital in Boston, who presented the data Friday at the European Society of Cardiology’s annual meeting in London.

Continue to STAT+ to read the full story…

So grab that cup of stimulation and get started. Our flavor today is pumpkin spice, 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. …

Delaware’s highest court agreed to hear an appeal by GSK and other drugmakers seeking to end more than 70,000 lawsuits claiming discontinued heartburn drug Zantac caused cancer, Reuters writes. GSK, Pfizer, Sanofi, and Boehringer Ingelheim are asking the court to overturn an order by a lower court judge allowing plaintiffs in the lawsuits to offer expert testimony on the alleged cancer link, which the companies argue is not supported by sound scientific methods. Without that testimony, the lawsuits cannot go forward. The drugmakers won a significant victory in 2022, when a federal judge in Florida rejected the plaintiffs’ expert witnesses in about 50,000 cases on the grounds that they did not use reliable scientific methods. Some of the Florida cases are being appealed, and the vast majority of the remaining cases are in Delaware.

Neurocrine Biosciences reported that the lowest dose of an experimental pill for schizophrenia reduced psychosis reported by patients in a mid-stage study, but higher doses of the drug also tested were ineffective, STAT informs us. The company said the study results supported advancing the medicine into Phase 3 studies next year. Investors viewed the mixed data with more concern, sending Neurocrine stock down 18% in early trading. The drug belongs to an emerging class of neuropsychiatric medicines that target muscarinic receptors in the brain. This type of drug has garnered a lot of attention due to the acquisitions of Karuna Therapeutics ($14 billion) and Cerevel Therapeutics ($8.7 billion) by Bristol Myers Squibb and AbbVie, respectively.

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