Af­ter re­port­ing pos­i­tive da­ta in non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis last month, No­var­tis’ block­buster Cosen­tyx was dealt a set­back on Fri­day.

In the 52-week EX­CEED tri­al in 800 bi­o­log­ic-naïve ac­tive pso­ri­at­ic arthri­tis pa­tients, the IL-17A drug was test­ed against Ab­b­Vie’s flag­ship Hu­mi­ra. The main goal of the study was to show Cosen­tyx was sta­tis­ti­cal­ly su­pe­ri­or us­ing re­sponse rates to ACR20, a stan­dard mea­sure that looks for a 20% re­cov­ery in the num­ber of ten­der and num­ber of swollen joints, and a 20% im­prove­ment in three oth­er cat­e­gories at week 52.

Al­though Cosen­tyx monother­a­py re­sult­ed in high­er re­sults ver­sus Hu­mi­ra, it “nar­row­ly” missed the main goal of sta­tis­ti­cal su­pe­ri­or­i­ty. De­tailed da­ta will be pre­sent­ed at a lat­er date.

Cosen­tyx — ap­proved for pso­ri­at­ic arthri­tis, plaque pso­ri­a­sis and anky­los­ing spondyli­tis — has been No­var­tis’ biggest sell­er in the first nine months of 2019, gen­er­at­ing about $2.6 bil­lion in sales over the pe­ri­od. It in­hibits a pro­tein called IL-17A from bind­ing to its re­cep­tor and was the first-ever ap­proved such ther­a­py to se­cure ap­proval, launch­ing in 2015.

Since then, ri­vals have emerged, in­clud­ing Eli Lil­ly’s IL-17A ther­a­py Taltz, and J&J’s an­ti-IL23 Trem­fya. Bausch Health’s (for­mer­ly Valeant’s) Siliq tar­gets IL-17RA and is ap­proved for plaque pso­ri­a­sis, but is cur­rent­ly be­ing eval­u­at­ed for pso­ri­at­ic arthri­tis.

For Ab­b­Vie, its TNF in­hibitor Hu­mi­ra — ap­proved for an ar­ray of au­toim­mune con­di­tions — has been the gift that keeps giv­ing. The drug — which hit a stu­pen­dous $20 bil­lion in sales last year, earn­ing it the crown of the world’s best sell­ing ther­a­py — has be­gun to see ero­sion in Eu­ro­pean sales due to biosim­i­lar com­pe­ti­tion, and a US patent cliff is loom­ing.

In Au­gust, Ab­b­Vie’s JAK in­hibitor upadac­i­tinib se­cured FDA ap­proval as part of the drug­mak­er’s post-Hu­mi­ra plans.  But the class of drugs has been blight­ed by safe­ty con­cerns — con­se­quent­ly, upadac­i­tinib’s ap­proval was ac­com­pa­nied by a black box warn­ing.  Mean­while, Ab­b­Vie has al­so planned for a post-Hu­mi­ra world with a $63 bil­lion deal to swal­low Al­ler­gan and its key­stone Botox fran­chise.

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.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.