Geoff Martha, Medtronic CEO

Some Medtron­ic in­sulin pumps are vul­ner­a­ble to hack­ers, FDA warns

One of the fea­tures Medtron­ic touts in its Min­iMed 600 se­ries in­sulin pumps is a se­ries of com­po­nents that con­nect wire­less­ly to al­low the re­mote de­liv­ery of in­sulin. On Tues­day, reg­u­la­tors warned that the tech­nol­o­gy al­so leaves the door open to po­ten­tial hack­ers.

The FDA is­sued an alert that unau­tho­rized users could gain con­trol of the pumps in cer­tain cir­cum­stances, re­sult­ing in ei­ther too much or too lit­tle in­sulin be­ing ad­min­is­tered. While too much in­sulin leads to low blood sug­ar — which in se­vere cas­es can cause seizure, co­ma or death — too lit­tle may lead to di­a­bet­ic ke­toaci­do­sis, a life-threat­en­ing con­di­tion where the body starts break­ing down fat too fast.

Medtron­ic re­as­sured pa­tients that no cy­ber­se­cu­ri­ty is­sues have been re­port­ed yet, and a near­by per­son can on­ly gain ac­cess at the ex­act time the pump is be­ing paired with oth­er com­po­nents — not via the in­ter­net, ac­cord­ing to a re­cent state­ment. On­ly 600 se­ries pumps are im­pact­ed, in­clud­ing the Min­iMed 630G and 670G pumps.

“Our in­ter­nal test­ing has in­di­cat­ed there is a re­mote like­li­hood of this is­sue oc­cur­ring as it would re­quire phys­i­cal prox­im­i­ty to the com­mu­ni­ca­tion sig­nal while the pump is be­ing paired and ad­vanced tech­ni­cal knowl­edge. This al­so can­not be done through the in­ter­net,” the com­pa­ny said in an email to End­points News. 

How­ev­er, the com­pa­ny still rec­om­mend­ed tak­ing a few pre­cau­tions, such as switch­ing off the “re­mote bo­lus” fea­ture, which is turned on by de­fault, and on­ly link­ing the de­vices in a pri­vate space. The com­pa­ny al­so cau­tioned against shar­ing a de­vice’s se­r­i­al num­bers, and ac­cept­ing, cal­i­brat­ing or ad­min­is­ter­ing in­sulin based on a blood glu­cose read­ing that wasn’t ini­ti­at­ed by the pa­tient.

This isn’t the first time Medtron­ic has run in­to cy­ber­se­cu­ri­ty prob­lems. Back in 2018, the com­pa­ny ac­knowl­edged a “po­ten­tial vul­ner­a­bil­i­ty” with its Min­iMed Par­a­digm pumps that could al­low hack­ers to copy the wire­less ra­dio fre­quen­cy sig­nals used by re­mote con­trollers and de­liv­er ex­tra in­sulin dos­es.

“Users should im­me­di­ate­ly stop us­ing and dis­con­nect the re­mote con­troller, dis­able the re­mote fea­ture, and re­turn the re­mote con­troller to Medtron­ic,” the com­pa­ny said of the old­er Par­a­digm and 508 mod­els.

Charles Frac­chia

Cy­ber­se­cu­ri­ty has been top of mind for com­pa­nies across the phar­ma in­dus­try, as the num­ber of cy­ber­at­tacks in the bio space has sky­rock­et­ed amid the pan­dem­ic, Charles Frac­chia, CEO and founder of Bio­Bright, told End­points ear­li­er this year. Ex­perts have en­cour­aged com­pa­nies to main­tain bet­ter “cy­ber hy­giene,” in­clud­ing train­ing em­ploy­ees and up­dat­ing their tech.

Medtron­ic’s lat­est threat marks yet an­oth­er tough blow for the com­pa­ny’s di­a­betes unit, which was slapped with an FDA warn­ing let­ter back in De­cem­ber over its al­leged fail­ure to prompt­ly re­call faulty in­sulin pumps. The re­call fol­lowed an in­crease in com­plaints about dam­aged re­tain­er rings, which can lead to an in­suf­fi­cient amount of in­sulin be­ing de­liv­ered.

CEO Ge­off Martha said on the com­pa­ny’s re­cent quar­ter­ly call that he’s “mak­ing good progress on our warn­ing let­ter com­mit­ments,” and is in ac­tive dis­cus­sion with the FDA about its sub­mis­sion for its lat­est Min­iMed 780G. In an at­tempt to boost sales for its smart in­sulin pen, the com­pa­ny re­cent­ly en­list­ed for­mer Dis­ney ac­tress Jen­nifer Stone to join its cam­paign.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

CHICAGO — Eight weeks before patients and industry find out if the FDA approves the first treatment for geographic atrophy, an advanced form of age-related macular degeneration, the biotech behind the drug is out with some new data on a secondary endpoint.

In what study investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment, Apellis Pharmaceuticals’ drug pegcetacoplan led to less loss of retinal sensitivity versus sham  within 250 microns on either side of the GA lesion over 24 months.

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BioCryst's new website for its HAE unbranded campaign encourages patients to take charge of treatment decisions.

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

While hereditary angioedema (HAE) is rare, treatment options for the condition have become much more common. So BioCryst Pharmaceuticals is taking a new angle in its recently launched HAE awareness campaign encouraging patients to take control of their disease management.

“Hereditary angioedema (HAE) isn’t the author of your story — you are … #cHAEngetheplan. Not the goal,” the US campaign website advises.

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EMA makes new rec­om­men­da­tions for Im­bru­vi­ca, med­i­cines with ter­li­pressin over res­pi­ra­to­ry and car­dio­vas­cu­lar risks

The EMA is handing out a new recommendation surrounding J&J and AbbVie’s cancer drug Imbruvica and some medicines containing terlipressin.

On Friday, the EMA’s safety committee (PRAC) stated that it has taken new measures to reduce the risk of respiratory failure and sepsis when medicines containing terlipressin that are used to treat people with hepatorenal syndrome (HRS-1), particularly for patients with advanced acute-on-chronic liver disease or advanced kidney failure.