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.

Continue to STAT+ to read the full story…

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.

Continue to STAT+ to read the full story…

Meanwhile, here are a few items of interest to get you started on your journey, which we hope will be meaningful and productive. Best of luck, and do keep in touch. …

Eli Lilly will start providing low-dose vials of its obesity drug Zepbound through its direct-to-consumer platform, a move that will likely ease supply constraints and draw more patients to the company’s online portal, STAT writes. Lilly is also selling the vials at a discount to the currently available injectable pens, which carry a list price of $1,060 for a month’s supply. Under the new offering, which is meant for patients paying on their own without insurance, 2.5-milligram vials will cost $399 for one month’s supply, and 5-milligram vials will cost $549, roughly the equivalent of the average monthly payment for a used car. Dosages of Zepbound pens go up to 10 and 15 milligrams, but Lilly is only offering low-dose vials for now and will evaluate the possibility of selling high-dose vials later.

Cigna plans to remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement in 2025, and recommend less-pricey biosimilar versions of the medicine instead, Reuters tells us. Going forward, Boehringer Ingelheim’s Cyltezo, Simlandi from Teva Pharmaceuticals and Alvotech, and an unbranded version of Hyrimoz from Sandoz will be covered on some lists that are managed by its pharmacy benefits unit Express Scripts. This is the second major U.S. pharmacy benefits manager to stop recommending coverage of Humira, following similar action by CVS Health’s Caremark unit in April. That move led more patients to switch to biosimilar versions of Humira in three weeks than had in the prior 15 months.

Continue to STAT+ to read the full story…

We also hope to hold another listening party, where the rotation will likely feature this, this, this, and this. And what about you? This is a grand time to enjoy the great outdoors. Beaches and lakes are beckoning. City streets want to be strolled. And woods are inviting the adventurous for long mysterious walks. Take your pick. Or you could simply hide indoors and binge-watch something on the telly. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

A U.S. court tossed a U.S. Chamber of Commerce lawsuit challenging the Medicare Drug Price Negotiation Program established through the Inflation Reduction Act, with a judge finding that several plaintiffs in the suit lacked standing, STAT reports. U.S. District Judge Michael Newman for the Southern District of Ohio found that the Chamber’s argument it could sue on behalf of its members through associational standing was incorrect. The plaintiffs argued they could sue on behalf of pharmaceutical companies that are members of the organization — in this case, AbbVie and its subsidiary Pharmacyclics. Pharmacyclics is based in California, and AbbVie operates in Illinois, California, Massachusetts, and Washington, D.C., but the suit was filed with a local Chamber chapter in Dayton, Ohio.

California lawmakers are making a last-minute push before adjourning to restrain pharmacy benefit managers against the background of a national effort to rein in prescription drug prices, Bloomberg Law writes. Proponents of the bill, led by pharmacists, argue SB 966 would help place needed safeguards on the middlemen who negotiate with drug manufacturers and manage prescription benefits for employers. The bill would require PBMs to be licensed. Supporters say the companies have undermined competition and are financially squeezing smaller pharmacies. The effort comes as lawmakers in 41 states have filed more than 170 related bills this year to regulate PBMs.

Continue to STAT+ to read the full story…

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 maple bourbon. Remember, a prescription is not required. So no need to fret over whether rebates are being passed along. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

Four pharmaceutical companies involved in the negotiations over prices for Medicare do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026, Reuters writes. Executives from Bristol Myers Squibb, Johnson & Johnson, AbbVie, and AstraZeneca, which have 5 of the 10 drugs chosen for the first wave of negotiations, described their views on quarterly conference calls. “I think the drugmakers were frightened (these prices) would be a big deal. But now, the ones who have reported or commented have actually said it seems to be OK and in line with expectations,” UBS analyst Trung Huynh.

The U.K.’s cost-effectiveness watchdog blocked the National Health Service from providing an innovative treatment for a form of advanced breast cancer, blaming AstraZeneca and Daiichi Sankyo for being “unwilling” to offer their Enhertu drug at a low enough price, The Financial Times tells us. Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence, said cost was to blame for the decision, the first breast cancer treatment NICE rejected in six years. If a drug is not recommended by NICE, it cannot be made available on the NHS. The decision also shows the challenge for stretched health care systems to fund complex, novel medicines.

Continue to STAT+ to read the full story…