STAT

STAT+: Pharmalittle: Genentech finds no evidence of fraud in paper by former top exec; FDA withdraws approval for premature-birth drug

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, once gain, rather modest. We plan to promenade with the official mascot and his stay-over playmate, catch up on our reading, and hold another listening party with Mrs.

Pharmalot — the rotation will include this, this and this. And what about you? Given the spate of tumultuous news these past few days, perhaps spending time by calming ocean waters or in the solitude of a woodsy area is in order. Or you could zone out and binge-watch something fanciful on the telly. Or perhaps this is an opportunity to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing, STAT reports. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab. The findings come after the university newspaper reported former Genentech employees claimed an internal review uncovered falsified data and that the neuroscientist tried to keep that information quiet.

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2 years 5 months ago

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STAT+: Pharmalittle: FDA panel backs conditional approval for Biogen ALS drug; pharma fights tactic for lowering specialty med costs

Rise and shine, everyone, another busy day is on the way. This morning is getting off to a fabulous start, though, as a delightfully warm sun is enveloping the subdued Pharmalot campus, where the official mascot is happily snoozing and the sounds of spring can be heard from our window.

As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …

A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.

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2 years 5 months ago

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STAT+: Drugmakers push back on a clever tactic employers use to avoid paying for specialty medicines

In the face of rising drug prices, health plan sponsors have quietly used a clever, but questionable tactic over the past few years to deflect costs. And now, some pharmaceutical companies are pushing back.

The maneuver goes by different names — it’s sometimes called a specialty carve out, or alternative funding – but relies on exploiting charitable programs. It works like this: a health plan sponsor excludes certain expensive specialty medicines from coverage and taps an outside vendor to help patients obtain the drugs for free from patient assistance programs run by drugmakers or foundations.

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2 years 5 months ago

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STAT

STAT+: Pharmalittle: Biden administration to fine drugmakers for price hikes on 27 meds; Dems push pharmacy chains over access to abortion pill

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember, there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation.

Our choice today is mocha marshmallow. No prescription is required, so no rebates must be paid or tracked. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Postcards and telegrams are welcomed. …

The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices, STAT notes. Pfizer had the most drugs on the list of any manufacturer, with five. AbbVie’s blockbuster rheumatoid arthritis drug, Humira, is on the list. Gilead Sciences, Endo International, Leadiant Biosciences, and Kamada had two drugs each. The fines are some of the first major changes to the U.S. drug pricing landscape since the Inflation Reduction Act became law. But White House officials said they intend to delay actual invoices for the price hikes until 2025.

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2 years 6 months ago

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STAT

STAT+: Pharmalittle: Lilly diabetes drug back on shelves after two-month shortage; AbbVie sued for human rights violations over Humira pricing

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is mocha marshmallow — and get started.

Meanwhile, do keep us in mind if you hear anything saucy. Our in-basket has been outfitted to accept postcards and telegrams. Have a smashing day. …

Eli Lilly says that all doses of its new Mounjaro diabetes drug are now available after social-media enthusiasm about weight-loss benefits sparked a two-month-long shortage, Bloomberg News tells us. The drug was approved in the U.S. last May to help people with type 2 diabetes control their blood sugar levels. Mounjaro is part of a group of diabetes treatments known as GLP-1s that have shown outsize potential for weight loss. Some of the drugs, including Mounjaro, are being recommended by doctors for weight loss even though they have not been explicitly approved as an obesity treatment in a common practice known as off-label prescribing.

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2 years 6 months ago

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STAT

STAT+: Pharmalittle: Study of Covid-19 therapy revives debate over FDA clearance; pharma companies are ready to make deals

Top of the morning to you, and a fine one it is.

Although gray skies are hovering over the Pharmalot campus, our spirits remain sunny because, as the Morning Mayor taught us, “Every brand new day should be unwrapped like a precious gift.” And so, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is salted caramel mocha. And you? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …

Pharmaceutical executives are ready to make deals, The Wall Street Journal says. Executives at Pfizer, Merck, and Novartis are looking for promising drugs to add to their pipelines and replenish sales as top-selling products lose patent protection in the coming years. Meanwhile, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. The acquisitions could help the companies add new sales to aging line-ups and suggest this year could be a busy one for industry dealmaking. The $88 billion in total deal value last year, involving 75 biopharma tie-ups of at least $100 million, was the lowest since 2017, according to Ernst & Young.

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2 years 7 months ago

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STAT

STAT+: New funding for scientist David Sabatini draws divided reactions

Billionaire New York hedge fund manager Bill Ackman built a record of going against the grain and taking whatever flack or controversy came his way.

True to form, Ackman announced last week that he and an anonymous donor had pledged $25 million over five years toward a new research lab for David Sabatini, a former star scientist from MIT and Whitehead Institute, whose career imploded in 2021 amid allegations of workplace misconduct and sexual harassment.

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2 years 7 months ago

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STAT+: Pharmalittle: AbbVie to lift $2B cap on deals as Humira rivals appear; India to spend $80M to bolster regulatory system

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of online meetings, conferences and deadlines has predictably returned. But what can you do? The world, such as it is, keeps spinning.

So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation. Our choice today is maple bourbon. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you start your journey. We hope your day is productive and meaningful. And of course, do keep in touch. We are searching for new pen pals …

Now that its blockbuster immune-disease therapy Humira is facing lower-priced competition, AbbVie is turning to a pair of next-generation successors to replenish the billions of dollars in sales that will be lost, The Wall Street Journal writes. The company is also betting on four drug approvals by the end of next year. In addition, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. AbbVie is counting most on persuading doctors that two newer immune drugs, Skyrizi and Rinvoq, are more effective than Humira and can pass peak Humira sales in four years.

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2 years 7 months ago

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STAT

STAT+: Inside the fall of star MIT scientist David Sabatini

The 7 a.m. Acela out of South Station in Boston trembled along the rails toward Manhattan. David Sabatini sat alone on the left side of the train. He had brought along a science paper to work on, but had a lot on his mind. He kept his Wordle streak alive on his phone, and stared out at the picturesque Connecticut coastline.

His clothing hung loose from recent weight loss, presumably from stress.

It was Jan. 4, 2022, a brisk sunny day. The tall, gangling scientist with a long mess of black hair had once generated Nobel Prize buzz for his discoveries in biology. But at that moment, he was unemployed in his 50s, his reputation ruined, spending many nights in his brother’s guest room or on his ex-wife’s sofa, so emotionally distraught that his family was afraid to leave him alone.

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2 years 7 months ago

In the Lab, scientists, STAT+

STAT

STAT+: A bellwether for biosimilars: Why the new competition for Humira matters to pharma, payers, and patients

After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.

For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders. In the process, it became the best-selling medicine in the world and generated billions of dollars in annual sales for AbbVie, which extended its monopoly time and again by filing dozens of patents that made it harder for would-be rivals to launch lower-cost biosimilar versions.

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2 years 7 months ago

Pharma, Pharmalot, drug pricing, Pharmaceuticals, STAT+

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