Ran­somware at­tack hit clin­i­cal tri­als soft­ware play­er ERT — two weeks lat­er, they’re com­ing back on­line

One of the largest bio­med­ical ran­somware at­tacks in US his­to­ry was re­vealed last week, when IT sys­tems at 250 lo­ca­tions in a ma­jor Amer­i­can hos­pi­tal chain fell vic­tim to face­less ex­tor­tion­ists — forc­ing them to take sys­tems of­fline, di­rect­ing staff to work off pen and pa­per, and bring­ing in out­side se­cu­ri­ty con­sul­tants to mit­i­gate the dam­age.

Turns out that a week pri­or, on Sept. 20, a sim­i­lar, much small­er at­tack be­fell eRe­searchTech­nol­o­gy, a lead­ing clin­i­cal tri­al soft­ware provider to CROs and spon­sors.

Drew Bus­tos

That Sun­day, staff at ERT were locked out of cru­cial da­ta and re­al­ized they were un­der a ran­somware at­tack. “Our net­work team iden­ti­fied the is­sue quick­ly, and we took our sys­tems of­fline,” Drew Bus­tos, ERT’s VP of mar­ket­ing, told me in an in­ter­view.

The CRO gi­ant IQVIA, who us­es ERT soft­ware in some of the tri­als they run for spon­sors, ac­knowl­edged the in­ci­dent in a state­ment to End­points News and said it had a lim­it­ed im­pact on op­er­a­tions. “[IQVIA] im­ple­ment­ed back­up pro­to­cols im­me­di­ate­ly to en­sure the con­ti­nu­ity and in­tegri­ty of sev­er­al on­go­ing tri­als that use ERT, and we no­ti­fied af­fect­ed spon­sors ac­cord­ing­ly. The cur­rent tech­ni­cal is­sues af­fect­ing ERT have not in­fil­trat­ed any IQVIA sys­tems.”

Bus­tos told me that no clin­i­cal source da­ta was im­pact­ed at ERT and that the ma­jor­i­ty of their sys­tems are now back on­line.

The IQVIA state­ment con­firms no sen­si­tive da­ta have been com­pro­mised, but that an in­ves­ti­ga­tion is still on­go­ing: “At this point in the in­ves­ti­ga­tion, we are not aware of any con­fi­den­tial da­ta or pa­tient in­for­ma­tion, re­lat­ed to our clin­i­cal tri­al ac­tiv­i­ties, which have been re­moved, com­pro­mised or stolen.”

The in­ci­dent rais­es ques­tions on the bio­phar­ma in­dus­try’s pre­pared­ness to deal with se­vere cy­ber­at­tacks that could en­dan­ger the in­tegri­ty of clin­i­cal tri­als and oth­er da­ta-rich R&D ef­forts.

Er­ic Per­ak­slis

“The abil­i­ty for com­pa­nies to quick­ly with­stand this kind of at­tack is com­plete­ly de­pen­dent on how good your IT is to be­gin with,” said Er­ic Per­ak­slis, who has served as the FDA’s CIO and held se­nior IT po­si­tions at J&J and Take­da, and is now a Ruben­stein Fel­low at Duke Uni­ver­si­ty.

While Per­ak­slis isn’t privy to any of the de­tails be­hind this par­tic­u­lar at­tack, he re­it­er­at­ed that a rig­or­ous and fre­quent­ly test­ed back­up sys­tem great­ly re­duces risk to ran­somware. “If your da­ta is backed up every evening at 5pm, and you test it know­ing it can all be re­stored by 8am the next morn­ing, that’s ba­sic IT hy­giene,” he told me.

Mon­ey is the mo­ti­vat­ing fac­tor be­hind most ran­somware at­tacks. “We’re gonna cut you off from your da­ta and trans­ac­tions un­til we get paid,” is how Per­ak­slis de­scribed it to me. This sum­mer the med­ical school at UCSF paid $1.14M — in vir­tu­al­ly un­trace­able Bit­coin — to ex­tor­tion­ists in ex­change for a tool to un­lock their da­ta.

Bus­tos de­clined to say whether ERT paid any ran­som to the hack­ers, nor would he iden­ti­fy the out­side se­cu­ri­ty ex­perts brought in to mit­i­gate the is­sue. He notes the com­pa­ny has tak­en steps to pre­vent a sim­i­lar in­ci­dent in the fu­ture. “We’re fol­low­ing the ad­vice of a world-class se­cu­ri­ty firm, and adopt­ing their best prac­tices to aug­ment our ex­ist­ing de­fens­es.”

“It’s some­thing that’s un­for­tu­nate and no­body wants to be im­pact­ed by cy­ber­se­cu­ri­ty is­sues. But it is some­thing that we feel that we are work­ing to­wards re­me­di­a­tion,” he added.

The in­ci­dent was first re­port­ed by the New York Times.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Lutz Hegemann, Novartis president of global health

No­var­tis li­cens­es out leukemia drug as part of new glob­al coali­tion to in­crease ac­cess to can­cer treat­ments

The Union for International Cancer Control (UICC) has gathered a slate of Big Pharmas for its new collaboration in hopes of increasing access to cancer medicines in lower income countries, UICC announced yesterday.

Dubbed ATOM, or Access to Oncology Medicines, the coalition includes AstraZeneca, BeiGene, Novartis, Bristol Myers Squibb, Roche, Gilead, and Sanofi, among other organizations. The goal of the partnership is to increase generic and biosimilar development of cancer drugs as well as license out essential medicines to these countries. The third part of the partnership includes building up the infrastructure to diagnose cancers and properly handle cancer medicines.

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Bris­tol My­ers dusts off an old Cel­gene chemother­a­py for use in chil­dren with a rare blood can­cer

Bristol Myers Squibb is bringing new life to a chemotherapy drug from the old Celgene pipeline as it touts another approval in a rare form of blood cancer affecting young children.

The FDA on Friday approved Vidaza (chemically known as azacitidine) for pediatric patients 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML). The new indication marks the first approval for Vidaza in more than a decade, though it’s commonly used to treat acute myeloid leukemia and myelodysplastic syndromes (MDS).