FDA chief Mar­ty Makary and new CBER Di­rec­tor Vinay Prasad said that fu­ture Covid-19 vac­cine ap­provals will fo­cus on adults over 65 and high-risk peo­ple 6 months to 64 years old, align­ing US pol­i­cy with what they say is the sta­tus quo in oth­er sim­i­lar na­tions.

The new frame­work, spelled out in an ed­i­to­r­i­al pub­lished in the New Eng­land Jour­nal of Med­i­cine on Tues­day, is the clear­est guid­ance yet from top health of­fi­cials on how they plan to reg­u­late fu­ture Covid-19 shots. The pol­i­cy mir­rors the ap­proval pa­ra­me­ters just grant­ed to No­vavax over the week­end.

“The U.S. pol­i­cy has some­times been jus­ti­fied by ar­gu­ing that the Amer­i­can peo­ple are not so­phis­ti­cat­ed enough to un­der­stand age- and risk-based rec­om­men­da­tions,” Makary and Prasad wrote. “We re­ject this view.”

The De­part­ment of Health and Hu­man Ser­vices pro­vid­ed the first de­tails for how it plans to tie US drug prices to rates paid in sim­i­lar­ly de­vel­oped coun­tries as part of Pres­i­dent Don­ald Trump’s most fa­vored na­tions ex­ec­u­tive or­der.

Un­der the pro­gram that was first an­nounced by Trump last week, the US would tar­get prices based on bench­marks from oth­er wealthy na­tions that have a per capi­ta GDP of at least 60% of the US, ac­cord­ing to a press re­lease Tues­day.

The Trump ad­min­is­tra­tion has said that it wants drug de­vel­op­ers to of­fer those low­er prices to con­sumers to buy di­rect­ly. If they don't com­ply, the ad­min­is­tra­tion would pur­sue reg­u­la­tion to force the low­er prices. HHS said it ex­pects drug man­u­fac­tur­ers to com­ply with this di­rec­tive for all brand­ed prod­ucts that don’t have gener­ics or biosim­i­lars avail­able.

Tour­ma­line Bio's ex­per­i­men­tal drug for ath­er­o­scle­rot­ic heart dis­ease re­duced mark­ers of in­flam­ma­tion in the blood in a mid-stage study.

The com­pa­ny must now show the drug cuts key events such as heart at­tack, stroke and death in a large Phase 3 study. It said Tues­day it plans to dis­cuss such a tri­al with the FDA by the end of the year.

The Phase 2 analy­sis in­clud­ed 126 par­tic­i­pants with el­e­vat­ed lev­els of an in­flam­ma­tion mark­er called high-sen­si­tiv­i­ty C-re­ac­tive pro­tein, or hs-CRP, and stage 3 or 4 chron­ic kid­ney dis­ease. Both are risk fac­tors for ath­er­o­scle­ro­sis, a heart dis­ease char­ac­ter­ized by buildup of plaque in the ar­ter­ies. The par­tic­i­pants were di­vid­ed in­to four arms: 25 mg quar­ter­ly, 50 mg quar­ter­ly, 15 mg month­ly and place­bo.

Plus, news about Beck­ley Psytech, Re­genxbio, Blue­print Med­i­cines, Van­tAI, Nov­elMed and Bay­er:

💰 SV Health clos­es sec­ond de­men­tia fund: The Lon­don-based biotech in­vest­ment firm closed its sec­ond De­men­tia Dis­cov­ery Fund with $269 mil­lion in com­mit­ments. The fund, called DDF-2, had a