Brett Giroir, HHS

Azar keen on nom­i­nat­ing Brett Giroir, di­vi­sive as­sis­tant HHS sec­re­tary, to top job at FDA — re­port

HHS sec­re­tary Alex Azar re­port­ed­ly has his eye on nom­i­nat­ing Brett Giroir — con­tro­ver­sial­ly con­firmed as as­sis­tant sec­re­tary of HHS last year — to head the FDA as judg­ment day on Ned Sharp­less’ term as act­ing com­mis­sion­er looms.

Pres­i­dent Don­ald Trump must make a de­ci­sion about the com­mis­sion­er of food and drugs by No­vem­ber 1, as man­dat­ed by the Fed­er­al Va­can­cies Re­form Act of 1998  that en­ti­tles a Sen­ate-con­firmed po­si­tion to be filled in an act­ing ca­pac­i­ty for a max­i­mum of 210 days, af­ter the po­si­tion is va­cat­ed.  The ef­fer­ves­cent Scott Got­tlieb re­signed as FDA com­mis­sion­er ear­li­er this year, de­part­ing of­fi­cial­ly on April 5.

Sharp­less, a physi­cian/sci­en­tist who pre­vi­ous­ly served as head of the Na­tion­al Can­cer In­sti­tute, was wide­ly seen as Got­tlieb’s cho­sen suc­ces­sor and was warm­ly em­braced by the bio­phar­ma in­dus­try when he as­cend­ed to the FDA throne. Back­ing him will be a smoother choice by the White House.

A re­port by Bio­Cen­tu­ry — which re­port­ed Azar is keen on Giroir, cit­ing ad­min­is­tra­tion of­fi­cials — has al­so sug­gest­ed in­flu­en­tial pa­tient groups are cir­cu­lat­ing a let­ter urg­ing Trump to pick Sharp­less per­ma­nent­ly.

Un­like Sharp­less who is gen­er­al­ly seen as par­ty-ag­nos­tic, Giroir is un­abashed­ly Re­pub­li­can — his stance on re­pro­duc­tive rights sparked De­mo­c­ra­t­ic op­po­si­tion that held up his con­fir­ma­tion as as­sis­tant HHS sec­re­tary for months. He was whisked in­to the Trump ad­min­is­tra­tion by for­mer Texas Gov­er­nor and cur­rent Sec­re­tary of En­er­gy Rick Per­ry, Bio­Cen­tu­ry not­ed.

His ap­point­ment as FDA com­mis­sion­er will trig­ger con­cerns that the agency will end up en­tan­gled in the ten­ta­cles of pol­i­tics re­gard­ing drug im­por­ta­tion, re­pro­duc­tive and women’s health, FDA civ­il ser­vants told Bio­Cen­tu­ry.

End­points News has con­tact­ed Azar and Got­tlieb for com­ment on the re­port.

Giroir, a Texas pe­di­a­tri­cian, su­per­vis­es HHS’ Of­fice of Pop­u­la­tion Af­fairs, which ad­min­is­ters Ti­tle X grants — fund­ing for fam­i­ly plan­ning clin­ics and re­pro­duc­tive health ser­vices — as well as the Of­fice of Ado­les­cent Health, which over­sees the teen preg­nan­cy pre­ven­tion pro­gram.

Un­der Giroir, the HHS launched a re­view in­to the use of fe­tal tis­sue for re­search last year. This June, med­ical re­search fund­ing for NIH sci­en­tists us­ing fe­tal tis­sue —  har­vest­ed from dead fe­tus­es, from in­duced or nat­ur­al abor­tions — was abort­ed. Ear­li­er this month, Planned Par­ent­hood re­ject­ed Ti­tle X fund­ing — in re­sponse to a gag rule im­posed by the Trump ad­min­is­tra­tion that cur­tails re­cip­i­ents from giv­ing abor­tion re­fer­rals.

Af­ter se­cur­ing con­fir­ma­tion to take on the role of HHS as­sis­tant sec­re­tary, Giroir left his post as chief of Texas-based biotech Vira­Cyte (now re­named AlloVir), which is de­vel­op­ing im­munother­a­pies for vi­ral dis­eases.

The hope is the Trump ad­min­is­tra­tion does, in fact, take steps to nom­i­nate a per­ma­nent suc­ces­sor — whether Sharp­less, Giroir or an­oth­er per­son al­to­geth­er. Of 731 key lead­er­ship po­si­tions (out of rough­ly 1,200 po­si­tions) re­quir­ing Sen­ate con­fir­ma­tion — 145 po­si­tions have no nom­i­nee cho­sen by the Trump ad­min­is­tra­tion, ac­cord­ing to a track­er set up by The Wash­ing­ton Post and Part­ner­ship for Pub­lic Ser­vice, a non­prof­it or­ga­ni­za­tion.

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.

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.

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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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.