Next week, a new coali­tion will be launched in Sin­ga­pore in an ef­fort to speed can­cer drug de­vel­op­ment and en­hance re­search co­op­er­a­tion be­tween the US and Chi­na, de­spite ris­ing ten­sions.

Launched by bil­lion­aire Michael Bloomberg’s eco­nom­ic fo­rum, dubbed the Bloomberg In­ter­na­tion­al Can­cer Coali­tion, the sum­mit will bring drug ex­ecs to­geth­er from the coun­tries with the two largest can­cer pop­u­la­tions in the world. The coali­tion will aim to cre­ate new can­cer drug stan­dards and cool tem­per­a­tures that have risen dur­ing the Covid-19 pan­dem­ic.

Rep­re­sen­ta­tives from sev­er­al high-pro­file drug­mak­ers will be in at­ten­dance, in­clud­ing J&J, Bay­er, Roche, No­var­tis, BeiGene, Zai Lab and aca­d­e­m­ic in­sti­tu­tions from Chi­na, the US and Eu­rope.

Some cur­rent and for­mer diplo­mats will al­so be in at­ten­dance, but rep­re­sen­ta­tives from Chi­na and its health reg­u­la­tor have not yet said whether they’ll be in Sin­ga­pore, the Fi­nan­cial Times re­port­ed Sun­day.

One diplo­mat, for­mer Aus­tralian Prime Min­is­ter and Asia So­ci­ety chief Kevin Rudd, told FT the ef­fort to lessen the pan­dem­ic-in­duced saber-rat­tling is akin to the 1970s dé­tente be­tween the US and Chi­na, which saw the coun­tries use ta­ble ten­nis as a way to thaw Cold War an­i­mosi­ties.

“The US-Chi­na re­la­tion­ship has got so bad that we at the Asia So­ci­ety have formed a view that can­cer treat­ment tri­als may well be­come the next it­er­a­tion of ping-pong diplo­ma­cy, to get this re­la­tion­ship back on the rails,” he told FT.

Rudd added that dis­agree­ments over in­tel­lec­tu­al prop­er­ty will like­ly be dis­cussed at the sum­mit.

The re­port al­so not­ed the group will at­tempt to use the FDA’s Pro­ject Or­bis as a mod­el to stream­line new drug sub­mis­sions out­side the US. Am­gen’s can­cer drug Lumakras won ap­proval in sev­er­al coun­tries in May un­der the project, and reg­u­la­tors from the US, Aus­tralia, Brazil, Cana­da and the UK re­viewed Am­gen’s sub­mis­sion si­mul­ta­ne­ous­ly.

Sev­er­al is­sues have emerged as flash points dur­ing the pan­dem­ic, caus­ing the re­la­tion­ship be­tween the US and Chi­na to head south. Chief among US con­cerns has been Chi­na’s re­luc­tance to al­low a full in­ves­ti­ga­tion in­to the ori­gins of the nov­el coro­n­avirus, with Chi­nese au­thor­i­ties block­ing WHO re­searchers ear­li­er this year from ac­cess­ing cer­tain da­ta.

Af­ter that group made its re­port in Feb­ru­ary, the WHO an­nounced a sec­ond at­tempt to look in­to the pan­dem­ic’s ori­gins in Ju­ly. But Chi­na said it couldn’t ac­cept the new terms be­cause it in­clud­ed a new pro­vi­sion to in­ves­ti­gate whether the coro­n­avirus might have leaked from a Chi­nese lab­o­ra­to­ry, NPR re­port­ed at the time.

A sci­en­tif­ic con­sen­sus emerged ear­ly in the pan­dem­ic that the SARS-CoV-2 virus jumped from an­i­mals to hu­mans, but one US in­tel­li­gence agency has not ruled out the “lab leak the­o­ry,” ac­cord­ing to a re­port. Four oth­er agen­cies dis­agreed while an­oth­er three couldn’t say for cer­tain one way or an­oth­er.

The WHO es­tab­lished a new sci­en­tif­ic ad­vi­so­ry group to look in­to Covid-19 ori­gins last month.

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.