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.

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.

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Klick Health co-founder and CEO Leerom Segal sat down for a one-on-one with former President Barack Obama in New York on Thursday night for a wide-ranging discussion about his time in office and current political divisiveness in the US, but also on some health and science topics.

Segal, for instance, asked the former chief executive about the decline of trust in science — that in 2022 “vaccines are still controversial and maybe even political”— and how it can be reinstated.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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