Charles Lieber (Charles Krupa, AP)

Har­vard's Charles Lieber in­dict­ed for ly­ing to the feds, bring­ing US re­searcher­s' Chi­na ties back to the spot­light

Five months af­ter his shock­ing ar­rest, Charles Lieber has been in­dict­ed by a fed­er­al grand ju­ry for ly­ing to au­thor­i­ties about his in­volve­ment in Chi­na’s Thou­sand Tal­ents Pro­gram.

The 61-year-old sci­en­tist — who chaired Har­vard’s chem­istry de­part­ment and led a lab spe­cial­iz­ing in nanoscience be­fore he was ar­rest­ed and placed on ad­min­is­tra­tive leave in late Jan­u­ary — is fac­ing two counts of mak­ing false state­ments. He will be ar­raigned in fed­er­al court at a lat­er date, and is ex­pect­ed to con­test the charges.

While Lieber was not the first Amer­i­can sci­en­tist not of Chi­nese eth­nic­i­ty to be swept up in the FBI’s probe in­to aca­d­e­m­ic es­pi­onage, his case stood out be­cause of his high pro­file and the sever­i­ty of the po­ten­tial con­se­quences. From a DOJ re­lease:

The charge of mak­ing false state­ments pro­vides for a sen­tence of up to five years in prison, three years of su­per­vised re­lease and a fine of $250,000.

Amid some re­newed ten­sion in US-Chi­na re­la­tions — with Pres­i­dent Don­ald Trump point­ing fin­gers at Chi­na’s ini­tial han­dling of the coro­n­avirus out­break, and Xi Jin­ping es­sen­tial­ly dar­ing the US by im­pos­ing a na­tion­al se­cu­ri­ty law on Hong Kong — Amer­i­can of­fi­cials are said to be con­sid­er­ing fur­ther re­stric­tions on the en­try of Chi­nese stu­dents as re­tal­i­a­tion. The re­ports sparked new de­bates around the Trump ad­min­is­tra­tion’s ac­cu­sa­tions that Chi­na has been steal­ing sci­en­tif­ic se­crets by in­fil­trat­ing top or­ga­ni­za­tions. With­in the bio­med­ical en­ter­prise, aca­d­e­m­ic es­pi­onage is an ac­knowl­edged prob­lem, al­though sci­en­tists are di­vid­ed on what counts as spy­ing, how per­va­sive it is and whether the gov­ern­ment is throw­ing out the ba­by with the bath wa­ter.

As an in­ter­nal in­ves­ti­ga­tion by the Mof­fitt Can­cer Cen­ter high­light­ed, col­lab­o­rat­ing with or even re­ceiv­ing funds from Chi­nese uni­ver­si­ties aren’t an of­fense in the gov­ern­ment and re­search in­sti­tu­tions’ eyes. It on­ly be­comes an is­sue when re­searchers hide their af­fil­i­a­tion — time com­mit­ment as well as pay­ments — even when no se­crets are ap­par­ent­ly di­vulged.

At Mof­fitt, the fail­ure to re­port cost six top of­fi­cials their job, in­clud­ing its for­mer CEO and ac­claimed hema­tol­o­gist Alan List.

Lieber’s ties to Chi­na al­leged­ly be­gan in 2011 when he, “un­be­knownst to Har­vard Uni­ver­si­ty,” be­came a strate­gic sci­en­tist at Wuhan Uni­ver­si­ty of Tech­nol­o­gy. For the next three years, he would sign on­to the Thou­sand Tal­ents Plan, which is de­signed to re­cruit top brains like him­self.

Un­der that con­tract, the DOJ said he was paid a salary of $50,000 per month, liv­ing ex­pens­es of up to ap­prox­i­mate­ly $158,000 USD, and award­ed more than $1.5 mil­lion to es­tab­lish a re­search lab at the uni­ver­si­ty. In re­turn, he al­leged­ly agreed to no less than nine months of work per year.

All of that came in on top of the $15 mil­lion in grants Lieber has re­ceived from the NIH over the years.

But when the feds came knock­ing in April 2018, he told in­ves­ti­ga­tors that he was nev­er asked to par­tic­i­pate in Thou­sand Tal­ents, ac­cord­ing to the com­plaint. Har­vard, al­leged­ly tak­ing him by his word, al­so told the NIH he had no for­mal as­so­ci­a­tion with WUT af­ter 2012 and that the Wuhan in­sti­tu­tion was false­ly ex­ag­ger­at­ing his role there.

His lawyer, Marc Mukasey, told the Har­vard Crim­son that the gov­ern­ment has it wrong, and that Lieber is the vic­tim, not the per­pe­tra­tor.

“Pro­fes­sor Lieber has ded­i­cat­ed his life to sci­ence and to his stu­dents,” Mukasey wrote. “Not mon­ey, not fame, just his sci­ence and his stu­dents. […] “When jus­tice is done, Char­lie’s good name will be re­stored and the sci­en­tif­ic com­mu­ni­ty again will be able to ben­e­fit from his in­tel­lect and pas­sion.”

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.

Alexander Vos, VarmX CEO

'Fun­da­men­tal­ly dif­fer­en­t' from Por­to­la, Dutch biotech lands €32M to steer an­ti-an­ti­co­ag­u­lant through the clin­ic

Portola may not have had much success proving the commercial value of an anti-anticoagulant, but that’s not stopping European investors from pouring $36.2 million (€32 million) into what they see as a superior approach put forth by a Dutch biotech.

VarmX’s blood thinner reversal agent stems from research done by founder and CSO Pieter Reitsma at Leiden University Medical Center. A modified recombinant form of factor X, VMX-C001 “has an insertion of 16 amino acids that replaces a stretch of 7 amino acids in the so-called serine protease domain” compared to the native coagulation factor, CEO Alexander Vos told Endpoints News.

Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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