The FDA on Thurs­day ap­proved Mod­er­na’s Covid-19 shot for kids six months through 11 years old who are at high­er risk of se­vere dis­ease, the lat­est move that fits the agency’s new vac­cine frame­work.

The de­ci­sion ex­pands full ap­proval of Spike­vax to younger chil­dren ahead of the up­com­ing res­pi­ra­to­ry sea­son. The vac­cine was pre­vi­ous­ly avail­able for this age group un­der emer­gency use au­tho­riza­tion. It's now ful­ly ap­proved for all adults 65 and old­er and at-risk in­di­vid­u­als six months through 64.

"We ap­pre­ci­ate the FDA's dili­gent sci­en­tif­ic re­view and ap­proval of Spike­vax for pe­di­atric pop­u­la­tions at in­creased risk for Covid-19 dis­ease,” Mod­er­na CEO Stéphane Ban­cel said in a re­lease.

The ap­proval is al­so the lat­est in a se­ries of FDA green lights for Mod­er­na vac­cines de­spite con­cerns from top health of­fi­cials about mR­NA tech­nol­o­gy.

Var­da Space In­dus­tries has raised $187 mil­lion in a pri­vate fund­ing round as the com­pa­ny lever­ages mi­cro­grav­i­ty to over­come for­mu­la­tion is­sues that have long plagued drug de­vel­op­ment.

Ac­tive phar­ma­ceu­ti­cal in­gre­di­ents crys­tal­lize dif­fer­ent­ly in space, en­abling drug for­mu­la­tions that the com­pa­ny says oth­er­wise could­n't be done. That's be­cause mi­cro­grav­i­ty sup­press­es two crit­i­cal process­es — flu­id con­vec­tion and sed­i­men­ta­tion — dur­ing crys­tal growth, re­sult­ing in a more uni­form and con­trolled process.

Adri­an Rado­cea, Var­da’s chief sci­ence of­fi­cer, likened crys­tal­liza­tion to build­ing a house: if done too quick­ly, bricks are mis­placed and com­pro­mise the struc­ture's in­tegri­ty.

"What mi­cro­grav­i­ty lets you do is re­al­ly slow down the growth rate of crys­tals," Rado­cea said.

In a his­toric first, the FDA on Thurs­day re­leased about 200 nov­el and gener­ic drug re­jec­tion let­ters, buck­ing the agen­cy's for­mer ret­i­cence to pub­li­cize the doc­u­ments in one place.

But it's a small step as near­ly all the let­ters re­viewed by End­points News were pre­vi­ous­ly dis­closed as part of the drugs' ap­proval pack­ages. Two of the com­plete re­sponse let­ters not pre­vi­ous­ly dis­closed in­clud­ed one for As­traZeneca's COPD treat­ment Breztri Aeros­phere in 2019 and one for a la­bel up­date for Astel­las' eye drug Iz­er­vay in 2024.

As­traZeneca dis­closed its CRL in a press re­lease but did not men­tion that the FDA said the sub­mit­ted da­ta "do not pro­vide sub­stan­tial ev­i­dence of the ef­fi­ca­cy and safe­ty for the use of Breztri Aeros­phere." The com­pa­ny has to yet to re­spond to a re­quest for com­ment on the CRL.

Jazz Phar­ma­ceu­ti­cals has named its next con­duc­tor.

Renée Galá, the Dublin-based com­pa­ny’s cur­rent pres­i­dent and COO, will be­come CEO on Au­gust 11. She will suc­ceed Jazz’s co-founder Bruce Cozadd, who in­formed the board in 2024 of his in­tent to re­tire af­ter 22 years at the com­pa­ny. He plans to stay on as chair­man of the board.

“I am thrilled to be hand­ing over the reins to Renée and am ex­cit­ed for her to lead Jazz in­to our next phase of growth,” Cozadd said in a press re­lease on Thurs­day.

Jazz’s pipeline is fo­cused on both on­col­o­gy and neu­ro­science, in­clud­ing sleep dis­or­ders and epilep­sy. Its top-sell­ing med­i­cine in 2024 was Xy­wav, a low­er-sodi­um al­ter­na­tive to its pri­or sleep dis­or­der block­buster Xyrem. The com­pa­ny said it de­liv­ered “record to­tal rev­enues” that year of $4.1 bil­lion.

To­day on Post-Hoc Live, we're talk­ing about Chi­na — and how some in biotech want to make it hard­er for US com­pa­nies to do deals there.

The drug in­dus­try has turned to Chi­na for new mol­e­cules like nev­er be­fore, which is caus­ing a split in the world of US ven­ture cap­i­tal. Some in­vestors see op­por­tu­ni­ty. Oth­ers are warn­ing of risks to Amer­i­ca's biotech lead­er­ship.

As Jared Whit­lock and I