Reynald Castaneda

In a slew of com­pa­ny up­dates, i2o Ther­a­peu­tics has closed a Se­ries A raise worth $46 mil­lion from biotech in­vestors and named Kurt Graves as its new chair­man, pres­i­dent and CEO. The biotech al­so ac­quired the car­diometa­bol­ic clin­i­cal pipeline of Intar­cia Ther­a­peu­tics, which has six can­di­dates, in­clud­ing IT­CA 650 — a type 2 di­a­betes drug/de­vice com­bo which has been re­ject­ed by the FDA twice. The oth­er five as­sets are all in the pre­clin­i­cal stage un­der con­si…

GSK is shak­ing up the way it does re­search and cre­at­ed three unique teams ze­ro­ing in on vac­cines and in­fec­tious dis­eases, res­pi­ra­to­ry and im­munol­o­gy, and on­col­o­gy. The changes went live Mon­day. Kaivan Kha­van­di is re­join­ing GSK from Benev­o­len­tAI to lead the res­pi­ra­to­ry and im­munol­o­gy re­search team. Phil Dor­mitzer, GSK’s se­nior vice pres­i­dent and glob­al head of vac­cines R&D, will broad­en his re­mit by al­so cov­er­ing in­fec­tious dis­eases. And GSK’s se…

Al­though Sanofi CEO Paul Hud­son was at the Fi­nan­cial Times’ Glob­al Phar­ma and Biotech Sum­mit to talk about AI, there was no avoid­ing the ques­tions about its re­cent move to spin out its con­sumer unit as well as the in­ves­ti­ga­tion in France over al­leged mis­lead­ing fi­nan­cial com­mu­ni­ca­tions. Hud­son re­it­er­at­ed that the con­sumer unit spin­out was all about Sanofi in­vest­ing in the sci­ence. But this was at the cost of aban­don­ing its earn­ings guid­ance for 2025.

CD­MO and biotech Forge Bi­o­log­ics will be ac­quired by Aji­nomo­to in an all-cash deal worth $620 mil­lion, a move that will see the Japan-based multi­na­tion­al con­glom­er­ate en­ter the gene ther­a­py man­u­fac­tur­ing space. “Clear­ly, Aji­nomo­to is see­ing this as a bet on the fu­ture of gene ther­a­py, and that this will be­come a more im­por­tant part of CD­MO of­fer­ings in­to the fu­ture,” Forge board chair Chris Garabe­di­an told End­points News in an in­ter­view.

Com­pu­gen is set to re­ceive an up­front pay­ment of $60 mil­lion from Gilead to kick­start an ex­clu­sive li­cens­ing deal for the biotech’s an­ti-in­ter­leukin-18 pro­tein bind­ing an­ti­body pro­gram for sol­id tu­mors, in­clud­ing the pre­clin­i­cal can­di­date COM503. Ac­cord­ing to the com­pa­nies, the li­cens­ing deal is worth $848 mil­lion, with Com­pu­gen set to re­ceive an ad­di­tion­al $30 mil­lion next year if COM503 se­cures an IND and a fur­ther $758 mil­lion in to­tal that cov­er…

The year of an­ti­body-drug con­ju­gates isn’t done yet, as GSK is adding an­oth­er li­cens­ing part­ner­ship with Han­soh Phar­ma for an­oth­er ADC with an up­front pay­ment of $185 mil­lion. There is al­so up to $1.525 bil­lion in mile­stone pay­ments in store for Han­soh, ac­cord­ing to a Hong Kong Stock Ex­change fil­ing. In Oc­to­ber, the com­pa­nies an­nounced that GSK will li­cense an ADC from Han­soh, named HS-20089, with an $85 mil­lion up­front and a fur­ther $1.48 bil­lion in mile­sto…

Na­tion­al Re­silience has laid off staff from its tech­ni­cal R&D and qual­i­ty as­sur­ance glob­al di­vi­sions in re­cent months, End­points News has learned. The man­u­fac­tur­er con­firmed that some roles had been re­duced, but it did not di­rect­ly ad­dress End­points spe­cif­ic ques­tions about the lay­offs. “We con­tin­u­ous­ly as­sess our op­er­a­tions to align with mar­ket re­al­i­ties and our cus­tomers’ needs. This in­cludes bal­anc­ing our re­sources across our net­work by re­duc­ing…

Na­tion­al Re­silience was hand­ed a Form 483 in No­vem­ber not­ing that the man­u­fac­tur­er did not prop­er­ly re­view or ad­dress mold-con­t­a­m­i­nat­ed prod­uct batch­es, and it may un­der­go more lay­offs this year, a source fa­mil­iar with the mat­ter told End­points News. The Nov. 10 form states that Re­silience’s in­ves­ti­ga­tions of the con­t­a­m­i­nat­ed batch­es, which start­ed in 2021, “failed to eval­u­ate all as­pects.” De­spite claim­ing that cer­tain ac­tive in­gre­di­ent batch…

Novo Nordisk is running into a speed bump with Wegovy's label expansion efforts in heart disease as it has pulled its FDA submission in heart failure with obesity and will ...

Sanofi CFO François Roger signals increased M&A activity, eyes China for innovation, as company expects cash from Opella sale and plans €5B share buyback.