Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

With the dust set­tled on an R&D spin­out, the ful­ly com­mer­cial op­er­a­tions at Iron­wood have come up with some late-stage da­ta to up its Linzess mar­ket­ing game.

Iron­wood, along with part­ner Al­ler­gan, set out to col­lect ev­i­dence that their drug can im­prove the over­all ab­dom­i­nal symp­toms of ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion (IBS-C), not just con­sti­pa­tion. And the com­pa­nies say that’s what they found in the Phase II­Ib: Pa­tients tak­ing Linzess for 12 weeks saw a 29.7% mean de­crease from base­line in a week­ly score that mea­sured bloat­ing, pain and dis­com­fort, com­pared to 18.3% for place­bo (p<0.0001).

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.

As­traZeneca and Mer­ck’s PARP in­hibitor Lyn­parza has carved it­self a niche in Eu­rope.

Five months af­ter get­ting a speedy ap­proval from the US reg­u­la­tor for front­line main­te­nance treat­ment for BR­CA-mu­tat­ed ovar­i­an can­cer, the EU has fol­lowed suit, mark­ing the first PARP in­hibitor to win ap­proval for the in­di­ca­tion in the re­gion.

The ap­proval is based on re­sults from a 391-pa­tient study un­veiled in Oc­to­ber, which test­ed Lyn­parza against a place­bo in pa­tients giv­en plat­inum-based chemother­a­py. Da­ta showed that 40.7 months of fol­low-up showed the me­di­an time of pro­gres­sion for pa­tients treat­ed with Lyn­parza had not yet been reached ver­sus 13.8 months for those on place­bo.

Am­gen, Mer­ck, Eli Lil­ly and the As­so­ci­a­tion of Na­tion­al Ad­ver­tis­ers on Fri­day sued the De­part­ment of Health and Hu­man Ser­vices (HHS) be­cause of a rule­mak­ing that would re­quire phar­ma­ceu­ti­cal list prices to be shown in di­rect-to-con­sumer (DTC) drug ad­ver­tise­ments on tele­vi­sion.

The rule, which was fi­nal­ized in May and is set to take ef­fect in Ju­ly, re­quires that tele­vi­sion ad­ver­tise­ments for pre­scrip­tion drugs or bi­o­log­i­cal prod­ucts with a list price of $35 or more con­tain a state­ment in­di­cat­ing the Whole­sale Ac­qui­si­tion Cost (al­so re­ferred to as WAC or the list price) for a typ­i­cal 30-day reg­i­men or for a typ­i­cal course of treat­ment.

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.

In the lat­est up­date on As­traZeneca’s de­lay-prone HQ project, the phar­ma gi­ant re­vealed that the cost of con­struc­tion has swelled to £750 mil­lion ($956 mil­lion) — more than dou­ble the orig­i­nal es­ti­mate in 2013.

The move-in date is still in 2020, a spokesper­son con­firmed, af­ter As­traZeneca pushed pro­ject­ed com­ple­tion from 2016 to 2017, and then to the spring of 2019. While the ini­tial plan called for a £330 mil­lion (then $500 mil­lion) in­vest­ment, the cost bal­looned to £500 mil­lion ($650 mil­lion), and more in the most re­cent up­date.