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.”


Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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