Covid-19 roundup: Hu­man er­ror to blame for steel found in Mod­er­na vials; Flu and Covid-19 shots safe to be tak­en to­geth­er — study

A month af­ter more than 1.6 mil­lion dos­es of Mod­er­na’s Covid-19 vac­cines were sus­pend­ed due to stain­less steel found in the vials, Take­da says that hu­man er­ror was the rea­son for the con­t­a­m­i­na­tion.

A Span­ish man­u­fac­tur­er no­ticed con­t­a­m­i­na­tion in Ju­ly, Reuters re­port­ed, but sup­plies were per­mit­ted to be shipped to Japan any­way. Three batch­es were sus­pend­ed for use in Japan, and Mod­er­na col­lab­o­rat­ed with Take­da and the Span­ish man­u­fac­tur­er Rovi to in­ves­ti­gate.

A new re­port says that the hu­man er­ror was due to mis­judg­ing a re­quired 1 mm gap be­tween the star-wheel and the stop­per of ma­chin­ery. Five lots man­u­fac­tured at Rovi be­tween June 27 and Ju­ly were in­ves­ti­gat­ed. Stain­less steel was found in­side of 39 vials in the first three lots, and a fourth and fifth lot failed in­spec­tion and were held back by Rovi.

Two men in their 30s died in Au­gust just days af­ter re­ceiv­ing the sec­ond dose of their shot, which was a part of the three lots that will be re­called. The cause of death is be­ing in­ves­ti­gat­ed right now.

De­spite more than a mil­lion dos­es be­ing held from dis­tri­b­u­tion, Japan’s vac­cine ef­forts have con­sis­tent­ly held up. Prime min­is­ter Yoshi­hide Suga has said that he was aim­ing for 60% of the pop­u­la­tion to be vac­ci­nat­ed by the end of Sep­tem­ber. On Sept. 30, 60.6% of Japan’s peo­ple had re­ceived both shots, while 70.8% re­ceived at least one shot.

Flu and Covid-19 shots safe to be tak­en to­geth­er – study

A UK study says it’s safe to re­ceive both the Covid-19 vac­cine and a flu shot at the same time, Reuters re­port­ed.

The study from the Uni­ver­si­ty of Bris­tol of 679 vol­un­teers at 12 sites across Eng­land and Wales found that side ef­fects were mild to mod­er­ate and that the im­mune re­sponse was not neg­a­tive­ly im­pact­ed for pro­tec­tion against ei­ther ill­ness.

Shots were giv­en to par­tic­i­pants on the same day in dif­fer­ent arms. When asked, 87% of par­tic­i­pants said that they would be will­ing to have the shots in the same day to save time plan­ning ap­point­ments.

The full re­sults will be pub­lished in the Lancet.

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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