House com­mit­tee wants to know a lot more about the cy­ber­at­tack that dam­aged Mer­ck

Up to now, Mer­ck has been re­luc­tant to go in­to much de­tail re­gard­ing just how dam­ag­ing a re­cent cy­ber­at­tack has been to op­er­a­tions. Now, though, it’s go­ing to have to as the House Com­mit­tee on En­er­gy and Com­merce has raised the mat­ter to an is­sue in­volv­ing na­tion­al se­cu­ri­ty.

Mer­ck has ac­knowl­edged that the at­tack on June 27 roiled its man­u­fac­tur­ing, sales and R&D ops. Drug and vac­cine man­u­fac­tur­ing was crimped weeks af­ter the at­tack and Mer­ck con­ced­ed that it would ham­per an­nu­al rev­enue as the com­pa­ny con­tin­ued to scram­ble to re­pair the crip­pling af­ter­ef­fects.

Ken Fra­zier, the CEO of Mer­ck, at the White House on Ju­ly 20, 2017, one month pri­or to re­sign­ing from the Pres­i­dent’s man­u­fac­tur­ing coun­cil AFP PHO­TO / SAUL LOEB

But the com­pa­ny has al­so been re­luc­tant to spell out ex­act­ly how hard it was hit and where, leav­ing law­mak­ers look­ing to learn more about the im­pact and how a more ef­fec­tive cy­ber­at­tack could wal­lop the en­tire health­care sec­tor.

The com­mit­tee wrote:

While there is no ev­i­dence, to date, that Mer­ck’s man­u­fac­tur­ing dis­rup­tion has cre­at­ed a risk to pa­tients, it cer­tain­ly rais­es con­cerns. For ex­am­ple, in a re­cent up­date on na­tion­al vac­cine sup­ply, the CDC re­port­ed that Mer­ck would not be dis­trib­ut­ing cer­tain for­mu­la­tions of the He­pati­tis B vac­cine. While it is un­clear if this is re­lat­ed to the Not­Petya dis­rup­tion, and much of the sup­ply can be filled by oth­er man­u­fac­tur­ers, it does raise ques­tions about how the na­tion is pre­pared to ad­dress a sig­nif­i­cant dis­rup­tion to crit­i­cal med­ical sup­plies.

In a state­ment to End­points News, Mer­ck says sup­ply is­sues with Re­com­bivax HB are not re­lat­ed to the cy­ber­at­tack and adds:

Mer­ck is ex­pe­ri­enc­ing man­u­fac­tur­ing con­straints in 2017 re­lat­ed to the grow­ing glob­al de­mand for our vac­cines and un­ex­pect­ed de­mand due to lack of com­pet­i­tive sup­ply. Sup­ply in­ter­rup­tions for the adult for­mu­la­tion of RE­COM­BIVAX­HB be­gan in the first quar­ter of 2017. Mer­ck does not ex­pect to be dis­trib­ut­ing RE­COM­BIVAX­HB in the Unit­ed States be­tween now and the end of 2018. Ad­di­tion­al­ly, Mer­ck ex­pects its pe­di­atric for­mu­la­tion of RE­COM­BIVAX­HB will be un­avail­able in the Unit­ed States be­tween ear­ly Au­gust 2017 un­til ear­ly 2018. The dial­y­sis for­mu­la­tion of  RE­COM­BIVAX­HB in the Unit­ed States is not af­fect­ed.

Law­mak­ers’ let­ter to Mer­ck CEO Ken Fra­zier asks for a for­mal pre­sen­ta­tion de­tail­ing the cy­ber­at­tack’s im­pact by Oc­to­ber 4. The com­pa­ny says they’re in touch with the com­mit­tee.

Not­Petya was based on stolen NSA tech­nol­o­gy. Mi­crosoft first en­coun­tered the virus with “worm ca­pa­bil­i­ties” in 12,500 com­put­ers in Ukraine, which then spread lat­er­al­ly to an­oth­er 64 coun­ties in­clud­ing the Unit­ed States, in­fect­ing com­put­ers that were not patched with crit­i­cal up­dates.

Mer­ck claims the patch­es were in­stalled. At the time they said, “gov­ern­ment au­thor­i­ties work­ing with us have con­firmed that the mal­ware re­spon­si­ble for the at­tack con­tained a unique com­bi­na­tion of char­ac­ter­is­tics that en­abled it to in­fect com­pa­ny sys­tems de­spite in­stal­la­tion of re­cent soft­ware patch­es.”

 

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.

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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Ted Love. HAVERFORD COLLEGE

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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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.

Fresh analy­sis spot­lights car­dio ben­e­fit of J&J's In­vokana in di­a­betes pa­tients with­out his­to­ry of CV dis­ease

In­vokana sales may be mut­ed, but the di­a­betes drug is set to get some love af­ter its mak­er J&J un­veiled da­ta at the Amer­i­can Di­a­betes As­so­ci­a­tion meet­ing on Tues­day sug­gest­ing the med­i­cine can con­fer a car­dio­vas­cu­lar ben­e­fit in pa­tients who do not have pre­ex­ist­ing CV dis­ease.

Back in April, J&J had re­port­ed that in the late-stage CRE­DENCE study, the SGLT2 drug scored a 30% re­duc­tion in the risk of a com­pos­ite of ail­ments: a pro­gres­sion to the dou­bling of serum cre­a­ti­nine, end-stage kid­ney dis­ease and re­nal or car­dio­vas­cu­lar death. In terms of sec­ondary end­points, the drug was al­so found be heart-pro­tec­tive: low­er­ing the risk of CV death and hos­pi­tal­iza­tion for heart fail­ure by 31%, as well as ma­jor ad­verse CV events by 20%. In March, the com­pa­ny sub­mit­ted an ap­pli­ca­tion to ex­pand In­vokana’s la­bel to re­flect its im­pact on chron­ic kid­ney dis­ease.

Sil­i­con Val­ley's most an­tic­i­pat­ed slide deck just dropped. What does it mean for bio­phar­ma's dig­i­tal teams?

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.