In an ef­fort to com­bat ris­ing Covid-19 cas­es world­wide, the World Health Or­ga­ni­za­tion has struck a deal to li­cense sero­log­i­cal tech­nol­o­gy for an­ti­body test­ing and pro­vide it roy­al­ty-free to low- and mid­dle-in­come coun­tries in the hopes of boost­ing pro­duc­tion.

The WHO’s Covid-19 Tech­nol­o­gy Ac­cess Pool (C-TAP) and the Med­i­cines Patent Pool (MPP) fi­nal­ized the deal with the Span­ish Na­tion­al Re­search Coun­cil (CSIC), a pub­lic re­search in­sti­tute, on Tues­day. It’s the first test li­cense signed by the MPP, a Unit­ed Na­tions-backed pub­lic health or­ga­ni­za­tion, and in­clud­ed in the WHO pool, ac­cord­ing to the or­ga­ni­za­tions. It cov­ers all re­lat­ed patents and bi­o­log­i­cal ma­te­r­i­al nec­es­sary for man­u­fac­tur­ing the tests, and CSIC has agreed to pro­vide know-how and train­ing.

So far, CSIC’s tech­nol­o­gy has re­sult­ed in four an­ti­body tests, in­clud­ing one that can dis­tin­guish the im­mune re­sponse of Covid-in­fect­ed in­di­vid­u­als from vac­ci­nat­ed in­di­vid­u­als.

“This is the kind of open and trans­par­ent li­cense we need to move the nee­dle on ac­cess dur­ing and af­ter the pan­dem­ic,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said in a state­ment. “I urge de­vel­op­ers of COVID-19 vac­cines, treat­ments and di­ag­nos­tics to fol­low this ex­am­ple and turn the tide on the pan­dem­ic and on the dev­as­tat­ing glob­al in­equity this pan­dem­ic has spot­light­ed.”

The move marks the lat­est in a string of ef­forts to con­tain the pan­dem­ic in low­er in­come coun­tries, where vac­cines are sore­ly need­ed. Back in Sep­tem­ber, the US gov­ern­ment said it would buy 500 mil­lion more dos­es of Pfiz­er’s vac­cine to do­nate to coun­tries in need. It al­so dumped more $200 mil­lion over the sum­mer in­to a South African man­u­fac­tur­ing plant to boost ac­cess to J&J’s vac­cine. How­ev­er, the New York Times re­port­ed in Au­gust that many of those dos­es had been ex­port­ed back to Eu­rope.

CSIC pres­i­dent Rosa Menén­dez em­pha­sized that tech­nol­o­gy re­lat­ed to Covid-19 should reach all coun­tries, adding: “In this sense, we would like this ac­tion by CSIC, of tak­ing part in the in­ter­na­tion­al ini­tia­tives of MPP and WHO, to be­come an ex­am­ple and a ref­er­ence for oth­er re­search or­ga­ni­za­tions in the world.”

US gov­ern­ment fights to up­hold work­place vac­cine man­date

The US gov­ern­ment is fight­ing to keep an Oc­cu­pa­tion­al Safe­ty and Health Ad­min­is­tra­tion (OS­HA) rule in place that re­quires work­ers to be vac­ci­nat­ed for Covid-19 or test­ed week­ly, ac­cord­ing to court doc­u­ments.

The OS­HA rule, which was is­sued Nov. 5 and re­quires busi­ness­es with at least 100 em­ploy­ees to com­ply by ear­ly next year, was ini­tial­ly shot down in the US 5th Cir­cuit Court of Ap­peals in New Or­leans. OS­HA es­ti­mat­ed that the rule would save a min­i­mum of 6,500 lives and pre­vent over 250,000 hos­pi­tal­iza­tions over the next six months. But chal­lengers called the stan­dard “stag­ger­ing­ly over­board,” Reuters re­port­ed.

Now, the US gov­ern­ment is ask­ing a Sixth Cir­cuit fed­er­al ap­peals court to “im­me­di­ate­ly” lift the 5th Cir­cuit’s stay, ac­cord­ing to court doc­u­ments filed Tues­day.

“A court or­der block­ing the Stan­dard is a far greater af­front to sov­er­eign pre­rog­a­tives. Such an or­der would al­so threat­en deaths and hos­pi­tal­iza­tions that em­ploy­ers wish to pre­vent. Those in­ter­ests, and the gov­ern­ment’s in­ter­ests in pro­tect­ing em­ploy­ees and em­ploy­ers while this case pro­ceeds, vast­ly out­weigh pe­ti­tion­ers’ as­sert­ed harm,” the mo­tion states.

The news comes as Covid-19 cas­es rise in the US, de­spite more than 82% of adults hav­ing got­ten at least one dose of a vac­cine. Last Fri­day, the FDA an­nounced that all adults who re­ceived two dos­es of an mR­NA Covid-19 vac­cine are now el­i­gi­ble for a boost­er shot.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.