Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Al­though Thurs­day’s Sen­ate health com­mit­tee hear­ing was fo­cused on how for­eign coun­tries and ad­ver­saries might be try­ing to steal or neg­a­tive­ly in­flu­ence bio­med­ical re­search in the US, the on­ly coun­try men­tioned by the sen­a­tors and ex­pert wit­ness­es was Chi­na.

Com­mit­tee chair Pat­ty Mur­ray (D-WA) made clear in her open­ing re­marks that the US can­not “let the few in­stances of bad ac­tors” over­shad­ow the hard work of the many im­mi­grant re­searchers in the US, many of which have won No­bel prizes for their work. But she al­so said, “There is more the NIH can be do­ing here.”

The hear­ing fol­lows a se­ries of high pro­file con­vic­tions of sci­en­tists for steal­ing in­tel­lec­tu­al prop­er­ty from top bio­med­ical re­search in­sti­tu­tions.

Just this week, Yu Zhou of Ohio was sen­tenced to 33 months in prison af­ter he plead­ed guilty to steal­ing sci­en­tif­ic trade se­crets re­lat­ed to ex­o­somes and ex­o­some iso­la­tion from Na­tion­wide Chil­dren’s Hos­pi­tal’s Re­search In­sti­tute, which he sought to sell in Chi­na.

Song Guo Zheng, A pro­fes­sor of in­ter­nal med­i­cine and re­searcher at The Ohio State Uni­ver­si­ty and Penn­syl­va­nia State Uni­ver­si­ty, al­so plead­ed guilty in late 2020 to mak­ing false state­ments to fed­er­al au­thor­i­ties as part of an im­munol­o­gy re­search grant fraud scheme. He ad­mit­ted to ly­ing on ap­pli­ca­tions in or­der to use more than $4 mil­lion in NIH grants to de­vel­op Chi­na’s ex­per­tise around rheuma­tol­ogy and im­munol­o­gy, ac­cord­ing to writ­ten tes­ti­mo­ny Thurs­day from Gary Cantrell, deputy in­spec­tor gen­er­al at HHS’ Of­fice of In­spec­tor Gen­er­al.

“The threat is sig­nif­i­cant,” Michael Lauer, deputy di­rec­tor for ex­tra­mur­al re­search at NIH, told the sen­a­tors. He said NIH has iden­ti­fied more than 500 sci­en­tists of con­cern, and reached out to the in­sti­tu­tions where over 200 of them work, al­though each one re­quires a tremen­dous amount of work.

But Lauer al­so not­ed in­stances where re­search in­sti­tu­tions are dis­cov­er­ing prob­lems on their own. For in­stance, Alan List, pres­i­dent and CEO of the Mof­fitt Can­cer Cen­ter in Flori­da, re­signed in late 2019 af­ter the cen­ter con­duct­ed an in­ter­nal re­view on col­lab­o­ra­tions with re­search in­sti­tu­tions in Chi­na.

Can­dice Wright, act­ing di­rec­tor of sci­ence, tech­nol­o­gy as­sess­ment, and an­a­lyt­ics at GAO, al­so ex­plained how non-fi­nan­cial con­flicts, such as ac­cess to cer­tain re­search labs or bi­o­log­ic ma­te­ri­als, can pose risks too. “Non-fi­nan­cial con­flicts can be great risks and we don’t see a lot of at­ten­tion paid to those,” she said.

But progress has been made in re­cent years to be more vig­i­lant of po­ten­tial crimes, even as crit­ics have raised ques­tions about whether this crack­down has un­fair­ly tar­get­ed Chi­nese re­searchers. Last year, two rep­re­sen­ta­tives, Jamie Raskin (D-MD) and Judie Chu (D-CA) wrote let­ters to the FBI and NIH, rais­ing con­cerns that in­no­cent Chi­nese sci­en­tists were be­ing pro­filed, and asked for in­for­ma­tion on the de­mo­graph­ic make­up of sci­en­tists un­der in­ves­ti­ga­tion.

Sen. Richard Burr (R-NC) con­ced­ed that the NIH has come a long way since 2018, when NIH Di­rec­tor Fran­cis Collins sent a let­ter to more than 10,000 re­search in­sti­tu­tions, urg­ing them to en­sure NIH grantees were re­port­ing their links with for­eign gov­ern­ments. But he and oth­er sen­a­tors specif­i­cal­ly took is­sue with Chi­na.

“It’s a con­cert­ed ef­fort from those in Chi­na, backed by their gov­ern­ment, to bring back any­thing they can learn, store or steal,” Burr said. Oth­er Re­pub­li­cans on the com­mit­tee like Sen. Bill Cas­sidy (LA) ques­tioned whether 23andMe’s op­er­a­tions in Chi­na might be wor­ri­some, but none of the wit­ness­es on the pan­el of­fered any specifics.

As an­ti-Asian sen­ti­ment has reached a fever pitch in re­cent months in the US, Lauer al­so sought to make clear that the over­whelm­ing ma­jor­i­ty of Chi­nese-born sci­en­tists work­ing in the US are not bad ac­tors. He said NIH has iden­ti­fied crim­i­nals who are Amer­i­cans too.

“We can­not re­ject bril­liant minds that are work­ing hon­est­ly,” Lauer added. “Le­git­i­mate in­ter­na­tion­al col­lab­o­ra­tions are great, and this is ex­treme­ly im­por­tant, but that’s dif­fer­ent from ly­ing, cheat­ing and steal­ing.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.