Pe­ter Thiel's Palan­tir scores con­tract with the FDA to speed up reg­u­la­to­ry re­views as de­lays keep grow­ing

Pe­ter Thiel, the bil­lion­aire lib­er­tar­i­an who qui­et­ly backed away in 2020 from his once-ar­dent sup­port of Pres­i­dent Don­ald Trump, is no stranger to gov­ern­ment con­tracts. His com­pa­ny Palan­tir has se­cured dozens of con­tracts with the feds and now has an­oth­er big fish on the hook.

Pe­ter Thiel

Palan­tir, the Den­ver-based da­ta and an­a­lyt­ics com­pa­ny Thiel co-found­ed in 2003, en­tered in­to an agree­ment this week with the FDA as the gov­ern­ment agency strug­gles to keep up with a surge of reg­u­la­to­ry ap­proval needs due to the Covid-19 pan­dem­ic.

As part of a three-year, $44.4 mil­lion con­tract, the FDA will use Palan­tir’s soft­ware to ex­pe­dite da­ta and an­a­lyt­ics ser­vices through the Cen­ter for Drug Eval­u­a­tion and Re­search with the goal of speed­ing up the re­view of po­ten­tial new med­i­cines and prod­ucts such as hand san­i­tiz­ers. Bloomberg first re­port­ed the ex­is­tence of the con­tract.

Ham­strung by Covid-re­lat­ed lock­downs, the FDA in re­cent months has had to de­lay nu­mer­ous ap­proval process­es for myr­i­ad drugs — main­ly due to fa­cil­i­ty in­spec­tion re­quire­ments made more dif­fi­cult by pan­dem­ic trav­el re­stric­tions.

Re­cent pub­li­cized FDA de­lays have in­clud­ed Bris­tol My­ers Squibb’s CAR-T liso-cel, Spec­trum‘s neu­trope­nia can­di­date Rolon­tis and dax­i­bot­u­linum­tox­i­nA, a frown-line in­jec­tion from Re­vance. Be­yond that, it’s un­known ex­act­ly how far be­hind the agency is on re­view process­es, but the out­sourc­ing of cer­tain re­view process­es to Palan­tir soft­ware could help of­fi­cials clear out the back­log.

Palan­tir has long worked close­ly with the US gov­ern­ment, a re­la­tion­ship which has on­ly grown clos­er since the pan­dem­ic be­gan. The com­pa­ny, Bloomberg al­so re­port­ed, has se­cured over 100 con­tracts with pri­vate com­pa­nies and gov­ern­ment health groups — in­clud­ing soft­ware that gov­ern­ment of­fi­cials have said is crit­i­cal to the Op­er­a­tion Warp Speed mis­sion to in­oc­u­late Amer­i­cans with a COVID-19 vac­cine.

Palan­tir went pub­lic on the Nas­daq at the end of Sep­tem­ber, with an ini­tial di­rect list­ing of $10 per stock share — trans­lat­ing to a val­u­a­tion of $22 bil­lion. The an­nounce­ment of the FDA con­tract alone boost­ed com­pa­ny shares 21% on Tues­day, and $PLTR is cur­rent­ly val­ued at $28.59 per share.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Madhu Natarajan, Takeda rare disease development head

Drawn to the idea of turn­ing B cells in­to 'pro­tein fac­to­ries,' Take­da jumps in­to a mile­stone-heavy, $900M pact

Madhu Natarajan can trace his fascination with the idea of taking B cells and turning them into protein factories back 20 years, when he had his own lab at UT Southwestern. So when Natarajan, now the rare disease development head for Takeda, sat down for a meet-up with execs from Seattle-based Immusoft at the last in-person JP Morgan conference, they went straight into a brainstorming session.

“That B cells can take up residence and do what they do for a long time,” says Natarajan, pumping out proteins and “leveraging it into a therapeutic context,” hits his sweet spot for discovery deals. And he was deeply impressed by what he heard.

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