STAT

STAT+: Lobbying spending dropped for companies that departed PhRMA

WASHINGTON — The three companies that recently left PhRMA all spent less on lobbying following their departures, according to newly released federal disclosures.

PhRMA, the brand-drug industry trade group, lost three members over a span of five months following the passage of Democrats’ drug pricing reform law last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt the group’s bottom line.

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1 year 8 months ago

Politics, Advocacy, Congress, life sciences, Pharmaceuticals, policy, STAT+, White House

STAT

STAT+: How to ‘break the logjam’? Economists pitch a plan to curb dire drug shortages

There are alarmingly frequent reports of shortages of vitally needed medicines. From tablets to treat ADHD and severe pain to injectable treatments for syphilis and various cancers, the U.S. has been facing a number of serious shortages recently. And this was before a U.S. Senate report found the number of active shortages reached a peak at 295 at the end of 2022.

The reasons can vary, from quality control failures at manufacturing plants to surging demand, including significant interest that has at times squelched availability of drugs taken for weight loss.

But the problem is not easily fixed. Most active pharmaceutical ingredients are made in China, and boosting production in the U.S. is not like flipping a switch. Many of the drugs in short supply are generics made in India, where regulators often find serious production lapses. So what to do? Along with a colleague, Marta Wosińska, a senior fellow in economic studies at The Brookings Institution, has three ideas to alleviate shortages of generic sterile injectable medicines, in particular. They suggest the U.S. government should provide incentives to upgrade facilities and create a buffer inventory. But they also argue hospital purchasing is in need of an overhaul. We discussed the possibilities; our conversation has been lightly edited. 

I’ve been writing about drug shortages on and off for many years, but the problem never goes away. And now, it seems even worse. Obviously, something has to change. But what exactly has been lacking with our policies to date?

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1 year 9 months ago

Pharma, Pharmalot, Biotech, Cancer, Pharmaceuticals, STAT+

STAT

STAT+: Pharmalittle: Eisai executive to retire; Express Scripts adds three Humira biosimilars to formulary

Top of the morning to you, and a fine one it is. Birds are chirping and cool breezes are wafting by the Pharmalot campus, where the official mascots are racing about the grounds. As for us, we are ensconced doing the usual sorts of things — updating our to-do list, brewing cups of stimulation (our choice today is chocolate raspberry) and foraging for items of interest.

Speaking of which, we have gathered the latest bushel for your perusal if you scroll down a wee bit. Of course, all of this means that it is time to get cracking. So here we go. We hope you have a smashing day and conquer the world. And as always, please do stay in touch …

Eisai announced that Ivan Cheung, who ran its global Alzheimer’s drug program, will retire at the end of the month and be replaced by the son of Eisai chief executive officer Haruo Naito, STAT writes. The move comes after Cheung led the push for U.S. approval of the breakthrough medicine Leqembi. Keisuke Naito, 34, a senior vice president and chief strategy and planning officer, will become acting global Alzheimer’s officer. Cheung’s resignation comes less than a week after Eisai and Biogen were granted full approval for Leqembi in the U.S. The drug is the first medicine shown to slow progression of the disease, which afflicts some 6 million Americans.

Express Scripts will add three biosimilar versions of AbbVie’s blockbuster arthritis treatment Humira to its list of preferred drugs, Reuters notes. The biosimilars include branded and unbranded versions from Sandoz, the generic unit of Novartis, as well as one from Boehringer Ingelheim. Express Scripts, the pharmacy benefits manager owned by Cigna, said the biosimilars would be included as preferred brands on its formulary. The drugs, launched this month, add to competition for Humira in the U.S. that started in January with the launch of a biosimilar by Amgen that is already on Express Scripts formulary.

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1 year 9 months ago

Pharma, Pharmalot, Biosimilars, Pharmaceuticals, STAT+

STAT

STAT+: The new weight loss drugs are revolutionizing our understanding of desire. Food cravings could be just the beginning

One month it was pizza. Starting in the late afternoon, while he was teaching a chem lab or grading student work, a part of Anthony Fernandez’s brain would stray to visions of steaming pies. The thought of sinking his teeth into one would tug at him as he packed up his things and walked to his car.

By the time he pulled out of the Merrimack College campus, the urge would become a tractor beam, reeling him into the small shop just shy of Route 125 for a slice or three.

It would go on like that for weeks. Intrusive phantom wafts of bubbling hot cheese seeping into his psychic space. An unwelcome rush of saliva. A pizza-shaped itch begging to be scratched. Then suddenly they would be gone. Replaced by a new fixation: coconut jelly sticks from Heav’nly Donuts one month, Dunkin’s Beyond Sausage sandwich the next.

Fernandez knew it was these roving food obsessions that were losing him his latest weight loss battle. The 53-year-old chemistry professor had been hovering between 275 and 295 pounds for most of his adult life. At 5’10”, that made him obese by most body mass index calculations. Then during the first year of the Covid-19 pandemic, while much of the rest of the country struggled with the “quarantine 15,” Fernandez shed 20 pounds while hunkering at his Massachusetts home. When he lost easy access to fast food, the weight followed.

But as stores and restaurants began to open up again, the numbers on his scale crept steadily higher. So did the number of fatty acids and excess sugar in his blood. Around Thanksgiving 2021, Fernandez’s doctor approached him about trying something different: a new weight loss drug called Wegovy.

Originally developed for people with type 2 diabetes like Fernandez’s parents, Wegovy — the brand name for one of an expanding class of injectable medicines known as GLP-1 receptor agonists — was helping people lose up to 15% of their body weight. The needles initially made him hesitate. But by late February last year, Fernandez came around to the idea. The first time he tried Wegovy, he made his wife stand next to him just in case he fainted. But the pen hid the needle from sight and he barely felt it pierce his skin. By the end of that first month, his urges had evaporated.

“From the get-go, I stopped having a lot of those in-between meal cravings,” Fernandez said. “I don’t find that I need those snacks in the middle of the day or late at night. I used to need something after I put the kids to bed. I’d pull out a bag of carrots and a jar of hummus and eat the whole damn thing. I don’t do that anymore.”

Fernandez is among an exploding number of Americans taking these drugs for weight loss — more than 5 million people in the U.S. were prescribed a GLP-1 agonist in 2022, up from about 230,000 in 2019, according to a recent analysis by data insights company Komodo Health. Their rapid adoption is a testament to their striking effectiveness — unmatched by any weight loss drugs in history. But even scientists who’ve spent decades dissecting the actions of the gut hormone these medicines are designed to mimic have been surprised by their potency.

GLP-1 was first identified more than 40 years ago as a chemical messenger produced in the gut that tells the pancreas to crank out more insulin. Scientists learned pretty quickly that it does so by binding to GLP-1 receptors dotting the surface of beta cells in the pancreas. But only in recent years have researchers begun to understand the extent to which the brain also uses GLP-1 as a signaling molecule. It’s through networks of neurons coated with GLP-1 receptors that GLP-1 agonists act to suppress eating — not only, as was long believed, by communicating feelings of fullness, but also by altering circuits in the brain that drive desire.

This wasn’t obvious back when these drugs were beginning to be developed. They weren’t, originally, even designed to get into the brain. But more and more, scientists are learning that’s where they work to cause weight loss. These revelations have the potential to lead to more potent versions of these drugs in the future. They also raise an even more tantalizing question: If hormone hacking can erase food cravings, what other destructive desires might it liberate us from one day?

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1 year 9 months ago

In the Lab, The Obesity Revolution, addiction, neuroscience, Obesity, STAT+

STAT

STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Reata Pharmaceuticals hired Rajiv Patni as executive vice president, chief R&D officer. Previously, he worked at Global Blood Therapeutics, where he was chief medical officer.

But all work and no play can make for a dull chief medical officer.

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1 year 9 months ago

Pharma, Pharmalot, Pharmaceuticals, STAT+

STAT

STAT+: Pharmalittle: PBMs are targeted in yet another congressional bill; access to new Alzheimer’s drug may not happen quickly

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of salted caramel mocha for the occasion. We can practically taste the Jersey shore.

Meanwhile, our ever-growing to-do list requires attention. Sound familiar? So, here are some items of interest. Have a great day and hope you conquer the world, everyone …

Coherus BioSciences agreed to resolve a dispute over its plans to launch a lower-priced version of AbbVie’s Humira rheumatoid arthritis drug, Reuters writes. Earlier this month, Coherus said it will launch a biosimilar version of the drug at an 85% discount to the $6,922 list price and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27. AbbVie alleged it breached an older deal granting Coherus a non-exclusive license to commercialize a biosimilar version in the U.S. as of July 1. AbbVie will not terminate the initial licensing deal based on its notice. It would have to serve another notice and give Coherus time to resolve the breach if it chooses to end the deal.

Expanded access to the Alzheimer’s drug from Eisai and Biogen is unlikely to happen quickly even if the Food and Drug Administration decides follow-up studies confirm the drug helps slow the disease, Bloomberg News explains. Medicare said that “broader” coverage would begin “on the same day the FDA grants traditional approval.” But patients, doctors, and analysts are all doubtful, citing the limited information publicized by the agency on how the registry will work. For the registry to succeed, it must be easy for prescribers to use, they argue. Researchers and others also will need real-time data to show whether the drug is beneficial and safe, they added.

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1 year 9 months ago

Pharma, Pharmalot, Biosimilars, Pharmaceuticals, STAT+

STAT

STAT+: Drug companies and pharmacies reach $17.3 billion settlement over opioid crisis

Two large drugmakers and two of the biggest pharmacy chains finalized a $17.3 billion deal to settle accusations by state governments that they contributed to the opioid crisis that swept across the U.S. for more than a decade and contributed to thousands of overdose deaths.

The agreement  —which involves Teva Pharmaceuticals; Allergan, a unit of AbbVie; CVS; and Walgreens — is the latest involving several major players blamed for the crisis. Last year, dozens of states and thousands of local communities reached a global settlement worth $26 billion with three largest pharmaceutical wholesalers as well as Johnson & Johnson to resolve civil lawsuits.

As part of the deal, Teva agreed not to market opioids and will provide its generic version of Narcan, the overdose reversal medication, which it has valued at $1.2 billion. Allergan is required to stop selling opioids for the next 10 years, while CVS and Walgreens have agreed to monitor, report, and share data about suspicious activity related to opioid prescriptions.

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1 year 10 months ago

Pharma, Pharmalot, addiction, legal, Opioids, STAT+

STAT

STAT+: Pharmalittle: Coherus undercuts AbbVie with discounted Humira; FDA approves second RSV vaccine

Good morning, everyone. Damian Garde here, filling in for Ed Silverman on the back half of what is, at least in this part of the world, a shortened work week. Temperatures are climbing and with them the number of out-of-office email replies from colleagues who’ve thought better of working while it’s nice out. May you join them soon.

In the meantime, here as always are some tidbits to get your day started. If you hear anything interesting out there, do let us know. …

Coherus BioSciences plans to sell a biosimilar version of Humira at a steep discount, STAT reports, and the company will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Coherus’ version of Humira, one of the world’s best-selling medicines, will carry a $995 list price for a carton of two autoinjectors, which is an 85% discount from the $6,922 that AbbVie charges for the branded product. Coherus will also sell its drug at a discount to the Mark Cuban Cost Plus Drug company, which will market the treatment for about $579.

The U.S. Food and Drug Administration approved a second vaccine to protect older adults against RSV, STAT tells us, licensing Pfizer’s Abrysvo for adults 60 and older. The decision comes about a month after the agency approved GSK’s Arexvy, the first-ever vaccine against respiratory syncytial virus, or RSV. Neither vaccine is currently available for use. The Centers for Disease Control and Prevention must recommend the vaccines before they can be sold, a process expected to conclude later this month.

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1 year 10 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.

In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.

Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.

The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.

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1 year 10 months ago

Pharma, Pharmalot, Biosimilars, finance, Pharmaceuticals, STAT+

STAT

STAT+: Addiction treatment center founder indicted in sprawling fraud scheme

Over the last few years, Daniel Cleggett Jr. appeared to be living a charmed life.

The founder of a small Boston-area addiction treatment empire knew he was under scrutiny; the Globe and STAT News published investigations in 2017 and 2019 into his questionable business dealings, and the Massachusetts attorney general’s office announced shortly after that it was examining alleged scams involving addiction treatment.

Still, Cleggett did little to hide his excess, nor did he seem to hit the brakes on new ventures. He opened business after business; took lavish vacations to Yellowstone, Mont., and Aruba; dined on caviar at expensive hotels; and got married at the luxury Chatham Bars Inn on Cape Cod. His Facebook page, filled with glowing shots of his family by the seashore and in the Virgin Islands, screamed success.

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1 year 10 months ago

Health, addiction, Opioids, patients, STAT+

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