The FDA ap­proved a high-dose ver­sion of No­vo Nordisk's block­buster weight loss in­jec­tion We­govy, giv­ing its go-ahead about two months faster than nor­mal thanks to a vouch­er re­ceived from the com­mis­sion­er's pro­gram.

Thurs­day's ap­proval is based on da­ta re­leased in Jan­u­ary, when No­vo re­port­ed that pa­tients giv­en the 7.2 mg dose had an av­er­age weight loss of 20.7% af­ter 72 weeks. That was bet­ter than the 17.5% weight loss for peo­ple giv­en the al­ready-ap­proved 2.4 mg dose in the tri­al.

While the high-dose We­govy is stronger than the pre­vi­ous­ly ap­proved ver­sion, it is slight­ly be­hind its com­peti­tor, Eli Lil­ly's Zep­bound. In its piv­otal tri­al, the 15 mg dose of Lil­ly’s GIP/GLP-1 ag­o­nist, ap­proved in No­vem­ber 2023, achieved 22.5% weight loss at 72 weeks.

GSK’s re­cent deal to li­cense out a rare liv­er dis­ease drug just got sweet­er.

The FDA on Thurs­day ap­proved liner­ix­i­bat to treat cholesta­t­ic itch in pa­tients with the au­toim­mune liv­er dis­ease pri­ma­ry bil­iary cholan­gi­tis, or PBC. The ap­proval makes GSK el­i­gi­ble for a $100 mil­lion pay­ment un­der a deal an­nounced ear­li­er this month that would give rights to Ital­ian phar­ma Al­fasig­ma. The deal has yet to close.

GSK will al­so get $300 mil­lion up­front, and there’s still $20 mil­lion on the ta­ble if liner­ix­i­bat gets ap­proved in the UK and Eu­rope, plus an­oth­er $270 mil­lion in mile­stones and cer­tain roy­al­ties on glob­al sales.

The ap­proval will like­ly fill a gap in Al­fasig­ma’s com­mer­cial port­fo­lio, af­ter its sub­sidiary In­ter­cept Phar­ma­ceu­ti­cals pulled PBC drug Ocali­va from the mar­ket last year. Liner­ix­i­bat will be mar­ket­ed as Ly­navoy. GSK did not im­me­di­ate­ly re­spond to a re­quest for com­ment on pric­ing.

Ver­i­ly has raised $300 mil­lion in new, out­side fund­ing that ends par­ent com­pa­ny Al­pha­bet's con­trol­ling po­si­tion in the health­care in­no­va­tion com­pa­ny, End­points News has learned ex­clu­sive­ly.

The fund­ing round was led by Se­ries X Cap­i­tal, a ven­ture fund formed with Google’s X moon­shot lab, along with par­tic­i­pa­tion from Al­pha­bet, UCHealth, the Uni­ver­si­ty of Col­orado An­schutz and oth­er in­vestors, Ver­i­ly said Thurs­day. Al­pha­bet re­mains a sig­nif­i­cant mi­nor­i­ty in­vestor.

Ver­i­ly has been mak­ing moves to step out of Al­pha­bet’s shad­ow, with plans to even­tu­al­ly go pub­lic. It’s been di­vest­ing busi­ness units, in­clud­ing its in­sur­ance busi­ness Gran­u­lar, and sharp­en­ing its fo­cus. Most re­cent­ly, it’s ze­roed in on an AI health­care plat­form, Pre, that pow­ers all Ver­i­ly so­lu­tions.

CSL Behring dis­closed a "tem­po­rary glob­al stock­out" of its gene ther­a­py for he­mo­phil­ia B that it says could de­lay treat­ment for some pa­tients.

In a let­ter to the pa­tient com­mu­ni­ty pub­lished this week, Deb­o­rah Long, CSL se­nior vice pres­i­dent of med­ical af­fairs, said the short­age of Hem­genix “re­flects the com­plex­i­ty of man­u­fac­tur­ing gene ther­a­pies.” She wrote that there was no is­sue with safe­ty or ef­fec­tive­ness and that the com­pa­ny was work­ing with reg­u­la­to­ry bod­ies to en­sure sta­ble sup­ply of the ther­a­py mov­ing for­ward.

A com­pa­ny spokesper­son said in an emailed state­ment that “the glob­al stock­out is due to a pre­lim­i­nary test re­sult that is cur­rent­ly un­der in­ves­ti­ga­tion.”