The FDA wants to in­cen­tivize US-based drug de­vel­op­ment by adding new fees for com­pa­nies that run their Phase 1 tri­als out­side the coun­try, ac­cord­ing to meet­ing min­utes shared by the agency on Tues­day.

The pro­pos­al, which is still in de­vel­op­ment, would raise the FDA's drug ap­pli­ca­tion user fees for com­pa­nies that con­duct their Phase 1 work abroad. While the US hosts more tri­als than any­where else in the world, ac­cord­ing to WHO da­ta, its share has fall­en off in fa­vor of coun­tries where costs are cheap­er, pa­tients are eas­i­er to find, and reg­u­la­tions can be more lax. Chi­na has par­tic­u­lar­ly de­vel­oped in­to a hotbed for ear­ly-stage clin­i­cal work.

De­tails from an in­ves­ti­ga­tion by CBER Di­rec­tor Vinay Prasad in­to 10 al­leged child deaths re­lat­ed to Covid-19 vac­cines won't be com­ing soon, an FDA spokesper­son told End­points News on Wednes­day.

FDA spokesper­son Caleb Michaud said the agency was not re­leas­ing any more de­tails in the "near term," since "there are ad­di­tion­al ad­verse event cas­es be­ing in­ves­ti­gat­ed." Michaud did not say what those ad­verse events were, or if they were deaths.

Late last week, Prasad sent an in­ter­nal email to CBER staff claim­ing that 10 vac­cine-re­lat­ed deaths were un­cov­ered by “an ini­tial analy­sis of 96 deaths be­tween 2021 and 2024.” The email was re­port­ed by End­points News and oth­er me­dia out­lets, but the agency has not made any of­fi­cial pub­lic state­ments, un­like in past in­stances when it has in­ves­ti­gat­ed sig­nif­i­cant safe­ty risks where it felt a need to in­form the pub­lic and med­ical pro­fes­sion­als.

Capri­cor Ther­a­peu­tics said that its cell ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy met both a pri­ma­ry and key sec­ondary end­point in a Phase 3 tri­al, boost­ing the com­pa­ny’s odds for ap­proval as it re­turns to the FDA fol­low­ing the re­jec­tion of its ther­a­py in Ju­ly.

Capri­cor is one of sev­er­al rare dis­ease drug de­vel­op­ers that have been en­tan­gled in FDA dra­ma. Ear­li­er this year, the agency sched­uled and then can­celed an ad­vi­so­ry com­mit­tee meet­ing for the treat­ment, called de­ramio­cel. It then turned down the ap­pli­ca­tion, say­ing de­ramio­cel did­n't show “sub­stan­tial ev­i­dence of ef­fec­tive­ness.”

At the time, the com­pa­ny said the re­jec­tion “came as a sur­prise,” since the FDA had en­cour­aged it to sub­mit an ap­pli­ca­tion based on its Phase 2 and ex­ten­sion stud­ies.

Tri­ana Bio­med­i­cines has reeled in a $120 mil­lion Se­ries B — $10 mil­lion high­er than its 2022 Se­ries A — to col­lect proof-of-con­cept da­ta for its lead ex­per­i­men­tal med­i­cine and de­vel­op fur­ther treat­ment can­di­dates in the mol­e­c­u­lar glue space.

The Wednes­day morn­ing fi­nanc­ing comes a year af­ter the Lex­ing­ton, MA-based start­up struck a $49 mil­lion up­front part­ner­ship with Pfiz­er. That deal, across mul­ti­ple ther­a­peu­tic ar­eas such as on­col­o­gy, could bal­loon to more than $1.5 bil­lion in pay­outs for Tri­ana.

It marks at least the 22nd megaround fi­nanc­ing since Sept. 30, ac­cord­ing to an End­points News tal­ly, as the biotech in­dus­try has picked up mo­men­tum head­ed in­to the new year.

A New York start­up that's look­ing to ac­cel­er­ate how quick­ly pre­clin­i­cal small mol­e­cule can­di­dates en­ter clin­i­cal tri­als has cor­ralled $95 mil­lion.

Ex­cel­sior Sci­ences has raised $70 mil­lion in a Se­ries A round, led by Deer­field Man­age­ment, Khosla Ven­tures and Sofinno­va Part­ners, with Eli Lil­ly and oth­ers pitch­ing in. The start­up al­so se­cured a $25 mil­lion grant from New York’s Em­pire State De­vel­op­ment, which sup­ports lo­cal busi­ness­es, the com­pa­ny said Wednes­day. The start­up is op­er­at­ing from a 1,500-square-foot lab­o­ra­to­ry on Park Av­enue.

The Se­ries A will be used in part to de­vel­op its chem­i­cal syn­the­sis tech­nol­o­gy, co-founder and chief op­er­at­ing of­fi­cer Jana Jensen told End­points News in an in­ter­view. It will al­so use the raise to de­vel­op its own pipeline of small mol­e­cules, she added.