Ursula von der Leyen (second right) speaks with Pfizer CEO Albert Bourla (left), Belgium Prime Minister Alexander De Croo (second left) and BioNTech's Özlem Türeci during an official visit to the Pfizer pharmaceutical company in Puurs, Belgium (John Thys/Pool via AP Images)

Eu­ro­pean Com­mis­sion says it does­n't have texts be­tween pres­i­dent Ur­su­la von der Leyen and Pfiz­er CEO Al­bert Bourla

Un­der fire from the Eu­ro­pean om­buds­man, the Com­mis­sion said on Wednes­day that it hasn’t found any text mes­sages be­tween pres­i­dent Ur­su­la von der Leyen and Pfiz­er chief Al­bert Bourla re­gard­ing the pur­chase of Covid-19 vac­cines.

The mes­sages be­came of in­ter­est last April, when the New York Times re­port­ed that a se­ries of texts and calls be­tween von der Leyen and Bourla led to Pfiz­er’s largest vac­cine deal — 900 mil­lion dos­es of the cur­rent vac­cine and a vac­cine adapt­ed to vari­ants, with the op­tion to pur­chase an ad­di­tion­al 900 mil­lion dos­es through 2023.

Emi­ly O’Reil­ly

Up­on a pub­lic ac­cess re­quest made by a jour­nal­ist, the EC re­spond­ed that it had no record of them. How­ev­er, it was lat­er re­vealed by om­buds­man Emi­ly O’Reil­ly, the EU’s in­ter­nal watch­dog, that the EC nev­er ex­plic­it­ly asked the cab­i­net to look for the texts.

In­stead, the EC re­quest­ed oth­er doc­u­ments that fall un­der its in­ter­nal cri­te­ria for record­ing, which doesn’t in­clude text mes­sages.

O’Reil­ly ac­cused the Com­mis­sion of “mal­ad­min­is­tra­tion,” and urged the ad­min­is­tra­tion to con­duct a more thor­ough search.

“When it comes to the right of pub­lic ac­cess to EU doc­u­ments, it is the con­tent of the doc­u­ment that mat­ters and not the de­vice or form,” she said in a state­ment back in Jan­u­ary. “If text mes­sages con­cern EU poli­cies and de­ci­sions, they should be treat­ed as EU doc­u­ments.”

On Wednes­day, the EC claimed to side with O’Reil­ly: “The Com­mis­sion and the Om­buds­man agree that what mat­ters is the con­tent of a doc­u­ment,” a spokesper­son said in an email to End­points News. 

How­ev­er, the Com­mis­sion main­tained that the texts were not reg­is­tered as doc­u­ments “due to their short-lived and ephemer­al na­ture.”

“Text and in­stant mes­sages in gen­er­al do not con­tain im­por­tant in­for­ma­tion re­lat­ing to poli­cies, ac­tiv­i­ties and de­ci­sions of the Com­mis­sion, nor are they in the pos­ses­sion of the in­sti­tu­tion,” the EC shared in a let­ter.

The ad­min­is­tra­tion added that it in­tends to is­sue fur­ther guid­ance on the use of “mod­ern com­mu­ni­ca­tion tools” such as text and in­stant mes­sages to clear up any con­fu­sion.

“The Om­buds­man could equal­ly be in­vit­ed to par­tic­i­pate in those dis­cus­sions, if she wish­es to do so,” the state­ment said.

Pfiz­er de­clined to com­ment on the con­tent of the text mes­sages.

Stel­la Kyr­i­akides

The EC struck its third vac­cine deal with Pfiz­er and BioN­Tech last May, af­ter its oth­er ma­jor sup­pli­er As­traZeneca ran in­to pro­duc­tion is­sues and an­nounced it would sig­nif­i­cant­ly re­duce de­liv­er­ies.

The con­tract, which called for up to 1.8 bil­lion dos­es through 2023, al­so re­served the EU right to re­sell or do­nate dos­es to coun­tries in need.

“We need to be one step ahead of the virus. This means hav­ing ac­cess to adapt­ed vac­cines to pro­tect us against the threat of vari­ants, boost­er vac­cines to pro­long im­mu­ni­ty, as well as pro­tect­ing our younger pop­u­la­tion,” com­mis­sion­er for health and food safe­ty Stel­la Kyr­i­akides said at the time.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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