An­oth­er GLP-1 drug is up for Medicare ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act.

Eli Lil­ly’s GLP-1 di­a­betes drug Trulic­i­ty is among 15 drugs se­lected for the third round of ne­go­ti­a­tions. Gilead’s HIV drug Bik­tarvy was al­so se­lect­ed. The two drugs were used by 617,000 and 101,000 Medicare en­rollees, re­spec­tive­ly, from No­vem­ber 2024 through Oc­to­ber 2025, CMS said.

For the first time, CMS has al­so se­lect­ed one ad­di­tion­al drug for rene­go­ti­a­tion: Boehringer In­gel­heim’s di­a­betes drug Trad­jen­ta. The ne­go­ti­a­tions will oc­cur this year and take ef­fect in 2028.

Drugs payable un­der Medicare Part B were in­clud­ed for the first time this year. Part B helps cov­er treat­ments that are typ­i­cal­ly ad­min­is­tered by a physi­cian. Ab­b­Vie’s Botox, Genen­tech and No­var­tis' asth­ma treat­ment Xo­lair, and Take­da’s ul­cer­a­tive col­i­tis and Crohn’s dis­ease treat­ment En­tyvio are some of the drugs on this year’s list that may be payable un­der Part B.

With launch time po­ten­tial­ly ap­proach­ing for TrumpRx, HHS un­veiled part of its plan to shield drug­mak­ers from an­ti-kick­back laws to al­low them to sell their prod­ucts on the new di­rect-to-con­sumer plat­form.

The guid­ance — re­leased via a "spe­cial ad­vi­so­ry" bul­letin from the agen­cy's Of­fice of In­spec­tor Gen­er­al — seeks to give drug­mak­ers con­fi­dence that they won't vi­o­late fed­er­al an­ti-kick­back laws by of­fer­ing cheap­er prices on the TrumpRx site for cash-pay­ing pa­tients who are cur­rent­ly en­rolled in fed­er­al health­care pro­grams.

The no­tice "pro­vides phar­ma­ceu­ti­cal man­u­fac­tur­ers with as­sur­ance that they may sell pre­scrip­tion drugs di­rect­ly to pa­tients who choose to pay cash — in­clud­ing pa­tients en­rolled in fed­er­al health care pro­grams — when the arrange­ment meets spe­cif­ic con­di­tions," HHS said in a state­ment. "These in­clude en­sur­ing the drug is not billed to Medicare, Med­ic­aid, or oth­er fed­er­al pro­grams, is not used to mar­ket oth­er fed­er­al­ly re­im­bursable prod­ucts, and is not tied to fu­ture pur­chas­es or re­fer­rals."

One of the biggest the­o­ries about the cause of ag­ing, and how to slow and po­ten­tial­ly even re­verse it, is about to be put to the test.

Life Bio­sciences, a biotech start­up co-found­ed by Har­vard bi­ol­o­gist David Sin­clair, got the FDA's per­mis­sion to be­gin a clin­i­cal study of its gene ther­a­py de­signed to rewind the clock on dy­ing cells, the start­up told End­points News in an ex­clu­sive in­ter­view.

The star­tup's ther­a­py has been a long time com­ing. In the late 1990s, Sin­clair pro­posed that ag­ing is pri­mar­i­ly due to the loss of epi­ge­net­ic in­for­ma­tion — the chem­i­cal marks that con­trol how DNA is turned on and off — which he dubbed the in­for­ma­tion the­o­ry of ag­ing. Life Bio’s ther­a­py de­liv­ers a trio of pro­teins that Sin­clair’s lab dis­cov­ered can re­set the epigenome to a more youth­ful state.

The FDA has placed stud­ies of two gene ther­a­pies from Re­genxbio on hold af­ter a five-year-old pa­tient in one of the tri­als was found to have a brain tu­mor.

The drug reg­u­la­tor's de­ci­sion is a big blow to the Rockville, MD-based com­pa­ny, which was await­ing an FDA de­ci­sion on one of the gene ther­a­pies.

The child had re­ceived an ex­per­i­men­tal gene ther­a­py de­vel­oped by the biotech for mu­copolysac­cha­ri­do­sis (MPS) type I, a rare ge­net­ic con­di­tion that is al­so known as Hurler syn­drome. The gene ther­a­py, known as RGX-111, is ad­min­is­tered di­rect­ly to the brain.

The FDA paused the study of that gene ther­a­py, as well as a sec­ond gene ther­a­py for MPS type II, or Hunter syn­drome, Re­genxbio an­nounced Wednes­day. The FDA has a dead­line of Feb. 8 to de­cide whether to ap­prove the Hunter syn­drome pro­gram.

The FDA has al­lowed In­tel­lia Ther­a­peu­tics to re­sume one of its two piv­otal tri­als of a gene edit­ing ther­a­py for transthyretin amy­loi­do­sis, which is a dis­ease caused by mis­fold­ed pro­teins.

In­tel­lia re­port­ed Tues­day that the FDA lift­ed a clin­i­cal hold on MAG­NI­TUDE-2, which ex­am­ines the gene edit­ing ther­a­py known as nex-z in a man­i­fes­ta­tion of the dis­ease that dam­ages the nerves — transthyretin amy­loi­do­sis (AT­TR) with polyneu­ropa­thy. The clin­i­cal hold was put in place in Oc­to­ber af­ter a pa­tient who re­ceived the ex­per­i­men­tal treat­ment was hos­pi­tal­ized for liv­er in­jury and sub­se­quent­ly died.

The gene edit­ing com­pa­ny’s oth­er Phase 3 tri­al, which is for the heart man­i­fes­ta­tion of the dis­ease known as AT­TR with car­diomy­opa­thy, is still sus­pend­ed. The pa­tient who died was part of that tri­al, known as MAG­NI­TUDE.

The Eu­ro­pean Union un­veiled de­tails of a pi­lot project that aims to ac­cel­er­ate the time­line for start­ing new multi­na­tion­al clin­i­cal tri­als.

The vol­un­tary pi­lot, called FAST‑EU, will fea­ture a max­i­mum 10‑week (70‑day) time­line from drug­mak­er sub­mis­sion to fi­nal de­ci­sion — about a month short­er than the cur­rent EU time­line when there's di­a­logue with the spon­sor.

The Biotech Act cre­at­ed the pi­lot and will ul­ti­mate­ly short­en multi­na­tion­al tri­al re­view time­lines from 75 to 47 days if there is no re­quest for fur­ther in­for­ma­tion, and from 106 days to 76 days when there is a re­quest, ac­cord­ing to the Eu­ro­pean Com­mis­sion.

The pi­lot aims to help Eu­rope in­crease its glob­al share of com­mer­cial­ly-spon­sored clin­i­cal tri­als, which has de­clined from 22% in 2013 to 12% in 2023, ac­cord­ing to the com­mis­sion.