President Biden (Patrick Semansky/AP Images)

Covid-19 roundup: Biden looks to in­crease ac­cess to Pfiz­er's Paxlovid; House re­quests up­date from FDA on vac­cines for youngest chil­dren

The Biden ad­min­is­tra­tion is look­ing to make Pfiz­er’s Covid-19 pill Paxlovid much more read­i­ly avail­able.

And that will be a key chal­lenge for this ad­min­is­tra­tion, as so far the US has used less than one-third of all Paxlovid cours­es dis­trib­uted to states, and less than one-tenth of the sup­plies the US ini­tial­ly bought last No­vem­ber.

One of the new mea­sures that the ad­min­is­tra­tion is pur­su­ing is a dou­bling of the num­ber of places where the oral an­tivi­rals are avail­able.

Ac­cord­ing to the ad­min­is­tra­tion, oral an­tivi­rals are cur­rent­ly avail­able in an es­ti­mat­ed 20,000 lo­ca­tions na­tion­wide, but now, start­ing this week, phar­ma­cies will be able to or­der sup­plies from the fed­er­al gov­ern­ment. HHS aims to work with phar­ma­cy part­ners to in­crease avail­abil­i­ty to up to 40,000 sites over the com­ing weeks.

The ad­min­is­tra­tion is al­so launch­ing a new ini­tia­tive to stand up for fed­er­al­ly sup­port­ed test-to-test sites in phar­ma­cies and oth­er clin­i­cal set­tings across the coun­try. These sites aim to have test­ing, as­sess­ments from a med­ical provider and oral an­tivi­ral treat­ments in a one-stop-shop. The ad­min­is­tra­tion is launch­ing this in part­ner­ship in co­or­di­na­tion with HHS and FE­MA. These sites will launch in se­lect com­mu­ni­ties in the com­ing weeks with the sites be­ing able to ex­pand if nec­es­sary.

It is al­so sup­port­ing med­ical providers with more guid­ance and tools to un­der­stand and pre­scribe treat­ments as well as no­ti­fy them to amount new treat­ments as well as com­mu­ni­cate to the pub­lic that treat­ments are wide­ly avail­able. — Tyler Patchen

House sub­com­mit­tee wants an up­date from the FDA on vac­cines for chil­dren 

A House sub­com­mit­tee is seek­ing an­swers from the FDA on the sta­tus of Covid-19 vac­cines for the youngest group of chil­dren (6 months to 5 years old).

James Clyburn, chair of the House Se­lect Sub­com­mit­tee on the Coro­n­avirus Cri­sis, sent a let­ter to FDA com­mis­sion­er Robert Califf re­quest­ing a staff brief­ing on the sub­ject.

“Mil­lions of young chil­dren re­main un­pro­tect­ed be­cause no vac­cine has yet been au­tho­rized for chil­dren un­der five,” Clyburn wrote. “Dur­ing the surge of the Omi­cron vari­ant, chil­dren younger than five were hos­pi­tal­ized at ap­prox­i­mate­ly five times the rate of the pre­vi­ous peak dur­ing the height of the Delta vari­ant. I, there­fore, write to­day to re­quest a staff brief­ing on the sta­tus of coro­n­avirus vac­cine can­di­dates for young chil­dren.”

The re­quest for a brief­ing fol­lows re­ports that the FDA is con­sid­er­ing post­pon­ing its de­ci­sion on whether to au­tho­rize Mod­er­na’s vac­cine for chil­dren un­der six un­til ear­ly sum­mer so that it can be eval­u­at­ed at the same time as Pfiz­er’s vac­cine.

Clyburn re­quest­ed that the FDA brief the sub­com­mit­tee staff by May 9, specif­i­cal­ly on whether the re­cent re­ports are ac­cu­rate for a po­ten­tial de­lay of FDA’s de­ci­sion and if the sci­en­tif­ic ba­sis or oth­er ra­tio­nale war­rants a de­lay. — Tyler Patchen

Treve­na drug dropped from NIH tri­al for Covid-19 com­pli­ca­tions

The NIH is drop­ping Treve­na’s AT1 re­cep­tor se­lec­tive ag­o­nist from a plat­form tri­al of Covid-19 ther­a­pies af­ter it met the in­fe­ri­or­i­ty stop­ping cri­te­ri­on, the biotech dis­closed.

One of many mas­ter tri­als de­signed to quick­ly eval­u­ate po­ten­tial treat­ments for Covid-19, the AC­TIV-4 host tis­sue pro­to­col was fo­cused on test­ing drugs for their abil­i­ty to pre­vent the “cas­cade of po­ten­tial­ly life-threat­en­ing com­pli­ca­tions such as blood ves­sel dam­age, lung dam­age, blood clots, and heart in­jury.”

TRV027, which was specif­i­cal­ly de­vel­oped for Covid-19, binds to the AT1 re­cep­tor in hopes that it would dis­rupt over­ac­ti­va­tion caused by the SARS-CoV-2 virus. Treve­na had al­so hoped that its mech­a­nism would pro­mote repar­a­tive ef­fects on lung tis­sue and re­duce ab­nor­mal blood clot­ting. It be­came part of the AC­TIV-4 pro­to­col last Ju­ly.

In an SEC fil­ing, the biotech said it re­ceived no­tice on Fri­day that en­roll­ment for the TRV027 arm “has ceased.”

“Based up­on da­ta at the in­ter­im analy­sis, the AC­TIV-4 Plat­form Da­ta and Safe­ty Mon­i­tor­ing Board has rec­om­mend­ed that cer­tain tri­als in the AC­TIV-4 Plat­form, in­clud­ing the TRV027 vs place­bo tri­al, should cease en­roll­ment and dis­con­tin­ue study med­ica­tion due to hav­ing met the in­fe­ri­or­i­ty stop­ping cri­te­ri­on,” the dis­clo­sure read. “The 90-day fol­low up of par­tic­i­pants in the TRV027 tri­al will pro­ceed as planned.”

Oth­er ex­per­i­men­tal drugs in the same tri­al arm are Con­stant Ther­a­peu­tics’ TXA127, an pep­tide ag­o­nist of Mas re­cep­tors, and Rigel’s fos­ta­ma­tinib, a ty­ro­sine ki­nase in­hibitor. At the last up­date, NIH records sug­gest they are still re­cruit­ing. — Am­ber Tong

Pfiz­er al­leged­ly pres­sured UNICEF to keep Paxlovid pric­ing se­cret  

The pric­ing of Paxlovid is con­tin­u­ing to be put un­der the mi­cro­scope. Ac­cord­ing to Gene­va Health Files, Pfiz­er al­leged­ly pres­sured UNICEF to agree to non-dis­clo­sure re­quire­ments on pric­ing that would pro­tect in­for­ma­tion on the prices of Paxlovid. UNICEF re­cent­ly con­clud­ed a sup­ply agree­ment with Pfiz­er for up to 4 mil­lion cours­es of treat­ment.

Gene­va Health Files stat­ed that UNICEF took the uni­lat­er­al de­ci­sion to fi­nal­ize the sup­ply agree­ment with Pfiz­er with­out con­sult­ing oth­er part­ners of the ther­a­peu­tics pil­lar of the ACT Ac­cel­er­a­tor in­clud­ing the WHO, the Glob­al Fund and Uni­taid.

A spokesper­son from Pfiz­er told Gene­va Health Files that the de­tails of sup­ply agree­ments re­main con­fi­den­tial and re­fused to com­ment on whether it in­deed in­sist­ed that UNICEF sign a non-dis­clo­sure agree­ment on pric­ing in­for­ma­tion. UNICEF said to Gene­va Health Files that the agency has demon­strat­ed trans­paren­cy by pub­lish­ing ne­go­ti­at­ed prices for a range of com­modi­ties over the last decade. How­ev­er, pub­li­ca­tion of prices in this way re­quires con­sent from sup­pli­ers.

The WHO re­cent­ly made a strong rec­om­men­da­tion for Pfiz­er’s pill Paxlovid for use in mild and mod­er­ate Covid-19 pa­tients, but al­so raised con­cerns about the avail­abil­i­ty, the lack of price trans­paren­cy and the need for quick and ac­cu­rate test­ing be­fore be­ing ad­min­is­tered. — Tyler Patchen

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.