Endpoints News
HHS drops legal fight over blocked 340B rebate pilot Read in browser
Endpoints News
Thank you for reading, dupa dupackia!
basic
UPGRADE
M T W Th Fri
6 February, 2026
Can the Comeback Continue? 2026 Biotech Outlook
Biotech is making money again. After a volatile year – for the markets broadly and biotech specifically – the sector had an extraordinary comeback
sponsored by Mizuho
spotlight
top stories
1. TrumpRx launches with few drugs, many with generic competitors available
2. HHS drops legal fight over blocked 340B rebate pilot, says it may consider new version
3. Orphan drug tweak in US spending bill will make life easier for the FDA
4.
peer review
Geoff McDonough's big plans for NodThera's NLRP3; Enhertu leader steps down at Daiichi
5. Roivant spinout heads to Phase 3 with ‘landmark’ data in immune skin disease
6. Illumina bets on healthcare customers after NIH funding disruptions
7. Biogen CEO expects Alzheimer's drug Leqembi to sustain growth
8. Agomab, SpyGlass cap biggest week for biotech IPOs since 2021
more stories
 
Alexis Kramer
.

ICYMI, our Post-Hoc Live today was all about the showdown between Novo Nordisk and Hims & Hers. There are so many questions up in the air, like why now, and what’s Novo (or the FDA) going to do next. You can watch the recording on YouTube here.

.
Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

When Pres­i­dent Don­ald Trump un­veiled his an­tic­i­pat­ed di­rect-to-con­sumer drug plat­form on Thurs­day, he said he'd done what oth­er politi­cians had promised but nev­er de­liv­ered. "They all failed,” he said. “It was all words as usu­al."

But the pres­i­den­t's new site, TrumpRx, does­n't yet ap­pear to match his promis­es.

On­ly 43 drugs are avail­able on TrumpRx, from about a third of the drug­mak­ers that have agreed to par­tic­i­pate in the pro­gram. In some cas­es, gener­ic ver­sions are avail­able else­where, which are of­ten cheap­er.

“It's most­ly smoke and mir­rors, de­signed to cre­ate the ap­pear­ance of ac­tion when it'll ac­tu­al­ly help few peo­ple,” Ian Spatz, a for­mer pub­lic pol­i­cy ex­ec­u­tive at Mer­ck who's now a prin­ci­pal at Rock Creek Pol­i­cy Group, told End­points News.

Click here to continue reading
2
by Nicole DeFeudis

The Trump ad­min­is­tra­tion is tak­ing a step back from its planned 340B re­bate pi­lot that a court blocked last month.

HHS asked a Maine fed­er­al court to set aside ac­tions re­lat­ed to the orig­i­nal pi­lot pro­gram and send it back to the agency for re­view. The Thurs­day re­quest marks the end of a hos­pi­tal group's le­gal chal­lenge and sug­gests that the agency will con­sid­er cre­at­ing a new ver­sion of the pi­lot.

The aim of the orig­i­nal pi­lot was to shift the 340B drug pric­ing pro­gram from up­front dis­counts to a re­bate mod­el. In a joint mo­tion filed Thurs­day, at­tor­neys for HHS and the Amer­i­can Hos­pi­tal As­so­ci­a­tion wrote that if the agency de­cides to be­gin a new re­bate pro­gram, it will is­sue a new no­tice, so­lic­it new ap­pli­ca­tions, and so­lic­it com­ments “ei­ther pri­or to or con­cur­rent­ly with a new no­tice, or both."

Click here to continue reading
Cell & Gene Day 2026
CGT has fresh momentum from new FDA frameworks and pharma deals, but do the latest advances in science, manufacturing, and regulation actually solve the core challenges? We’re asking the hard questions — join us.
3
by Zachary Brennan

The FDA can con­tin­ue to grant sev­en years of ex­clu­siv­i­ty for or­phan drugs with new in­di­ca­tions, as Pres­i­dent Don­ald Trump this week signed a gov­ern­ment fund­ing ex­ten­sion that in­clud­ed a pro­vi­sion that cod­i­fies that process and runs counter to a 2021 ap­peals court de­ci­sion against the agency.

The al­ter­ation on or­phan ex­clu­siv­i­ty in the spend­ing pack­age, which the FDA had been lob­by­ing Con­gress to fix since at least 2022, means the agency can still ap­prove drugs for nar­row­er us­es or in­di­ca­tions even if a com­peti­tor has an ap­proved drug for the same dis­ease.

While the agency an­nounced that it would­n't change its or­phan des­ig­na­tion process in Jan­u­ary 2023, the move ran counter to what the US Court of Ap­peals for the Eleventh Cir­cuit told the FDA in 2021. The de­ci­sion said the agency shouldn’t have ap­proved two drugs for the same dis­ease when one had ex­clu­siv­i­ty, even if the two were geared to­ward dif­fer­ent pa­tient pop­u­la­tions.

Click here to continue reading
Peer Review: Weekly biopharma job report
4
by Alex Hoffman, Kyle LaHucik, Kathy Wong

Ge­off Mc­Do­nough is tip­ping his hat to one of the hottest tar­gets in drug de­vel­op­ment right now.

The for­mer Gen­er­a­tion Bio CEO has joined NodThera to get its NL­RP3 pro­gram in­to Phase 3 next year as a bevy of drug de­vel­op­ers shut­tle their prospects through the clin­ic. That in­cludes Lil­ly-ac­quired Ven­tyx Bio­sciences, BioAge Labs, re­cent pub­lic en­trant In­sil­i­co Med­i­cine, Neumo­ra and count­less oth­ers.

“I got re­al­ly in­trigued by the pow­er of the mech­a­nism, and it’s an or­thog­o­nal mech­a­nism to the oth­er things that we know are im­por­tant in those dis­eases: in­sulin con­trol, SGLT2s, GLP-1s, lipid-low­er­ing agents,” Mc­Do­nough said in an in­ter­view with End­points News on his fourth day on the job. He joined NodThera’s board in De­cem­ber and, as of Feb. 2, he’s al­so CEO. He suc­ceed­ed Daniel Swish­er, who left in Oc­to­ber af­ter an 18-month stint at the UK and US biotech.

Click here to continue reading