NewAms­ter­dam Phar­ma’s lead car­dio pro­gram obice­trapib passed an­oth­er Phase 3 tri­al, demon­strat­ing its abil­i­ty to low­er “bad cho­les­terol” in com­bi­na­tion with a drug called eze­tim­ibe.

The TAN­DEM study en­rolled 407 pa­tients with ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease and/or het­erozy­gous fa­mil­ial hy­per­c­ho­les­terolemia, a ge­net­ic con­di­tion that re­sults in el­e­vat­ed cho­les­terol lev­els. The pri­ma­ry end­point of LDL-C re­duc­tion was mea­sured by least squares mean (LS mean), a fig­ure that ac­counts for im­put­ed da­ta from pa­tients who dropped out of the study.

By that mea­sure, pa­tients who took obice­trapib and eze­tim­ibe saw a 49% re­duc­tion in LDL-C over 84 days, while pa­tients who took on­ly obice­trapib saw a 32% re­duc­tion. Back in Ju­ly, a sep­a­rate study in a dif­fer­ent pop­u­la­tion showed that obice­trapib monother­a­py achieved a slight­ly high­er LS mean re­duc­tion in LDL-C. That study, called BROOK­LYN, on­ly en­rolled pa­tients with het­erozy­gous fa­mil­ial hy­per­c­ho­les­terolemia.

How to reg­u­late gen­er­a­tive AI was the cen­tral top­ic of the in­au­gur­al two-day meet­ing of the FDA’s new dig­i­tal health ad­vi­so­ry com­mit­tee that be­gan on Wednes­day.

FDA Com­mis­sion­er Rob Califf opened the meet­ing, ex­plain­ing how the agency since 1995 has re­ceived more than 1,000 sub­mis­sions for AI-en­abled med­ical de­vices, more than 300 sub­mis­sions for drugs and bi­o­log­ics with AI com­po­nents, and that al­most every drug ap­pli­ca­tion us­es AI some­where in the de­vel­op­ment process. But he al­so warned that with­out prop­er safe­guards, AI may not make the US health­i­er in the end.

"I'm hear­ing in­creas­ing con­cerns that cri­te­ria for adopt­ing AI are al­most pure­ly fi­nan­cial," Califf said, warn­ing that rur­al Amer­i­ca might be left out. "Clin­i­cal out­come mea­sure­ment is hard. Un­less you take this is­sue very se­ri­ous­ly and form al­liances of those con­cerned about im­prov­ing health out­comes, this tech­nol­o­gy will im­prove prof­its at the cost of de­te­ri­o­ra­tion in our over­all health sta­tus."

Ven­rock has added half a bil­lion dol­lars to its health­care in­vest­ing strat­e­gy, the firm con­firmed to End­points News on Wednes­day.

It comes on top of its $650 mil­lion 10th fund — which goes to­ward both tech and health­care — that the firm re­vealed dur­ing the 2024 JPM Health­care Con­fer­ence in Jan­u­ary.

A reg­u­la­to­ry doc­u­ment out­lin­ing a $500 mil­lion fund was filed on Wednes­day.

"We can con­firm this $500M fund is sep­a­rate from the $650M fund an­nounced in Jan­u­ary," a Ven­rock spokesper­son said in an email to End­points. "This is a new pool of cap­i­tal, though not a new strat­e­gy; it will in­vest in cer­tain in­vest­ment op­por­tu­ni­ties along­side ex­ist­ing Ven­rock Health­care Cap­i­tal Part­ner funds."

The FDA on Wednes­day up­dat­ed the la­bel for San­doz's decades-old leukemia drug flu­dara­bine phos­phate, as part of a wider ini­tia­tive to re­vamp the la­bels for can­cer drugs ap­proved long ago.

Flu­dara­bine phos­phate, which first won ap­proval in 1991, is now au­tho­rized for use as part of a com­bi­na­tion reg­i­men for adults with B cell chron­ic lym­pho­cyt­ic leukemia (CLL) and for adults with B cell CLL whose dis­ease got worse af­ter treat­ment with one alky­lat­ing-agent con­tain­ing reg­i­men, or who did­n't re­spond to that treat­ment.

The FDA al­so up­dat­ed the dosage reg­i­men for the in­jec­tion and re­moved the boxed warn­ing, in­cor­po­rat­ing that in­for­ma­tion in­to the "Warn­ings and Pre­cau­tions" part of the la­bel.

Two oth­er on­col­o­gy drugs have been eval­u­at­ed through the On­col­o­gy Cen­ter of Ex­cel­lence's Project Re­new­al, in­clud­ing the brain can­cer chemo temo­zolo­mide and capecitabine, which can treat breast and col­orec­tal can­cer.