J&J and Sanofi have gone back and forth in their mul­ti­ple myelo­ma tug-of-war. Ear­li­er this year, Sanofi notched an ap­proval of Sar­clisa in com­bi­na­tion with Am­gen’s Kypro­lis to try to out­flank the big con­glom­er­ate, but J&J is clap­ping back.

Wednes­day af­ter­noon, Am­gen an­nounced that the sub­cu­ta­neous ver­sion of J&J’s block­buster Darza­lex is al­so now ap­proved as a com­bo with Kypro­lis and dex­am­etha­sone. The green light came through for adults with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma who had pro­gressed on one to three ear­li­er lines of ther­a­py.

Am­gen ex­ecs praised the de­ci­sion, with R&D chief David Reese say­ing in a state­ment the al­ter­na­tive Darza­lex ad­min­is­tra­tion “will of­fer in­creased flex­i­bil­i­ty and con­ve­nience for pa­tients.”

The FDA de­ci­sion comes af­ter the IV for­mu­la­tion of Darza­lex ini­tial­ly clinched ap­proval with Kypro­lis back in Au­gust 2020. That OK came as Sar­clisa had just won an ap­proval the pre­ced­ing March in third-line mul­ti­ple myelo­ma pa­tients.

Though Sar­clisa has a long way to go to eclipse Darza­lex on the mar­ket, it man­aged to se­cure the same Kypro­lis com­bo green light in April 2021 — Sar­clisa plus Kypro­lis plus dex­am­etha­sone in pa­tients who pro­gressed on one to three treat­ments. The back-and-forth be­tween the two drugs will like­ly con­tin­ue as Sanofi looks to carve out more of the mar­ket.

Should it prove suc­cess­ful, there’s quite a slice of pie to be had. The IV form of Darza­lex ini­tial­ly launched in 2015 and quick­ly be­came one of J&J’s top sell­ers with $1.4 bil­lion in sales its first year. And in 2020, the drug tal­lied its best sales year yet with $4.2 bil­lion.

J&J re­ports sales to­geth­er for both forms of the drug — the IV form and the sub­cu­ta­neous ver­sion dubbed Darza­lex Faspro.

Sar­clisa has not seen as sharp an up­take, as the drug was first ap­proved about a week and a half be­fore the WHO de­clared a glob­al pan­dem­ic last year, lim­it­ing pa­tient ac­cess. Nonethe­less, it marked a mile­stone for Sanofi, be­com­ing the com­pa­ny’s first in-house can­cer ap­proval since 2010.

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.