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A New Innovation for Type 2 Diabetes

It is often the simple fixes (and fixers) that make all the difference in the world: the genius who came up with giving out numbers to deli customers rather than having them mob the counter; assigned seating in movie theaters; E-ZPass.

Indeed, for all the excitement over paradigm-shifting technologies in healthcare and medicine—gene-editing through CRISPR, virtual reality surgical training—it seems we are seeing more and more examples of people solving age-old problems through a stroke of ingenuity. With the proverbial popsicle stick and chewing gum, that is.

And sometimes, the two are combined: a bold new technology is coupled with a strikingly simple, intuitive innovation. That has been my initial impression of a new drug-delivery system, called the Medici, which is made by Intarcia Therapeutics. The Medici is an osmotic pump about the size of a matchstick, which—in a procedure that takes about a minute or so to perform—is inserted under the skin. From there, its makers claim, the pump delivers medicine in a steady-state dose for several months (and even up to a year).

Intarcia has completed several late-stage clinical trials in which it uses the pump to deliver a glucose-controlling drug continuously for months—an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels. One big reason why is that it’s often hard to adhere to rigorous schedules for administering medicine.

Intarcia is expected to seek a new drug application for the product from the FDA soon, says Christine Aylward, managing director at Foresight Capital Management, which has backed the company. I’m always leery of writing about medicines and procedures that are still in the experimental stage—so assume all the normal qualifiers and caveats here. But what’s worth noting is that somebody set out in this case not just to make a new drug but to solve a problem that often consumes the lives of diabetes patients. Move over E-ZPass.

More news below.

Clifton Leaf
@CliftonLeaf
clifton.leaf@fortune.com

DIGITAL HEALTH

Health data breaches declined in October. The newest monthly report from the Protenus Breach Barometer finds that both the number of data breaches targeting healthcare organizations and the number of patients' whose information was breached declined in October. It was the second straight month of declining breaches following a harrowing summer for health providers—but the numbers are still significantly higher than they were earlier in 2016. According to the report, there were 35 incidents and more than 776,500 records were affected, with 40% of the incidents involving ransomware, malware, or hacking which breached the vast majority of the records. One potential reason for the monthly decline? The falling price for health records on the digital black market. (Healthcare IT News)
A nanoparticle "barcode" to track cancer drugs? Researchers at Israel's Technion Institute of Technology are experimenting with a nanoparticle "barcode" system in order to trace the efficacy of cancer drugs. The method involves tagging a molecular drug delivery vehicle with synthetic DNA that can then be used to see how cancerous tumors are responding to specific treatments (the drugs themselves are placed into these tagged nanoparticles). One key potential use of this technology (which has so far only been used on mouse models) is to track drug resistance, since tumors can eventually stop responding to chemotherapy and other treatments. (Mass Device)
This "brain game" maker isn't giving up after $2 million settlement. Lumos Labs still believes that its "Lumosity" gaming platform, which is being designed to help patients with Alzheimer's, ADHD, and other neurological disorders, can be a success despite a disheartening setback earlier this year when the Federal Trade Commission (FTC) sued it for $2 million over marketing practices. "The FTC never had issues with the quality of the product," the firm's new CEO, Steve Berkowitz, tells Fortune. "It was with the advertising language." Lumosity features a series of "brain games" that the company believes can help slow or ward off cognitive decline—but those claims haven't been definitely proven, which is what got the firm into hot water over its marketing in the first place. And there is some controversy about whether or not brain games can actually translate into real world outcomes for patients. (Fortune)
Experts still expect health IT to be a big priority under Trump. Healthcare Information and Management Systems Society (HIMSS) officials tell Healthcare IT News that, while we can expect to see some major changes to health policy under President Trump (including rollbacks to the Affordable Care Act, aka Obamacare), health IT will continue to get "plenty of airtime in Congress" and could even become an important jobs priority for the incoming president. "We anticipate that he will be pushing for more telehealth inclusions," said Tom Leary, vice president of government relations at the massive health IT industry group. "Telehealth is a real opportunity for both jobs and efficiency in care delivery." (Healthcare IT News)

INDICATIONS

Bristol-Myers is exploring how gut organisms may affect cancer drugs. The "microbiome," or the collection of organisms that reside within the human body (especially the gut), has become a big new interest area for a number of major pharma companies like Merck and smaller biotechs alike. Researchers hope that these little creatures could be harnessed to make drugs more effective or to even treat diseases. Now, Bristol-Myers Squibb has struck an alliance with the Paris-based microbiome firm Enterome to find out how gut organisms can interact with next-gen cancer immunotherapies (such as BMS' hugely successful Opdivo). Immuno-oncology drugs have proven promising and effective for many patients; but they also don't produce a response in a sizable chunk of the patient pool and may eventually wane in efficacy. BMS hopes to understand exactly why this happens, and whether or not the microbiome has a part to play in non-response to these drugs. (Endpoints, Fortune)
Sanofi and Regeneron still have a ways to go to show the downstream benefits of their next-gen cholesterol drug. Amgen unveiled some promising news during the American Heart Association's annual meeting involving its next-gen cholesterol-busting medication Repatha, which has been shown to significantly reduce the level of "bad" cholesterol in patients, announcing that more than 60% of patients who were receiving the therapy in a trial had a reduction in arterial plaque. That's significant because doctors have been slow to prescribe the pricey therapy, waiting to see whether or not the impressive cuts in LDL cholesterol lead to improved outcomes for heart disease patients. But Amgen's rivals in the space, Sanofi and Regeneron (which have their own PCSK9 blocking medicine called Praluent), announced that an independent data monitoring committee hasn't seen enough significant evidence in a huge, 18,000-patient cardiovascular outcomes trial to stop the study early. Now, the firms are hoping that the completion of the study will show cardiovascular improvement in these patients, giving them a strong argument to present to reticent physicians.
Merck is testing out its rock star cancer drug in a combo against HPV cancers. Merck's cancer immunotherapy Keytruda is one of the pharma giant's rising stars, especially in the wake of evidence that the therapy had a survival benefit over standard chemotherapy in advanced lung cancer patients. Now, Merck wants to see whether Keytruda, combined with South Korean biotech Genexine's experimental cancer vaccine, can be effective in treating HPV-related cancers. Cancer vaccines have been a mixed bag, efficacy-wise; but pharma firms are now testing out whether or not they might get a boost when used in conjunction with powerful new treatments that harness the power of the immune system. (FiercePharma)

THE BIG PICTURE

Jim Chanos says the hedge fund industry's bet on Valeant was worse than Enron. Chanos is a noted short-seller who's hedged against major firms like Tesla and Alibaba. And he says that the hedge fund industry's bets on the ever-embattled Valeant Pharmaceuticals was a mistake of epic proportions, rivaling the losses from Enron and other spectacular failures. Chanos said that he pegs those losses through long bets on Valeant at $40 billion, representing “the largest single security loss hedge funds have incurred, greater than Lehman, Enron, AIG.” On Thursday, U.S. attorneys charged Valeant Pharmaceuticals exec Gary Tanner and the former CEO of the now-defunct specialty pharmacy Philidor Rx (with whom Valeant had an exclusive relationship) with running a multi-million dollar fraud and kickback scheme. Valeant shares have plunged more than 83% in 2016. (Fortune)
Private eyes say Glaxo's actions led to their imprisonment in China. In another bizarre twist to GlaxoSmithKline's 2014 Chinese bribery scandal, two investigators who were hired by Glaxo officials in China have filed a lawsuit alleging that the company's actions eventually led to their unfair imprisonment in the country. Peter Humphrey and Yu Yingzeng, who are married, say that GSK officials in China asked them to investigate former employee Vivian Shi for spreading lies about the company. But the investigators allege that the investigation was actually an intimidation tactic against Shi launched for her suspected role as a whisteblower who spilled the beans about Glaxo's marketing tactics in China, and that they eventually became scapegoats who were arrested and imprisoned for their investigation of Shi. GlaxoSmithKline paid a $492 million fine over the bribery scheme and issued a public apology on the matter. (STAT News)

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