Sen­ate Re­pub­li­cans seek to re­peal new gov­ern­ment drug price ne­go­ti­a­tions

With the midterm elec­tions ap­proach­ing next month and Re­pub­li­cans like­ly to win back con­trol of ei­ther the House, Sen­ate or both, Re­pub­li­can Sens. James Lank­ford (OK) and Mike Lee (UT) re­cent­ly in­tro­duced a bill that would gut the De­moc­rats’ re­cent drug pric­ing vic­to­ry.

That new law will al­low for drug price ne­go­ti­a­tions, and even po­ten­tial­ly price con­trols (via the threat of steep fines), for a sliv­er of the most ex­pen­sive drugs for se­niors, all of which will have al­ready been on the mar­ket for years.

But the Re­pub­li­cans aren’t seek­ing to just roll back the fed­er­al gov­ern­ment’s new ne­go­ti­a­tion au­thor­i­ty un­der Medicare, but al­so re­move the new­ly passed re­bates that drug com­pa­nies would have to pay if their prices rise faster than the rate of in­fla­tion, and yank a pro­vi­sion that would cap se­niors’ out-of-pock­et costs at $2,000 per year.

“Price con­trols nev­er work. In­stead, they ex­ac­er­bate the prob­lems they seek to re­solve,” Lee said in a state­ment. “Man­dat­ing fixed pre­scrip­tion drug prices will ul­ti­mate­ly re­sult in the short­en­ing of Amer­i­can lives.”

But on the ef­fort to re­peal the caps on se­niors’ out-of-pock­et costs, ex­perts not­ed that Re­pub­li­cans have sup­port­ed such price caps in re­cent mem­o­ry.

For in­stance, House En­er­gy & Com­merce com­mit­tee Re­pub­li­can leader Cathy Mc­Mor­ris Rodgers (R-WA), Ways and Means com­mit­tee Re­pub­li­can leader Kevin Brady (R-TX), and Ed­u­ca­tion and La­bor com­mit­tee Re­pub­li­can leader Vir­ginia Foxx (R-NC) un­veiled leg­is­la­tion in April 2021 that the spon­sors said of­fered the “first-ever out-of-pock­et cap for se­niors in the Medicare Part D pro­gram.”

But Lank­ford main­tained that any pre­scrip­tion drug price re­forms should take on phar­ma’s foes, like the mid­dle­men that make mon­ey from the gaps in the list and net prices of drugs.

“The on­go­ing is­sues with phar­ma­cy ben­e­fit man­agers, the drug pric­ing mid­dle­men, were al­so not ad­dressed in the De­moc­rats’ bill. We need more drug op­tions, not less. We need more com­pe­ti­tion, not price con­trols. We need in­no­va­tion, not stag­na­tion,” he said.

De­moc­rats, mean­while, who passed the In­fla­tion Re­duc­tion Act with­out a sin­gle Re­pub­li­can vote, are rapid­ly pulling to­geth­er a team at CMS to im­ple­ment these new au­thor­i­ties, and have $3 bil­lion from the new law to start.

Ac­cord­ing to a re­port in STAT News last week, for­mer Arnold Ven­tures VP Kristi Mar­tin, who al­so helped im­ple­ment the Af­ford­able Care Act, will over­see staffing of the new CMS drug pric­ing team.

Arnold Ven­tures, which praised the pas­sage of the IRA and helped start the drug cost-ef­fec­tive­ness watch­dog ICER with $5 mil­lion that be­gan with a grant al­most 10 years af­ter ICER grew from a re­search pro­gram at Har­vard Med­ical School’s De­part­ment of Pop­u­la­tion Med­i­cine in 2006. ICER has made a name for it­self as one of the biggest thorns in the side of bio­phar­ma com­pa­nies. And its deep pock­ets have meant that the non­prof­it has spent up­wards of $170 mil­lion since 2014 in its fight to bring down the price of drugs, ac­cord­ing to the Pink Sheet.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed to note that Arnold Ven­tures pro­vid­ed its first grant to ICER 10 years af­ter it be­gan at Har­vard.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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