Swiss court keeps ex-GSK sci­en­tist's broth­er be­hind bars as US push­es to ex­tra­dite him on R&D theft charges

A Swiss crim­i­nal court is keep­ing Chi­nese sci­en­tist Gong­da Xue in jail for now as US of­fi­cials look to ex­tra­dite him for his role in a fam­i­ly en­ter­prise that stole more than a half bil­lion dol­lars in drug se­crets and trans­ferred them to Chi­na.

Lo­cal news sources in Switzer­land re­port that the crim­i­nal court re­ject­ed the sci­en­tist’s ap­peal, say­ing that a po­ten­tial 20-year prison sen­tence makes him a clear flight risk.

The US has been af­ter Gong­da Xue for his al­leged in­volve­ment in a crim­i­nal con­spir­a­cy with his sis­ter, Yu “Joyce” Xue, a GSK sci­en­tist in Up­per Meri­on, PA, who pled guilty to one count of trans­fer­ring the phar­ma gi­ant’s trade se­crets to a com­pa­ny they had cre­at­ed called Renophar­ma in Nan­jing. That biotech was sub­si­dized by the Chi­nese gov­ern­ment.

Ac­cord­ing to US charges, Yu Xue stole se­crets and trans­ferred them to her broth­er in Switzer­land, where he did work on them at the Friedrich Mi­esch­er In­sti­tute. Reuters con­firmed with the in­sti­tute that he had been a post-doc there. From there the se­crets went to Chi­na, where they were mar­ket­ed by an al­leged ac­com­plice.

Yu Xue’s guilty plea last sum­mer came with the caveat that she nev­er be­lieved she was steal­ing ac­tu­al se­crets, say­ing that the in­for­ma­tion on patents was all pub­licly avail­able.

Yu Xue leaves court in Au­gust 2018. Matt Rourke, AP Im­ages

Click on the im­age to see the full-sized ver­sion

The FBI ar­rest­ed an­oth­er Chi­nese sci­en­tist, Tao Li, in 2016 and found “a num­ber of GSK doc­u­ments con­tain­ing trade se­cret and con­fi­den­tial in­for­ma­tion” on his com­put­er re­gard­ing prod­ucts un­der de­vel­op­ment, re­search da­ta as well as re­search, man­u­fac­tur­ing and de­vel­op­ment process­es. He al­so pled guilty to one charge.

The con­spir­a­cy case that US of­fi­cials made against Yu Xue came just ahead of sev­er­al re­cent in­stances where Chi­nese sci­en­tists were ex­pelled from their jobs at MD An­der­son and Emory for mis­con­duct — fail­ing to dis­close re­search and busi­ness ties in Chi­na. In the most re­cent case, Emory fired two sci­en­tists born in Chi­na — nat­u­ral­ized US cit­i­zens Xi­ao­jiang Li and Shi­hua Li — and shut down their lab, or­der­ing sev­er­al post-docs in the lab back to Chi­na.

The sci­en­tists, though, have fired back, say­ing that the uni­ver­si­ty had act­ed im­prop­er­ly and that their ties to Chi­nese re­search or­ga­ni­za­tions were dis­closed.

There may well be more of these cas­es com­ing up, as the US gov­ern­ment and the NIH have put uni­ver­si­ties on no­tice that they’re be­ing vig­i­lant about los­ing im­por­tant and ex­pen­sive re­search in­for­ma­tion to the Asian pow­er­house.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.