Moncef Slaoui (AP Images)

Mon­cef Slaoui to step down from Op­er­a­tion Warp Speed in a month — re­port

Mon­cef Slaoui’s tu­mul­tuous reign as chief of Op­er­a­tion Warp Speed is com­ing to an end.

The for­mer Glax­o­SmithK­line vac­cine ex­ec has sub­mit­ted his res­ig­na­tion at the re­quest of the in­com­ing Biden ad­min­is­tra­tion, CN­BC re­port­ed. Un­der his cur­rent con­tract and agreed plan, he will stay on for a month to aid with tran­si­tion — al­though his role is ex­pect­ed to be di­min­ished af­ter the in­au­gu­ra­tion on Jan. 20.

In the sev­en months since he was tapped by out­go­ing Pres­i­dent Don­ald Trump to the role, Slaoui has co­or­di­nat­ed an un­prece­dent­ed sci­en­tif­ic ef­fort to de­vel­op vac­cines and ther­a­peu­tics against the back­drop of a rag­ing pan­dem­ic. Of­ten crit­i­cized for his ex­ten­sive ties and fi­nan­cial in­ter­est in the bio­phar­ma in­dus­try, he stood on his ground guard­ing the ini­tia­tive he led from politi­ciza­tion, go­ing so far as to, on oc­ca­sion, con­tra­dict Trump’s claims on when a vac­cine might be ready at a time many were con­cerned about a rush job.

Op­er­a­tion Warp Speed was hailed as a bright spot in the Trump ad­min­is­tra­tion’s oth­er­wise chaot­ic and in­ad­e­quate pan­dem­ic re­sponse, stand­ing out among fail­ures in sort­ing out pro­tec­tive equip­ment, test­ing, so­cial dis­tanc­ing mea­sures or crit­i­cal­ly need­ed med­ical care.

To­geth­er with Gen. Gus­tave Per­na, the chief op­er­at­ing of­fi­cer, Slaoui draft­ed con­tracts worth at least $12 bil­lion in to­tal as the duo as­sem­bled a port­fo­lio of can­di­dates that might help take Covid-19 out.

As he de­scribed to Sci­ence mag­a­zine back in Sep­tem­ber:

Once we set that strat­e­gy, we start­ed to op­er­a­tional­ize it. Sur­pris­es come every day. New ques­tions from the FDA. Or a clin­i­cal tri­al site that’s not re­cruit­ing. Or im­bal­ances in the kind of pop­u­la­tions that we want to have in the study. Or chang­ing the ge­o­graph­ic lo­ca­tion of the sites be­cause the epi­demi­ol­o­gy is evolv­ing. There are 25 dif­fer­ent sites in the U.S in­volved in the man­u­fac­tur­ing of these six vac­cines and Gen­er­al Per­na and my­self tour all of them. Frankly, it’s ac­tu­al­ly work­ing even bet­ter than I was hop­ing.

The 61-year-old had pre­vi­ous­ly in­di­cat­ed that he planned to step down by ear­ly this year once two vac­cines and two ther­a­peu­tics have been au­tho­rized. Both of those goals had been reached by the end of 2020 as the FDA is­sued emer­gency use au­tho­riza­tions for the mR­NA vac­cines from Pfiz­er/BioN­Tech and Mod­er­na as well as an­ti­bod­ies from Eli Lil­ly and Re­gen­eron.

The onus now falls on the dis­tri­b­u­tion team, as the Trump ad­min­is­tra­tion makes sev­er­al big changes to the vac­cine roll­out strat­e­gy in a bid to get more shots in arms quick­ly.

Biden has out­lined a goal to hit 100 mil­lion vac­ci­na­tions in the first 100 days of his tenure, but it’s un­clear who on the Biden team will take the sci­en­tif­ic lead on the oth­er Op­er­a­tion Warp Speed-backed projects that are still in clin­i­cal tri­als. Jeff Zients is his co­or­di­na­tor of Covid-19 re­sponse, and Bechara Chou­cair, the for­mer chief health of­fi­cer at Kaiser Per­ma­nente, has been tapped as the vac­ci­na­tions co­or­di­na­tor.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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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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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.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.