President Biden at last year's State of the Union address, March 1, 2022 (Al Drago/Pool via AP Images)

Biden to tout phar­ma's de­feat in State of the Union, call for $35 in­sulin for all

Pres­i­dent Joe Biden will take to his sec­ond State of the Union this evening with plans for op­ti­mism, and a call for uni­ver­sal, $35 per month in­sulin, along with high­lights of one of his biggest self-de­scribed suc­cess­es so far — the de­feat of phar­ma com­pa­nies with the in­sti­tu­tion of Medicare ne­go­ti­a­tions for drug prices.

“Pres­i­dent Biden took on Big Phar­ma — and won,” a White House fact sheet said ahead of the speech this evening.

More than 60 mil­lion Medicare re­cip­i­ents will ben­e­fit from the ne­go­ti­a­tions, the Biden team claims, al­though it doesn’t men­tion what the ne­go­ti­a­tions might do for launch prices, and it’s still un­clear the ex­tent to which the law will be uti­lized, par­tic­u­lar­ly as com­pa­nies work around it.

But in the win col­umn for Medicare re­cip­i­ents is the cap on an­nu­al out-of-pock­et phar­ma­cy costs at $2,000 un­der Part D, and drug com­pa­nies will pay re­bates to CMS if they try to hike their prices faster than the rate of in­fla­tion, al­though the me­chan­ics of how those re­bates will be paid has yet to be ironed out.

Since Jan. 1, se­niors un­der Medicare al­so be­gan see­ing a $35 month­ly cap on in­sulin out-of-pock­et ex­pens­es.

And Biden is ex­pect­ed to call on Con­gress to ex­tend that cap to all who re­ly on the life-sav­ing in­sulin. Sen­ate Re­pub­li­cans last sum­mer re­buffed a sim­i­lar bill that would’ve al­lowed for a $35 cap.

The White House team al­so stressed that there are more adult vac­cines avail­able for free for those on Medicare, in­clud­ing the shin­gles vac­cine, which pre­vi­ous­ly cost as much as $200 out of pock­et.

Biden is al­so ex­pect­ed to tout his re-worked can­cer moon­shot. Sit­ting in First La­dy Jill Biden’s box this evening will be Mau­rice and Kandice Bar­ron of New York City. The cou­ple’s three-year old daugh­ter is a sur­vivor of a rare form of pe­di­atric can­cer.

Ahead of tonight’s speech, White House can­cer moon­shot co­or­di­na­tor Danielle Car­ni­val told the press in a call that wider ac­com­plish­ments could be on the hori­zon:

[I]t’s time for an­oth­er bi­par­ti­san ef­fort to come to­geth­er and re­al­ize a 21st cen­tu­ry can­cer sys­tem with clin­i­cal tri­al net­works that reach every com­mu­ni­ty, mod­ern da­ta sys­tem so we can share knowl­edge and make progress faster. And in 2016, as I said ear­li­er, Con­gress came to­geth­er to pass the 21st Cen­tu­ry Cures Act, which pro­vid­ed ad­di­tion­al fund­ing for the fight against can­cer. We can lock in that strong bi­par­ti­san sup­port go­ing for­ward.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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