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.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.