On Thurs­day, the FDA fi­nal­ly did what sev­er­al pri­or agency com­mis­sion­ers on­ly promised to do: pub­lish redact­ed com­plete re­sponse let­ters for drugs that are still un­der con­sid­er­a­tion by the agency de­spite the ini­tial re­jec­tion.

The 89 let­ters in­clude some re­cent high-pro­file — and some­times con­tentious — re­jec­tions of drugs from Replimune, Capri­cor Ther­a­peu­tics, Stealth Bio­Ther­a­peu­tics and many oth­ers. And while the let­ters will add in­sight in­to why the FDA turned down the drugs, the ac­tion is al­most cer­tain to be con­tro­ver­sial, or chal­lenged legal­ly, if some com­pa­nies ob­ject to the re­lease of what has long been thought of as pro­pri­etary and con­fi­den­tial in­for­ma­tion.

"This def­i­nite­ly seems like a his­toric first in en­sur­ing trans­paren­cy," Resh­ma Ra­machan­dran, a Yale physi­cian and chair of the Doc­tors for Amer­i­ca FDA Task Force, told End­points News. "It’ll be in­ter­est­ing to see if mov­ing for­ward, FDA will pro­vide ac­tu­al re­al-time ac­cess to these let­ters."

Sen­a­tors on both sides of the aisle lam­bast­ed HHS Sec­re­tary Robert F. Kennedy Jr. on Thurs­day over the up­heaval of CDC lead­er­ship and re­cent agency de­ci­sions that have mud­dled Covid-19 vac­cine ac­cess in the US.

Dur­ing a con­tentious three-hour hear­ing be­fore the Sen­ate Fi­nance Com­mit­tee, Kennedy said changes at the CDC, in­clud­ing the fir­ing of Di­rec­tor Su­san Monarez and the res­ig­na­tions of three se­nior lead­ers, were “ab­solute­ly nec­es­sary.” But sev­er­al sen­a­tors ex­plic­it­ly dis­agreed, and ques­tioned the vac­cine de­ci­sions that Monarez her­self took is­sue with, which she says prompt­ed her ouster.

"I was afraid she was go­ing to bend the knee to you and Don­ald Trump, and it looks like she did­n't bend the knee, so you fired her," Sen. Eliz­a­beth War­ren (D-MA) said.

The gov­ern­ment won an­oth­er chal­lenge against Medicare drug price ne­go­ti­a­tions on Thurs­day, as an ap­peals court threw out cas­es brought by John­son & John­son and Bris­tol My­ers Squibb.

In a ma­jor­i­ty opin­ion, the US Court of Ap­peals for the Third Cir­cuit up­held a low­er court’s de­ci­sion that the ne­go­ti­a­tion pro­gram is vol­un­tary and doesn’t con­sti­tute a tak­ing of prop­er­ty with­out just com­pen­sa­tion, or a vi­o­la­tion of free speech. The de­ci­sion deals an­oth­er blow to drug­mak­ers seek­ing to chal­lenge the law on con­sti­tu­tion­al grounds.

“The pro­gram per­mits the gov­ern­ment to ac­quire the com­pa­nies’ drugs on­ly when it pays prices the com­pa­nies have agreed to. If the com­pa­nies dis­like the prices the gov­ern­ment is will­ing to pay, they are free to stop do­ing busi­ness with the gov­ern­ment,” the judges wrote in their opin­ion.

As­traZeneca is ter­mi­nat­ing a man­u­fac­tur­ing li­cense at its fac­to­ry in Ben­galu­ru, In­dia, af­ter an­nounc­ing its plans to sell the fa­cil­i­ty last year, a com­pa­ny spokesper­son con­firmed to End­points News.

The man­u­fac­tur­ing li­cense at the site was pre­vi­ous­ly ex­pect­ed to run un­til De­cem­ber 2027, ac­cord­ing to a Tues­day fil­ing.

“In No­vem­ber 2023, As­traZeneca Phar­ma In­dia Lim­it­ed an­nounced its de­ci­sion to ex­it from its man­u­fac­tur­ing fa­cil­i­ty in Ben­galu­ru,” the com­pa­ny spokesper­son ex­plained to End­points. While no buy­er for the fa­cil­i­ty has been an­nounced, the com­pa­ny has al­ready suc­cess­ful­ly "tran­si­tioned its pro­duc­tion ac­tiv­i­ties” from the fac­to­ry, the spokesper­son said.

No de­tails on where op­er­a­tions have been moved were giv­en.

MindMed de­tailed promis­ing Phase 2b re­sults for its LSD treat­ment for gen­er­al­ized anx­i­ety dis­or­der as it press­es on with three late-stage tri­als in the in­creas­ing­ly com­pet­i­tive field of psy­che­del­ic med­i­cine.

The com­pa­ny pub­lished da­ta Thurs­day in JA­MA, al­most two years af­ter first an­nounc­ing that spe­cif­ic dos­es of the drug were suc­cess­ful at im­prov­ing pa­tients' anx­i­ety symp­toms com­pared to place­bo. The 100 µg dose that went in­to Phase 3 test­ing al­so showed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in pa­tients' de­pres­sion symp­toms, a sec­ondary end­point of the anx­i­ety tri­al.

MindMed now faces a ques­tion that all com­pa­