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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2 years 4 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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2 years 4 months ago

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

MedCity News

AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease

FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

2 years 5 months ago

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STAT

AstraZeneca is third member to leave PhRMA in five months

WASHINGTON — AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said.

The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.

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2 years 5 months ago

Pharma, Politics, Advocacy, biotechnology, Congress, drug pricing, life sciences, Pharmaceuticals, policy

STAT

STAT+: Pharmalittle: U.S. Senate committee passes PBM bills; Pfizer CEO predicts pharma will sue over Medicare price negotiations

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 will focus largely on Mrs. Pharmalot as she turns another page on the calendar and also on fostering a potential mascot — wish us luck. And of course, we hope to squeeze in another listening party.

The rotation will likely include this, this, this and this. And what about you? Once again, this is a wonderful time to enjoy the great outdoors — beaches, woods, and lakes are beckoning. Or you could putter about your castle — a little spring cleaning is a good thing. And if mom is around, remember to say hi. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers, but it failed to pass an ambitious reform despite strong bipartisan support, STAT explains. The committee passed, 18 to 3, a bill that would ban pharmacy benefit managers from using spread pricing. The bill would also require that pharmacy benefit managers disclose rebates, fees, and other payments they receive and pass them on to the insurers for whom they negotiate the concessions. Lawmakers did not vote on a bill that would ban pharmacy benefit managers from charging administrative fees based on a percentage of a drug’s list price.

Pfizer chief executive officer Albert Bourla indicated that pharmaceutical companies will likely take legal action against Medicare drug price negotiations, CNBC tells us. Bourla referred to a provision in the Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. Bourla called the plan “negotiation with a gun to your head.” The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the plan, but noted he is “not optimistic” about that happening.

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2 years 5 months ago

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STAT

STAT+: AbbVie sues a behind-the-scenes company for exploiting its patient assistance program

AbbVie has filed a lawsuit against a behind-the-scenes company that helps health plan sponsors take advantage of the assistance programs created by drug companies to provide specialty medicines to patients for free.

At issue is a maneuver called alternative funding, which a growing number of drugmakers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help patients obtain the medicines for free from patient assistance programs run by drug makers or foundations.

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2 years 5 months ago

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STAT

STAT+: Wyden decries ‘astonishingly low’ tax rates for pharma companies as he probes business maneuvers

Thanks to changes in tax law six years ago, several of the largest pharmaceutical companies saw their tax rates fall substantially, but they also reported that most of their profits were shifted offshore in an effort to avoid paying U.S.

taxes, according to a memo by a U.S. Senate Committee.

Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.

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2 years 5 months ago

Pharma, Pharmalot, Congress, finance, Pharmaceuticals, STAT+

MedCity News

Acelyrin Plans IPO to Fund Pivotal Tests of Drug That Could Rival AbbVie’s Humira

Biotech IPOs continues to be almost non-existent, but Acelyrin wants to see if the public markets have an appetite for its lead drug candidate. The small protein drug could match up favorably against blockbuster biologics and it has reached pivotal testing in three inflammatory disorders.

2 years 6 months ago

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MedCity News

What Do Payers Need to Help Value-Based Contracting Deals for Novel Therapies Succeed? [Sponsored]

A panel discussion at the annual Abarca Forward conference in Puerto Rico last month sought to identify some of the innovative financial approaches that can be applied to managing the high price of novel therapies. Conversations also addressed what payers need for these financing models to be sustainable.

2 years 6 months ago

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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 6 months ago

Pharma, Pharmalot, pharmalittle, STAT+

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