It was Wednes­day af­ter­noon last week at the White House, and Pres­i­dent Don­ald Trump was work­ing the room. There with him were CEOs from the world’s biggest com­pa­nies, all of whom had pledged bil­lions of dol­lars in new US man­u­fac­tur­ing in­vest­ments.

He jok­ing­ly chid­ed John­son & John­son CEO Joaquin Du­a­to, com­par­ing the phar­ma com­pa­ny’s $55 bil­lion in­vest­ment an­nounce­ment to oth­er cor­po­rate gi­ants there at the White House.

“You got to catch up with Ap­ple and some of the oth­ers,” Trump told Du­a­to. “You’re one of the few com­pa­nies that could do that, right?”

Mer­ck got a shout-out, as did Genen­tech, Ab­b­Vie and No­var­tis.

A fed­er­al court hand­ed the FDA and Eli Lil­ly a ma­jor win in a case chal­leng­ing the end of the tirzepatide short­age.

On Wednes­day, The US Dis­trict Court for the North­ern Dis­trict of Texas de­nied a com­pound­ing phar­ma­cy trade group’s mo­tion for sum­ma­ry judg­ment, rul­ing in fa­vor of the fed­er­al agency and the phar­ma gi­ant, ac­cord­ing to a dock­et en­try. The opin­ion and or­der are un­der seal.

The de­ci­sion, while ex­pect­ed, is con­se­quen­tial. The judge had al­ready de­nied the com­pound­ing group's re­quest for a pre­lim­i­nary in­junc­tion in the case, say­ing it was un­like­ly to suc­ceed on the mer­its. The lat­est rul­ing means that com­pound­ing phar­ma­cies, which mix, com­bine and al­ter in­gre­di­ents of drugs, will con­tin­ue to be barred from churn­ing out copies of tirzepatide, sold by Lil­ly as Zep­bound and Moun­jaro.

To­day at 11 a.m. ET, we're go­ing to talk about the sur­prise news that Vinay Prasad will re­place Pe­ter Marks at the FDA, and lead the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search.

You can join us on YouTube, and we've al­so set up a cal­en­dar re­minder so you won't miss the livestream.

Prasad has evolved from an aca­d­e­m­ic who made his name ques­tion­ing the use of ac­cel­er­at­ed ap­proval and thin da­ta in tri­als, in­to a YouTube stream­er (and some­times in­ter­net troll) crit­i­ciz­ing the agency that he'll now help lead.

I’ll be joined by Se­nior Ed­i­tor Zach Bren­nan, who has known Prasad for years, and Re­porter Lei Lei Wu, who has cov­ered many of the drugs whose ap­provals Prasad has crit­i­cized.

FDA Com­mis­sion­er Mar­ty Makary named Vinay Prasad as the next di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, putting a stri­dent crit­ic of the agency in charge of one of its most im­por­tant cen­ters.

In an email to FDA staff that was re­viewed by End­points News, Makary said that Prasad has a "long and dis­tin­guished his­to­ry in med­i­cine." And in a fol­low-up post on post on X con­firm­ing the ap­point­ment, Makaray said Prasad  “brings the kind of sci­en­tif­ic rig­or, in­de­pen­dence, and trans­paren­cy we need at CBER.”

Prasad will take over CBER from Pe­ter Marks, who re­signed in late March af­ter a dis­agree­ment with Robert F. Kennedy Jr. over vac­cines. And if Prasad holds to his past pub­lic state­ments, he's like­ly to be more con­ser­v­a­tive in his ap­proach to CBER than Marks, giv­en his fo­cus on over­all sur­vival in can­cer tri­als and calls for tight­en­ing stan­dards for ac­cel­er­at­ed ap­provals.

How did bio­phar­ma stocks re­act to Vinay Prasad’s ap­point­ment as di­rec­tor of one of the FDA's top jobs? Not well.

Prasad, a hema­tol­o­gist-on­col­o­gist by train­ing who gained promi­nence for crit­i­ciz­ing the FDA and for­mer NI­AID Di­rec­tor An­tho­ny Fau­ci dur­ing the Covid-19 pan­dem­ic, is ex­pect­ed to take a more con­ser­v­a­tive ap­proach to drug reg­u­la­tion than pre­de­ces­sor Pe­ter Marks. His ap­point­ment as head of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search sent a tremor through biotech stocks Tues­day, with the XBI suf­fer­ing its worst day of the year and falling more than 6.5%.

Wall Street an­a­lysts ex­pect a broad im­pact on com­pa­nies de­vel­op­ing drugs un­der CBER — vac­cines, some bi­o­log­ics, and cell and gene ther­a­pies. Leerink an­a­lyst Mani Foroohar told End­points News that those com­pa­nies will be “high­ly ex­posed” as many of their pro­grams are de­pen­dent on the reg­u­la­to­ry flex­i­bil­i­ty Prasad has railed against. (Prasad, in ref­er­ence to that flex­i­bil­i­ty, has called Marks a "bob­ble­head doll that just stamps ap­proval.")