Stephen Hahn. MD Anderson

Stephen Hahn, 'clear fron­trun­ner' for FDA com­mish job, has met with Trump — re­ports

MD An­der­son of­fi­cial Stephen Hahn is now re­port­ed­ly a top can­di­date to lead the FDA, pos­si­bly re­plac­ing act­ing com­mis­sion­er — and crowd fa­vorite — Ned Sharp­less.

Hahn, chief med­ical ex­ec­u­tive and chief of ra­di­a­tion on­col­o­gy at the Hous­ton-based can­cer cen­ter, made the leap from un­named can­di­date to top con­tender vir­tu­al­ly overnight, with mul­ti­ple news out­lets get­ting word that he’s the on­ly fi­nal­ist out of three to meet with Pres­i­dent Don­ald Trump about a po­ten­tial nom­i­na­tion. Politi­co Pro re­port­ed that he’s a “clear fron­trun­ner” and “will be the nom­i­nee pend­ing a suc­cess­ful back­ground check” cit­ing sources, just one day af­ter the Wall Street Jour­nal first iden­ti­fied him in the run­ning.

Ned Sharp­less

An ad­min­is­tra­tion of­fi­cial told the Wash­ing­ton Post the de­ci­sion has not been made but Hahn “is a strong can­di­date.”

Har­vard der­ma­tol­ogy pro­fes­sor Alexa Boer Kim­ball has al­so sur­faced as an ap­par­ent ri­val to Sharp­less, the for­mer di­rec­tor of the Na­tion­al Can­cer In­sti­tute.

Sharp­less was wide­ly seen as Scott Got­tlieb’s cho­sen suc­ces­sor af­ter the pop­u­lar agency chief abrupt­ly hand­ed in his res­ig­na­tion in March. Four oth­er for­mer heads of the FDA al­so voiced their sup­port for Sharp­less along­side non­prof­it pa­tient ad­vo­ca­cy groups.

But HHS Sec­re­tary Alex Azar might want a big­ger hand in the pick, un­named at­tor­neys on the hill told STAT.

Hahn spent nine years at the Uni­ver­si­ty of Penn­syl­va­nia’s Perel­man School of Med­i­cine be­fore join­ing MD An­der­son in 2015 amid an in­sti­tu­tion-wide re­form. Pri­or to that, his post­grad­u­ate train­ing had tak­en him to Sharp­less’ old digs at NCI in Bethes­da, MD, com­plet­ing a clin­i­cal res­i­den­cy and clin­i­cal fel­low­ship.

Alexa Kim­ball

That ap­peared to be the clos­est Hahn ever got to Wash­ing­ton, hav­ing ded­i­cat­ed him­self to re­search since then. His ex­per­tise is in lung can­cer and sar­co­ma, with a par­tic­u­lar fo­cus on the chem­i­cal sig­nals with­in the tu­mor en­vi­ron­ment and pro­ton ther­a­py, ac­cord­ing to a Q&A from MD An­der­son.

In that ex­change from 2017, Hahn was asked to sum­ma­rize him­self in one word:

What word best de­scribes you?

En­er­getic.

The dead­line for nom­i­nat­ing a new com­mis­sion­er of food and drugs is No­vem­ber 1 to com­ply with a fed­er­al law that man­dates va­can­cies to be filled with­in 210 days.

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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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.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.