A new­ly re­built CDC vac­cine ad­vi­so­ry pan­el will meet for the first time this week, in­form­ing whether Amer­i­ca's pub­lic health agency will con­tin­ue to back da­ta and ev­i­dence that have long guid­ed its im­mu­niza­tion rec­om­men­da­tions.

HHS chief Robert F. Kennedy Jr. has fre­quent­ly ques­tioned the in­de­pen­dence and rec­om­men­da­tions of the Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices in his years-long cam­paign to sow doubt about the safe­ty and pub­lic health val­ue of vac­cines. His move to fire and re­place its mem­bers was a worst-case sce­nario for many doc­tors who have been wait­ing with bat­ed breath to see how his past ad­vo­ca­cy would trans­late in­to pol­i­cy.

Am­gen plans on us­ing a low­er start­ing dose for its long-act­ing obe­si­ty shot Mar­i­Tide in Phase 3 than it did in Phase 2 in an ef­fort to mit­i­gate gas­troin­testi­nal side ef­fects, mid-stage re­sults showed on Mon­day.

The com­pa­ny will al­so es­ca­late dos­es more grad­u­al­ly, ac­cord­ing to the re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine. Am­gen’s stock AMGN was down 5.7% on Mon­day af­ter the re­sults were re­leased.

Mar­i­Tide demon­strat­ed “mean­ing­ful weight loss” in the Phase 2 study, with the po­ten­tial for fur­ther weight re­duc­tion af­ter 52 weeks, the com­pa­ny said in a news re­lease. But “gas­troin­testi­nal ad­verse events were com­mon,” al­beit less fre­quent in pa­tients who re­ceived Mar­i­Tide with dose es­ca­la­tion and at a low­er start­ing dose, ac­cord­ing to the NE­JM re­sults.

The top drug reg­u­la­tor at the FDA is re­tir­ing, ac­cord­ing to an email re­viewed by End­points News and con­firmed by sev­er­al in­di­vid­u­als with­in the agency.

Jacque­line Cor­ri­g­an-Cu­ray, who’s been at the FDA's Cen­ter for Drug Eval­u­a­tion and Re­search for more than eight years, said in a note to staff on Mon­day that she has de­cid­ed to re­tire as act­ing CDER di­rec­tor in Ju­ly. She called the de­ci­sion "in­cred­i­bly chal­leng­ing."

"What has made this de­ci­sion so dif­fi­cult for me is all of you," she wrote. "Your un­wa­ver­ing sup­port, es­pe­cial­ly dur­ing re­cent chal­leng­ing times, has been hum­bling."

Cor­ri­g­an-Cu­ray, who did not re­spond to a re­quest for com­ment on the de­ci­sion, said she'll be stay­ing on "for sev­er­al more weeks to en­sure a smooth tran­si­tion."

The FDA on Mon­day ap­proved As­traZeneca and Dai­ichi Sankyo’s TROP2-tar­get­ing drug Da­troway in a new lung can­cer in­di­ca­tion, broad­en­ing the amount of pa­tients for what the com­pa­ny hopes is their next big block­buster.

Da­troway is now in­di­cat­ed to treat EGFR-mu­tat­ed, lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer. The FDA’s ac­cel­er­at­ed ap­proval de­ci­sion came near­ly three weeks ahead of the Ju­ly 12 PDU­FA date.

The com­pa­ny will need to con­firm the drug's ben­e­fit in an ad­di­tion­al Phase 3 study called TRO­PI­ON-Lung15, an As­traZeneca spokesper­son told End­points News. A read­out is ex­pect­ed in June 2026.

The price in lung can­cer will re­main the same as the ap­proved in­di­ca­tion for HER2-pos­i­tive, HR-neg­a­tive metasta­t­ic breast can­cer, a Dai­ichi spokesper­son told End­points. The whole­sale ac­qui­si­tion cost for one vial of Da­troway is $4,891.07 per 100 mg vial, or a month­ly list price of around $28,259.52. The price and dose will de­pend on a pa­tient’s weight.