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.

There are plen­ty of qual­i­fied peo­ple that this does­n't need to be a neg­a­tive. But the thing I do wor­ry about with the en­vi­ron­ment in Wash­ing­ton these days is that it will take for­ev­er for the next per­son to get ap­proved.

— Brad Lon­car (@brad­lon­car) March 5, 2019

….Scott has helped us to low­er drug prices, get a record num­ber of gener­ic drugs ap­proved and on­to the mar­ket, and so many oth­er things. He and his tal­ents will be great­ly missed!

— Don­ald J. Trump (@re­al­Don­aldTrump) March 5, 2019

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

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.