Janet Woodcock and Francis Collins (FDA/NIH)

Covid-19 roundup: FDA and NIH lead­ers con­tin­ue shar­ing lessons from the pan­dem­ic; Slove­nia halts J&J vac­cine roll­out to in­ves­ti­gate death — re­port

Back in March, FDA act­ing com­mis­sion­er Janet Wood­cock and NIH di­rec­tor Fran­cis Collins be­gan the long, slow process of ex­plain­ing some of the lessons they’ve learned since the start of the Covid-19 pan­dem­ic — rang­ing from the lack of re­search in­fra­struc­ture to the im­por­tance of part­ner­ships with in­dus­try.

Yes­ter­day, they went in­to round 2 on what needs to change in prepa­ra­tion for the next pan­dem­ic, point­ing to the White House’s $65 bil­lion Pan­dem­ic Pre­pared­ness Plan.

Ac­cord­ing to Wood­cock, the FDA has an­a­lyzed and col­lect­ed in­for­ma­tion from Jan­u­ary through May of this year on the fed­er­al gov­ern­ment’s over­all re­sponse to the pan­dem­ic — con­dens­ing every­thing in­to a draft of 29 rec­om­men­da­tions. Some of them have been re­peat­ed­ly called for by Wood­cock and Collins, such as in­vest­ments in­to pub­lic health in­fra­struc­ture and im­prov­ing the struc­ture of clin­i­cal tri­als.

“If we’re re­al­ly se­ri­ous about prepar­ing for the next pan­dem­ic, while we’re still try­ing to fin­ish deal­ing with this one, it’s go­ing to take re­sources,” Collins said.

Al­bert Bourla

One of the points in the Biden ad­min­is­tra­tion’s plan in­clud­ed vac­cine de­vel­op­ment and dis­tri­b­u­tion, with the pro­pos­al call­ing for $24.2 bil­lion in spend­ing to de­vel­op and man­u­fac­ture shots with­in 100 days af­ter a new threat has been de­tect­ed, a feat Pfiz­er CEO Al­bert Bourla has said his com­pa­ny can ac­com­plish. Of­fi­cials would ide­al­ly de­liv­er enough shots for every Amer­i­can in the sub­se­quent 30 days, fol­lowed by the glob­al pop­u­la­tion in the 70 days af­ter that, ac­cord­ing to the plan.

This would be a sig­nif­i­cant change of pace, con­sid­er­ing the av­er­age time­frame for a vac­cine to go from R&D through test­ing and mar­ket ap­proval cur­rent­ly takes years, not months. Even with the Covid-19 vac­cines, it took 9 months to start dis­tri­b­u­tion, and that was the fastest launch ever. Es­sen­tial­ly, the plan calls for go­ing from iden­ti­fy­ing a po­ten­tial pan­dem­ic to mak­ing close to 8 bil­lion dos­es in less than sev­en months.

While Wood­cock praised the amount of col­lab­o­ra­tion be­tween in­ter-gov­ern­men­tal agen­cies over the course of the pan­dem­ic, Collins em­pha­sized the im­por­tance of pub­lic-pri­vate part­ner­ships, like the one known as AC­TIV, which came to­geth­er to pri­or­i­tize dif­fer­ent ther­a­peu­tic can­di­dates. — Paul Schloess­er

Slove­nia halts J&J vac­cine roll­out to in­ves­ti­gate death — re­port

Sev­er­al months af­ter the US lift­ed its hold on J&J’s Covid-19 shot, an­oth­er coun­try has tem­porar­i­ly sus­pend­ed the vac­cine over the death of a young woman, Reuters re­port­ed.

Slove­nia is halt­ing the dis­tri­b­u­tion of J&J’s sin­gle-dose vac­cine as it in­ves­ti­gates the death of a 20-year-old woman, ac­cord­ing to the na­tion­al STA news agency. The woman, who died with­in two weeks of re­ceiv­ing the shot, had both blood clots and bleed­ing in the brain, ac­cord­ing to Reuters.

“I can’t make com­ments, but the con­di­tions have been met for clar­i­fy­ing all the cir­cum­stances of what hap­pened,” said Ig­or Rigler, a neu­rol­o­gist at the Ljubl­jana hos­pi­tal cen­ter, per Reuters.

The FDA and CDC joint­ly de­cid­ed to stop ad­min­is­ter­ing J&J’s shot in the US back in April af­ter re­ceiv­ing re­ports of a rare but se­ri­ous type of blood clot. Most cas­es have oc­curred in women be­tween the ages of 18 and 49, and some have been fa­tal, the FDA said at the time.  How­ev­er, reg­u­la­tors lift­ed the pause less than two weeks lat­er, de­cid­ing that the vac­cine’s known and po­ten­tial ben­e­fits out­weigh the risks.

The agency up­dat­ed fact sheets for vac­cine re­cip­i­ents to note the risk of blood clots and low lev­els of platelets, al­so known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome. Over in Eu­rope, the EMA’s safe­ty com­mit­tee al­so rec­om­mend­ed adding a warn­ing to the la­bel re­gard­ing the risk of clots.

In Ju­ly, the FDA added a sec­ond warn­ing to the vac­cine’s la­bel, af­ter da­ta was dis­cov­ered “con­nect­ing the shot to an in­creased risk” of Guil­lain-Bar­ré syn­drome, a rare con­di­tion where the body’s im­mune sys­tem at­tacks its nerves. Once again, the agency em­pha­sized that the ben­e­fits of tak­ing the vac­cine “clear­ly” out­weigh the risks. — Nicole De­Feud­is 

FDA re­port­ed­ly con­sid­ers a half-dose of Mod­er­na vac­cine — but some Amer­i­cans aren’t wait­ing

Af­ter au­tho­riz­ing a boost­er shot of Pfiz­er’s Covid-19 vac­cine for cer­tain high-risk in­di­vid­u­als, reg­u­la­tors are re­port­ed­ly con­sid­er­ing half-dose boost­ers of the Mod­er­na vac­cine, ac­cord­ing to Bloomberg News. 

Ahead of an up­com­ing an­nounce­ment, un­named sources told Bloomberg on Tues­day that the FDA is lean­ing to­ward au­tho­riz­ing 50-mi­cro­gram boost­er shots of Mod­er­na’s vac­cine. The com­pa­ny’s ini­tial shots were 100-mi­cro­gram dos­es, com­pared to the Pfiz­er shot, which has been au­tho­rized for 30-mi­cro­gram ini­tial dos­es fol­lowed by a 30-mi­cro­gram boost­er.

Au­tho­riz­ing a third half-dose would al­low Mod­er­na to put out more dos­es in the near-term, while low­er­ing the risk of side ef­fects, Bloomberg re­port­ed.

The news comes a week af­ter the FDA au­tho­rized a third Pfiz­er shot for some peo­ple, in­clud­ing those over 65 years old, at high-risk of se­vere Covid-19, or those whose “in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure” put them at risk. That in­cludes groups like teach­ers, gro­cery work­ers, and those in pris­ons or home­less shel­ters.

The FDA’s OK is much nar­row­er than Pfiz­er had hoped. The phar­ma had ini­tial­ly ap­plied for sup­ple­men­tal ap­proval of the boost­er shot for any­one who’s el­i­gi­ble for the ini­tial shots.

But some Amer­i­cans aren’t wait­ing for the FDA’s bless­ing to get their third shot. Ac­cord­ing to a Wall Street Jour­nal re­port, doc­tors and phar­ma­cies are rapid­ly ad­min­is­ter­ing the shots, of­ten­times with­out proof of el­i­gi­bil­i­ty. Some pa­tients have re­port­ed get­ting a third dose of the Mod­er­na vac­cine — which is not yet au­tho­rized — with no trou­ble at all. CVS spokesper­son Michael DeAn­ge­lis told the WSJ that the chain is dol­ing out third Mod­er­na dos­es to those who self-at­test to their el­i­gi­bil­i­ty. — Nicole De­Feud­is 

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

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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ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

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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