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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Covid-19 roundup: Mod­er­na dos­es first pa­tients in PhII vac­cine tri­al; Eli Lil­ly touts clin­i­cal en­try of Ab­Cellera-dis­cov­ered an­ti­body

With an eye on kick-starting Phase III for its mRNA vaccine in July, Moderna said it’s dosed the first participants of each age cohort enrolled in the Phase II study.

Moderna is responsible for the whole trial, which is designed to recruit 600 healthy volunteers — 300 between the ages of 18 and 55, and another 300 older than 55. Two doses (50 μg and 100 μg) will be tested alongside placebo, and each participant receives two shots.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Jean-Jacques Bienaime, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Lynn Seely, Myovant CEO

My­ovant’s re­l­u­golix wins a piv­otal prostate can­cer show­down with an old stan­dard — com­ing down to the wire on ap­provals

Myovant $MYOV has rounded the final turn in its development race to get relugolix down to the regulatory wire at the FDA. And the biotech joined the virtual crowd at ASCO with the kind of data needed to keep the investor crowd’s attention.

Much of the attention on the drug has been focused on uterine fibroids, where AbbVie just scored a regulatory win for their rival drug Oriahnn (elagolix) as the biotech posted results in prostate cancer at the ASCO meeting.

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