No­var­tis is lat­est vic­tim of cy­ber­at­tack, but claims no con­fi­den­tial da­ta com­pro­mised — re­port

Just a few months ago, cy­ber­se­cu­ri­ty ex­perts told End­points News that the bio­phar­ma in­dus­try is large­ly un­pre­pared for cy­ber­at­tacks. No­var­tis is the lat­est com­pa­ny to fall vic­tim.

Spe­cial­ized IT web­site Bleep­ing Com­put­er re­port­ed that No­var­tis got hacked late last week, af­ter hack­ing group In­dus­tri­al Spy of­fered up da­ta on its “ex­tor­tion mar­ket­place” that was ap­par­ent­ly stolen from No­var­tis labs.

The news comes as as ex­perts warn that many com­pa­nies are leav­ing them­selves vul­ner­a­ble to ma­jor at­tacks, es­pe­cial­ly as more in­fra­struc­ture moves on­line. In the words of Bio­Bright CEO Charles Frac­chia, “we are thor­ough­ly f***ed.”

In­dus­tri­al Spy claimed that the da­ta are re­lat­ed to RNA and DNA-based drug tech­nol­o­gy and tests from No­var­tis, which were stolen “di­rect­ly from the lab­o­ra­to­ry en­vi­ron­ment of the man­u­fac­tur­ing plant.”

The da­ta were like­ly stolen a few months ago, as the date list­ed on files was Feb. 25, ac­cord­ing to a screen­shot the hack­ers post­ed.

The hack­ing group of­fered to sell the da­ta, a few files on­ly 7.7 MB in size, for $500,000 in bit­coins, ac­cord­ing to Bleep­ing Com­put­er. It was not clear if these were the on­ly files In­dus­tri­al Spy had in its pos­ses­sion, or if there were more.

A No­var­tis spokesper­son did not say much, but told End­points that:

No­var­tis is aware of this mat­ter. We have thor­ough­ly in­ves­ti­gat­ed it and we can con­firm that no sen­si­tive da­ta has been com­pro­mised. We take da­ta pri­va­cy and se­cu­ri­ty very se­ri­ous­ly and have im­ple­ment­ed in­dus­try stan­dard mea­sures in re­sponse to these kind of threats to en­sure the safe­ty of our da­ta.

No­var­tis did not clar­i­fy how the hack­ers got ac­cess or what type of da­ta was stolen. How­ev­er, In­dus­tri­al Spy is known to use ran­somware in at­tacks, ac­cord­ing to Bleep­ing Com­put­er — and as far as it was able to tell, there is no ev­i­dence that com­pa­ny de­vices were en­crypt­ed.

Mean­while, cy­ber­se­cu­ri­ty ex­perts are en­cour­ag­ing com­pa­nies to im­prove their dig­i­tal se­cu­ri­ty ef­forts. Mer­ck was al­so hit hard back in 2017, when a mal­ware known as Not­Petya — based on stolen NSA tech­nol­o­gy — crip­pled Gar­dasil 9 pro­duc­tion fa­cil­i­ties, de­stroyed years of re­search and caused more than a bil­lion dol­lars in dam­ages. While in­sur­ers called the at­tack an “act of war” and sought to de­ny Mer­ck’s pol­i­cy cov­er­age, a court de­cid­ed ear­ly this year that the in­sur­er’s war ex­clu­sion pol­i­cy on­ly ap­plied to tra­di­tion­al forms of war­fare.

Dig­i­tal risk pro­tec­tion com­pa­ny Con­stel­la found more than 9,800 breach­es and leak­ages at the top 20 phar­ma com­pa­nies on the For­tune Glob­al 500 list, af­ter an­a­lyz­ing records be­tween 2018 and 2021. With J&J, Mer­ck, Pfiz­er and oth­ers on the list, those breach­es re­sult­ed in sev­er­al mil­lion ex­posed records, and the ma­jor­i­ty of those in­clud­ed per­son­al­ly iden­ti­fi­able in­for­ma­tion. Even so, more than 75% of those breach­es oc­curred af­ter the start of the pan­dem­ic.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.