Seast­ead­er, drug lib­er­tar­i­an and now FDA Com­mis­sion­er? Pe­ter Thiel backs a rad­i­cal shift

Once Bloomberg broke the word that Pe­ter Thiel as­so­ciate Jim O’Neill was be­ing con­sid­ered for the top job at the FDA, re­porters start­ed to nose out the most out­ra­geous re­marks had made. And there are some doozies.

The busi­ness news ser­vice start­ed out with the most rel­e­vant: O’Neill has called for a new sys­tem that would ap­prove drugs that es­tab­lish a base­line on safe­ty, let­ting con­sumers sort out the ef­fi­ca­cy side of thing.

“We should re­form FDA so there is ap­prov­ing drugs af­ter their spon­sors have demon­strat­ed safe­ty — and let peo­ple start us­ing them, at their own risk, but not much risk of safe­ty,” O’Neill said in a speech two years ago at what was called Re­ju­ve­na­tion Biotech­nol­o­gy. “Let’s prove ef­fi­ca­cy af­ter they’ve been le­gal­ized.”

His own re­sume pro­vides some quick hits. 1. Not a doc­tor. 2. Not a sci­en­tist. And he’s on the board of the Seast­eading In­sti­tute, which hopes to set up float­ing towns free of gov­ern­ment in­ep­ti­tude.

The Yale grad got his ca­reer start­ed as a speech­writer at Health & Hu­man Ser­vices and was prin­ci­pal as­so­ciate deputy sec­re­tary un­der the George W. Bush ad­min­is­tra­tion.

STAT not­ed sources who say that it’s Thiel — the bil­lion­aire Face­book backer who broke with Sil­i­con Val­ley in sup­port­ing the pres­i­dent-elect — who’s pro­mot­ing the lib­er­tar­i­an for the top job at the FDA. O’Neill has worked at Thiel Cap­i­tal, helmed the Thiel Foun­da­tion and now runs Thiel-backed Mithril Cap­i­tal, which in­vest­ed in med tech — Au­ris Sur­gi­cal was a re­cent in­vest­ment — that the FDA reg­u­lates.

Among his many in­volve­ments in the R&D field, O’Neill is on the board at SENS Re­search Foun­da­tion, which is fo­cused on ag­ing R&D. And his 2014 speech in­clud­ed a claim that on­go­ing re­search would make it pos­si­ble to achieve hu­man im­mor­tal­i­ty in 40 years, ac­cord­ing to Bio­Cen­tu­ry. His bio at SENS in­cludes a note that he was on the steer­ing com­mit­tee at BAR­DA.

But now that word is out about his pos­si­ble se­lec­tion, his dig­i­tal re­sume is start­ing to dis­ap­pear. STAT notes that a speech has gone miss­ing overnight.

You can still hear him talk about seast­eading here.

He’s no shoe in. Scott Got­tlieb has long been con­sid­ered a kind of Re­pub­li­can shad­ow com­mis­sion­er for the FDA, and re­mains one of the most fre­quent­ly cit­ed can­di­dates for the post.

Since the elec­tion Trump has made two points re­lat­ed to biotech­nol­o­gy. He wants drug ap­provals to come faster and he wants drug prices to come down. There hasn’t been a word yet about how he plans to ac­com­plish the low­er drug prices, but the 21st Cen­tu­ry Cures Act pas­sage yes­ter­day gives him some ear­ly boasts to tout.

We’ll find out soon if his ideas about rad­i­cal change in gov­ern­ment ex­tend to the top job at the FDA.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.