Im­munomedics CEO Michael Pehl hits the ex­it on the heels of a CRL and ac­cu­sa­tions of a da­ta in­tegri­ty breach

Fol­low­ing a rough few weeks, the re­volv­ing door at the ex­ec­u­tive suite to Im­munomedics $IM­MU is turn­ing once more.

Michael Pehl

Af­ter the mar­ket closed on Mon­day the com­pa­ny put out word that CEO Michael Pehl has de­cid­ed to leave for per­son­al rea­sons. His abrupt ex­it af­ter 15 months on the job comes a lit­tle more than a month af­ter the FDA hand­ed the com­pa­ny a CRL for its ap­pli­ca­tion to mar­ket the an­ti­body drug con­ju­gate IM­MU-132, or sac­i­tuzum­ab govite­can.

The biotech’s shares slid 8% in af­ter-mar­ket trad­ing.

At the time the re­jec­tion let­ter ar­rived, Pehl and Im­munomedics said that the FDA had cit­ed man­u­fac­tur­ing is­sues for the re­jec­tion. 

This lat­est dis­rup­tion oc­curred just days af­ter an agency re­port be­gan to cir­cu­late show­ing that the FDA had cit­ed the com­pa­ny for a breach of da­ta in­tegri­ty af­ter an Au­gust in­spec­tion. The reg­u­la­to­ry re­port on the fa­cil­i­ty spot­light­ed the agency’s con­cerns about ma­nip­u­lat­ed sam­ples and back­dat­ed doc­u­ments.

Be­hzad Ag­haz­adeh

Pehl was brought in to end the long-run­ning dra­ma over the drug and the com­pa­ny, which had been tak­en over by the crew led by ven­Bio’s Be­hzad Ag­haz­adeh. Ag­haz­adeh de­railed a $300 mil­lion up­front pact with Im­munomedics on their lead drug — oust­ing the hus­band and wife team who had run the com­pa­ny for years in the process — in the spring of 2017 and lat­er land­ed a $250 mil­lion roy­al­ty deal to fund the com­pa­ny’s work. 

Charles Baum, the CEO of Mi­rati Ther­a­peu­tics, mean­while has joined the Im­munomedics board of di­rec­tors.

“Our pri­ma­ry fo­cus is to en­sure a high-qual­i­ty BLA re­sub­mis­sion and gain FDA ap­proval of sac­i­tuzum­ab govite­can for pa­tients with metasta­t­ic triple-neg­a­tive breast can­cer (mTNBC). In that re­gard, we have im­ple­ment­ed a ded­i­cat­ed CRL team, led by our ex­ec­u­tive board mem­ber, Scott Canute, a rec­og­nized ex­pert in man­u­fac­tur­ing and qual­i­ty span­ning decades in the bio­phar­ma­ceu­ti­cal in­dus­try,” ex­ec­u­tive chair­man Ag­haz­adeh said in a pre­pared state­ment. 

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Anderson, incoming Bayer CEO (David Paul Morris/Bloomberg via Getty Images)

Bay­er taps Roche's Bill An­der­son to lead phar­ma gi­ant as CEO

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

Iya Khalil, Merck VP and head of data, AI and genome sciences (Novartis)

Mer­ck-No­var­tis re­volv­ing door spins again as AI leader Iya Khalil switch­es phar­mas

As talk of AI this-and-that gobbles up headline after headline, one Big Pharma is losing its AI leader as she transitions to another drug giant: Iya Khalil will trade in her hat as Novartis’ go-to expert and leader in the space for Merck as VP and head of data, AI and genome sciences next week.

After nearly three years leading the artificial intelligence team at Novartis — as Big Pharma and biotechs alike latch onto the ripening AI-for-drug-discovery mode of operation — Khalil will switch employers to head up a similar post at Merck, where she’ll work out of Cambridge, MA beginning Feb. 13, the company tells Endpoints News.

Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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