FDA chief Mar­ty Makary said the agency is in­ves­ti­gat­ing whether the Covid-19 vac­cines caused any deaths in kids, build­ing on the gov­ern­men­t's month­s­long ef­fort to ques­tion the safe­ty of the prod­ucts.

In an in­ter­view on CNN, Makary de­scribed the probe as an “in­tense in­ves­ti­ga­tion.” The FDA is re­ly­ing on self-re­port­ed cas­es to the CDC’s Vac­cine Ad­verse Event Re­port­ing Sys­tem (VAERS), Makary said. He added that the agency is fol­low­ing up with the par­ents of chil­dren claimed to have been killed, re­view­ing au­top­sy re­ports, and ask­ing physi­cians to ex­am­ine the da­ta.

Ad­verse events re­port­ed to VAERS alone are not in­dica­tive of a vac­cine caus­ing a par­tic­u­lar side ef­fect.

Gener­ic phar­ma­ceu­ti­cals from Japan will be ex­empt from a 15% rec­i­p­ro­cal tar­iff on the coun­try’s ex­ports to the US, Pres­i­dent Don­ald Trump said in a new ex­ec­u­tive or­der.

The or­der marks the sec­ond trade deal Trump has an­nounced that ex­empts gener­ic phar­ma prod­ucts from tar­iffs. But the in­dus­try still awaits the out­come of the ad­min­is­tra­tion’s in­ves­ti­ga­tion in­to phar­ma­ceu­ti­cals, which could lead to levies on both gener­ic and brand­ed drugs.

Un­der the EO re­leased Thurs­day, near­ly all im­ports from Japan will be sub­ject to a base­line 15% tar­iff rate. But the rate for gener­ic phar­ma­ceu­ti­cals, their in­gre­di­ents and chem­i­cal pre­cur­sors will be set to 0%.

Japan has al­so agreed to in­vest $550 bil­lion in­to the US to boost the coun­try’s do­mes­tic man­u­fac­tur­ing and cre­ate new jobs across dif­fer­ent sec­tors, ac­cord­ing to the or­der.

BETHES­DA, MD — FDA Com­mis­sion­er Mar­ty Makary said the agency will soon be­gin in­spect­ing more for­eign drug man­u­fac­tur­ers with­out ad­vance no­tice, a move that's been in the works for years and would align its over­sight of do­mes­tic and over­seas fa­cil­i­ties.

The FDA is in the process of chang­ing to more "sur­prise in­spec­tions and hav­ing a ba­sic safe­ty in­spec­tion list so we're not putting com­pa­nies through the ringer in the Unit­ed States and then let­ting com­pa­nies over­seas have a much lighter in­spec­tion load," Makary said Thurs­day at the Mary­land Tech­nol­o­gy Coun­cil's Bio In­no­va­tion Con­fer­ence.

The agency said in May that it was plan­ning on do­ing more sur­prise in­spec­tions of for­eign fac­to­ries.

→ Mer­ck KGaA has se­lect­ed David Wein­re­ich as glob­al R&D chief and CMO for the health­care busi­ness sec­tor. Wein­re­ich’s ex­pe­ri­ence with larg­er phar­mas goes back to his days at Am­gen as ex­ec­u­tive med­ical di­rec­tor, glob­al prod­uct area leader for an­gio­gen­e­sis. He then jumped to Bay­er and was pro­mot­ed to cor­po­rate SVP, head of glob­al de­vel­op­ment spe­cial­ty med­i­cine dur­ing his four-year tenure. He made his way to Re­gen­eron in 2016 and stayed there for the next sev­en years as a clin­i­cal de­vel­op­ment ex­ec. Since 2023, he’s been an op­er­at­ing part­ner at Fore­site Labs and a se­nior ad­vi­sor at Fore­site Cap­i­tal. Mer­ck KGaA joined forces with Bill Haney’s crew at Sky­hawk Ther­a­peu­tics in a re­cent RNA deal that could be worth more than $2 bil­lion.

BioN­Tech said its most ad­vanced an­ti­body-drug con­ju­gate has suc­ceed­ed in a Phase 3 Chi­na-based tri­al in hard-to-treat breast can­cer pa­tients. The win will raise ex­pec­ta­tions for an on­go­ing glob­al late-phase tri­al of the drug.

Known as trastuzum­ab pamirte­can, and pre­vi­ous­ly called BNT323 or DB-1303, the ADC tar­gets HER2. The Chi­na study is con­duct­ed by Shang­hai-based Du­al­i­ty­Bio, from which BioN­Tech li­censed the drug i