Rob Califf (AP Images)

Does bio­phar­ma sup­port the Califf nom for FDA? Yeah, what­ev­er

Now that Pres­i­dent Joe Biden has drug his heels as long as pos­si­ble in se­lect­ing a new FDA com­mis­sion­er, we’re set to wel­come the new boss — same as the old boss.

Janet Wood­cock, whose pub­lic lega­cy may now boil down to the ap­proval of an un­proven Alzheimer’s drug and whose in­dus­try lega­cy cen­ters on putting the agency in sync with the largest drug de­vel­op­ers, is set to step aside as Robert Califf makes his way back to the helm. And the in­dus­try large­ly ap­pears to think that’s just fine.

We asked our read­ers what they thought about the move — which Wash­ing­ton in­sid­ers be­lieve is large­ly a slam dunk giv­en the last vote in Califf’s fa­vor. And 58% of­fered a quick and em­phat­ic thumbs up. True, right at 1 in four were not hap­py about the move. But with an­oth­er 18% lined up among the un­de­cid­eds, it’s clear he won’t face much if any crit­i­cism from in­sid­ers, who most­ly like him fine.

Califf, notes one sup­port­er, “knows what he is do­ing. FDA is in a good place and does not need rein­vent­ing. He will have to avoid Bio­gen like is­sues, but that is not hard.”

A key mo­ment in his past ex­pe­ri­ence run­ning the FDA oc­curred when Califf let Wood­cock move ahead with her con­tro­ver­sial OK for Sarep­ta’s still ex­per­i­men­tal Duchenne MD drug. Af­ter de­lay­ing the start of its con­fir­ma­to­ry tri­al, Sarep­ta will need more than 9 years to see through its post-ap­proval study. Bio­gen al­so gets 9 years. And no one is look­ing for the FDA to make things much hard­er for the av­er­age drug de­vel­op­er.

Califf will al­ways look a lit­tle lack­lus­ter com­pared to Scott Got­tlieb, a dy­nam­ic com­mish who al­so helped spot­light the re­volv­ing door be­tween the FDA and in­dus­try by leap­ing straight to Pfiz­er’s board. Califf is jump­ing in from Ver­i­ly. But he got his aca­d­e­m­ic cred at Duke, and he gets a lot of sup­port for that alone.

— He’s the clear best op­tion among some not-great can­di­dates (aside from Scott Got­tlieb, who ap­par­ent­ly was not in­ter­est­ed in the job).

“We need an FDA head and there isn’t any­one else who seems bet­ter,” notes an­oth­er read­er.

Oth­ers find that hard to be­lieve.

— This is a crit­i­cal time in the FDA’s fu­ture and it is time for new blood.

“Too close­ly con­nect­ed to in­dus­try and cur­rent gov­ern­ment,” writes an­oth­er in a com­ment re­peat­ed­ly echoed among the crit­ics.

That in­sid­er knowl­edge, though, can cut both ways with this crowd.

— Prag­mat­ic leader with an ex­cel­lent un­der­stand­ing of the clin­i­cal de­vel­op­ment process and a true com­mit­ment to in­no­va­tion for pa­tients that im­prove pa­tient out­comes.

— Thought­ful, ded­i­cat­ed, great per­spec­tive, trained as a clin­i­cian and clin­i­cal re­searcher, so he sees the field of ther­a­peu­tic de­vel­op­ment from a won­der­ful per­spec­tive. Cares about peo­ple and pub­lic health, does not view him­self as a “reg­u­la­tor”. He has all the right skills to lead FDA back to a trust­ed po­si­tion of lead­er­ship and pub­lic ser­vice in these fraught times of pub­lic opin­ion.

But the praise was large­ly mut­ed:

— Good enough con­sid­er­ing the al­ter­na­tives.

At this point, just mak­ing a choice and clear­ing up any un­cer­tain­ty will be re­as­sur­ing to a large seg­ment of in­dus­try lead­ers. And what­ev­er Janet Wood­cock does next, her dom­i­nant spir­it will con­tin­ue to in­flu­ence events at the FDA.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.