Stephen Hahn, AACR

Right on dead­line, Trump taps Stephen Hahn as new FDA com­mish. Now what?

Stephen Hahn’s nom­i­na­tion as the new com­mis­sion­er of the FDA was de­liv­ered right on sched­ule Fri­day, with the clock tick­ing down on the No­vem­ber 1 dead­line Pres­i­dent Don­ald Trump faced in find­ing a per­ma­nent re­place­ment for Scott Got­tlieb. The pend­ing news had be­come the worst kept se­cret in Wash­ing­ton. But the full mean­ing of the move is still un­de­ter­mined.

The Chief Med­ical Ex­ec­u­tive at MD An­der­son had a rep for steer­ing straight in­to con­fronta­tion, when the fu­ture of the in­sti­tu­tion was at stake. More prob­lem­at­ic, per­haps, will be his role in dis­miss­ing Chi­nese re­searchers at a time the Trump ad­min­is­tra­tion has been bear­ing down on the Asian gi­ant. Just how Hahn will man­age drug de­vel­op­ment, which is my pri­ma­ry are­na of in­ter­est, is go­ing to take some time to fig­ure out.

In­ter­im chief Ned Sharp­less was the clear in­sti­tu­tion­al fa­vorite for get­ting the job full time af­ter a stint at the NCI. Pa­tient groups loved him and the in­dus­try deeply re­spect­ed his ex­per­tise, even if he nev­er gen­er­at­ed the kind of en­thu­si­asm Scott Got­tlieb achieved at the agency’s helm as the first com­mis­sion­er with re­al celebri­ty sta­tus.

Hahn’s nom­i­na­tion, though, won’t trig­ger any ob­vi­ous back­lash in bio­phar­ma. As a re­spect­ed ex­ec­u­tive at MD An­der­son with a track record in re­search and a ca­reer in on­col­o­gy that ex­tend­ed back through a stint at the pres­ti­gious Uni­ver­si­ty of Penn­syl­va­nia’s Perel­man School of Med­i­cine, he’ll be ex­pect­ed to main­tain the gold stan­dard in drug de­vel­op­ment.

Mar­garet Foti, chief ex­ec­u­tive of­fi­cer of AACR, set the tone with a pre­pared com­ment for the oc­ca­sion:

Dr. Hahn, who is board cer­ti­fied in both ra­di­a­tion and med­ical on­col­o­gy, is es­teemed for the breadth and depth of his sci­en­tif­ic knowl­edge and ex­per­tise, and he has con­sis­tent­ly ad­vo­cat­ed for a drug re­view process at the FDA that is both sci­ence-di­rect­ed and pa­tient-fo­cused.

The ques­tion is whether he’ll keep push­ing the en­ve­lope on greater reg­u­la­to­ry flex­i­bil­i­ty that has helped rev­o­lu­tion­ize can­cer drug de­vel­op­ment and changed the dy­nam­ics of R&D.

That’s some­thing no one seems to know much about. But they’ll get a chance to hear much more once the Sen­ate picks up the nom­i­na­tion.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.