The BIOSECURE Act would prohibit many biotech and pharmaceutical companies from conducting certain research and development activities, including the manufacturing of drugs through named Chinese companies. On Monday, an updated version of the bill passed the House of Representatives with strong bipartisan support. Notably, a number of representatives with expertise in health care and the life sciences ultimately voted against the legislation. The Senate is expected to take up a slightly different version later this year.

BIOSECURE proponents argue that allowing the Chinese Communist Party access to U.S. patient information is a national security concern, as is the overreliance on China for drug development. They aren’t wrong. Protecting that information and being able to make our own medicines should be a national priority.

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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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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 Keytruda’s biggest market.

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 on the brink of failure, developed a breakthrough cancer drug, and sold the company to AbbVie for $21 billion.

Duggan, 80, is a living rebuke to a pharmaceutical industry self-image that is increasingly crafted in Cambridge, Mass. and San Francisco. Before Pharmacyclics, he had no drug industry experience, having worked in cookie stores and then surgical robots. He lacks a college degree, and is a practicing scientologist who told STAT in an interview that he reads the works of Scientology founder L. Ron Hubbard every day and who has in the past said he’d given the church more than $360 million. He speaks in long, dramatic arcs, often spelling out words, referencing their roots, or giving itemized lists.

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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.

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LONDON — Novo Nordisk made worldwide headlines last year when a study demonstrated that Wegovy, its powerful and exceedingly popular weight loss medicine, helped reduce the risk of cardiovascular emergencies like heart attacks. 

Researchers on Friday unveiled results demonstrating another benefit that the drug offered to patients in that study: Compared to placebo, it cut the chances of dying from Covid-19 by roughly a third. 

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. Some studies have indicated that the drug, also known as semaglutide, bolsters the immune system, tamps down inflammation, and strengthens other organs, including the liver and kidneys, in ways that scientists are only beginning to tease out. 

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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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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.

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WASHINGTON — The day drugmakers dreaded has finally arrived. 

Medicare officials on Thursday unveiled the results of the program’s first 10 drug price negotiations, despite the industry’s two-decade, multimillion-dollar lobbying campaign and barrage of lawsuits to stop them. 

The drugs that received negotiated prices are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, J&J and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog. 

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Gavin Newsom to support food makers’ nightmare scenario — a first-in-the-nation law banning certain food additives in the state, which was signed into law last year.

Wagner is best known for his co-ownership of Magnolia Pictures alongside his longtime business partner Mark Cuban. But now, he told STAT in an extended interview, he’s dedicating himself to fighting food makers and their industrial creations, ultra-processed foods.

“I want people angry,” said Wagner, who is worth an estimated $1.9 billion. “This is an indictment of the food companies that have tainted our food supply, and now we wake up 50, 60 years later with a nation that is unhealthy.”

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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.

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