Donald Trump at the National American Veterans Convention. Susan Walsh/AP Images

Get as much Spra­va­to as you can, Trump or­ders VA while sug­gest­ing J&J should of­fer it to vet­er­ans for free

Pres­i­dent Don­ald Trump is mak­ing good on his ear­li­er pledge to of­fer Spra­va­to, J&J’s re­for­mu­lat­ed ke­t­a­mine nasal spray, to as many vet­er­ans in need, as soon as pos­si­ble — how­ev­er it may hap­pen.

Ad­dress­ing the is­sue of vet­er­an sui­cide at the Amer­i­can Vet­er­ans Na­tion­al Con­ven­tion Wednes­day, Trump said he’s “in­struct­ed the top of­fi­cials to go out and get as much of it as you can from John­son & John­son.”

He fol­lowed that with a call to the drug­mak­er to “make a con­tri­bu­tion” to the US.

Rege Ri­ley AmVets

“They’ve done so well in this coun­try, they’ve made so much mon­ey, I think they should give it to us for free,” he said, draw­ing ap­plause, then ges­tured to AmVets Na­tion­al Com­man­der Rege Ri­ley, urg­ing him: “Give it a shot! Give it a shot!”

The pres­i­dent has been re­port­ed cham­pi­oning the drug re­port­ed­ly — which is known for its quick ef­fect in curb­ing sui­ci­dal thoughts but is al­so plagued by safe­ty con­cerns — since June when he told Vet­er­ans Af­fairs Sec­re­tary Robert Wilkie to “give it to any­body that has the prob­lem.”

The VA had an­nounced in March just days af­ter Spra­va­to was ap­proved that its health­care providers would of­fer the drug for treat­ment-re­sis­tant de­pres­sion. De­spite Trump’s en­dorse­ment, clin­i­cians at the de­part­ment vot­ed in June against plac­ing it on the for­mu­la­ry, keep­ing it to more lim­it­ed use. Un­der this pol­i­cy, vet­er­ans would on­ly be pre­scribed Spra­va­to if they have not re­spond­ed to oth­er treat­ments and gone through an au­tho­riza­tion process.

Robert Wilkie US De­part­ment of De­fense

Per cur­rent pro­to­col, health­care pro­fes­sion­als must al­so be present to mon­i­tor the use of Spra­va­to due to side ef­fects such as dis­so­ci­a­tion.

It’s un­clear how Trump plans to over­ride these re­stric­tions even if the VA is able to ne­go­ti­ate a fa­vor­able price with J&J or even — as he sug­gest­ed — get it for free.

ICER, the drug price watch­dog, has pre­vi­ous­ly chas­tised the phar­ma gi­ant for over­pric­ing the treat­ment, which is close­ly re­lat­ed to in­tra­venous gener­ic ke­t­a­mine, an­oth­er for­mu­la­tion of the horse tran­quil­iz­er prone to abuse in par­ty scenes. While the lat­ter is un­ap­proved and thus not cov­ered by in­sur­ers, Spra­va­to’s an­nu­al list price of $32,400 is still low val­ue for mon­ey, ICER claimed.

For now, Trump has noth­ing but praise for the drug. Back on the stage at the AmVets con­ven­tion:

They have some­thing that, what­ev­er it may do, it re­al­ly takes that hor­ri­ble anx­i­ety, what­ev­er caus­es some­body to be so des­per­ate to com­mit sui­cide, you take it, it’s an in­haler, you take it, and its re­sults are in­cred­i­ble. […] It does some­thing — some­thing pret­ty amaz­ing.

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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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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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.”

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.