Viravuth Yin (MDI Biological Laboratory)

Biotech co-founder set­tles ma­jor re­search mis­con­duct al­le­ga­tions with HHS

In one life, Vi­ravuth Yin is an in­ter­na­tion­al­ly-rec­og­nized ex­pert in re­gen­er­a­tive bi­ol­o­gy who pi­o­neered the use of the ze­brafish as a drug screen­ing plat­form, dis­cov­ered a po­ten­tial new re­gen­er­a­tive heart drug and spun that dis­cov­ery in­to a new biotech start­up known as No­vo Bio­sciences, where he now serves as co-founder and CSO.

But in an­oth­er life, a life that he’s try­ing to move past with an HHS set­tle­ment on Wednes­day, Yin is al­leged to have com­mit­ted ma­jor re­search mis­con­duct, in­clud­ing “know­ing­ly, in­ten­tion­al­ly, and/or reck­less­ly fal­si­fy­ing and/or fab­ri­cat­ing da­ta” on three pub­lished pa­pers and two man­u­scripts. Those three pub­lished pa­pers, two of which were pub­lished in iScience, will now be re­tract­ed, at Yin’s re­quest, ac­cord­ing to the set­tle­ment.

The set­tle­ment al­so ef­fec­tive­ly means that Yin, who was in­ves­ti­gat­ed be­cause of his NIH grant fund­ing, does not ad­mit nor de­ny those find­ings of re­search mis­con­duct, and it’s not an ad­mis­sion of li­a­bil­i­ty. But the set­tle­ment al­so means that Yin has agreed to al­low a com­mit­tee of two to three se­nior fac­ul­ty mem­bers at an aca­d­e­m­ic in­sti­tu­tion who are fa­mil­iar with his field of re­search, but not in­clud­ing his su­per­vi­sor or col­lab­o­ra­tors, to pro­vide over­sight and guid­ance to him for two years.

How that stip­u­la­tion will play out in the re­al world re­mains un­known as Yin no longer works at the Mount Desert Is­land Bi­o­log­i­cal Lab­o­ra­to­ry where the mis­con­duct al­leged­ly oc­curred.

It was the re­search Yin did at MDI­BL that al­lowed him to move over and co-found No­vo Bio­sciences along­side Kevin Strange, who stepped down as pres­i­dent of the MDI­BL in Ju­ly 2018 to work as the oth­er No­vo co-founder.

NIH’s grants data­base notes that Yin was the project leader for one grant worth more than $82,000 on com­par­a­tive an­i­mal mod­els at MDI­BL. The data­base notes, “This re­search in turn re­sult­ed in mul­ti­ple firsts for the MDI­BL in­clud­ing the dis­cov­ery of three lead small mol­e­cules for re­gen­er­a­tive med­i­cine ap­pli­ca­tions, six U.S. and in­ter­na­tion­al patent ap­pli­ca­tions, one is­sued U.S. patent and the launch of the spin­off com­pa­ny No­vo Bio­sciences.”

The Maine-based biotech No­vo has since re­ceived a two-year, $1.5 mil­lion re­search grant from the NIH for the fur­ther de­vel­op­ment of its po­ten­tial new heart treat­ment, as well as an­oth­er $4 mil­lion in funds raised for the com­pa­ny’s first hu­man tri­als.

Whether or not this re­search mis­con­duct, which HHS said in­clud­ed “re­port­ing re­search meth­ods and sta­tis­tics that were not per­formed” in at least five ex­per­i­men­tal re­sults, catch­es up with No­vo Bio­sciences re­mains to be seen.

Strange told Re­trac­tion Watch: “We are ful­ly con­fi­dent that the stud­ies cit­ed by ORI [Of­fice of Re­search In­tegri­ty] have no re­la­tion­ship to nor do they pro­vide any sci­en­tif­ic foun­da­tions for our pre­vi­ous and on­go­ing work. Dr. Yin re­mains a valu­able mem­ber of the No­vo Bio­sciences team.”

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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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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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.