STAT

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.

Continue to STAT+ to read the full story…

2 years 2 months ago

Pharma, Pharmalot, Pharmaceuticals, STAT+

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 2 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 2 months ago

Pharma, Pharmalot, drug pricing, Pharmaceuticals, STAT+

STAT

STAT+: Focused exclusively on life sciences, three top investors set out on their own

Almost a year ago, three top investors at Lux Capital and Obvious Ventures announced they were leaving the firms, teasing on Twitter that they were starting “something new.”

That something is a new venture capital firm, which launched Wednesday with $350 million for its first fund.

Almost a year ago, three top investors at Lux Capital and Obvious Ventures announced they were leaving the firms, teasing on Twitter that they were starting “something new.”

That something is a new venture capital firm, which launched Wednesday with $350 million for its first fund.

Continue to STAT+ to read the full story…

2 years 2 months ago

Biotech, biotechnology, finance, STAT+, venture capital

STAT

STAT+: Pharmalittle: Lilly and AbbVie exit U.K. drug-pricing program; J&J scales back Covid-19 vaccine production

Good morning, everyone, and welcome to another working week, which is only getting started on this side of the pond, due to an extended holiday weekend. Whatever your schedule, we hope you are feeling invigorated and inspired, because the ever-present to-do list is, no doubt, expanding. To cope, we are brewing a delicious cup of stimulation.

Our choice today is Jack Daniels (yes, this is a real thing) in honor of our 16th anniversary since Pharmalot debuted. We would like to take a moment to thank you for tuning in all these years and, moreover, lift our cup to recognize those of you who provide feedback, suggestions, criticism, and tips. Now, though, time to get cracking once again. We hope your day is productive and meaningful. And of course, do stay in touch. …

After mobilizing to quickly develop and manufacture a Covid-19 vaccine, Johnson & Johnson has vastly scaled back efforts to produce the shots as it faces slumping demand, The Wall Street Journal reports. In recent months, J&J terminated manufacturing agreements with companies that helped produce the shot, such as Catalent and Sanofi. Meanwhile, a partnership with Merck to help make the shots, forged at the urging of the U.S. government, has not lived up to expectations. The companies are now engaged in arbitration. Merck made J&J vaccines at only one plant, but did not make commercial doses at another plant involved a more complex part of the manufacturing process.

Continue to STAT+ to read the full story…

2 years 3 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Former MIT professor tried to influence investigation of harassment at lab, report states

Former Massachusetts Institute of Technology professor David Sabatini attempted to influence a legal investigation into complaints of gender bias and sexual harassment at his lab, according to what appears to be a copy of the investigation report, leaked online Wednesday.

Former Massachusetts Institute of Technology professor David Sabatini attempted to influence a legal investigation into complaints of gender bias and sexual harassment at his lab, according to what appears to be a copy of the investigation report, leaked online Wednesday. The report further found his denials were not credible. Portions of the report had been leaked earlier.

A spokesperson for MIT’s Whitehead Institute, which commissioned the investigation by a law firm, declined to comment on the leaked document.

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2 years 3 months ago

In the Lab, legal, scientists, STAT+

STAT

STAT+: Pharmalittle: AbbVie leaves pharma industry trade groups; net drug prices see big drop after inflation

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 quickly filling up. Besides the usual promenading with the official mascot, we plan to hang with at least two of our short people, one of whom returns from an institution of higher learning.

We are also readying another listening party with Mrs. Pharmalot (the rotation will include this, this and this) and will stop to observe some ancient rituals (sufganiyot, anyone?). And what about you? Holidays are nearing, but there is still time to squeeze in a visit to a nearby temple of consumption. You could also plan a much-needed getaway. Or work on your list of resolutions for the next year — if so, we wish you much luck. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon….

AbbVie is leaving several major industry groups representing its interests in Washington, D.C., STAT reports. The company is leaving the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, the two prominent pharmaceutical trade associations, according to the groups. AbbVie is also leaving the Business Roundtable, a group comprising the chief executives of the largest U.S. companies. The decision comes as regulators begin to implement the drug-pricing provisions of the Inflation Reduction Act that drugmakers spent millions in lobbying to defeat.

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2 years 4 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: AbbVie exits major pharmaceutical industry lobbying groups

WASHINGTON — The maker of one of the world’s most profitable medicines is exiting the pharmaceutical industry’s two major lobbying organizations next year, just as Washington pledges to crack down on high drug costs.

AbbVie, which for years has fought off competition for its blockbuster autoimmune drug Humira — the world’s top-selling medicine before Pfizer’s Covid-19 vaccine hit the market — has been the target of congressional hearings and legislation aimed at so-called patent thickets that can stall rival products.

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2 years 4 months ago

Politics, Advocacy, Congress, drug pricing, Medicare, Pharmaceuticals, STAT+, White House

STAT

STAT+: Study points to new ‘king on the block’ for treatment of chronic lymphocytic leukemia

NEW ORLEANS — One of the best therapies for some types of lymphoma and leukemia has been a drug called ibrutinib, made by AbbVie. When it hit the market in 2013, the drug revolutionized the treatment of these cancers and represented a major step forward from chemotherapy and some other drugs at the time.

But research presented at the American Society of Hematology meeting in New Orleans suggested that a second-generation drug called zanubrutinib from BeiGene is about to unseat ibrutinib as “the king on the block” for the treatment of chronic lymphocytic leukemia, said Catherine Diefenbach, medical director of the lymphoma program at the NYU Langone’s Perlmutter Cancer Center.

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2 years 4 months ago

Biotech, Health, ASH22, biotechnology, Cancer, STAT+

STAT

STAT+: Pharmalittle: Medicare willing to reevaluate coverage of Alzheimer’s drugs; judge tosses shingles-vaccine lawsuits against Merck

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, so far, appears to be rather modest. We plan to promenade extensively with the official mascot, tidy up around the castle, check in on the Pharmalot ancestors, and have a listening party with Mrs.

Pharmalot (this will be first up). And what about you? There are some holidays just around the bend, so this may be an opportunity to open those catalogs or visit the nearest temple of consumption. You know what they say — act now, before prices rise still further. There is still time, of course, to plan a holiday getaway. Or you could hit the pause button and take stock of life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, STAT tells us. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, the Centers for Medicare and Medicaid Services administrator, said at the Milken Institute Future of Health Summit when asked about how the agency will approach the drug. “We will look at it as new data comes.” Last April, Medicare finalized a coverage policy in which it would only pay for Aduhelm if patients were enrolled in a clinical trial.

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2 years 4 months ago

Pharma, Pharmalot, pharmalittle, STAT+

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