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.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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