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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Jim Tananbaum, Foresite

Fore­site re­turns to the SPAC well, as in­vestors won­der how long the run can last

Six months after launching his first biotech SPAC, Foresite’s Jim Tananbaum has started a second. On Tuesday, the longtime life science investor filed to raise $100 million by selling 10 million shares of the blank check company FS development II.

It’s a quick return to Wall Street for Foresite, although other firms have moved quicker. Perceptive Advisors raised a $130 million SPAC in June and were back before the end of July to raise another $125 million. By that point, the firm was evidently nearing a deal for the June SPAC, which would announce a half-billion-dollar merger with Cerevel Therapeutics on July 30.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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