Buf­fett, Di­mon and Be­zos find their mir­a­cle man, charged with fix­ing a bro­ken health­care sys­tem

War­ren Buf­fett, Jamie Di­mon and Jeff Be­zos have found the per­son they think can fix a bro­ken US health­care sys­tem. And they’re go­ing with a Re­nais­sance man.

At­ul Gawande is tak­ing the reins on Ju­ly 9 with a mis­sion to cre­ate a new en­ti­ty un­bound by prof­it goals. And he’s one of the best-known fig­ures in the in­dus­try.

The com­pa­ny — which still doesn’t have a name — will be based in Boston.

Gawande is a sur­geon at Brigham and Women’s Hos­pi­tal, a pro­fes­sor at the Har­vard TH Chan School of Pub­lic Health and Har­vard Med­ical School plus a best­selling au­thor who has penned 4 books. He al­so writes for The New York­er from time to time.

The three ex­ecs from Ama­zon, Berk­shire Hath­away and JP Mor­gan Chase say they know they’re in for a tough chal­lenge, but Gawande has their con­fi­dence.

“We said at the out­set that the de­gree of dif­fi­cul­ty is high and suc­cess is go­ing to re­quire an ex­pert’s knowl­edge, a be­gin­ner’s mind, and a long-term ori­en­ta­tion,” said Be­zos. “At­ul em­bod­ies all three, and we’re start­ing strong as we move for­ward in this chal­leng­ing and worth­while en­deav­or.”

The three busi­ness head­lin­ers have at­tract­ed plen­ty of at­ten­tion with their al­liance on tam­ing health­care costs, and al­so a lot of skep­ti­cism about what they plan to do as well as what they can ac­com­plish. That skep­ti­cism was height­ened by a Wall Street Jour­nal piece out­lin­ing Di­mon’s rapid as­sur­ances to his big health­care clients that he wasn’t set­ting up a ri­val or­ga­ni­za­tion, liken­ing the ven­ture to a group pur­chas­ing or­ga­ni­za­tion.

Pub­licly, though, the three have lament­ed a sys­tem where ram­pant price in­creas­es have left the na­tion with an in­creas­ing­ly heavy fi­nan­cial bur­den, and it’s a dis­cus­sion which bio­phar­ma com­pa­nies have a di­rect in­ter­est in.

We will have to wait and see what Gawande has in mind for trans­form­ing the sys­tem.

Here’s what he had to say to­day:

I’m thrilled to be named CEO of this health­care ini­tia­tive. I have de­vot­ed my pub­lic health ca­reer to build­ing scal­able so­lu­tions for bet­ter health­care de­liv­ery that are sav­ing lives, re­duc­ing suf­fer­ing, and elim­i­nat­ing waste­ful spend­ing both in the US and across the world. Now I have the back­ing of these re­mark­able or­ga­ni­za­tions to pur­sue this mis­sion with even greater im­pact for more than a mil­lion peo­ple, and in do­ing so in­cu­bate bet­ter mod­els of care for all. This work will take time but must be done. The sys­tem is bro­ken, and bet­ter is pos­si­ble.

Im­age: At­ul Gawande Get­ty/Geisinger Health Sys­tem

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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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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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.

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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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