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.

Achiev­ing Dig­i­tal Trans­for­ma­tion: Un­lock­ing Cost Re­duc­tion, Clin­i­cal Ex­cel­lence & Pre­ci­sion Ther­a­peu­tics Man­u­fac­tur­ing

In the dynamic landscape of pharmaceutical and biotech industries, L7 Informatics is leading the charge in transforming traditional operations through digital innovation. With a firm focus on cost reduction, clinical improvements, reducing tech-transfer times, L7 Informatics is revolutionizing the way companies research, develop, and manufacture while also prioritizing the well-being of patients and providers thereby paving the way for a future where patients receive better treatments at lower costs.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.

Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.