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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.