Af­ter jump­ing ship at Eli Lil­ly, Politi­co re­ports Alex Azar may soon land top HHS job

Back at the be­gin­ning of this year, Eli Lil­ly’s US chief Alex Azar left his post dur­ing the big ex­ec­u­tive shuf­fle as Dave Ricks re­placed John Lech­leit­er at the helm. But he may be about to line up a much bet­ter job than the one he ex­it­ed.

Politi­co re­ports that Azar is a fa­vorite in the race to re­place Tom Price, the ex­pe­ri­enced po­lit­i­cal hand who had a weak­ness for pri­vate jets. De­pend­ing on who the re­porters were talk­ing to in the ad­min­is­tra­tion, Azar had ei­ther been short­list­ed or was al­ready in­for­mal­ly tapped for the job.

The move would bring Azar back to Wash­ing­ton, where he did a stint as gen­er­al coun­sel and deputy sec­re­tary at HHS un­der George W Bush. Azar — a Yale Law School grad — was on one of my pan­els about 15 months ago and ably rep­re­sent­ed Lil­ly with a sharp and con­cise rep­re­sen­ta­tion of the kind of op­por­tu­ni­ties and pit­falls a Big Phar­ma like Lil­ly has to nav­i­gate every day.

Azar did not im­me­di­ate­ly jump to an­oth­er po­si­tion in the in­dus­try, up­ping the odds that he was pushed out rather than jumped as Ricks be­gan to re­struc­ture the com­pa­ny from top to bot­tom. Azar set up a con­sul­tan­cy called Seraphim Strate­gies in Feb­ru­ary as he “ex­plored lead­er­ship op­por­tu­ni­ties.”

What­ev­er Azar’s thoughts on Lil­ly, he’d be viewed as a de­pend­able and tal­ent­ed ad­vo­cate for the in­dus­try, some­one who isn’t like­ly to dis­com­fort the Big Phar­ma play­ers.

De­pend­ing on when he’s talk­ing, Pres­i­dent Don­ald Trump has been a caus­tic crit­ic of the bio­phar­ma in­dus­try’s drug pric­ing poli­cies. Just yes­ter­day he dou­bled down on his ear­li­er crit­i­cisms, not­ing that US drug prices are a mul­ti­ple of what they cost in oth­er coun­tries with a sin­gle-pay­er sys­tem — some­thing he would nev­er abide.

“Some­times it’s a frac­tion of what we pay in this coun­try,” Trump said in pre­pared re­marks. “The drug com­pa­nies frankly are get­ting away with mur­der and we want to bring our prices down to what oth­er coun­tries pay.”

We’ve been sub­si­diz­ing oth­er coun­tries, he added, “pay­ing dou­ble, triple, quadru­ple.”

But un­like his first slap­downs, this time Trump’s at­tack bare­ly caused a rip­ple in the in­dus­try, where top ex­ecs led by Mer­ck’s Ken Fra­zier ex­it­ed the pres­i­dent’s in­dus­try ad­vi­so­ry groups in the wake of the con­tro­ver­sy over the Char­lottesvil­lle, VA con­fronta­tion by ex­trem­ist or­ga­ni­za­tions.

One oth­er hot­ly ru­mored can­di­date for this job has been FDA com­mis­sion­er Scott Got­tlieb, who’s made an im­pres­sive en­try in­to a job that calls on the fed­er­al agency to bal­ance the gold stan­dard on ef­fi­ca­cy and safe­ty drug de­vel­op­ment with the man­date to speed new ap­provals. Got­tlieb re­cent­ly said he’d pre­fer to stay at the FDA, where his tal­ents lay, with­out ac­tu­al­ly rul­ing out a quick pro­mo­tion.

It ap­pears he may get his wish.


Deputy Health and Hu­man Ser­vices Sec­re­tary Alex Azar meets re­porters at de­part­ment head­quar­ters on June 8, 2006 to an­nounce the ap­proval of Gar­dasil, the first vac­cine de­vel­oped to pro­tect women against cer­vi­cal can­cer. AP Pho­to/Evan Vuc­ci

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Biotech grieves over Tachi’s pass­ing; $3 tril­lion mi­rage?; Sanofi has a new Pompe drug; 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.

While I did not personally know Dr. Tachi Yamada, it’s clear from the outpouring of tributes just how many lives he touched and changed. Once again, our deepest condolences to his family and loved ones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Court de­ci­sion push­es FDA to make his­tor­i­cal shift and reg­u­late bor­der­line drug/de­vice prod­ucts as de­vices

In a major shift, and a big win for the pharmaceutical industry, the FDA said Friday that moving forward it intends to regulate products that meet both the device and drug definitions as devices.

The announcement is the result of a loss in court for the agency in April, when the US Court of Appeals for the District of Columbia said that Genus Medical Technologies’ contrast agent barium sulfate, known as Vanilla SilQ, should not be regulated as a drug, as the FDA had said, but as a medical device.

Alexis Borisy (L) and Melanie Nallicheri (EQRx)

Drug pric­ing dis­rup­tor EQRx makes the big leagues with $1.8B SPAC deal and a new CEO at the helm

EQRx, a would-be drug pricing disruptor that has emerged as an investor darling, has everything but an approval to show in its fight against financial toxicity in biopharma. With the homestretch closing in, the team is now ready for its close-up.

EQRx will reverse merge with the CM Life Sciences III SPAC, kickstarted by biotech blue chipper Casdin Capital and Corvex Management, and go public as part of a deal that will infuse around $1.8 billion into the drug pricing disruptor’s bank account, the partners said Friday.

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Stéphane Bancel (AP Images)

mGx M&A? Mod­er­na ex­ecs are lever­ag­ing their Covid cash on gene edit­ing, gene ther­a­py deals

Moderna’s little business deal with Autolus earlier this week looks like a predinner snack ahead of the main course to come.

During his Q2 call with analysts on Thursday, Moderna CEO Stéphane Bancel got more than a few eyebrows to raise with his comments on BD plans. Now that the company’s market cap has hit an Everest-high cruising altitude above $165 billion — levitating up 78% in the past month — with a megablockbuster ginning money on hand, Bancel is prepared to put that cash and kind to use. And he made it clear that gene editing/gene therapies are right at the heart of this new move.

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Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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UP­DAT­ED: Courts to de­cide on whether drug­mak­ers have to sup­ply dis­count­ed drugs to un­lim­it­ed con­tract phar­ma­cies

The 340B program may soon be in a moment of upheaval. Two different courts will soon weigh in on whether President Biden’s HHS can rein in drugmakers’ interpretation of how 340B works.

Back in May, Biden’s HRSA acting administrator Diana Espinosa sent identical letters to AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi and United Therapeutics, explaining how the administration has determined the companies’ policies that place restrictions on 340B program pricing (which is steeply discounted drug prices meant for hospitals’ poorest patients) for contract hospital pharmacies are in direct violation of the 340B statute.

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Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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