As the com­bined fre­quen­cy of the Covid-19 vari­ants first iden­ti­fied in Brazil and South Africa now ex­ceeds 10% in Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon and Wash­ing­ton, the US said Wednes­day that it’s halt­ing all ship­ments to those states of Eli Lil­ly’s mAb com­bo to treat Covid-19 pri­or to hos­pi­tal­iza­tions.

The FDA rec­om­mends that health care providers in those six states use Re­gen­eron’s mAb cock­tail as an al­ter­na­tive au­tho­rized mon­o­clon­al an­ti­body ther­a­py be­cause it’s more ef­fec­tive against the vari­ants than the Lil­ly treat­ment.

“RE­GEN-COV is like­ly to re­tain ac­tiv­i­ty against the P.1 and B.1.351 vari­ants,” the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse and FDA said in a state­ment.

Pre­vi­ous­ly, the US halt­ed ship­ments of the Lil­ly com­bo of bam­lanivimab and ete­se­vimab to Illi­nois and Mass­a­chu­setts be­cause of the vari­ant first iden­ti­fied in Brazil. FDA al­so re­voked the EUA for bam­lanivimab alone last month be­cause it was no longer as ef­fec­tive as a com­bo ther­a­py.

The con­tin­u­al­ly shift­ing land­scape of mAbs to treat Covid-19 al­so saw the ad­di­tion of an EUA for an­oth­er mAb treat­ment from Vir and Glax­o­SmithK­line on Wednes­day. Vir says their sin­gle an­ti­body can neu­tral­ize each of the vari­ants sci­en­tists sus­pect are pro­lif­er­at­ing, al­though it’s still un­known how many dos­es of the new mAb will be avail­able.

After seeing a “robust” immune response in 6- to 11-year-olds dosed with its Covid-19 vaccine, Moderna says it’s headed to the FDA.

The results came from the Phase II/III KidCOVE study, which enrolled 4,753 participants between the ages of 6 and under 12 years old. The kids were given two half-doses of the Moderna vaccine (50 µg each), and showed “strong immune response” a month after the second dose.

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

This fall’s harvest is proving fruitful for Dupixent.

Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.

It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.