Covid-19 roundup: Pfiz­er says Xel­janz re­duced death and lung fail­ure in hos­pi­tal­ized Covid-19 pa­tients; US halts dis­tri­b­u­tion of Eli Lil­ly’s mAb com­bo to Rhode Is­land due to vari­ants

In ad­di­tion to its ul­tra-ef­fec­tive mR­NA vac­cine, Pfiz­er be­lieves it could have an­oth­er weapon to fight the Covid-19 pan­dem­ic.

The com­pa­ny re­port­ed on Wednes­day that its rheuma­toid arthri­tis block­buster Xel­janz sig­nif­i­cant­ly low­ered the in­ci­dence of death or res­pi­ra­to­ry fail­ure in hos­pi­tal­ized pa­tients with Covid-19 pneu­mo­nia in Brazil.

“To ef­fec­tive­ly com­bat the COVID-19 pan­dem­ic, there re­mains a crit­i­cal need for mul­ti­ple ther­a­peu­tic op­tions to treat pa­tients who have con­tract­ed the virus,” Tamas Kon­cz, CMO of Pfiz­er In­flam­ma­tion & Im­munol­o­gy, said in a state­ment.

The tri­al — con­duct­ed in col­lab­o­ra­tion with the Aca­d­e­m­ic Re­search Or­ga­ni­za­tion (ARO) from the Hos­pi­tal Is­raeli­ta Al­bert Ein­stein in Sao Paulo, Brazil — en­rolled 289 hos­pi­tal­ized adults who were not on ven­ti­la­tion. Most of the pa­tients (89.3%) al­so used glu­co­cor­ti­coids dur­ing hos­pi­tal­iza­tion, pre­dom­i­nant­ly dex­am­etha­sone.

Pa­tients in the treat­ment arm re­ceived two 10 mg dos­es a day, for up to 14 days or un­til hos­pi­tal dis­charge. At Day 28, death or res­pi­ra­to­ry fail­ure oc­curred in 18.1% of Xel­janz pa­tients, com­pared to 29% in the place­bo group (p=0.04).  Death from any cause through day 28 was 2.8% in the Xel­janz group and 5.5% in the place­bo group.

As for safe­ty, se­ri­ous ad­verse events oc­curred in 20 pa­tients (14.1%) in the Xel­janz group and 17 pa­tients (12%) in the place­bo group.

“We look for­ward to our con­tin­ued col­lab­o­ra­tion as we an­a­lyze the full dataset from this study and as­sess next steps,” Kon­cz said.

US halts dis­tri­b­u­tion of Eli Lil­ly’s mAb com­bo to Rhode Is­land due to vari­ants

The US gov­ern­ment is adding Rhode Is­land to the list of states that will no longer re­ceive Eli Lil­ly’s Covid-19 mon­o­clon­al an­ti­body com­bo treat­ment due to an el­e­vat­ed fre­quen­cy of con­cern­ing vari­ants.

Com­bined fre­quen­cies of the Gam­ma (or P.1) vari­ant first iden­ti­fied in Brazil and the Be­ta (B.1.351) vari­ant first iden­ti­fied in South Africa now ex­ceed 10% in Rhode Is­land and are trend­ing up­ward, ac­cord­ing to the CDC. And re­sults from in vit­ro as­says, us­ing “pseu­do-virus par­ti­cles,” sug­gest that Eli Lil­ly’s bam­lanivimab and ete­se­vimab com­bi­na­tion isn’t ac­tive against ei­ther vari­ant.

As a re­sult, the as­sis­tant sec­re­tary for pre­pared­ness and re­sponse (AS­PR) is paus­ing the dis­tri­b­u­tion of bam­lanivimab and ete­se­vimab — and ete­se­vimab alone, to pair with an ex­ist­ing sup­ply of bam­lanivimab at one fa­cil­i­ty — to Rhode Is­land “un­til fur­ther no­tice.” The gov­ern­ment has al­ready slammed the brakes on dis­tri­b­u­tion to Ari­zona, Cal­i­for­nia, Flori­da, Illi­nois, In­di­ana, Mass­a­chu­setts, Ore­gon and Wash­ing­ton, where the fre­quen­cy of the Gam­ma and Be­ta vari­ants has al­so sur­passed 10%.

Back in March, the US gov­ern­ment and Eli Lil­ly agreed to halt all dis­tri­b­u­tion of bam­lanivimab alone due to the “sus­tained in­crease” of coro­n­avirus vari­ants coun­try­wide. How­ev­er, all treat­ment de­liv­ery sites were still able to or­der Lil­ly’s com­bo treat­ment, or Re­gen­eron’s an­ti­body cock­tail, the AS­PR and FDA said.

Go­ing forth, the AS­PR said health­care providers in the pre­vi­ous­ly men­tioned states should re­ly on Re­gen­eron’s RE­GEN-COV and Glax­o­SmithK­line’s sotro­vimab, which are “like­ly to re­tain ac­tiv­i­ty” against the Gam­ma and Be­ta vari­ants.

“AS­PR and FDA will con­tin­ue to work with the CDC and the Na­tion­al In­sti­tutes of Health on sur­veil­lance of vari­ants that may im­pact the use of the mon­o­clon­al an­ti­body ther­a­pies au­tho­rized for emer­gency use,” the AS­PR said in an an­nounce­ment.

Hun­dreds of health work­ers who re­ceived Sino­vac’s vac­cine are in­fect­ed with Covid-19 — re­port

De­spite re­ceiv­ing Sino­vac’s Covid-19 vac­cine, more than 350 med­ical work­ers in In­done­sia have been in­fect­ed with the virus, ac­cord­ing to Reuters.

The shot — which was just ef­fec­tive enough to meet reg­u­la­to­ry stan­dards — was giv­en the World Health Or­ga­ni­za­tion’s OK for emer­gency use ear­li­er this month. It’s al­so the first Chi­nese Covid-19 vac­cine to be con­sid­ered by the Eu­ro­pean Med­i­cines Agency, which kicked off a rolling re­view of the in­ac­ti­vat­ed vac­cine back in May.

Badai Is­moyo, head of the health of­fice in Kudus, said most of the work­ers are asymp­to­matic, but dozens have been hos­pi­tal­ized, ac­cord­ing to Reuters. And across the whole coun­try, at least six health work­ers have died from Covid-19 af­ter re­ceiv­ing the vac­cine (one of them had on­ly re­ceived a first shot).

The out­break is be­lieved to be caused by the Delta vari­ant, first iden­ti­fied in In­dia, Reuters re­port­ed.

Up­on fil­ing for con­di­tion­al mar­ket au­tho­riza­tion with Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion back in Feb­ru­ary, Sino­vac said that tri­al re­sults from Brazil and Turkey sug­gest­ed the shot pre­vent­ed 50.65% of all Covid-19 cas­es, 83.70% of cas­es re­quir­ing med­ical treat­ment, and 100% of hos­pi­tal­iza­tions, and se­vere or fa­tal cas­es 14 days af­ter the sec­ond dose was ad­min­is­tered.

Aus­tralia push­es age lim­it for As­traZeneca’s vac­cine to 60 

Months af­ter lim­it­ing the use of As­traZeneca’s vac­cine to peo­ple over 50 years old, Aus­tralia is now push­ing the age lim­it to 60, Reuters re­port­ed. 

The move fol­lows the deaths of two peo­ple who had re­ceived the vac­cine, Aus­tralia’s Min­is­ter for Health Greg Hunt told Reuters. Six­ty cas­es of blood clots have been linked to the vac­cine, out of 3.3 mil­lion dos­es ad­min­is­tered in the coun­try, he said.

“This up­dat­ed ad­vice re­ceived to­day is based on new ev­i­dence demon­strat­ing a high­er risk for the very rare (throm­bo­cy­tope­nia syn­drome) con­di­tion in the 50-59 year-old age group,” Hunt said, per Reuters.

It marks the lat­est re­stric­tion around As­traZeneca’s shot fol­low­ing a se­ries of safe­ty con­cerns. Af­ter con­duct­ing an in-depth re­view of cere­bral ve­nous si­nus throm­bo­sis (CVST) and splanch­nic vein throm­bo­sis cas­es back in April, the EMA con­clud­ed that very rare but some­times fa­tal blood clots should be list­ed as a side ef­fect for As­traZeneca’s Covid-19 vac­cine. How­ev­er, a num­ber of coun­tries have moved to re­strict the vac­cine’s use to peo­ple un­der a cer­tain age.

Ger­many said back in March that it would stop us­ing the vac­cine in peo­ple un­der 60 years old, and in April the Philip­pines fol­lowed suit. That same week, the French health reg­u­la­tor Haute Au­torité de San­té said pa­tients un­der 55 who had re­ceived the first dose of As­traZeneca’s vac­cine should get their sec­ond dose from one of Pfiz­er/BioN­Tech or Mod­er­na’s mR­NA-based shots. Of­fi­cials rec­om­mend­ed a 12-week in­ter­val be­tween each dose.

In May, the UK’s Joint Com­mit­tee on Vac­ci­na­tion and Im­mu­ni­sa­tion called to re­strict the use of the vac­cine to on­ly those who are over 40 years old.

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

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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#JPM23: What's re­al­ly dri­ving the cost of health­care and drugs in 2023?

Executive Editor Drew Armstrong spoke with PhRMA CEO Steve Ubl, EmsanaRx CEO Greg Baker and ICER President Steve Pearson about how the debate over drug costs has changed (or not) in the last decade, the shifting payer landscape and why there seems to be so little movement on drug rebates. This transcript has been edited for brevity and clarity.

Drew Armstrong:

So first of all, thank you to everybody for being here and for our panel for being here. Incredibly excited to have this discussion on the cost of healthcare and drugs and what’s driving that. We’re here with Steve Ubl, the head of PhRMA. Thank you so much. Steve Pearson from ICER, and Greg Baker from EmsanaRx. I want to start this conversation with a little bit of a personal reminiscence. So about almost 10 years exactly. I was a reporter back in my previous job and I was covering drug pricing and Gilead had just launched their hepatitis C drug and I was having a conversation with another Steve over at Express Scripts and he made some comments essentially about how they intended to launch a price war over hepatitis C therapies.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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