Covid-19 roundup: Sup­ply chain short­ages lead to half the Mod­er­na dos­es de­liv­ered to Cana­da; J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed — re­port

The num­ber of dos­es of Mod­er­na’s vac­cine ex­pect­ed to be de­liv­ered to Cana­da by the end of April has near­ly been cut in half, ac­cord­ing to the coun­try’s pro­cure­ment min­is­ter Ani­ta Anand.

Be­tween 1 mil­lion and 2 mil­lion dos­es of the 12.3 mil­lion ex­pect­ed to be de­liv­ered in time for the sec­ond quar­ter will be de­layed un­til the third, as Mod­er­na said Fri­day that ship­ments to Cana­da and the UK are be­hind sched­ule af­ter a sup­ply chain short­age will de­lay de­liv­er­ies.

De­liv­er­ies to the EU and Switzer­land are on sched­ule, the com­pa­ny said.

These com­pli­ca­tions have short­ened the vac­cine sup­ply in Eu­rope, as side ef­fects linked to J&J and As­traZeneca’s vac­cines have led the UK to ad­vise preg­nant women to get ei­ther Mod­er­na or Pfiz­er’s shot. — Josh Sul­li­van

J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed re­port

A week af­ter the CDC and FDA joint­ly de­cid­ed to pause the roll­out of John­son & John­son’s Covid-19 vac­cine due to re­ports of blood clots, we’re get­ting a clos­er look at why.

Un­named sources told the Wall Street Jour­nal that health au­thor­i­ties rec­om­mend­ed sus­pend­ing the shots out of con­cern that doc­tors would im­prop­er­ly treat the con­di­tion. The CDC has ad­vised against us­ing he­parin, which is nor­mal­ly used for blood clots, but could be dan­ger­ous in this set­ting.

Sources told the WSJ that 4 of 6 women who de­vel­oped the clots af­ter be­ing vac­ci­nat­ed with J&J’s jab were treat­ed with the an­ti­co­ag­u­lant, which may have wors­ened their con­di­tion. While the clots haven’t of­fi­cial­ly been linked to the vac­cine, of­fi­cials are be­com­ing more per­suad­ed that the cas­es are re­lat­ed, ac­cord­ing to the WSJ.

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices held off last week on de­cid­ing whether or not to rec­om­mend lift­ing the pause, af­ter many of the com­mit­tee mem­bers said they want­ed to wait for more da­ta. They’re now sched­uled to meet again on Fri­day, to dis­cuss whether to con­tin­ue the roll­out with a warn­ing, lim­it the use of the vac­cine, or slam the brakes on the jabs al­to­geth­er.

On “Meet the Press” on Sun­day, An­tho­ny Fau­ci told NBC’s Chuck Todd that he ex­pects to know more by then.

“I think by Fri­day we’ll know which way we’re go­ing on this. Hope­ful­ly we’ll get back on track,” he said.

One of the op­tions on the ta­ble is lim­it­ing the vac­cine’s use to old­er peo­ple, as the blood clots oc­curred in younger women. —Nicole De­Feud­is

Italy throws sup­port in­to do­mes­tic mR­NA vac­cine pro­duc­tion

Af­ter sup­port for the ade­n­ovirus-based J&J and As­traZeneca Covid-19 vac­cines have wa­vered due to re­ports of safe­ty con­cerns, Italy has held talks with man­u­fac­tur­ers about pro­duc­ing more mR­NA-based vac­cines do­mes­ti­cal­ly, ac­cord­ing to the Fi­nan­cial Times.

Mod­er­na, No­var­tis and Ital­ian drug­mak­er Re­i­Thera have been in talks with the cap­i­tal in Rome about pro­duc­ing Cure­Vac’s vac­cine. All of the par­ties in­volved have de­clined to com­ment, the FT re­port­ed.

Faith in the ade­n­ovirus-based vac­cines has fal­tered af­ter a re­cent de­ci­sion in the US to tem­porar­i­ly halt ad­min­is­ter­ing the J&J vac­cine af­ter 6 re­ports of blood clots in pa­tients. Pre­vi­ous­ly, some Eu­ro­pean coun­tries have put a hold on the use of the As­traZeneca shot af­ter the EMA found a very rare link be­tween the vac­cine and sim­i­lar blood clots.

There was no in­di­ca­tion that the Ital­ian-made dos­es would be sole­ly for the peo­ple of Italy, but rather, all of Eu­rope, the FT re­port­ed. — Josh Sul­li­van

Rus­sia RDIF reach­es man­u­fac­tur­ing agree­ment for Sput­nik V

A Chi­nese drug­mak­er has reached an agree­ment with Rus­sia’s RDIF sov­er­eign wealth fund to pro­duce more than 100 mil­lion dos­es of the Sput­nik V vac­cine.

Reuters re­port­ed that the two sides have com­mit­ted to a long-term part­ner­ship, though fi­nan­cial terms or the length of that deal were not dis­closed. Last week, Ger­man Health Min­is­ter Jens Spahn said that the coun­try will en­ter pre­lim­i­nary ne­go­ti­a­tions with Rus­sia for the use of Sput­nik V, but on­ly af­ter the EMA has giv­en it au­tho­riza­tion.

The Fi­nan­cial Times re­port­ed that the EMA is in­ves­ti­gat­ing whether the vac­cine meets good clin­i­cal prac­tice (GCP) stan­dards, af­ter con­cerns that tri­als weren’t run eth­i­cal­ly. — Josh Sul­li­van

Amidst con­cerns sur­round­ing oth­er vac­cines, the EU ups its Pfiz­er vac­cine dos­es

An­oth­er 100 mil­lion dos­es of the Pfiz­er-BioN­Tech Covid-19 vac­cine are head­ed to the EU, Bloomberg has re­port­ed.

The op­tion ex­er­cised rais­es its or­der to 600 mil­lion dos­es, as part of an agree­ment signed in Feb­ru­ary. Last week, the two com­pa­nies agreed to up ship­ments to the EU by 25% this quar­ter. That brought an­oth­er 50 mil­lion dos­es to the coun­try that had orig­i­nal­ly been sched­uled to be de­liv­ered in the fourth quar­ter. — Josh Sul­li­van

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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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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