New re­search found that self-re­port­ed con­flicts of in­ter­est among fed­er­al vac­cine ad­vi­so­ry mem­bers were at their low­est lev­el in 25 years through 2024, coun­ter­ing an ar­gu­ment of po­lit­i­cal­ly-ap­point­ed health of­fi­cials who have sought to over­haul the com­mit­tees.

Re­searchers at the Uni­ver­si­ty of South­ern Cal­i­for­nia found that the av­er­age an­nu­al preva­lence of con­flicts of in­ter­est re­port­ed by mem­bers of the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices de­clined from 42.8% in 2000 to 5.0% in 2024. For mem­bers of the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee, the av­er­age an­nu­al preva­lence dropped from 11.1% in 2000 to less than 4.0% since 2010.

The au­thors of the re­search let­ter that pub­lished Mon­day in JA­MA con­clud­ed that “re­port­ed COI preva­lence rates have de­clined for ACIP and VRB­PAC over the last 25 years and were at his­tor­i­cal­ly low lev­els through 2024.” They used pub­licly avail­able re­ports from ACIP mem­bers that were up­loaded ear­li­er this year and study waivers sub­mit­ted by VRB­PAC mem­bers.

Af­ter se­cur­ing an ac­cel­er­at­ed ap­proval, No­vo Nordisk’s We­govy is the sec­ond drug to re­ceive a green light in the US to treat fat­ty liv­er dis­ease, or MASH.

The block­buster drug will join Madri­gal Phar­ma­ceu­ti­cals’ Rezd­if­fra on the mar­ket for the con­di­tion, and the ques­tion is how big a slice of the mar­ket No­vo’s drug can take, giv­en Rezd­if­fra’s first-mover ad­van­tage.

No­vo’s shares climbed 6% on the Copen­hagen ex­change on Mon­day morn­ing. Madri­gal’s MDGL were down 4% pre­mar­ket on the Nas­daq.

We­govy and Rezd­if­fra are ap­proved on very sim­i­lar terms. Both may be used in pa­tients with MASH and mod­er­ate-to-ad­vanced liv­er scar­ring or fi­bro­sis, known to doc­tors as stages F2 to F3. Nei­ther is rec­om­mend­ed for pa­tients with F4 fi­bro­sis, which is the sever­est form of liv­er tis­sue scar­ring and is al­so known as cir­rho­sis.

Some of the stud­ies that un­der­pin the Trump ad­min­is­tra­tion’s de­ci­sion to veer away from mR­NA vac­cine re­search are be­ing mis­ap­plied, co-au­thors of the work say, mud­dling the move by HHS Sec­re­tary Robert F. Kennedy Jr. to back away from the tech­nol­o­gy.

End­points News reached out to au­thors rep­re­sent­ing more than 100 ci­ta­tions pro­vid­ed by the gov­ern­ment af­ter near­ly two dozen con­tracts re­lat­ed to mR­NA vac­cines were cut two weeks ago. At least a dozen au­thors said that HHS and Kennedy ei­ther mis­in­ter­pret­ed their find­ings out­right, or em­pha­sized that re­search in­to the plat­form should con­tin­ue. On­ly a cou­ple of re­searchers con­tact­ed by End­points ap­peared to sup­port the gov­ern­ment’s pull­back in fund­ing. Most did not re­spond when con­tact­ed about their re­search be­ing in­clud­ed and whether they felt it was be­ing ac­cu­rate­ly ap­plied.

The FDA grant­ed an un­ex­pect­ed full ap­proval to Pre­ci­gen's treat­ment for a rare dis­ease caused by hu­man pa­pil­lo­mavirus, or HPV.

Thurs­day's de­ci­sion al­so came ear­li­er than an­tic­i­pat­ed, at a time when the agency’s han­dling of rare dis­ease ther­a­pies is un­der scruti­ny.

Known as zopa­po­gene imade­n­ovec, the treat­ment is an im­munother­a­py that will be mar­ket­ed as Pa­pz­imeos. The ther­a­py was ap­proved to treat adults with re­cur­rent res­pi­ra­to­ry pa­pil­lo­mato­sis, which are wart-like growths on or around the vo­cal cords that re­turn even af­ter they are re­moved. The dis­ease is caused by in­fec­tion with chron­ic HPV 6 or 11, and is es­ti­mat­ed to af­fect around 27,000 adults in the US.

Pre­ci­gen said Mon­day on an an­a­lyst call that the ther­a­py would be $115,000 per vial, which equates to $460,000 for a course of treat­ment.

The FDA re­ject­ed PTC Ther­a­peu­tics’ Friedre­ich’s atax­ia drug va­tiquinone, the com­pa­ny an­nounced Tues­day morn­ing.

The agency said that “sub­stan­tial ev­i­dence of ef­fi­ca­cy” was not shown for the Friedre­ich’s atax­ia ther­a­py, ac­cord­ing to PTC’s press re­lease. An ad­di­tion­al “ad­e­quate and well-con­trolled” study would be need­ed for a re­sub­mis­sion to the FDA.

Va­tiquinone failed its piv­otal study in Friedre­ich’s atax­ia in 2023, but the com­pa­ny point­ed to mea­sures that sug­gest­ed the ther­a­py could im­prove bal­ance and fa­tigue in ask­ing the FDA for ap­proval.

In Friedre­ich’s atax­ia, pa­tients lack the pro­tein fratax­in, which is key for the mi­to­chon­dria to func­tion prop­er­ly. Va­tiquinone is a small mol­e­cule drug that's de­signed to ad­dress that mi­to­chon­dr­i­al dys­func­tion and ox­ida­tive stress by block­ing an en­zyme called 15-lipoxy­ge­nase.