→ FDA com­mish Scott Got­tlieb was spread­ing the love Mon­day morn­ing, wel­com­ing back FDA staff and look­ing to get the world’s fastest drug reg­u­la­to­ry agency back up to full swing AS­AP. Of course, it could all come crash­ing to a halt again Feb­ru­ary 15, un­less law­mak­ers ei­ther out­law gov­ern­ment shut­downs or come to a com­pro­mise of sorts. In the mean­time, the FDA is open for busi­ness.

I look for­ward to be­ing out­side Build­ing 1 to­day to greet ALL my col­leagues as we re­turn to our posts TO­GETH­ER. I know there will be ad­di­tion­al chal­lenges ahead as we catch up on missed work and dead­lines. I’ll sup­port you in all of these ef­forts as we forge ahead as ONE #FDA pic.twit­ter.com/0zJSm­NXU9o

— Scott Got­tlieb, M.D. (@SGot­tliebF­DA) Jan­u­ary 28, 2019

→ Not every­thing was shut­tered at the FDA. The agency has ap­proved Al­lo­gene’s IND for a clin­i­cal tri­al us­ing their off-the-shelf CAR-T AL­LO-501 for non-Hodgkin lym­phoma. The drug will be in­fused in­to pa­tients fol­low­ing fly/cy lym­phode­ple­tion and AL­LO-647, their CD52 an­ti­body.

→ The FDA has giv­en Xenon’s $XENE XEN007 rare pe­di­atric dis­ease sta­tus to treat Al­ter­nat­ing Hemi­ple­gia of Child­hood (AHC) — a rare, se­vere and de­bil­i­tat­ing neu­ro­log­i­cal move­ment dis­or­der that presents in in­fan­cy and has no ap­proved treat­ments. The agency has al­so al­lowed the CNS drug de­vel­op­er to test its XEN1101 in hu­mans for epilep­sy and oth­er neu­ro­log­i­cal dis­or­ders.

→ Fib­ri­ot­ic dis­ease drug de­vel­op­er In­da­lo Ther­a­peu­tics has ap­point­ed Robert Jacks as its pres­i­dent and CEO, who comes  from Sym­bio­mix Ther­a­peu­tics where he served as co-founder, pres­i­dent and CFO. The com­pa­ny is ex­pect­ed to take its lead drug, IDL-2965, in­to the clin­ic in ear­ly 2019.

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.