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.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 76,800+ biopharma pros reading Endpoints daily — and it's free.

Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.

VBL and its “gene ther­a­py” can­cer treat­ment are back — with a peek at PhI­II po­ten­tial

Three years after a brain cancer failure sent the company reeling, VBL Therapeutics is touting its first hint of positive Phase III results.

The Israeli biotech announced its lead drug, VB–111, met an interim efficacy benchmark in a trial testing it against standard-of-care alone in recurrent, chemotherapy-resistant ovarian cancer.  The patients in the treatment arm had a CA-125 response rate — a measure of cancer antigen often used as a proxy in ovarian cancer studies and in detecting ovarian cancer — at least 10% higher than those in the control, the independent review determined.