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.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”