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.

As the process to con­firm Dr. Hahn be­gins, I will re­turn to @theN­CI to re­sume my role as @NCIDi­rec­tor. I am con­fi­dent Dr. Hahn will pro­vide strong lead­er­ship for the FDA. https://t.co/3vc­syj7Pf4

— Dr. Ned Sharp­less (@FDA­Com­mis­sion­er) No­vem­ber 1, 2019

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.

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.