Stephen Hahn speaks at an FDA and AACR workshop, February 2018 [via the American Association for Cancer Research]

Trump will pick Stephen Hahn as his next FDA com­mis­sion­er — re­ports

Pres­i­dent Don­ald Trump will nom­i­nate MD An­der­son ex­ec­u­tive Stephen Hahn to lead the FDA, mul­ti­ple out­lets are re­port­ing.

The move breaks from a con­sen­sus among for­mer FDA lead­ers and pa­tient ad­vo­ca­cy groups push­ing the ad­min­is­tra­tion to stick with act­ing com­mis­sion­er Ned Sharp­less, the Na­tion­al Can­cer In­sti­tute di­rec­tor who has helmed the FDA on an in­ter­im ba­sis since Scott Got­tlieb end­ed his en­er­getic and wide­ly ad­mired 2-year stint in April.

Sharp­less was Got­tlieb’s hand-picked suc­ces­sor, with the for­mer com­mish tweet­ing his sup­port as late as a month ago when his man was still in the run­ning. But it wasn’t enough. Politi­co Pro re­port­ed in the be­gin­ning of Sep­tem­ber that Hahn was a “clear fron­trun­ner” who would be­come the nom­i­nee pend­ing a suc­cess­ful back­ground check. The vet­ting process is still on­go­ing.

Trump has un­til No­vem­ber 1 to for­mal­ly make the nom­i­na­tion or name a new act­ing chief. Steve Us­din at Bio­Cen­tu­ry first re­port­ed the news.

Hahn, the chief med­ical of­fi­cer at MD An­der­son in Hous­ton and a ra­di­a­tion on­col­o­gist by train­ing, is a long­time Re­pub­li­can donor who has giv­en to Mitt Rom­ney, John Mc­Cain, and George W Bush, among oth­ers, but not Trump. Sharp­less has ex­clu­sive­ly con­tributed mon­ey to De­moc­rats, in­clud­ing Barack Oba­ma and a hand­ful of De­moc­rats run­ning for con­gress in North Car­oli­na.

If and when Hahn is con­firmed by the Sen­ate, he’d im­me­di­ate­ly face a swarm of ques­tions on an en­tire­ly non-bio­phar­ma mat­ter re­gard­ing the FDA’s role — or lack there­of — in reg­u­lat­ing e-cig­a­rettes fol­low­ing re­cent out­break of va­p­ing-in­duced lung in­juries and deaths.

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.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

J&J and Sanofi's mul­ti­ple myelo­ma tit-for-tat con­tin­ues, as sub­cu­ta­neous Darza­lex wins com­bo ap­proval

J&J and Sanofi have gone back and forth in their multiple myeloma tug-of-war. Earlier this year, Sanofi notched an approval of Sarclisa in combination with Amgen’s Kyprolis to try to outflank the big conglomerate, but J&J is clapping back.

Wednesday afternoon, Amgen announced that the subcutaneous version of J&J’s blockbuster Darzalex is also now approved as a combo with Kyprolis and dexamethasone. The green light came through for adults with relapsed or refractory multiple myeloma who had progressed on one to three earlier lines of therapy.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Michael Handley, Statera Biopharma CEO

Stat­era Bio­phar­ma gets the OK to re­sume the study of a po­ten­tial stock­pile drug for lethal ra­di­a­tion ex­po­sure

Last summer, when Cytocom merged with Cleveland BioLabs to grab a spot on Nasdaq, it also inherited an intriguing rare disease program that was under clinical hold. With a new name and brand, the company says it’s ready to bring that program back to the forefront.

The FDA has lifted its clinical hold on entolimod, a toll-like receptor 5 (TLR5) agonist being developed for patients exposed to lethal amounts of radiation, the company — now called Statera Biopharma — announced on Wednesday.