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.”

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.

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.”

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.

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.