Say what? Trump de­clares a big vic­to­ry in the war on drug prices — for De­cem­ber, any­how

Pres­i­dent Don­ald Trump wants you to know he’s win­ning the war on drug prices.

For one month, in any case.

“Al­ready,” Trump said dur­ing the State of the Union ad­dress Tues­day night, “as a re­sult of my ad­min­is­tra­tion’s ef­forts, in 2018 drug prices ex­pe­ri­enced their sin­gle largest de­cline in 46 years.”

That com­ment may take a lot of peo­ple in the bio­phar­ma in­dus­try by sur­prise. Yes, drug price in­creas­es have mod­er­at­ed, as most any phar­ma ex­ec will quick­ly tell you, but there’s been no rush by the drug mak­ers to slash prices.

AP fact check­ers tack­led this one quick­ly. They con­clud­ed that Trump’s boast was con­nect­ed to the De­cem­ber CPI on pre­scrip­tion drug prices, which dropped 0.6% — and which scores as the biggest drop in close to half a cen­tu­ry. But if you look at all of last year, the price fig­ure jumped 1.6%.

Paul Hugh­es-Cromwick of Al­tarum, a non­prof­it re­search or­ga­ni­za­tion, told the AP: “It could be that some­thing quirky hap­pened in De­cem­ber.”

An AP analy­sis al­so found “2,712 price in­creas­es in the first half of this Jan­u­ary, as com­pared with 3,327 in­creas­es dur­ing the same pe­ri­od last year.”

Trump will take cred­it for the De­cem­ber num­ber. But he al­so wants Con­gress to pass leg­is­la­tion that di­rect­ly tack­les drug costs. 

I am ask­ing the Con­gress to pass leg­is­la­tion that fi­nal­ly takes on the prob­lem of glob­al free­load­ing and de­liv­ers fair­ness and price trans­paren­cy for Amer­i­can pa­tients. We should al­so re­quire drug com­pa­nies, in­sur­ance com­pa­nies, and hos­pi­tals to dis­close re­al prices to fos­ter com­pe­ti­tion and bring costs down.

The ad­min­is­tra­tion has been push­ing a new pro­pos­al to strip away the safe har­bor pro­tec­tions that safe­guard the re­bates built in­to the drug pric­ing sys­tem we have now from an­ti-kick­back pro­vi­sions. Trump’s health­care team is ask­ing for a new fee-based sys­tem with dis­counts di­rect to con­sumers. And HHS Sec­re­tary Alex Azar wants leg­is­la­tion that would ap­ply these changes to pub­lic and pri­vate op­er­a­tions.

Drug pric­ing has emerged as a bi­par­ti­san is­sue in a di­vid­ed Con­gress. De­moc­rats have been propos­ing new laws while Re­pub­li­can Chuck Grass­ley and De­mo­c­rat Ron Wyden in the Sen­ate have been try­ing to line up the top CEOs in the in­dus­try to tes­ti­fy lat­er this month. So far, on­ly Mer­ck CEO Ken Fra­zier has pub­licly agreed to take the hot seat. The sen­a­tors say they have an­oth­er one, still anony­mous, and Olivi­er Brandi­court’s peo­ple are re­port­ed­ly check­ing his sched­ule to see if he can make it.

“This is an op­por­tu­ni­ty for com­pa­nies that pro­duce life-sav­ing treat­ments to ex­plain how they price these treat­ments and whether the sta­tus quo is ac­cept­able,” Grass­ley said in a state­ment. “Pa­tients and tax­pay­ers de­serve to hear from lead­ers in the in­dus­try about what’s be­hind this un­sus­tain­able trend and what can be done to low­er costs.”

The top ex­ecs at Ab­b­Vie, As­traZeneca, Bris­tol-My­ers Squibb, J&J and Pfiz­er al­so qual­i­fied for the least cov­et­ed in­vi­ta­tions in Wash­ing­ton, DC.

The pres­i­dent is like­ly to find con­sid­er­able warmth for his pro­pos­al on Tues­day to spend $500 mil­lion on re­search in­to new ther­a­pies for child­hood can­cer as well as a com­mit­ment to wip­ing out HIV/AIDS in 10 years.

Im­age: Pres­i­dent Don­ald Trump de­liv­er­ing the State of the Union.AP IM­AGES

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

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.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

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.

Plagued by de­lays, As­traZeneca HQ costs soar to £750M as it edges to­ward 2020 com­ple­tion

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.