Robert Califf (Michael Brochstein/Sipa USA via AP Images)

Ed­i­to­r­i­al: With Califf con­firmed, FDA needs to re­turn to pri­or­i­ties lost to the pan­dem­ic and im­prove its mes­sag­ing

The pan­dem­ic is by no means over, and the FDA will sure­ly con­tin­ue to pri­or­i­tize the nec­es­sary EUAs for ad­di­tion­al ther­a­pies and tar­get­ed vac­cines as well as oth­er mea­sures to bring down the bal­loon­ing death toll.

In fact, the first big item on new­ly Sen­ate-con­firmed FDA com­mish Rob Califf’s plate will be the or­deal around Pfiz­er’s vac­cine for the youngest chil­dren.

The FDA last week rubbed egg on its own face by not on­ly call­ing for Pfiz­er to sub­mit da­ta, but sched­ul­ing an ad­comm to re­view the da­ta on this low­est-dose vac­cine, con­tem­plat­ing start­ing with two dos­es be­fore wait­ing for da­ta on a third.

But as the ad­comm drew close, FDA pulled back and post­poned it af­ter re­ceiv­ing some “late-break­ing” da­ta from Pfiz­er. In­stead, the agency de­cid­ed to just wait for the third dose for these youngest chil­dren, con­firm­ing what Pfiz­er had said all along.

These are the kinds of own-goals the FDA needs to avoid un­der Califf.

He’s al­so go­ing to have to come up with a plan to shep­herd all of these Covid-re­lat­ed emer­gency use au­tho­riza­tions in­to full ap­provals as politi­cians seek to halt the pub­lic health emer­gency now that Omi­cron cas­es are wan­ing, and as gov­ern­ment funds may be scarce.

But be­yond Covid, Califf will have to help ush­er in the lat­est ne­go­ti­at­ed deals for in­dus­try user fees, which fund the ma­jor­i­ty of the agency’s drug re­views. Con­gress has un­til the end of Sep­tem­ber to reau­tho­rize the leg­is­la­tion and Califf will be the one who has to en­sure the pack­ages get passed.

Califf al­so can lay out some of his own agen­da and tar­get pri­or­i­ties that have fall­en to the way­side over the past two-plus years, like re­form­ing the ac­cel­er­at­ed ap­proval path­way, which he’s promised Sen. Ron Wyden he would take on, and ce­ment­ing how the agency us­es re­al-world ev­i­dence (ran­dom­ized or not) in its de­ci­sion mak­ing.

Lucky for Califf, both Janet Wood­cock, at least to start, will be there to sup­port him with her 35+ years of agency ex­pe­ri­ence, and Pe­ter Marks at CBER will con­tin­ue to ex­plain vac­cine de­ci­sions as on­ly he can.

While Wood­cock pre­vi­ous­ly told me that FDA isn’t re­al­ly in the busi­ness of polic­ing mis­in­for­ma­tion about Covid-19 vac­cines, Califf may turn over a new page here too.

“I’m go­ing to be very ag­gres­sive in this area of med­ical mis­in­for­ma­tion,” he told sen­a­tors on the health com­mit­tee.

In­deed, the FDA un­der Califf should take a page out of Scott Got­tlieb’s book and bet­ter ex­plain each de­ci­sion, not on­ly to the pub­lic but to the me­dia too (to avoid head­lines like the one in NBC News last week that said, “Pfiz­er pulls FDA re­quest for Covid vac­cine for kids un­der 5”).

This is im­por­tant al­so be­cause so many Amer­i­cans have lost faith in gov­ern­ment-run sci­en­tif­ic in­sti­tu­tions and be­cause Marks and oth­ers at the agency are very ar­tic­u­late in ex­plain­ing what’s go­ing on. At the very least, those ex­perts should be speak­ing to the me­dia more reg­u­lar­ly.

While it’s un­der­stand­able that an agency like FDA has to keep con­fi­den­tial in­dus­try da­ta se­cret, the agency still needs to do more than just is­sue a PR, and then copy and paste bits and pieces of that PR in re­spons­es to me­dia. Make se­nior of­fi­cials avail­able for dis­cus­sions, find new ways to com­mu­ni­cate with the pub­lic, and most of all, stick with the da­ta. That shouldn’t be a prob­lem for Rob Califf.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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