The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee on Thurs­day vot­ed 5-3 against the over­all ben­e­fit-risk of GSK’s Blenrep as a sec­ond-line mul­ti­ple myelo­ma treat­ment in com­bi­na­tion with borte­zomib and dex­am­etha­sone. The com­mit­tee al­so vot­ed 7-1 against — with the pa­tient rep­re­sen­ta­tive as the on­ly vote in fa­vor — the over­all ben­e­fit-risk of Blenrep in com­bi­na­tion with po­ma­lido­mide and dex­am­etha­sone.

FDA of­fi­cials raised con­cerns at the meet­ing and in brief­ing doc­u­ments about eye-re­lat­ed tox­i­c­i­ties, find­ing a safe and ef­fec­tive dose of Blenrep and how it var­ied be­tween pa­tients, as well as lim­it­ed en­roll­ment of Amer­i­cans, old­er adults and Black or African Amer­i­cans in Blenrep's de­vel­op­ment pro­gram.

ODAC Chair Neil Vasan vot­ed against both Blenrep com­bi­na­tions, ex­plain­ing the ef­fi­ca­cy da­ta were "strong," but the dosage is­sues "swayed the de­ci­sion." He said he thought GSK missed an op­por­tu­ni­ty to iden­ti­fy the cor­rect dose.

Bris­tol My­ers Squibb and Pfiz­er have an­nounced a di­rect-to-con­sumer of­fer­ing for their megablock­buster blood thin­ner Eliquis, mark­ing a vol­un­tary ef­fort to low­er drug prices amid the threat of Pres­i­dent Don­ald Trump’s “most fa­vored na­tion” plan.

Start­ing this Sep­tem­ber, the com­pa­nies will of­fer Eliquis at a 40% dis­count for unin­sured or un­der­in­sured pa­tients, which amounts to $346 for a 30-day sup­ply. Bris­tol My­ers and Pfiz­er said they will ship the drug di­rect­ly to pa­tients.

The drug’s list price is $606 for that month-long pe­ri­od. Eliquis’ world­wide sales to­taled more than $13.3 bil­lion last year.

The com­pa­nies vol­un­tar­i­ly launched the pro­gram af­ter dis­cus­sions with the White House, ac­cord­ing to a per­son fa­mil­iar with the sit­u­a­tion. The in­di­vid­ual added they are con­tin­u­ing to talk with the Trump ad­min­is­tra­tion about boost­ing af­ford­abil­i­ty and trans­paren­cy and cut­ting out the mid­dle­man — the last part a like­ly ref­er­ence to phar­ma­cy ben­e­fit man­agers that have long drawn in­dus­try ire.

Eli Lil­ly and Pfiz­er launched new ser­vices last year meant to give pa­tients eas­i­er ac­cess to clin­i­cians who can pre­scribe their drugs.

The di­rect-to-con­sumer sites, called Lil­ly­Di­rect and Pfiz­er­ForAll, quick­ly at­tract­ed scruti­ny from law­mak­ers who ques­tioned whether the phar­ma­ceu­ti­cal gi­ants’ re­la­tion­ships with tele­health star­tups in­flu­enced doc­tors to pre­scribe cer­tain treat­ments and led to in­ap­pro­pri­ate pre­scrib­ing.

A re­port out Thurs­day from a group of US sen­a­tors sheds light on those re­la­tion­ships, in­clud­ing some of the first de­tails on the pay­ments passed be­tween the phar­ma and tele­health com­pa­nies. The re­port is based on a nine-month in­ves­ti­ga­tion by Sens. Dick Durbin (D-IL), Bernie Sanders (I-VT), Eliz­a­beth War­ren (D-MA) and Pe­ter Welch (D-VT).

"At best, these re­la­tion­ships raise ques­tions about con­flicts of in­ter­est. At worst, they cre­ate the po­ten­tial for in­ap­pro­pri­ate pre­scrib­ing that can un­nec­es­sar­i­ly in­crease spend­ing for fed­er­al health care pro­grams,” the re­port found.

New da­ta from Ire­land’s Cen­tral Sta­tis­tics Of­fice sug­gest that phar­ma­ceu­ti­cal com­pa­nies are ex­port­ing more in­ven­to­ry to the US as the threat of drug tar­iffs per­sists.

Med­ical and phar­ma­ceu­ti­cal prod­uct ex­ports from Ire­land in­creased by 73.9% in May com­pared to the same month last year, reach­ing a to­tal of €13.7 bil­lion ($15.9 bil­lion), ac­cord­ing to trade da­ta pub­lished Thurs­day morn­ing.

Ex­ports to the US from Ire­land in­creased by around 86.5% com­pared to May 2024, ac­cord­ing to the da­ta.

The mass ex­o­dus of phar­ma prod­ucts from Ire­land re­flects an in­crease com­pared to the month pri­or, which reached a to­tal of €10.9 bil­lion ($12.6 bil­lion). Phar­ma ex­ports had re­turned large­ly to nor­mal in April af­ter a pre­vi­ous surge in March.

Pres­i­dent Don­ald Trump has hint­ed that phar­ma-spe­cif­ic tar­iffs could be ar­riv­ing as soon as “the end of the month.”