The Eu­ro­pean Com­mis­sion on Wednes­day an­nounced that it would on­ly pur­chase 1.25 mil­lion dos­es of Val­ne­va’s new­ly au­tho­rized Covid-19 vac­cine, af­ter orig­i­nal­ly pur­chas­ing 60 mil­lion dos­es.

The EC first sent a no­tice of in­tent to ter­mi­nate the pur­chase agree­ment back in May, as the reg­u­la­to­ry re­view of Val­ne­va’s vac­cine stalled. In late June, the Eu­ro­pean Med­i­cines Agency rec­om­mend­ed Val­ne­va’s shot for the pri­ma­ry vac­ci­na­tion of adults, but the com­pa­ny warned that its sup­ply deal might be dead in the wa­ter.

Stel­la Kyr­i­akides

“The Val­ne­va vac­cine is adding an­oth­er op­tion to the broad EU vac­cine port­fo­lio, and thanks to our Health Emer­gency Pre­pared­ness and Re­sponse Au­thor­i­ty, we are pro­vid­ing the pos­si­bil­i­ty to those Mem­ber States who so wish to of­fer al­so this vac­cine to cit­i­zens,” Stel­la Kyr­i­akides, EU com­mis­sion­er for health and food safe­ty, said in a state­ment.

France-based Val­ne­va’s stock shares (EPA: $VLA) plunged al­most 10% Wednes­day, and are down more than 60% year-to-date on the Paris stock ex­change.

The pur­chase of 1.25 mil­lion dos­es al­so comes with the op­tion to pur­chase an equiv­a­lent quan­ti­ty lat­er this year for de­liv­ery in 2022, the com­pa­ny said, adding:

The first vac­cine dos­es will be de­liv­ered to par­tic­i­pat­ing EU Mem­ber States (Ger­many, Aus­tria, Den­mark, Fin­land and Bul­gar­ia) in the com­ing weeks. Val­ne­va will re­tain in­ven­to­ry for po­ten­tial ad­di­tion­al sup­ply to these EU Mem­ber States should de­mand in­crease and, in par­al­lel, will aim to de­ploy ap­prox­i­mate­ly eight to ten mil­lion dos­es of re­main­ing in­ven­to­ry in­to in­ter­na­tion­al mar­kets. Giv­en that VLA2001’s shelf life is ex­pect­ed to reach up to 24 months over time, the Com­pa­ny will aim to de­ploy these dos­es in the next six to twelve months.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.