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.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.