President Biden (Doug Mills/The New York Times/Bloomberg via Getty Images)

Covid-19 roundup: Pres­i­dent Biden or­ders in­tel­li­gence com­mu­ni­ty to re­dou­ble ef­forts to de­ter­mine if virus orig­i­nat­ed in an­i­mals or a lab in Chi­na

The brew­ing con­tro­ver­sy over the ori­gins of Covid-19 erupt­ed on Wednes­day as Pres­i­dent Joe Biden or­dered the US in­tel­li­gence com­mu­ni­ty and gov­ern­ment labs to dou­ble down on their ef­forts to reach a con­sen­sus over 2 com­pet­ing the­o­ries in the next 90 days.

As of now, Biden said in a state­ment re­leased by the White House, the in­tel­li­gence com­mu­ni­ty is di­vid­ed in­to 2 camps: 1 that be­lieves the virus like­ly orig­i­nat­ed in an­i­mals in Chi­na and jumped to hu­mans, and 1 that be­lieves it like­ly re­sult­ed from a lab ac­ci­dent in Chi­na.

Biden not­ed:

I have now asked the In­tel­li­gence Com­mu­ni­ty to re­dou­ble their ef­forts to col­lect and an­a­lyze in­for­ma­tion that could bring us clos­er to a de­fin­i­tive con­clu­sion, and to re­port back to me in 90 days. As part of that re­port, I have asked for ar­eas of fur­ther in­quiry that may be re­quired, in­clud­ing spe­cif­ic ques­tions for Chi­na. I have al­so asked that this ef­fort in­clude work by our Na­tion­al Labs and oth­er agen­cies of our gov­ern­ment to aug­ment the In­tel­li­gence Com­mu­ni­ty’s ef­forts. And I have asked the In­tel­li­gence Com­mu­ni­ty to keep Con­gress ful­ly ap­prised of its work.

Chi­nese of­fi­cials have ve­he­ment­ly de­nied that the Wuhan In­sti­tute of Vi­rol­o­gy in Chi­na had any­thing to do with the out­break, which quick­ly spread around the world and killed more than 3 mil­lion peo­ple. Doubts were plant­ed ear­ly on, though, as of­fi­cials were barred from Chi­na when they set out to learn more about the ori­gins of the pan­dem­ic. And re­cent­ly the the­o­ry about a lab ac­ci­dent has gained trac­tion in Wash­ing­ton — with NI­AID chief An­tho­ny Fau­ci say­ing he’s un­cer­tain about the ori­gins and that it de­serves a clos­er in­ves­ti­ga­tion — af­ter an ini­tial push­back from the ex­perts to the heat­ed rhetoric on this of­fered by Don­ald Trump.

Fau­ci tes­ti­fied be­fore the Sen­ate Ap­pro­pri­a­tions Com­mit­tee on Wednes­day and Sen. John Kennedy (R-LA) pressed him on why the NIH fund­ed re­search at the Wuhan in­sti­tute in the first place. Fau­ci ex­plained that the bats that have coro­n­avirus­es are lo­cat­ed in Chi­na, and not else­where so the re­search was nec­es­sary. Kennedy al­so ques­tioned how NIH knows that Chi­na didn’t lie about what re­search was con­duct­ed there and Fau­ci said NIH has seen the re­sults of the stud­ies, al­though he can’t guar­an­tee that they haven’t lied.

“Cer­tain­ly, the peo­ple who in­ves­ti­gat­ed it say it like­ly was the emer­gence from an an­i­mal reser­voir that then in­fect­ed in­di­vid­u­als, but it could have been some­thing else, and we need to find that out. So, you know, that’s the rea­son why I said I’m per­fect­ly in fa­vor of any in­ves­ti­ga­tion that looks in­to the ori­gin of the virus,” Fau­ci said.

Sen. Josh Haw­ley (R-MO) al­so in­tro­duced a bill on Wednes­day to re­quire the Di­rec­tor of Na­tion­al In­tel­li­gence to de­clas­si­fy in­for­ma­tion re­lat­ing to the ori­gin of Covid.

The in­quiry is be­ing con­duct­ed against a back­drop of in­creas­ing­ly volatile trade talks with Chi­na, threat­en­ing to spark a con­fronta­tion over the virus that could spill in­to oth­er are­nas.

EMA to health providers: ‘in­suf­fi­cient ev­i­dence’ that in­haled cor­ti­cos­teroids help with Covid-19

The Eu­ro­pean Med­i­cines Agency’s Covid-19 task force said Thurs­day that there is cur­rent­ly in­suf­fi­cient ev­i­dence that in­haled cor­ti­cos­teroids are ben­e­fi­cial for peo­ple with COVID-19.

“Al­though the task­force found no safe­ty risks from stud­ies so far, it could not ex­clude the pos­si­bil­i­ty of harm from the use of in­haled cor­ti­cos­teroids in pa­tients with COVID-19 who have nor­mal lev­els of oxy­gen,” EMA said. But the agency al­so not­ed that clin­i­cal tri­als do still sup­port the use of dex­am­etha­sone, a sys­temic cor­ti­cos­teroid, in pa­tients with Covid-19.

Rus­sia’s Supreme Court re­jects Gilead law­suit over unau­tho­rized remde­sivir gener­ic

Rus­sia’s Supreme Court on Thurs­day re­ject­ed a law­suit from Gilead chal­leng­ing the Russ­ian gov­ern­ment’s de­ci­sion last year to al­low the de­vel­op­ment of a gener­ic ver­sion of remde­sivir with­out Gilead’s con­sent, Reuters re­port­ed.

Ear­li­er this week, Rus­sia shipped 225,000 packs of the gener­ic, known as Remde­form, to In­dia as part of its hu­man­i­tar­i­an aid con­tri­bu­tions, and more may be on the way.

WHO to mem­ber states: Please sup­port the Covid-19 Tech­nol­o­gy Ac­cess Pool

Tedros Ad­hanom, the di­rec­tor-gen­er­al of the WHO, and Cos­ta Ri­ca’s pres­i­dent, Car­los Al­vara­do Que­sa­da, on Thurs­day sent a let­ter to all mem­ber states, call­ing on them to im­prove eq­ui­table glob­al ac­cess to Covid-19 health tech­nolo­gies through the vol­un­tary pool­ing of knowl­edge, in­tel­lec­tu­al prop­er­ty and da­ta to sup­port tech­nol­o­gy trans­fer and rapid­ly ex­pand man­u­fac­tur­ing through­out the world in need.

“As a glob­al com­mu­ni­ty we must lever­age C-TAP’s po­ten­tial to ac­com­mo­date dif­fer­ent stake­hold­ers and pro­vide time­ly, sus­tain­able, and ef­fec­tive so­lu­tions to pro­mote ac­cess and ac­cel­er­ate lo­cal pro­duc­tion,” the let­ter says.

Sep­a­rate­ly, the WHO al­so an­nounced Thurs­day that Africa needs at least 20 mil­lion dos­es of the Ox­ford-As­traZeneca vac­cine in the next six weeks to get sec­ond dos­es to all who re­ceived a first dose with­in the 8—12-week in­ter­val rec­om­mend­ed by the WHO.

“To date, 28 mil­lion COVID-19 dos­es, of dif­fer­ent vac­cines, have been ad­min­is­tered in Africa, which rep­re­sents less than two dos­es ad­min­is­tered per 100 peo­ple in Africa,” WHO said.

An­oth­er 200 mil­lion dos­es of any vac­cine are al­so need­ed so that the con­ti­nent can vac­ci­nate 10% of its pop­u­la­tion by Sep­tem­ber, the non­prof­it added.

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

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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