The FDA late Wednes­day ex­tend­ed the EUA for Eli Lil­ly’s rheuma­toid arthri­tis drug Olu­mi­ant (baric­i­tinib) to be used as a so­lo treat­ment for Covid-19 in hos­pi­tal­ized adults and pe­di­atric pa­tients who need sup­ple­men­tal oxy­gen.

The oral drug was pre­vi­ous­ly cleared in con­junc­tion with Gilead’s remde­sivir to treat those hos­pi­tal­ized with Covid-19.

In a Phase III study re­port­ed in April, Olu­mi­ant did not meet its pri­ma­ry end­point. The drug failed to reach sta­tis­ti­cal sig­nif­i­cance for the dif­fer­ence in rate of pa­tients need­ing non-in­va­sive or in­va­sive ven­ti­la­tion for the first time, or those who died af­ter 4 weeks. But FDA said that the re­vised EUA for baric­i­tinib was sup­port­ed by da­ta from that study, which showed a re­duc­tion in the pro­por­tion of pa­tients who died af­ter 4 weeks of fol­low-up com­pared to pa­tients treat­ed with the stan­dard of care alone.

In May, Eli Lil­ly ex­pand­ed its drug li­cense with three gener­ic drug­mak­ers out of In­dia, in an ef­fort to curb the coun­try’s sec­ond wave of Covid cas­es. Baric­i­tinib was grant­ed emer­gency use ap­proval in In­dia for the treat­ment of adult pa­tients who need oxy­gen and are hos­pi­tal­ized.

Emer­gent re­sumes man­u­fac­tur­ing at Bayview site

Rough­ly three months af­ter man­u­fac­tur­ing at Emer­gent BioSo­lu­tions’ Bal­ti­more Bayview plant was halt­ed, the FDA has giv­en the com­pa­ny the go-ahead to re­sume pro­duc­tion.

The pro­duc­tion of J&J’s Covid-19 vac­cine will re­sume — af­ter the site shut down fol­low­ing a con­t­a­m­i­na­tion in­ci­dent that re­sult­ed in the dis­card­ing of mil­lions of Covid-19 dos­es. A batch of drug sub­stances in­tend­ed for the As­traZeneca vac­cine came in close prox­im­i­ty with a J&J batch, con­t­a­m­i­nat­ing it.

“The Amer­i­can peo­ple should have high ex­pec­ta­tions of the part­ners its gov­ern­ment choos­es to help pre­pare them for dis­as­ter, and we have even high­er ex­pec­ta­tions of our­selves,” Emer­gent CEO Bob Kramer said in a state­ment. “We have fall­en short of those lofty am­bi­tions over the past few months but re­sump­tion of man­u­fac­tur­ing is a key mile­stone and we are grate­ful for the op­por­tu­ni­ty to help bring this glob­al pan­dem­ic to an end. We’d like to thank our gov­ern­ment part­ners as well as John­son & John­son for their sup­port.”

De­mand for J&J’s sin­gle-dose jab has waned in the US re­cent­ly, but it re­mains a vi­able op­tion for coun­tries over­seas that are lack­ing ad­e­quate dos­es, par­tic­u­lar­ly those try­ing to in­oc­u­late peo­ple in rur­al ar­eas.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.