Joe Biden (Carolyn Kaster, AP Images)

Covid-19 roundup: Biden in­vests $1.7B to ad­dress Covid vari­ants; EU puts faith in Pfiz­er with new vac­cine deals

The Biden ad­min­is­tra­tion said Fri­day that it’ll pump $1.7 bil­lion in­to var­i­ous pro­grams to ad­dress Covid-19 vari­ants as the orig­i­nal strain of Covid-19 makes up on­ly about half of all US cas­es to­day.

Most of those new funds, $1 bil­lion in to­tal, will go to ex­pand ge­nom­ic se­quenc­ing so the CDC, states and oth­er ju­ris­dic­tions can im­prove their ca­pac­i­ty to iden­ti­fy Covid mu­ta­tions and mon­i­tor the cir­cu­la­tion of vari­ants. Back in Feb­ru­ary, US labs were on­ly se­quenc­ing about 8,000 Covid-19 strains per week, al­though the rate of se­quenc­ing has in­creased sub­stan­tial­ly since then, the ad­min­is­tra­tion said.

In ad­di­tion, the ad­min­is­tra­tion will spend $400 mil­lion to launch six new Cen­ters of Ex­cel­lence in Ge­nom­ic Epi­demi­ol­o­gy, which will work in part­ner­ship with state health de­part­ments and aca­d­e­m­ic in­sti­tu­tions. “For ex­am­ple, the part­ner­ships could fo­cus on de­vel­op­ing new ge­nom­ic sur­veil­lance tools to bet­ter track pathogens of pub­lic health in­ter­est with the ob­jec­tive of de­vel­op­ing sur­veil­lance meth­ods to be used more wide­ly in the pub­lic health sys­tem.  Ar­eas of fo­cus will like­ly in­clude bioin­for­mat­ic work­flows and the crit­i­cal in­te­gra­tion of ge­nom­ic and epi­demi­o­log­ic da­ta,” the ad­min­is­tra­tion said.

An­oth­er $300 mil­lion will go to­ward build­ing and sup­port­ing a na­tion­al bioin­for­mat­ics in­fra­struc­ture to bet­ter con­nect the dots be­tween how pathogens spread and mu­tate. This fund­ing al­so will sup­port train­ing to in­crease se­quenc­ing in clin­i­cal set­tings and ex­pand CDC’s Bioin­for­mat­ics Fel­low­ship pro­gram. — Zachary Bren­nan

EU adds 50m new Pfiz­er dos­es

As months of ten­sion be­tween As­traZeneca and the EU fi­nal­ly boil over, EC pres­i­dent Ur­su­la von der Leyen has an­nounced the bloc is now putting its faith in Pfiz­er/BioN­Tech.

The EC has reached an agree­ment with Pfiz­er and BioN­Tech to speed up the de­liv­ery of their vac­cine to the bloc, von der Leyen said in a state­ment Wednes­day. An ad­di­tion­al 50 mil­lion dos­es are set to be de­liv­ered in Q2, which were ini­tial­ly sched­uled for de­liv­ery in Q4. That’ll bring the bloc’s to­tal Q2 sup­ply to 250 mil­lion dos­es of the Pfiz­er/BioN­Tech jab.

The EC is al­so strik­ing a third con­tract with the com­pa­nies for 1.8 bil­lion more dos­es be­tween 2021 and 2023.

“I want to thank BioN­Tech-Pfiz­er,” von der Leyen said. “It has proven to be a re­li­able part­ner. It has de­liv­ered on its com­mit­ments, and it is re­spon­sive to our needs.”

Ten­sions flared be­tween the EU and As­traZeneca back in Feb­ru­ary, when an EU of­fi­cial said the com­pa­ny would miss its sup­ply tar­get by about half. CEO Pas­cal So­ri­ot said the con­tracts are not legal­ly bind­ing due to a “best ef­fort” clause in the text. But in March, Italy blocked the de­liv­ery of about 250,000 dos­es of the As­traZeneca/Ox­ford vac­cine to Aus­tralia — the first such in­ter­ven­tion in vac­cine ex­ports af­ter the EU in­tro­duced new rules gov­ern­ing such ship­ments in late Jan­u­ary.

Since then, a list of coun­tries have paused the roll­out of As­traZeneca’s vac­cine due to re­ports of blood clots. Last week, the EMA ac­knowl­edged a link be­tween the jab and rare but some­times fa­tal blood clots, sug­gest­ing they should be list­ed as a side ef­fect.

Von der Leyen said on Wednes­day:

At a cer­tain point in time, we might need boost­er jabs to re­in­force and pro­long im­mu­ni­ty; and if es­cape-vari­ants oc­cur, we will need to de­vel­op vac­cines that are adapt­ed to new vari­ants; and we will need them ear­ly and in suf­fi­cient quan­ti­ties. Hav­ing this in mind we need to fo­cus on tech­nolo­gies that have proven their worth. mR­NA vac­cines are a clear case in point.

Pfiz­er CEO Al­bert Bourla says a boost­er shot could be need­ed in near fu­ture — re­port

As coun­tries strug­gle to get vac­cines in arms, Pfiz­er CEO Al­bert Bourla says it’s like­ly a third dose will be need­ed in the next six to 12 months.

Bourla told CN­BC’s Bertha Coombs on April 1 that in ad­di­tion to a boost­er dose in the near fu­ture, it’s pos­si­ble peo­ple will need to get vac­ci­nat­ed against Covid-19 an­nu­al­ly, much like the sea­son­al flu. The in­ter­view wasn’t made pub­lic un­til Thurs­day.

This is on par with what Mod­er­na CEO Stéphane Ban­cel told End­points News ear­li­er this week: Be­cause the virus is like­ly to mu­tate very quick­ly in the next cou­ple years, there may be a need for “sev­er­al boosts,” es­pe­cial­ly for peo­ple at high risk.

“We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts,” Ban­cel said.

Mod­er­na re­leased pre­clin­i­cal da­ta this week sug­gest­ing its vari­ant-spe­cif­ic boost­ers pro­duced a suf­fi­cient im­mune re­sponse against con­cern­ing vari­ants.

Ear­li­er this month, Pfiz­er said its BioN­Tech-part­nered jab demon­strat­ed “strong pro­tec­tion” six months af­ter the sec­ond dose, with an over­all ef­fi­ca­cy rate of 91.3% and an over 95% ef­fi­ca­cy rate against se­vere dis­ease. Mod­er­na said its own up­dat­ed re­view con­firms the jab is more than 90% ef­fec­tive against all cas­es, and over 95% ef­fec­tive against se­vere cas­es.

Take­da’s Fi­razyr flops I-SPY tri­al with crit­i­cal­ly ill Covid-19 pa­tients

An­oth­er day, an­oth­er re­pur­posed Covid-19 treat­ment fail­ure.

Quan­tum Leap Health­care Col­lab­o­ra­tive is drop­ping Take­da’s Fi­razyr (icat­i­bant) from its I-SPY tri­al af­ter a da­ta mon­i­tor­ing com­mit­tee con­clud­ed that it had a low prob­a­bil­i­ty of re­duc­ing pa­tients’ time to re­cov­ery or mor­tal­i­ty when added to razuprotafib and apremi­last.

Re­searchers not­ed no safe­ty con­cerns, Quan­tum Leap said in a state­ment.

The I-SPY Tri­als were de­signed to rapid­ly screen promis­ing ex­per­i­men­tal Covid-19 treat­ments and iden­ti­fy the most ef­fec­tive. Fi­razyr, ap­proved for acute at­tacks of hered­i­tary an­gioede­ma (HAE), was giv­en to pa­tients every 8 hours for 6 days, in com­bi­na­tion with the “back­bone” ther­a­py. Af­ter all pa­tients reached a 28-day fol­low-up, da­ta sug­gest­ed there was a low prob­a­bil­i­ty that the drug made a dif­fer­ence com­pared to the con­trol arm.

“While this drug did not meet our high bar for im­prov­ing time to re­cov­ery in this pop­u­la­tion, the I-SPY COVID Tri­al was suc­cess­ful in quick­ly achiev­ing its ob­jec­tive of rul­ing out a ben­e­fi­cial ef­fect of icat­i­bant on the pri­ma­ry end­point of time to re­cov­ery,”  Derek Rus­sell, co-chap­er­one of the icat­i­bant arm in the I-SPY tri­al, said in a state­ment.

“The study will con­tin­ue to eval­u­ate oth­er agents with the po­ten­tial to im­prove the grave out­comes of this pop­u­la­tion,” he added.

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

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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