Sen. Tom Cotton (R-AR) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Black­list Chi­nese ge­net­ic se­quenc­ing com­pa­nies, law­mak­ers ar­gue — cit­ing po­ten­tial for 'bioweapons,' na­tion­al se­cu­ri­ty risk

As Chi­nese biotech com­pa­nies spread their wings glob­al­ly, a pair of law­mak­ers — and known Chi­na hawks on the Hill — are call­ing for a promi­nent ge­net­ic se­quenc­ing play­er to be black­list­ed.

Sen. Tom Cot­ton (R-AR) and Rep. Mike Gal­lagher (R-WI) sin­gled out Bei­jing Ge­nomics In­sti­tute, which has re­brand­ed it­self as BGI Ge­nomics, as a com­pa­ny that should be added to mul­ti­ple sanc­tion lists along with oth­er, un­named Chi­nese biotech com­pa­nies.

Al­low­ing BGI to ac­cess US DNA da­ta, they warned, is a mat­ter of na­tion­al se­cu­ri­ty be­cause its re­search with the mil­i­tary “could have an ap­pli­ca­tion in fu­ture bioweapons.”

In a let­ter ad­dressed to Trea­sury Sec­re­tary Janet Yellen, Com­merce Sec­re­tary Gi­na Rai­mon­do, and De­fense Sec­re­tary Lloyd Austin, they asked for BGI to be put on the De­part­ment of the Trea­sury’s Non-SDN Chi­nese Mil­i­tary In­dus­tri­al Com­plex Com­pa­nies List, the De­part­ment of Com­merce’s En­ti­ty List, and the De­part­ment of De­fense’s list of Chi­nese mil­i­tary com­pa­nies.

Found­ed in 1999 by Chi­nese sci­en­tists who had par­tic­i­pat­ed in the Hu­man Genome Pro­ject, BGI of­fers next-gen­er­a­tion se­quenc­ing ser­vices rang­ing from re­search to every­day use. Dur­ing the Covid-19 pan­dem­ic, its di­ag­nos­tics have been de­ployed in mul­ti­ple coun­tries — al­though its at­tempt to build test­ing labs in the US was shot down by in­tel­li­gence of­fi­cials.

Still, BGI and at least 14 oth­er Chi­nese health­care com­pa­nies per­form ge­net­ic se­quenc­ing for US health­care pa­tients in oth­er ar­eas.

What makes its tac­tics to ac­quire Amer­i­can ge­nom­ic da­ta ag­gres­sive, ac­cord­ing to Cot­ton and Gal­lagher, is sus­pect­ed da­ta shar­ing with the Chi­nese gov­ern­ment and BGI’s “his­to­ry of col­lab­o­ra­tion” with the Peo­ple’s Lib­er­a­tion Army and serv­ing mil­i­tary in­ter­ests.

They point­ed out that the for­mer head of PLA Na­tion­al De­fense Uni­ver­si­ty “iden­ti­fied bi­ol­o­gy as one of sev­en ‘new do­mains of war­fare’ in­clud­ing the pos­si­bil­i­ty of ‘spe­cif­ic eth­nic ge­net­ic at­tacks,’ in a 2017 pub­li­ca­tion.”

A re­view of 40 pub­licly-avail­able re­search pa­pers demon­strates BGI’s work on PLA pri­or­i­ties, such as im­proved high-al­ti­tude sol­dier per­for­mance, neu­ro­science, and pathogens. BGI’s world­wide pre­na­tal test was it­self de­vel­oped in col­lab­o­ra­tion with the PLA. BGI has al­so part­nered with the PLA’s Na­tion­al Uni­ver­si­ty of De­fense Tech­nol­o­gy (NUDT) to ad­vance bioin­for­mat­ics re­search and lever­age su­per­com­put­ers for bi­o­log­i­cal re­search. Joint BGI-PLA re­search could have an ap­pli­ca­tion in fu­ture bioweapons — which is es­pe­cial­ly con­cern­ing be­cause BGI’s na­tion­al gene bank is pre­sum­ably made avail­able for mil­i­tary re­search.

The two al­so high­light­ed Chi­na’s fi­nan­cial sup­port for the com­pa­ny, in­clud­ing $1.5 bil­lion in state sub­si­dies that al­lowed it to “un­der­cut the DNA se­quenc­ing mar­ket,” and a con­tract giv­ing BGI the re­spon­si­bil­i­ty of run­ning Chi­na’s na­tion­al gene data­base.

“The Unit­ed States must not turn a blind eye to the threat posed by Chi­nese biotech­nol­o­gy com­pa­nies op­er­at­ing at the CCP’s be­hest,” they wrote. “Black­list­ing BGI and its fel­low biotech com­pa­nies will help the Unit­ed States counter the Chi­nese Com­mu­nist Par­ty’s ef­forts to cap­ture Amer­i­cans’ most pri­vate in­for­ma­tion—their DNA.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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