President Biden delivers his State of the Union address on March 1, 2021 (Al Drago, Pool via AP Images)

Biden con­tin­ues his pledge for Medicare drug price ne­go­ti­a­tions in State of the Union speech

Pres­i­dent Joe Biden is not back­ing down on ad­vo­cat­ing for Medicare to ne­go­ti­ate drug prices. In his first State of the Union on Tues­day evening, which in ad­di­tion took Rus­sia to task over its in­va­sion of Ukraine, Biden re­vealed that cut­ting phar­ma­ceu­ti­cal prices is chief among the pri­or­i­ties of his do­mes­tic agen­da.

Biden and con­gres­sion­al De­moc­rats craft­ed wide-rang­ing drug pric­ing pro­vi­sions, in­clud­ing al­low­ing Medicare to ne­go­ti­ate for the first time, in the Build Back Bet­ter Act. But that bill and its parts now ap­pear dead, large­ly thanks to Sen. Joe Manchin (D-WV), who balked at some of the non-drug-re­lat­ed pro­vi­sions.

Still, Biden came out swing­ing for drug price ne­go­ti­a­tions Tues­day evening in the Capi­tol, pledg­ing his sup­port for cap­ping the cost of in­sulin for those with in­sur­ance at $35 a month as part of a last-ditch ef­fort to get some­thing passed, adding, “Drug com­pa­nies will still do very well. And while we’re at it let Medicare ne­go­ti­ate low­er prices for pre­scrip­tion drugs, like the VA al­ready does.”

Sev­enth grad­er Joshua Davis of Mid­loth­i­an, VA, and his moth­er sat in First La­dy Jill Biden’s box for the speech, and Biden, who was pre­vi­ous­ly in­tro­duced by Joshua at a re­cent in­sulin-re­lat­ed event, ex­plained his sto­ry.

“He and his Dad both have type 1 di­a­betes, which means they need in­sulin every day. In­sulin costs about $10 a vial to make. But drug com­pa­nies charge fam­i­lies like Joshua and his dad up to 30 times more. I spoke with Joshua’s mom. Imag­ine what it’s like to look at your child who needs in­sulin and have no idea how you’re go­ing to pay for it,” Biden said.

In­sulin prices have been in the crosshairs of Con­gress for years now, with House E&C com­mit­tee chair Frank Pal­lone (D-NJ) and sub­com­mit­tee chair Di­ana DeGette (D-CO) most re­cent­ly ex­plain­ing in let­ters to the largest three in­sulin man­u­fac­tur­ers that the price in the US is more than 10 times that of 33 oth­er coun­tries.

Sanofi’s own pric­ing re­port this year, re­leased Wednes­day, ex­plains how even pa­tients’ out-of-pock­et spend­ing on its in­sulin Lan­tus rose 82% be­tween 2012 and 2020.

But Sanofi and the oth­er in­sulin man­u­fac­tur­ers of­ten point to the fact that the rise in in­sulin prices and out-of-pock­et costs is due to the phar­ma mid­dle­men, the PBMs, which cre­ate this ever-widen­ing gap be­tween the list and net prices.

PhRMA CEO Stephen Ubl re­leased a rare state­ment fol­low­ing the SO­TU last night, con­tin­u­ing the in­dus­try group’s ar­gu­ment against al­low­ing Medicare to ne­go­ti­ate on drug prices, say­ing:

We urge Pres­i­dent Biden and Con­gress to work on a holis­tic so­lu­tion that fix­es what’s bro­ken in our health care sys­tem. Al­low­ing the gov­ern­ment to set the price of med­i­cines isn’t the an­swer. We know that sto­ry will end with less ac­cess to med­i­cines and less fu­ture in­no­va­tion, and we know there’s a bet­ter way. Let’s work to­geth­er on so­lu­tions that low­er costs for pa­tients, ad­dress abu­sive prac­tices with­in the in­sur­ance sys­tem and pro­tect the de­vel­op­ment of new cures and treat­ments.

In ad­di­tion to the drug pric­ing pro­vi­sions, Biden al­so an­nounced a new ini­tia­tive around Covid-19 ther­a­peu­tics.

Known as the “Test to Treat” ini­tia­tive, Biden said it will help peo­ple “get test­ed at a phar­ma­cy, and if they’re pos­i­tive, re­ceive an­tivi­ral pills on the spot at no cost.”

In clar­i­fy­ing com­ments, the White House said the ini­tia­tive is meant to “min­i­mize the time be­tween a pos­i­tive test re­sult and re­ceiv­ing an ef­fec­tive Covid-19 treat­ment, in­clud­ing an­tivi­ral pills and mon­o­clon­al an­ti­bod­ies … The Ad­min­is­tra­tion will be launch­ing these one-stop shops this month, with hun­dreds of sites open­ing na­tion­wide in­clud­ing at phar­ma­cy clin­ics at places like CVS, Wal­greens, and Kroger. The Ad­min­is­tra­tion will con­tin­ue to grow the pro­gram over time.”

Biden al­so dis­cussed get­ting clos­er to re­turn­ing to “nor­mal” af­ter Covid, and said that start­ing next week, Amer­i­cans can or­der an­oth­er round of Covid self-tests, even if they’ve al­ready or­dered some.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.