→ Al­most a year af­ter it was ap­proved for rheuma­toid arthri­tis, Ab­b­Vie’s JAK in­hibitor Rin­voq was shown for the first time to work as a monother­a­py in atopic der­mati­tis. In a Phase III study, two dif­fer­ent dos­es of the drug beat place­bo on all pri­ma­ry and sec­ondary end­points. Of pa­tients in the high dose group, 80% saw at least 75% skin clear­ance ver­sus 16% for place­bo. That num­ber was 70% in the low dose group.

→ Dicer­na has re­ceived a rare pe­di­atric dis­ease des­ig­na­tion from the FDA for its lead drug, ne­dosir­an, be­ing de­vel­oped for pri­ma­ry hy­per­ox­aluria. The des­ig­na­tion makes Dicer­na el­i­gi­ble for a pri­or­i­ty re­view vouch­er they can sell or use for any fu­ture mar­ket­ing ap­pli­ca­tion. Dicer­na is com­pet­ing with their RNAi ri­val and part­ner Al­ny­lam in this in­di­ca­tion. Al­ny­lam al­so re­ceived the pe­di­atric des­ig­na­tion, along with pri­or­i­ty re­view as they await FDA de­ci­sion. Dicer­na has not yet filed.

→ Beef­ing up its nascent cell and gene ther­a­py unit, Sarep­ta Ther­a­peu­tics has en­tered a li­cense pact with Se­lec­ta Bio­sciences that gives it ac­cess to Se­lec­ta’s im­mune tol­er­ance plat­form. Imm­TOR is de­signed to min­i­mize or pre­vent the for­ma­tion of neu­tral­iz­ing an­ti­bod­ies to AAV — the vi­ral vec­tor Sarep­ta de­ploys to de­liv­er its gene ther­a­pies for Duchenne and limb-gir­dle mus­cu­lar dy­s­tro­phies — there­by mak­ing re­dos­ing pos­si­ble.

“As we build our en­dur­ing gene ther­a­py en­gine, we in­tend not on­ly to rapid­ly ad­vance treat­ments for rare, life-end­ing dis­eases, but at the same time, to ad­vance the state of ge­net­ic med­i­cine sci­ence by con­tin­u­al­ly im­prov­ing the util­i­ty of gene ther­a­py,” Sarep­ta CEO Doug In­gram said in a state­ment.

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.