The White House is prepar­ing to un­veil sev­er­al new deals with large drug­mak­ers on Fri­day as part of the ad­min­is­tra­tion’s “most fa­vored na­tion” pric­ing push, ac­cord­ing to sources fa­mil­iar with the plans.

The an­nounce­ment is like­ly to mim­ic oth­er re­cent most fa­vored na­tion un­veil­ings, with com­pa­ny CEOs and Pres­i­dent Don­ald Trump in the Oval Of­fice, said the sources, all of whom spoke on con­di­tion of anonymi­ty be­cause the an­nounce­ment isn’t yet pub­lic.

The ad­min­is­tra­tion has been work­ing to fi­nal­ize the deals, un­der which drug­mak­ers have agreed to cash-pay prices for some drugs, and give the gov­ern­ment dis­counts on oth­ers in Medicare or Med­ic­aid. So far, Pfiz­er, As­traZeneca, Eli Lil­ly, No­vo Nordisk and EMD Serono have made deals.

FDA Com­mis­sion­er Mar­ty Makary of­fered a soft­er ver­sion of the FDA's view of Covid-19 vac­cines than emerged in a re­cent in­ter­nal memo, say­ing that the agency was­n't plan­ning to add its most se­vere warn­ing to the shots, and sug­gest­ing that pre­vi­ous risks might have di­min­ished over time.

Makary's com­ments, made to Bloomberg TV in an in­ter­view Mon­day, were a sig­nif­i­cant con­trast to an in­ter­nal email sent late last month from the FDA’s chief of vac­cines and bi­o­log­ics Vinay Prasad, in which Prasad claimed with cer­tain­ty that the shots had caused at least 10 chil­dren's deaths.

An FDA staff analy­sis of the safe­ty of pe­di­atric Covid-19 shots has been fi­nal­ized and sent to the agency’s vac­cine and bi­o­log­ics head Vinay Prasad. But the re­port comes to many few­er firm con­clu­sions than two of the agency’s biggest crit­ics of the vac­cines have sug­gest­ed it would.

End­points News spoke to two peo­ple with knowl­edge of the analy­sis, who said that a re­view of ad­verse event re­ports found sev­en deaths in chil­dren that are “pos­si­bly” or “prob­a­bly” re­lat­ed to the Covid-19 vac­cines. The de­scrip­tion of the deaths as pos­si­bly or prob­a­bly linked rep­re­sents an in­ter­me­di­ate lev­el of cer­tain­ty, short of a de­fin­i­tive as­sess­ment that the shots caused the deaths.

The FDA will con­sid­er more re­al-world da­ta in drug and de­vice ap­pli­ca­tions, in­clud­ing from large datasets that don't have iden­ti­fi­able pa­tient da­ta, Com­mis­sion­er Mar­ty Makary told a Wall Street au­di­ence on Mon­day in New York.

In his re­marks to biotech in­vestors and bankers, Makary al­so re­it­er­at­ed the agen­cy's de­sire to make changes to the ear­li­est phas­es of hu­man test­ing — part of the ad­min­is­tra­tion's ef­forts to find poli­cies that will help com­pa­nies com­pete with fast-mov­ing Chi­na-based biotechs.

As part of the FDA's da­ta plans, the agency an­nounced Mon­day that it will al­low the use of da­ta that don't in­clude “pri­vate, con­fi­den­tial in­for­ma­tion at the in­di­vid­ual pa­tient lev­el," a broad­en­ing of its cur­rent stan­dard that could in­clude large, re­al-world datasets from in­sur­ers, hos­pi­tals or pa­tient reg­istries, for ex­am­ple.

John­son & John­son's Tec­vayli and Darza­lex com­bi­na­tion treat­ment scored an­oth­er win in sec­ond-line mul­ti­ple myelo­ma, with the FDA mov­ing with un­prece­dent­ed speed af­ter the lat­est da­ta to is­sue a new vouch­er that ex­pe­dites the com­bo's re­view to one to two months.

"Vig­i­lant FDA lead­ers just saw an im­pres­sive mul­ti­ple myelo­ma tri­al re­sult" pub­lished ahead of last week's Amer­i­can So­ci­ety of Hema­tol­ogy con­fer­ence in Or­lan­do, FL, Com­mis­sion­er Mar­ty Makary wrote on X on Mon­day. Agency ex­perts con­ferred and "con­tact­ed the com­pa­ny THE NEXT DAY to is­sue them a na­tion­al pri­or­i­ty vouch­er."

Hand-pick­ing a treat­ment for an ac­cel­er­at­ed re­view so quick­ly af­ter the re­lease of Phase 3 tri­al re­sults is rare for an agency that typ­i­cal­ly avoids com­ment­ing on da­ta un­der re­view. The com­pa­ny said the com­bo treat­men­t's sup­ple­men­tal drug ap­pli­ca­tion is al­ready in­clud­ed in the FDA's Re­al-Time On­col­o­gy Re­view pro­gram, where it will see its re­view ex­pe­dit­ed too.