Top FDA of­fi­cials said that a sin­gle piv­otal tri­al re­quire­ment will be the “new de­fault stan­dard” for drug ap­provals, a move that goes be­yond the agency’s pri­or dis­cre­tion around not re­quir­ing two tri­als.

In a "Sound­ing Board" pub­lished Wednes­day evening in the New Eng­land Jour­nal of Med­i­cine, FDA Com­mis­sion­er Mar­ty Makary and vac­cines chief Vinay Prasad ex­plain that two tri­als can re­duce false-pos­i­tive con­clu­sions. But, they write, "as drug dis­cov­ery be­comes in­creas­ing­ly pre­cise and sci­en­tif­ic," an "over­re­liance on two tri­als no longer makes sense."

The NE­JM piece con­tin­ues Makary's push to make the drug de­vel­op­ment process more seam­less and eas­i­er for in­dus­try. But the shift to one tri­al runs in di­rect con­trast to Prasad's aca­d­e­m­ic ca­reer where he has ar­gued that new on­col­o­gy drugs should be re­quired to demon­strate im­proved over­all sur­vival or qual­i­ty of life rather than just an ef­fect on a sur­ro­gate end­point, which is nec­es­sary for an ac­cel­er­at­ed ap­proval.

Pfiz­er’s pur­chase of obe­si­ty biotech Met­sera last year threw the spot­light on long-act­ing weight loss drugs. And the launch of No­vo Nordisk’s We­govy pill in Jan­u­ary did the same for oral drugs. So a long-act­ing pill ought to be just the tick­et — pro­vid­ed there are da­ta that show it works.

This is where the UK biotech Ver­di­va Bio finds it­self. The com­pa­ny emerged in Jan­u­ary 2025 with $411 mil­lion and a plan to de­vel­op a week­ly oral form of a GLP-1 ag­o­nist it had li­censed from a Chi­na-based com­pa­ny, Sci­wind Bio­sciences.

That as­set, called ec­nog­lu­tide or VRB-101, en­tered Phase 2 late last year. A week­ly pill ap­pears to be a unique ap­proach, CEO Khurem Fa­rooq told End­points News, and in­ter­im da­ta from the tri­al could come in the next few months.

Plus, news about Com­pass Path­ways, Star­get Phar­ma and Ten63 Ther­a­peu­tics:

🛑 Bio­gen halts com­bo por­tion of MS tri­al: The biotech is not mov­ing for­ward with the sec­ond part of the Phase 2 tri­al that was test­ing a BTK in­hibitor, named BI­IB091, in com­bi­na­tion with its oral mul­ti­ple scle­ro­sis med­i­cine known as Vumer­i­ty, a spokesper­son con­firmed to End­points News. It still ex­pects monother­a­py da­ta from the first part of the tri­al in the sec­ond quar­ter. Mul­ti­ple scle­ro­sis has long been a ma­jor part of Bio­gen's com­mer­cial port­fo­lio: MS prod­uct rev­enues were $4.03 bil­lion in 2025, about a 7% de­cline over the pri­or year, ac­cord­ing to a full-year earn­ings re­port ear­li­er this month. That ac­count­ed for 40% of to­tal 2025 rev­enues. — Kyle LaHu­cik