Mi­cro­bio­me play­er uBio­me puts founders on leave, in­ter­im CEO promis­es to as­sist in fed­er­al probe

When Joe Jimenez signed on to the board at uBio­me last fall, the new­ly ex-No­var­tis chief was clear­ly hop­ing to put the con­tro­ver­sy over his re­la­tion­ship with Pres­i­dent Trump’s per­son­al at­tor­ney — Michael Co­hen — be­hind him and start a new chap­ter in his sto­ried ca­reer.

Joe Jimenez

In­stead, he’s found him­self in­volved in a fresh scan­dal in­volv­ing an FBI in­ves­ti­ga­tion in­to uBio­me’s billing prac­tices. To­day, the com­pa­ny’s founders who re­cruit­ed Jimenez, Jes­si­ca Rich­man and Zac Apte, have been placed on leave while gen­er­al coun­sel John Rakow steps up as in­ter­im CEO in charge of an in­ter­nal in­ves­ti­ga­tion.

John Rakow

In a state­ment out Wednes­day af­ter­noon, Rakow said:

As in­ter­im CEO of uBio­me, I want all of our stake­hold­ers to know that we in­tend to co­op­er­ate ful­ly with gov­ern­ment au­thor­i­ties and pri­vate pay­ors to sat­is­fac­to­ri­ly re­solve the ques­tions that have been raised, and we will take any cor­rec­tive ac­tions that are need­ed to en­sure we can be­come a stronger com­pa­ny bet­ter able to serve pa­tients and health­care providers.

The Wall Street Jour­nal first re­port­ed a few days ago about the fed­er­al probe.

Jes­si­can Rich­man

Billing it­self as the “lead­ing mi­cro­bial ge­nomics com­pa­ny,” uBio­me was launched 6 years ago from its base in the Bay Area, mar­ket­ing a pair of con­sumer tests that can do at-home tests on your gut or the STDs that women face, like chlamy­dia and gon­or­rhea. When I talked to Rich­man last fall, the com­pa­ny said it had raised $83 mil­lion from ven­ture back­ers — led by OS Fund — in a new dri­ve to join the pack de­vel­op­ing mi­cro­bio­me ther­a­pies. 

A few months lat­er, though, uBio­me was al­ready lay­ing off em­ploy­ees from its staff of some 300, say­ing it want­ed to fo­cus more on drugs and part­ner­ships with drug com­pa­nies, where Jimenez could help.

Zac Apte

I nev­er got a chance to talk to Jimenez last fall, but he told one oth­er writer that he had put the Co­hen af­fair be­hind him and moved on. Dur­ing his last year as CEO, No­var­tis paid Co­hen $1.2 mil­lion for what it said was a brief con­sult­ing pe­ri­od as they sought to learn more about Trump’s health­care pol­i­cy.

The mon­ey, though, went in­to the same ac­count that paid porn ac­tress Stormy Daniels hush mon­ey. And when that emerged, the phar­ma gi­ant and Jimenez were caught in one of the ugli­est scan­dals to hit Wash­ing­ton DC.

Co­hen told law­mak­ers that No­var­tis had want­ed him to open a back door to the White House, seek­ing help in mak­ing con­nec­tions with the top play­ers in the ad­min­is­tra­tion. He re­fused, and while No­var­tis paid out the con­tract, they even­tu­al­ly stopped talk­ing. By that time, No­var­tis spokes­peo­ple had shut the win­dow on com­ments.

A new at­tempt to reach Jimenez this af­ter­noon has so far been un­suc­cess­ful.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Stéphane Bancel, Moderna CEO (AP Photo/Charles Krupa)

French pres­i­dent names Stéphane Ban­cel a Cheva­lier for Mod­er­na's Covid tri­umph

Moderna’s rapid fire development of its hugely successful mRNA vaccine for Covid saved lives, changed the vaccine industry forever and made CEO Stéphane Bancel a billionaire. But perhaps the sweetest reward came this week, when Bancel was named a Chevalier — basically knighted — by the president of France.

Prestigious European titles like this are rare in biopharma, but not unknown, as AstraZeneca’s Mene Pangalos could tell you after being knighted by the Queen, named on the honors list in 2020 for his contribution to science.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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