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.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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 this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News. 

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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