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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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