Rob Califf (AP Photo/Pablo Martinez Monsivais, File)

Biden like­ly to nom­i­nate Ver­i­ly's Rob Califf to lead the FDA again

Cap­ping a con­tro­ver­sial­ly long pe­ri­od for the FDA to go with­out a per­ma­nent leader, Pres­i­dent Joe Biden is like­ly to se­lect Ver­i­ly’s Rob Califf, a for­mer FDA com­mis­sion­er un­der Pres­i­dent Oba­ma, as the next FDA com­mis­sion­er nom­i­nee.

A for­mer Duke car­di­ol­o­gist and mem­ber of the pres­ti­gious Na­tion­al Acad­e­my of Med­i­cine, Califf will be a wel­come face for an agency grap­pling with high-pro­file re­tire­ments in CBER and CDER. He’ll al­so re­turn to a role that he was com­fort­able in for a short stint at the end of Oba­ma’s pres­i­den­cy. The Wash­ing­ton Post first re­port­ed the news.

Califf, un­like oth­er po­ten­tial nom­i­nees like act­ing FDA com­mis­sion­er Janet Wood­cock, isn’t like­ly to draw much ire from De­moc­rats even though he’s most re­cent­ly been work­ing for Google’s Ver­i­ly and as Sens. Joe Manchin (D-WV) and Richard Blu­men­thal (D-CT) pre­vi­ous­ly op­posed his nom­i­na­tion. But as the agency saw more re­cent­ly with Scott Got­tlieb, a for­mer FDA com­mis­sion­er with in­dus­try con­nec­tions who im­me­di­ate­ly fol­lowed Califf in his pre­vi­ous run, a for­mer po­si­tion does not nec­es­sar­i­ly af­fect how well one per­forms in the top role at FDA.

Califf’s ex­pect­ed nom­i­na­tion al­so caps a long and in­creas­ing­ly con­tro­ver­sial tenure for Janet Wood­cock at the top of FDA as an act­ing com­mis­sion­er. In some cir­cles of De­moc­rats Wood­cock was a non­starter be­cause of her back­ing from bio­phar­ma in­dus­try and be­cause of her role in the opi­oid cri­sis.

As a 35-year vet­er­an of the FDA, it’s un­clear what Wood­cock will do now with Califf mov­ing to the helm of FDA. She pre­vi­ous­ly led the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search since 1994, but that po­si­tion has been tak­en by Pa­trizia Cavaz­zoni, and Wood­cock might take a role re­lat­ed to Covid-19 as she served re­cent­ly as the top leader of Op­er­a­tion Warp Speed’s de­vel­op­ment of ther­a­peu­tics.

A source close to the de­ci­sion mak­ing process said that Ni­rav Shah, for­mer health com­mis­sion­er for New York, and Mon­i­ca Bertag­nol­li, a pro­fes­sor of surgery at Har­vard Med­ical School who al­so works at Dana-Far­ber, were al­so vet­ted for the per­ma­nent FDA com­mis­sion­er role.

White House press sec­re­tary Jen Psa­ki said at Thurs­day’s press brief­ing, “Well, the Pres­i­dent is def­i­nite­ly ea­ger to make a de­ci­sion about an FDA nom­i­nee and, of course, make that de­ci­sion pub­lic once it’s made. We’re just not quite at that point yet. In terms of the time­line, I’m not aware of what ex­act­ly that time­line is.”

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 159,000+ biopharma pros reading Endpoints daily — and it's free.