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San Diego couple charged with stealing trade secrets, opening Chinese biotech as DOJ crackdown continues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

Li Chen, 46, and her husband Yu Zhou, 49, were accused by federal prosecutors of conspiring to, attempting and successfully stealing secrets related to exosome research from Nationwide Children’s Hospital in Columbus, Ohio, where they worked for 10 years.

Liu, head of the China Association for International Exchange of Personnel (CAIEP-NY), is accused of conspiring to obtain research scholar visas for persons whose purpose was to recruit US experts to China.

The charges follow a string of investigations, prosecutions and firings across the biotech and pharmaceutical industry over the past two years. US officials and some US pharma executives have argued the charges have been warranted and necessary, with FBI Assistant Director William F. Sweeney Jr calling Liu’s purported actions part of a broader trend.

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William Pao (L) and Hans Clevers

Pfizer raids Roche executive committee for new drug development chief — and Schwan plucks his replacement from the board

Pfizer has found its new chief of drug development, and they’ve dispatched a raiding party to Basel to pluck him off the executive committee at Roche.

William Pao, who took over as head of pRED after John Reed exited to take the R&D chief post at Sanofi in 2018, is headed to the executive committee at Pfizer now, where he’ll report to Albert Bourla in New York. And he has a big remit that includes “inflammation and immunology, internal medicine, hospital, oncology and rare disease, as well as regulatory affairs in support of Pfizer’s R&D pipeline and portfolio of marketed therapies.”

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Pfizer CEO Albert Bourla (Evan Vucci, AP Images)

UPDATED: Waking up from some big blockbuster dreams, Pfizer scraps a $250M drug deal as data sour, safety fears rise

A little over 2 years after Pfizer paid Ionis $250 million cash to in-license rights to vupanorsen (AKCEA-ANGPTL3-LRx) – immediately vaulting the drug onto its list of top prospects — the pharma giant has decided to ax its ambitious late-stage work on the drug and hand it all back to Ionis, which has had more than its share of setbacks recently.

Pfizer had at one time been extremely bullish on this drug’s mid-stage data, grabbing exclusive worldwide rights, but researchers say they took a cold, hard look at the data from their Phase IIb and found the therapy wanting on efficacy as well as safety.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Novartis axes a once 'first-in-class' prospect as another JAK program fails to clear a risk/benefit analysis

The JAK class can count one more clinical failure, the latest in a long string of setbacks that continues to cloud the future of these therapies.

In its Q4 update today pharma giant Novartis noted that it has swept out a pan-JAK program for CEE321. Details are scant, and the work was very much early-stage, but Novartis had held it up as a bright prospect before for atopic dermatitis.

In their pipeline summary, the company noted that the program had been discontinued because it had failed to clear the bar on risk/benefit.

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Lars Fruergaard Jørgensen, Novo Nordisk CEO, at EUBIO21

Novo surges on upbeat Q4 review and a move to produce Wegovy in-house. But charge of insulin price manipulation lingers

Novo Nordisk shares $NOVO surged close to 3% on Wednesday morning as rising profits, a key beat on the numbers and evidence that the pharma giant is putting its manufacturing woes in the rearview mirror encouraged a shaky set of investors to buy into a low-risk performer in the big cap arena.

Novo got hit when its manufacturer for Wegovy — their weight-loss version of the blockbuster diabetes drug semaglutide — had to shutter production after they were handed a 483 by FDA regulators.

Fred Chereau, LogicBio CEO

FDA slams clinical hold on LogicBio's gene editing drug after clotting cases in child patients

Another day, another AAV-delivered gene therapy running into roadblocks with the FDA.

The agency has placed a clinical hold on LogicBio’s AAV-delivered gene editing therapy LB-001 after two adolescent patients in an early trial for the drug were diagnosed with thrombotic microangiopathy (TMA), a clinical syndrome defined by the formation of tiny clots in blood vessels, the company said Wednesday.

Christopher Missling, Anavex Life Sciences CEO

A win in Rett syndrome? Not so fast — biotech shares slide amid concerns of last-minute trial changes

Normally, an announcement that a Phase III trial met all primary and secondary efficacy and safety endpoints is sure to get a biotech’s shares up.

But Anavex found itself in an opposite situation Tuesday after declaring success in its Rett syndrome study, when observers pointed out that the New York-based biotech changed its endpoints just ahead of the readout.

Shares $AVXL fell 15.60% to $11.04, but rose again in pre-market trading to $11.75 as Anavex CEO Christopher Missling framed the critiques as an “inaccurate impression.”

GSK grabs $1.25B cash and a cut of Gilead's megablockbuster Biktarvy sales as HIV rivals settle patent suit

Three years after ViiV Healthcare, the HIV specialist majority owned by GlaxoSmithKline, first sued Gilead over alleged patent infringement on one of its top drugs, the two companies have settled the case.

Gilead will pay ViiV $1.25 billion in cash — while agreeing to set aside a 3% royalty on all US sales of Biktarvy until October 2027.

A megablockbuster triplet therapy given as a daily pill, Biktarvy brought in $6.09 billion from the US alone in 2020. By 2027, Jefferies analysts estimate that cumulative US sales would reach about $50 billion — translating to about $2 billion in total royalties for ViiV.

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Pavan Cheruvu, Sio Gene Therapies outgoing CEO

Biotech's very bad start to the year continues as microcap gene therapy player Sio ditches CEO, lead partnership

In a biotech market hit from top to bottom by dwindling investor sentiment, small firms, in particular, are bearing the brunt of the burden. Now, a tiny gene therapy player is rethinking its direction and cutting away a key partnership to make ends meet.

Sio Gene Therapies has elevated CFO David Nassif into the interim CEO role as it says goodbye to current helmsman Pavan Cheruvu, who has left the company to “pursue new opportunities,” the biotech said Monday.

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Raquel Fortunato, GenIbet CEO

Recipharm's global deal spree continues with acquisition of Portuguese CDMO

Following a monster 2021, in which CDMO Recipharm expanded its footprint across the world in places with a smaller manufacturing presence, it’s expanding its footprint in a European country where it’s already established: Portugal.

The Swedish company announced its acquisition of GenIbet, a CDMO based in Oeiras, Portugal that was spun out of an iBET – Instituto de Biologia Experimental e Tecnológica – lab in 2016.  The move will help Recipharm build out its biologics capabilities, and benefit from GenIbet’s experience with viral vectors and vaccines, as it looks to focus on the manufacturing of novel advanced therapy medicines. It will inherit GenIbet’s 70 employees at the nearby site just 11 km from Recipharm’s facility in Lisbon.