Charles Lieber, AP

Em­bat­tled Har­vard sci­en­tist Charles Lieber goes on a counter-of­fen­sive, hir­ing high-pro­file lawyer and su­ing Har­vard for aban­don­ing him amid fed­er­al probe

Charles Lieber, the Har­vard sci­en­tist fac­ing fed­er­al charges for al­leged­ly ly­ing about Chi­nese fund­ing, is mount­ing a fierce le­gal de­fense, be­gin­ning with the en­list­ment of a high-pro­file at­tor­ney and a law­suit against his em­ploy­er.

Marc L. Mukasey

Lieber hired Marc Mukasey, a crim­i­nal at­tor­ney who de­fend­ed for­mer Navy Seal Ed­ward Gal­lagher against war crime charges last year and cur­rent­ly rep­re­sents Er­ic Trump in a New York state fraud case, the New York Times first re­port­ed. And on Fri­day, he filed suit against Har­vard, al­leg­ing the uni­ver­si­ty aban­doned him and their re­spon­si­bil­i­ty to in­dem­ni­fy him or aid his le­gal de­fense.

The le­gal ma­neu­ver­ing sets Lieber apart from the oth­er re­searchers caught up in the Jus­tice De­part­ment’s ef­fort to weed out sci­en­tists it claims were si­phon­ing re­search from the US to Chi­na, un­der the so-called Thou­sand Tal­ents pro­gram. The drag­net had large­ly caught up grad­u­ate stu­dents and pro­fes­sors of Chi­nese ori­gin, some of whom left the coun­try or oth­er­wise did not con­test charges in court.

Lieber was ar­rest­ed in Jan­u­ary on charges of ly­ing to the US gov­ern­ment about re­ceiv­ing mil­lions of dol­lars from the Chi­nese state and par­tic­i­pat­ing in a Chi­nese tal­ent re­cruit­ment pro­gram, while NIH and DoD spent over $15 mil­lion fund­ing his lab. The tenured pro­fes­sor, a pi­o­neer in med­ical nan­otech­nol­o­gy and the chair of Har­vard’s chem­istry de­part­ment, plead­ed not guilty on Ju­ly 30.

The new law­suit ar­gues that Har­vard ben­e­fit­ed from years of Lieber’s re­search, on­ly to dis­tance them­selves en­tire­ly when fed­er­al of­fi­cials rolled in. He is cur­rent­ly on paid leave from the uni­ver­si­ty.

Pros­e­cu­tors say Lieber signed an agree­ment to be­come a “strate­gic sci­en­tist” at the Wuhan Uni­ver­si­ty of Tech­nol­o­gy in Chi­na, a po­si­tion that grant­ed him $200,000 per year in liv­ing ex­pens­es and salary and an­oth­er $1.5 mil­lion to open a sec­ond lab in the Chi­nese city. They added that he was se­lect­ed for Thou­sand Tal­ents — a pro­gram meant to re­cruit top for­eign sci­en­tists that fed­er­al of­fi­cials say was a con­duit to steal­ing re­search — in 2012 but claimed to have nev­er tak­en part in the pro­gram when he was in­ter­viewed by fed­er­al of­fi­cials in 2018.

He could face more than 10 years in prison for fail­ing to dis­close the Chi­nese fund­ing, fil­ing false tax re­turns and fail­ing to re­port a for­eign bank ac­count.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.