Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

Covid-19 roundup: Sci­en­tists pull pre-print with in­flat­ed in­ci­dence of my­ocardi­tis post mR­NA vac­cine; As­traZeneca seeks EUA for long-act­ing an­ti­body

Cana­di­an sci­en­tists re­cent­ly with­drew an alarm­ing pre-print man­u­script that mis­tak­en­ly said the in­ci­dence of the heart con­di­tion my­ocardi­tis was a lot more fre­quent than ac­tu­al­ly iden­ti­fied fol­low­ing vac­ci­na­tion with ei­ther Mod­er­na’s or Pfiz­er’s mR­NA shot.

“In or­der to avoid mis­lead­ing ei­ther col­leagues or the gen­er­al pub­lic and press, we the au­thors unan­i­mous­ly wish to with­draw this pa­per on the grounds of in­cor­rect in­ci­dence da­ta. We thank the many peer re­view­ers who went out of their way to con­tact us and point out our er­ror. We apol­o­gize to any­one who may have been up­set or dis­turbed by our re­port,” they wrote in an up­date.

The man­u­script, first pub­lished on the preprint site medRx­iv last month iden­ti­fied 32 pa­tients with my­ocardi­tis and in­cor­rect­ly said that 32,379 dos­es were ad­min­is­tered, lead­ing to an es­ti­mat­ed in­ci­dence of 1 in 1,000. In re­al­i­ty, the num­ber of ad­min­is­tered dos­es dur­ing the pe­ri­od was more than 800,000, the re­searchers said, mean­ing the cor­rect in­ci­dence rate was re­al­ly about 1 in 25,000.

As of mid-Au­gust, the CDC said that it iden­ti­fied 2,574 re­ports of my­operi­cardi­tis or peri­cardi­tis in a fed­er­al data­base of ad­verse events, fol­low­ing more than 350 mil­lion dos­es ad­min­is­tered. The CDC al­so not­ed that most pa­tients (77%) re­cov­ered from symp­toms at time of re­port or fol­low-up.

Walid Gel­lad, a physi­cian and pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News that his un­der­stand­ing of the risk of vac­cine-as­so­ci­at­ed my­ocardi­tis ac­cord­ing to CDC es­ti­mates and oth­ers is that it is be­tween 1 in 6,000 and 1 in 10,000 for young men, af­ter the 2nd dose in par­tic­u­lar.

“CDC most re­cent­ly had it at 1 in 14,000 af­ter 2nd dose in men <30. If you look at On­tario da­ta which re­ports reg­u­lar­ly but al­so in­cludes peri­cardi­tis, it is 1 in 6,000 for 18-24 and 1 in 8,000 for un­der 17. It varies wide­ly and CDC needs to up­date what they are see­ing. In women, it is much much low­er and of much less con­cern. This is re­al­ly about males,” he added.

As­traZeneca sub­mits EUA for pro­phy­lac­tic treat­ment

As­traZeneca on Tues­day sought an EUA from the FDA for its long-act­ing an­ti­body (LAAB) com­bi­na­tion drug, which, like the Re­gen­eron mAb, can be used pro­phy­lac­ti­cal­ly for symp­to­matic Covid-19.

The ap­pli­ca­tion re­lies on da­ta from a Phase III tri­al show­ing the LAAB com­bo re­duced the risk of de­vel­op­ing symp­to­matic Covid-19 by 77% (95% con­fi­dence in­ter­val (CI): 46, 90) com­pared to place­bo, based on 25 cas­es of symp­to­matic Covid-19 at the pri­ma­ry analy­sis. More than 75% of the tri­al pop­u­la­tion in­clud­ed peo­ple with co-mor­bidi­ties and who may see an in­creased risk of se­vere dis­ease or a re­duced im­mune re­sponse to vac­ci­na­tion.

As­traZeneca li­censed the drug from Van­der­bilt Uni­ver­si­ty, which dis­cov­ered it. The com­pa­ny has re­ceived al­most $700 mil­lion from the US gov­ern­ment to fund the late stage clin­i­cal tri­al and large scale man­u­fac­tur­ing of the treat­ment. Un­der the terms of the li­cens­ing agree­ment with Van­der­bilt, As­traZeneca will pay sin­gle-dig­it roy­al­ties on fu­ture net sales.

The com­pa­ny pre­vi­ous­ly es­ti­mat­ed 100,000 dos­es of AZD 7442 could be avail­able from this project for the na­tion’s high-risk pop­u­la­tion.

Pfiz­er/BioN­Tech vac­cine 90% ef­fec­tive against hos­pi­tal­iza­tions for at least 6 months, Lancet study shows

New da­ta pub­lished Mon­day evening in the Lancet show that the Pfiz­er/BioN­Tech vac­cine ef­fec­tive­ness against hos­pi­tal­iza­tion for all vari­ants, in­clud­ing Delta, re­mains at 90% for at least six months.

The Pfiz­er-fund­ed study pro­vides ad­di­tion­al da­ta to sup­port the FDA’s re­cent de­ci­sion to au­tho­rize boost­ers for Amer­i­cans at high­er risk of in­fec­tions. Re­searchers an­a­lyzed more than 3 mil­lion elec­tron­ic health records from the Kaiser Per­ma­nente South­ern Cal­i­for­nia health sys­tem be­tween Dec. 2020, and Aug. 2021, find­ing vac­cine ef­fec­tive­ness against Delta vari­ant in­fec­tions at one month af­ter two dos­es of the Pfiz­er vac­cine was 93%, but that fell to 53% af­ter four months.

In a vari­ant-spe­cif­ic analy­sis, the Pfiz­er and Kaiser re­searchers found that re­duc­tions in the vac­cine’s ef­fec­tive­ness against in­fec­tions over time were more like­ly due to wan­ing than the Delta vari­ant es­cap­ing vac­cine pro­tec­tion.

Ef­fec­tive­ness against Delta-re­lat­ed hos­pi­tal­iza­tions re­mained high (93%) for the du­ra­tion of the study pe­ri­od.

J&J sub­mits boost­er da­ta to FDA for EUA

J&J on Tues­day morn­ing of­fi­cial­ly said it’s sub­mit­ted da­ta to the FDA for its boost­er shot.

The sub­mis­sion re­lies on re­cent re­sults from the Phase III EN­SEM­BLE 2 study that found a boost­er of the vac­cine giv­en 56 days af­ter the pri­ma­ry dose pro­vid­ed 94% pro­tec­tion against symp­to­matic Covid-19 in the U.S. (CI, 58%-100%) and 100% pro­tec­tion (CI, 33%-100%) against se­vere/crit­i­cal Covid-19, at least 14 days post-boost­er.

J&J said it plans to sub­mit the da­ta to oth­er reg­u­la­tors too, as well as the WHO and Na­tion­al Im­mu­niza­tion Tech­ni­cal Ad­vi­so­ry Groups world­wide to in­form de­ci­sion-mak­ing on lo­cal vac­cine ad­min­is­tra­tion strate­gies, as need­ed.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Aaron Siri, Siri & Glimstad

FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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