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.

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.

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.

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.