Christi Shaw at JP Morgan 2019. Jeff Rumans for Endpoints News

Fresh out of Eli Lil­ly, Christi Shaw sur­faces as Daniel O'­Day's new CEO at CAR-T pi­o­neer Kite

Well, that didn’t take long. 

We found out Thurs­day evening that Christi Shaw has giv­en up her top post as the head of the Bio-Med­i­cines group at Eli Lil­ly for the helm at CAR-T pi­o­neer Kite. New Gilead CEO Daniel O’Day, a Roche vet­er­an, had made find­ing a Kite CEO a top pri­or­i­ty on his ar­rival at Gilead. And he went right for a head­lin­er.

O’Day was clear­ly ex­cit­ed about the coup.

Geor­gios Ke­falas for AP

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“We con­duct­ed an ex­ten­sive search for a new leader at Kite and we be­lieve that Christi’s unique set of skills will al­low us to con­tin­ue to build on our lead­er­ship po­si­tion in cell ther­a­py,” he said in a pre­pared state­ment. “Christi’s vast ex­pe­ri­ence across com­plex ther­a­peu­tic ar­eas, and par­tic­u­lar­ly in on­col­o­gy, will serve Kite very well. She is clear­ly a leader who will bring teams and in­di­vid­u­als to­geth­er and I am con­fi­dent she will build up­on the en­tre­pre­neur­ial spir­it at Kite as we seek to help more peo­ple with can­cer around the world.”

Kite was the num­ber two com­pa­ny — be­hind No­var­tis — to in­tro­duce per­son­al­ized cell ther­a­pies to can­cer pa­tients. But it quick­ly leapfrogged to the front af­ter es­tab­lish­ing a more re­li­able man­u­fac­tur­ing process — a key piece of the puz­zle in terms of build­ing that mar­ket.

More re­cent­ly, though, the fo­cus in R&D has turned to off-the-shelf ver­sions of CAR-T, where the lead­ers like Arie Bellde­grun have be­gun seek­ing out new ther­a­pies that don’t have to use adapt­ed cells from pa­tients.

Shaw brings a rare per­son­al ap­proach to drug de­vel­op­ment. A vet­er­an phar­ma ex­ec, she left a big job run­ning No­var­tis’ US busi­ness to help care for her ail­ing sis­ter. She talked about that a few months ago dur­ing our pan­el con­ver­sa­tion on drug pric­ing and the rel­a­tive val­ue of new ther­a­peu­tics, putting the is­sue in a hu­man con­text.

If we want to take, like my sis­ter, rare dis­ease, mul­ti­ple myelo­ma. Thank God we in­vest­ed be­cause she was on sev­en dif­fer­ent med­i­cines. She had a great qual­i­ty of life for three out of four years, while she would’ve on­ly got­ten sev­en months be­fore. Now, that may not mean a lot to every­body un­til it’s your own sis­ter, un­til it’s your own pa­tient, your own child, your moth­er.

That makes her a po­tent spokesper­son for cell ther­a­pies at a time that seg­ment of on­col­o­gy is still find­ing its feet on the mar­ket.

Bellde­grun, the CEO who guid­ed Kite to its land­mark suc­cess, of­fered a thumbs up from Eu­rope.

“I had  re­cent­ly the plea­sure to meet with Christi and dis­cuss with her the unique op­por­tu­ni­ty to be­come the first CEO of a stand-alone com­pa­ny with­in Gilead. With Christi’s im­pres­sive track record and with her great lead­er­ship skills I have no doubt that she will ex­cel in keep­ing Kite as the pre­miere force in the rapid­ly grow­ing space of en­gi­neered cell ther­a­py and in ex­pand­ing its reach glob­al­ly.”

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.