Pop­u­lar FDA com­mish Scott Got­tlieb has hand­ed in his res­ig­na­tion

In a stun­ning turn of events, FDA com­mis­sion­er Scott Got­tlieb is re­sign­ing from his post and leav­ing of­fice in a mat­ter of weeks.

The Wash­ing­ton Post re­port­ed that Got­tlieb, who’s been com­mut­ing from Con­necti­cut, told ad­min­is­tra­tion of­fi­cials that he wants to spend more time with his fam­i­ly.

Got­tlieb ar­rived at the FDA short­ly af­ter the Trump ad­min­is­tra­tion took of­fice, vow­ing to up­hold the gold stan­dard in drug de­vel­op­ment while do­ing every­thing pos­si­ble to fa­cil­i­tate drug mak­ers’ work — at least for the le­git­i­mate play­ers.

He has been enor­mous­ly pop­u­lar in his short stint, with the vast ma­jor­i­ty of bio­phar­ma ex­ecs ac­claim­ing his work at the agency. He’s al­so been pop­u­lar with Pres­i­dent Don­ald Trump, find­ing a se­cure spot for him­self in an ad­min­is­tra­tion not­ed for rapid turnover.

So what hap­pened here?

Just weeks ago Got­tlieb in­sist­ed on Twit­ter that ru­mors of his pend­ing de­par­ture from the agency were flat wrong. He tweet­ed:

We’ve got a lot im­por­tant pol­i­cy we’ll ad­vance this year. I look for­ward to shar­ing my 2019 strate­gic roadmap soon.

The big ques­tion now is who will re­place him. Trump freaked out many ex­ecs by en­ter­tain­ing Pe­ter Thiel’s push for a lib­er­tar­i­an ap­proach, which would have erased many of the bar­ri­ers to in­tro­duc­ing new drugs — along with the cred­i­bil­i­ty that goes with an FDA sanc­tion. Trump, though, has many open po­si­tions in his ad­min­is­tra­tion, in­clud­ing Cab­i­net-lev­el posts. Stephen Os­troff has tak­en the helm on a strict­ly in­ter­im ba­sis be­fore, but he re­tired last fall, re­placed by Wal­mart ex­ec­u­tive Frank Yian­nas.

Got­tlieb’s let­ter of res­ig­na­tion in­cludes his list of ac­com­plish­ments for the past 23 months, from a record num­ber of new drug ap­provals to their con­tin­ued work on mas­ter­ing new tech­nolo­gies and tak­ing on e-cig­a­rette use by mi­nors.

I’m con­fi­dent that the FDA will con­tin­ue to ad­vance all these ef­forts, and many oth­er goals.

In­dus­try lead­ers quick­ly not­ed the sig­nif­i­cance of the move to­day.

“We’re go­ing to miss him. He was a ter­rif­ic leader of the FDA,” Al­ny­lam CEO and BIO chair­man John Maraganore told me.

“It’s a damn shame,” Tweet­ed long­time se­r­i­al en­tre­pre­neur Mike Gilman, echo­ing the sharp lev­el of dis­ap­point­ment about the news.

 


Im­age: Scott Got­tlieb, com­mis­sion­er of the Food and Drug Ad­min­is­tra­tion (FDA), pos­es for por­trait pho­tographs in front of the old FDA sign at the FDA in White Oak, MD on No­vem­ber 5, 2018 The Wash­ing­ton Post

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

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In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

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Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.