House Speaker Nancy Pelosi at her weekly press conference, March 9 (Michael Brochstein/Sipa USA/Sipa via AP Images)

Covid-19 as a po­lit­i­cal foot­ball: Gov­ern­ment fund­ing for more vac­cine, treat­ment sup­plies stalls

House Speak­er Nan­cy Pelosi late Wednes­day had to pull out $15.6 bil­lion in coro­n­avirus re­lief funds from a mas­sive tril­lion-dol­lar spend­ing bill to avert a gov­ern­ment shut­down as her col­leagues re­volt­ed against pay­ing for that aid with their home states’ stock­piles of al­ready-promised pan­dem­ic funds.

While the spend­ing bill and bil­lions in Ukraine aid cleared the House last night in a short-term ex­ten­sion that will like­ly pass in full ear­ly next week, what hap­pens next for the Covid-19 funds re­mains un­clear.

Ear­li­er Wednes­day, De­mo­c­ra­t­ic in-fight­ing hit a fever pitch as at least a dozen De­moc­rats threat­ened to re­volt over how Pelosi planned to pay for the new Covid funds. CNN re­port­ed that some Dems “pa­rad­ed in and out of Pelosi’s of­fice through­out Wednes­day morn­ing and in­to the af­ter­noon, some no­tice­ably up­set and try­ing to avoid talk­ing to the press.”

Pelosi then sent a let­ter to her col­leagues lat­er in the day yes­ter­day an­nounc­ing that she would pull the funds, say­ing, “It is heart­break­ing to re­move the COVID fund­ing, and we must con­tin­ue to fight for ur­gent­ly need­ed COVID as­sis­tance, but un­for­tu­nate­ly that will not be in­clud­ed in this bill.”

The White House im­me­di­ate­ly ex­pressed out­rage over the sit­u­a­tion, par­tic­u­lar­ly as much of the key funds for ef­fec­tive an­tivi­rals and mon­o­clon­al an­ti­bod­ies will run dry in the com­ing months, say­ing in a state­ment:

We re­quest­ed $22.5 bil­lion for im­me­di­ate needs to avoid se­vere dis­tri­b­u­tions to our Covid re­sponse, and we re­quest­ed Con­gress pro­vide these funds as emer­gency re­sources – as law­mak­ers have done mul­ti­ple times on a bi­par­ti­san ba­sis un­der the pri­or Ad­min­is­tra­tion. With­out ad­di­tion­al Covid re­sponse re­sources the re­sults are dire: In March, test­ing ca­pac­i­ty will de­cline; in April, the unin­sured fund – which of­fers cov­er­age of test­ing and treat­ments for mil­lions of Amer­i­cans who lack health in­sur­ance – will run out of mon­ey; and in May, Amer­i­ca’s sup­ply of mon­o­clon­al an­ti­bod­ies will run out.

House De­moc­rats al­so tried to si­mul­ta­ne­ous­ly in­tro­duce a sep­a­rate, $15.6 bil­lion Covid-19 re­lief bill last night, but the time­line on that re­mains un­known. Sen­ate GOP op­po­si­tion may be fierce, es­pe­cial­ly as De­moc­rats would need 60 votes for pas­sage (and the Sen­ate is split 50-50).

Sen. Mitt Rom­ney of Utah led a group of fel­low Re­pub­li­can sen­a­tors in a let­ter last week re­quest­ing that the White House ex­plain where the $6 tril­lion in Covid-19 funds al­ready doled out by the gov­ern­ment have been spent.

Ac­cord­ing to NPR, the White House says the ad­min­is­tra­tion spent all of the funds Con­gress des­ig­nat­ed for vac­cines, treat­ments, tests, and masks.

That mon­ey “sup­port­ed our force­ful re­sponse to the surge in in­fec­tions and hos­pi­tal­iza­tions caused by the Omi­cron vari­ant, as well as the ear­li­er surge re­sult­ing from the Delta vari­ant. But those de­mands have large­ly ex­haust­ed ex­ist­ing funds,” Sha­lan­da Young, act­ing di­rec­tor of the Of­fice of Man­age­ment and Bud­get, wrote in a let­ter to con­gres­sion­al lead­ers.

Mean­while, the gov­ern­ment spend­ing bill still in­cludes $1 bil­lion to kick-start Biden’s new­ly pro­posed Ad­vanced Re­search Pro­jects Agency for Health or ARPA-H, which is go­ing to sit with­in NIH but mir­ror DARPA with risky in­vest­ments in new re­search for projects like can­cer vac­cine de­vel­op­ment, or mak­ing man­u­fac­tur­ing process­es for pa­tient-spe­cif­ic T cells cheap­er and eas­i­er.

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

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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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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.

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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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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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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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.