The WTO’s TRIPS Coun­cil is meet­ing to­day and to­mor­row to dis­cuss a Covid-19 vac­cine IP waiv­er that re­mains di­vi­sive and un­like­ly to be adopt­ed thanks to Eu­ro­pean op­po­si­tion, but which pro­po­nents still think could un­lock more vac­cine dos­es for low and mid­dle-in­come coun­tries.

Fol­low­ing the meet­ings this week, it’s ex­pect­ed there will be a bet­ter sense if some kind of waiv­er can be agreed to by De­cem­ber, Tahir Amin, an IP lawyer and co-ex­ec­u­tive di­rec­tor of I-Mak, told End­points News.

But he said that the odds of meet­ing the De­cem­ber dead­line are “al­ready look­ing slim giv­en the block­ing coun­tries’ time wast­ing with re­dun­dant counter pro­pos­als that of­fer more of a failed IP trad­ing sys­tem and the US not putting its whole weight in­to ne­go­ti­a­tions and an ac­tu­al text.”

De­spite ini­tial sup­port from the Biden ad­min­is­tra­tion, the bio­phar­ma in­dus­try and Eu­ro­pean coun­tries — pre­dom­i­nant­ly the UK, Ger­many and Switzer­land — have re­mained firm­ly op­posed to the waiv­er. Pfiz­er went so far as to call it a “dis­trac­tion” and Mod­er­na CEO Stéphane Ban­cel said it wouldn’t help sup­ply any more mR­NA vac­cines over the next two years.

Even some promi­nent De­moc­rats are now rais­ing doubts about the waiv­er too.

Gary Locke, for­mer Com­merce Sec­re­tary and am­bas­sador to Chi­na un­der the Oba­ma ad­min­is­tra­tion, told End­points via email, “The pro­posed TRIPS waiv­er would do noth­ing to ex­pand mR­NA man­u­fac­tur­ing ca­pac­i­ty. Every sci­en­tist and com­pa­ny that knows how to make the vac­cines is al­ready work­ing to scale pro­duc­tion. And every fa­cil­i­ty on earth that can safe­ly and re­li­ably pro­duce shots is do­ing so.”

He al­so said he didn’t think the US should give away its tax­pay­er-fund­ed mR­NA re­search to coun­tries like Chi­na as that could “jeop­ar­dize Amer­i­can eco­nom­ic com­pet­i­tive­ness.”

But non­prof­its like Pub­lic Cit­i­zen have called on the US gov­ern­ment to start build­ing new sites and retro­fitting old­er ones to make more vac­cines.

“A $25 bil­lion in­vest­ment in vac­cine pro­duc­tion by the US gov­ern­ment would pro­duce enough vac­cine for low- and mid­dle-in­come coun­tries in one year,” the group says.

Locke agreed that wealthy na­tions “should fo­cus on do­nat­ing sur­plus Covid-19 vac­cine dos­es to de­vel­op­ing coun­tries, while al­so in­vest­ing in so­lu­tions to ac­tu­al­ly help dis­trib­ute those dos­es. For ex­am­ple, The De­mo­c­ra­t­ic Re­pub­lic of the Con­go re­turned 1.3 mil­lion dos­es to CO­V­AX, the glob­al vac­ci­na­tion-shar­ing ini­tia­tive, in part be­cause it couldn’t get the dos­es in­to rur­al ar­eas.”

Over the next two days, all eyes will be on the IP waiv­er, and whether it can ac­tu­al­ly ramp up vac­cine sup­plies.

“I’m hop­ing, al­beit not con­fi­dent, the US will ta­ble some lan­guage/text in sup­port of the In­dia/South Africa’s waiv­er — even if it does not to­tal­ly match the cur­rent re­vised waiv­er text. It will be need­ed to push the coun­tries block­ing to come with some­thing more in line with a broad­er IP waiv­er,” Amin said.

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.

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

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.