White House: Mer­ck and oth­ers hit by Not­Petya were col­lat­er­al dam­age in Rus­sia’s cy­ber­war on the Ukraine

Gov­ern­ment of­fi­cials in the US and UK say they are now cer­tain they know who launched the Not­Petya cy­ber­war that slammed op­er­a­tions at Mer­ck and a num­ber of US com­pa­nies.

The Russ­ian mil­i­tary did it.

In a short but blunt state­ment on the White House home page, the gov­ern­ment says that the Rus­sians aimed Not­Petya at its op­po­nents in the Ukraine in a clear as­sault that quick­ly jumped na­tion­al bor­ders and ran amuck, caus­ing vast dam­age around the world. One of the com­pa­nies that was hard­est hit, at least par­tial­ly with the help of leaked NSA hack­ing tech, was Mer­ck.

Last fall Mer­ck ex­ecs con­ced­ed that the Not­Petya cy­ber at­tack had cost the com­pa­ny $135 mil­lion in lost sales along with $175 mil­lion in re­lat­ed costs while forc­ing them to bor­row $240 mil­lion worth of Gar­dasil from fed­er­al stock­piles. That ex­tra $310 mil­lion in costs, they added, would be re­peat­ed in Q4 as over­all dam­ages rolled up to the $1 bil­lion mark.

Here’s the full state­ment from the White House, where Pres­i­dent Don­ald Trump has re­peat­ed­ly dissed ev­i­dence that the Rus­sians in­ter­fered in the pres­i­den­tial elec­tion with a spe­cial on­line at­tack that se­cu­ri­ty of­fi­cials warn will be re­peat­ed this year.

In June 2017, the Russ­ian mil­i­tary launched the most de­struc­tive and cost­ly cy­ber-at­tack in his­to­ry.

The at­tack, dubbed “Not­Petya,” quick­ly spread world­wide, caus­ing bil­lions of dol­lars in dam­age across Eu­rope, Asia, and the Amer­i­c­as.  It was part of the Krem­lin’s on­go­ing ef­fort to desta­bi­lize Ukraine and demon­strates ever more clear­ly Rus­sia’s in­volve­ment in the on­go­ing con­flict.  This was al­so a reck­less and in­dis­crim­i­nate cy­ber-at­tack that will be met with in­ter­na­tion­al con­se­quences.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

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Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

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We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

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The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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