HHS Sec­re­tary Robert F. Kennedy Jr. de­fend­ed the FDA and Com­mis­sion­er Mar­ty Makary dur­ing a House hear­ing on Thurs­day morn­ing, say­ing that Makary is un­der a lot of pres­sure from the phar­ma in­dus­try.

Rep. Darin La­Hood (R-IL) ques­tioned Kennedy be­fore the House Ways and Means Com­mit­tee on Thurs­day re­gard­ing Makary's "mis­man­age­ment and bun­gled drug re­views," and say­ing that the FDA has "chilled in­vest­ments in life-sav­ing, in­no­v­a­tive cures, and that Chi­na is rapid­ly be­com­ing the re­cip­i­ent of those in­vest­ment dol­lars."

Kennedy pushed back on La­Hood's char­ac­ter­i­za­tion of Makary. He then in­cor­rect­ly point­ed to "record" new and gener­ic drug ap­provals last year. While Kennedy said the 91 first gener­ic ap­provals are a record, the FDA ap­proved 107 first gener­ic drugs in 2022. And ac­cord­ing to the FDA, 2018 is con­sid­ered the record year with the most ap­provals of new drugs.

Ope­nAI is the lat­est tech gi­ant to move in­to bio­phar­ma, an­nounc­ing a life sci­ences-fo­cused AI of­fer­ing on Thurs­day.

The San Fran­cis­co-based com­pa­ny an­nounced GPT-Ros­alind, ef­fec­tive­ly a ver­sion of Chat­G­PT tai­lored to the spe­cial­ized work of life sci­ences re­searchers. Ear­ly ac­cess users of the mod­el in­clude Am­gen, Mod­er­na and Ther­mo Fish­er Sci­en­tif­ic.

Thurs­day’s re­lease will be lim­it­ed to the US, with plans to soon ex­pand to oth­er ge­o­gra­phies. It al­so re­quires pass­ing a qual­i­fi­ca­tion re­view to en­sure it is used re­spon­si­bly by or­ga­ni­za­tions that have suf­fi­cient se­cu­ri­ty con­trols — hope­ful­ly weed­ing out ne­far­i­ous us­es. Ope­nAI launched "Chat­G­PT for Health­care" in Jan­u­ary, fo­cused on hos­pi­tals and health sys­tems.

A new re­port try­ing to set­tle a decades-old de­bate about Alzheimer’s dis­ease has reached a dra­mat­ic con­clu­sion: An­ti­body drugs that tar­get sticky amy­loid be­ta pro­teins in the brain sim­ply don’t work.

The meta-analy­sis, which com­piles da­ta from more than 20,000 pa­tients across 17 clin­i­cal tri­als, de­ter­mined that treat­ment with amy­loid an­ti­bod­ies re­sult­ed in “lit­tle to no dif­fer­ence” in cog­ni­tive func­tion, de­men­tia sever­i­ty and func­tion­al abil­i­ty. The au­thors con­clud­ed that fu­ture Alzheimer’s drugs “should fo­cus on oth­er mech­a­nisms of ac­tion.”

But the study is filled with lim­i­ta­tions sure to send many neu­ro­sci­en­tists who have de­vot­ed their lives to these drugs in­to a tizzy. It over­looks the strongest ar­gu­ments about why so many old­er at­tempts have failed; it ig­nores re­cent tech­no­log­i­cal break­throughs in de­liv­er­ing these kinds of drugs in­to the brain more ef­fi­cient­ly; and it skirts over big­ger and longer clin­i­cal tri­als that are still on­go­ing but promise to pro­vide the most con­clu­sive ev­i­dence on amy­loid drugs yet.

Eli Lil­ly’s re­cent­ly ap­proved obe­si­ty pill Foun­dayo cut the risk of car­dio­vas­cu­lar events like heart at­tack and stroke by 16% ver­sus a form of in­sulin, new da­ta show, and the com­pa­ny is plan­ning to file the drug in di­a­betes as a re­sult.

Per­haps as im­por­tant­ly, the study found no sign of he­pat­ic tox­i­c­i­ty. In its ap­proval let­ter for Foun­dayo, the FDA had re­quest­ed da­ta on drug-in­duced liv­er in­jury from this tri­al called ACHIEVE-4.

“ACHIEVE-4 in­clud­ed a thor­ough analy­sis of po­ten­tial drug-in­duced liv­er in­jury (DILI), and these analy­ses con­firmed there was no he­pat­ic safe­ty sig­nal, con­sis­tent with all pri­or stud­ies in the ACHIEVE and AT­TAIN pro­grams,” Lil­ly said Thurs­day.

As the prices paid for pri­or­i­ty re­view vouch­ers (PRVs) have crept up over the past year — the last two have sold for at least $200 mil­lion each — com­pa­nies now have to make dif­fi­cult de­ci­sions on whether us­ing the vouch­ers to speed up their own ap­provals makes fi­nan­cial sense.

For Mod­er­na, the FDA re­cent­ly dis­closed, and the com­pa­ny con­firmed, that it re­deemed two of its PRVs to ex­pe­dite its own RSV vac­cine ap­provals in old­er and then younger adults in 2024 and 2025 — in­clud­ing via its ma­te­r­i­al threat med­ical coun­ter­mea­sure PRV that it ac­quired af­ter win­ning ap­proval for its Covid vac­cine in 2022.

But those months of shaved FDA re­view times haven't trans­lat­ed in­to ear­ly ad­di­tion­al sales so far. Mod­er­na not­ed just $33 mil­lion in RSV sales in an SEC fil­ing in Feb­ru­ary and cit­ed its fierce com­pe­ti­tion with Pfiz­er and GSK, which en­tered the US mar­ket pri­or to Mod­er­na.