→ 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.

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.