FDA Com­mis­sion­er Mar­ty Makary’s un­suc­cess­ful at­tempt to in­ter­vene in an on­go­ing drug re­view, as de­scribed by mul­ti­ple agency sources, rais­es fur­ther con­cerns about the reg­u­la­tor un­der its new lead­er­ship.

Ac­cord­ing to three agency sources, Makary asked FDA re­view­ers on June 18 to pre­pare and is­sue a com­plete re­sponse let­ter, or a CRL, that day for KalVista Phar­ma­ceu­ti­cals’ un­der-re­view rare dis­ease drug. FDA sci­en­tists pushed back, rais­ing le­gal con­cerns, and Makary aban­doned the re­quest with­in a few hours, with the re­view car­ry­ing on as be­fore.

Three aca­d­e­m­ic and le­gal ex­perts told End­points News the in­ci­dent is un­usu­al and rais­es fur­ther con­cerns about the agency, shar­ing some sim­i­lar­i­ties with a pre­vi­ous re­port that Makary and his of­fice in­ter­vened this spring in the re­view of No­vavax’s Covid-19 vac­cine.

In­novent said on Fri­day that its obe­si­ty med­i­cine maz­du­tide has been ap­proved in Chi­na, be­com­ing the first dual GLP-1/glucagon ag­o­nist to be green­lit for the dis­ease any­where in the world.

The drug will be­come the third of the new gen­er­a­tion of in­cretin-based drugs to reach the mar­ket in Chi­na, af­ter No­vo Nordisk’s We­govy and Eli Lil­ly’s Zep­bound.

The ap­proval was part­ly based on da­ta from the Chi­na-based GLO­RY-1 tri­al. In that Phase 3 study, 3 mg and 6 mg dos­es of maz­du­tide caused an av­er­age weight loss of 12% and 14.8% af­ter rough­ly 11 months of treat­ment. The weight loss with place­bo was 0.5%.

Around half the par­tic­i­pants treat­ed with the high­er dose lost at least 15% of their weight.

Plus, news about XO­MA Roy­al­ty, Turn­stone Bi­o­log­ics, CorMedix, the No­vo Nordisk Foun­da­tion, Achieve Life Sci­ences and Cidara Ther­a­peu­tics:

BioCryst sells Or­ladeyo busi­ness in Eu­rope: The com­pa­ny will get $250 mil­lion up­front and up to $14 mil­lion in mile­stones from Ital­ian drug­mak­er Neopharmed Gen­tili. It plans to use the pro­ceeds to re­tire debt from Phar­makon. Or­ladeyo, which brought in $437.6 mil­lion in glob­al sales last year, is used to pre­vent hered­i­tary an­gioede­ma at­tacks. — Jaimy Lee

UCB’s Phase 3 win for rare neu­rode­vel­op­ment dis­or­der drug: The biotech said Fin­tepla met the pri­ma­ry and sec­ondary end­points in a study of 87 chil­dren and adults with CD­KL5 de­fi­cien­cy dis­or­der. The pri­ma­ry end­point looked at change in mo­tor seizures. UCB plans to sub­mit the da­ta to reg­u­la­tors. Fin­tepla is al­ready ap­proved in the US for Dravet syn­drome and Lennox-Gas­taut syn­drome. — Ay­isha Shar­ma

For Blue­print Med­i­cines, a mon­u­men­tal meal in the City of Bridges helped bring back to life Sanofi's in­ter­est in ac­quir­ing the com­mer­cial-stage drug­mak­er.

Blue­print had al­most lost out on a $9.5 bil­lion ex­it op­por­tu­ni­ty to Sanofi, but an April din­ner in Paris be­tween the two com­pa­ny CEOs led to a re­vival of dis­cus­sions. The deal-sav­ing meal would even­tu­al­ly lead to the sec­ond-biggest phar­ma ac­qui­si­tion an­nounced so far in 2025.

Dur­ing a din­ner on April 16, Sanofi CEO Paul Hud­son com­mu­ni­cat­ed to Blue­print CEO Kate Hav­i­land that the French phar­ma gi­ant was con­tin­u­ing to dis­cuss in­ter­nal­ly whether to pur­sue a deal with Blue­print, ac­cord­ing to re­cent reg­u­la­to­ry fil­ings.