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.

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.