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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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