THE weather bureau said it was not caught off guard by the intensity of the storm that tore through southeast Queensland on Sunday. An emergency situation was in place on the Sunshine Coast after the wild weather hit.

Sydney, Australia (SPX) Nov 04, 2024
In a recent study led by Professor Xin Li and Dr. Yanlong Guo of the Institute of Tibetan Plateau Research, Chinese Academy of Sciences, researchers analyze how scientific research is evolving through the power of big data and artificial intelligence (AI). The paper discusses how the traditional "correlation supersedes causation" model is being increasingly challenged by new "data-intensive scie

Des voleurs ont réussi à dérober un guichet automatique en le tirant à travers la devanture vitrée de l’immeuble à l’aide d’un camion.

Non aux rencontres amoureuses, au sexe, au mariage ou à élever des enfants avec un homme.

L’ex-maire, qui a passé cette année le cap des cinq ans depuis son diagnostic, continue de s’impliquer pour sensibiliser les hommes à ce fléau.

Un «faucon» anti-Chine à la diplomatie, une gouverneure «tueuse de chiens» à la sécurité intérieure.

Le ministre du Travail, Steven MacKinnon, ordonne la reprise des activités dans les ports au pays qui sont à l’arrêt en raison de conflits de travail.

Un mois après la mystérieuse disparition d’un comptable sans histoire de Saint-Jean-sur-Richelieu, le corps de l’homme de 68 ans a été retrouvé.

Laurence Jalbert a dû tout arrêter pendant deux mois

Ottawa aurait laissé trop de liberté aux syndicats, en leur donnant «carte blanche» pour déclencher des grèves dans les ports du pays.

L’une des lubies des wokes est d’enfermer les gens dans leur identité raciale ou sexuelle.

Laissez les beaux-pères au chalet et vos candidats libres de vous étonner. S’ils en sont capables, ils le feront.

Donald Trump va nommer la représentante Elise Stefanik, républicaine du nord de l’État de New York, ambassadrice des États-Unis à l’ONU.

Le Bloc Québécois trône toujours en tête, à 35% des intentions de vote, selon un sondage Léger-Le Journal-TVA.

Citing national security concerns, the federal government has ordered TikTok to shutter its Canadian operations — but users will still be able to access the popular video app.

A lockout at the Port of Montreal began Sunday night. The CEO of the Montreal Port Authority says if the dispute between dockworkers and the Maritime Employers Association drags on, it will have disastrous consequences for the economy.

Canada’s privacy commissioner has launched an investigation into the World Anti-Doping Agency (WADA) and “its handling of biological samples collected from athletes.”

Prime Minister Justin Trudeau sounded an upbeat note Tuesday on the prospect of working with U.S. president-elect Donald Trump, saying Canada has dealt with his trade threats before and can do so again.

Les spectateurs québécois auront encore l’embarras du choix durant le temps des Fêtes.

Le chanteur Zach Bryan aurait demandé à son ex-copine Brianna LaPaglia de ne pas parler de leur relation en lui offrant 12 millions de dollars.

La nouvelle saison sera déposée sur illico+ le 13 novembre.

La vedette colombienne du reggaeton Karol G s’est excusée pour des paroles de son nouveau single «+57» jugées offensantes.

La majorité des billets encore offerts en ligne pour aller voir Taylor Swift à Toronto sont des arnaques, constate un expert en cybersécurité.

Elle tiendra la vedette de l’adaptation québécoise du succès mondial Ménopause aux côtés de Claudine Mercier, Catherine Sénart et Geneviève Charest.

GOT a hankering for bacon? The best bacon from across Australia has been judged at Australian Bacon Week.

They can cost hundreds of pounds, but are these products actually worth the money?

Jesse James has a legendary moniker, and now the martial arts black belt is set to make his own name known on the world stage, representing Australia.

Dans une étude, on rapporte qu’un médicament antidiabétique très utilisé retarde les effets négatifs du vieillissement sur les fonctions cognitives.

Les fromages vendus en portions individuelles sont des plus pratiques pour l’école et le bureau.

Une découverte biochimique intrigante pourrait permettre d’identifier rapidement les patients à haut risque.

The secretary of the Union Ayush Ministry, Dr Rajesh Kotecha, will inaugurate the 61st Ayurveda Seminar organized by the Kottakkal Aryavaidyasala (Kottakkal AVS) on November 10 at Kottakkal in

The Federation of Pharmaceutical Entrepreneurs (FOPE) has identified potential opportunities for Indian pharmaceutical companies to expand in Australia. Further, the India─Australia Economic Cooperation and Trade

Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024.

No, but the direction of our hair whorls could teach us about human development

Long before it orbited Earth, the Hubble Space Telescope starred in a famous Superman comic

Analysis of a strain of the virus circulating in Central Africa shows genetic mutations indicative of sustained human-to-human spread

Jonny Kim—a former Navy SEAL and ER doctor—is now a NASA astronaut who will soon launch to the International Space Station as flight engineer for the crew of Expedition 72/73

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer […]

The UK’s first postal inhaler recycling scheme has been launched by pharmaceutical company Chiesi to support a more sustainable way of living for people with respiratory illnesses.

1. Misstated an odds ratio of 4 as “4 times more likely to”
2. Overstated the recruitment success findings as being based on a sample 3 times larger than it actually was
3. Re-interpreted, without reservation, a statistical association as a causal relationship
4. Misstated the difference between the patient involvement categories as being a matter of merely “involving just one or two patients in the study team”

And you did these consistently and repeatedly – in Dr Wykes's blog post, in the KCL press release, and in the NIHR-written Guardian article.

This new 10-minute TEDMED talk is getting quite a bit of attention:


 (if embedded video does not work, try the TED site itself.)

In it, Roger Stein claims to have created an approach to advancing drugs through clinical trials that will "fundamentally change the way research for cancer and lots of other things gets done".

Because the costs of bringing a drug to market are so high, time from discovery to marketing is so long, and the chances of success of any individual drug are so grim, betting on any individual drug is foolish, according to Stein. Instead, risks for a large number of potential assets should be pooled, with the eventual winners paying for the losers.

To do this, Stein proposes what he calls a "megafund" - a large collection of assets (candidate therapies). Through some modeling and simulations, Stein suggests some of the qualities of an ideal megafund: it would need in the neighborhood of $3-15 billion to acquire and manage 80-150 drugs. A fund of this size and with these assets would be able to provide an equity yield of about 12%, which would be "right in the investment sweet spot of pension funds and 401(k) plans".

Here's what I find striking about those numbers: let's compare Stein's Megafund to everyone's favorite Megalosaurus, the old-fashioned Big Pharma dinosaur sometimes known as Pfizer:

	Megafund (Stein)	Megalosaurus (Pfizer)
Funding	$3-15 billion	$9 billion estimated 2013 R&D spend
Assets	80-150	81 (in pipeline, plus many more in preclinical)
Return on Equity	12% (estimated)	9.2% (last 10 years) to 13.2% (last 5)

Since Pfizer's a dinosaur, it can't possibly compete with the sleek, modern Megafund, right? Right?

These numbers look remarkably similar. Pfizer - and a number of its peers - are spending Megafund-sized budget each year to shepherd through a Megafund-sized number of compounds. (Note many of Pfizer's peers have substantially fewer drugs in their published pipelines, but they own many times more compounds - the pipeline is just the drugs what they've elected to file an IND on.)

What am I missing here? I understand that a fund is not a company, and there may be some benefits to decoupling asset management decisions from actual operations, but this won't be a tremendous gain, and would presumably be at least partially offset by increased transaction costs (Megafund has to source, contract, manage, and audit vendors to design and run all its trials, after all, and I don't know why I'd think it could do that any more cheaply than Big Pharma can). And having a giant drug pipeline's go/no go decisions made by "financial engineers" rather than pharma industry folks would seem like a scenario that's only really seen as an upgrade by the financial engineers themselves.
A tweet from V.S. Schulz pointed me to a post on Derek Lowe's In the Pipeline blog. which lead to a link to this paper by Stein and 2 others in Nature Biotechnology from a year and a half ago. The authors spend most of their time differentiating themselves from other structures in the technical, financial details rather than explaining why megafund would work better at finding new drugs. However, they definitely think this is qualitatively different from existing pharma companies, and offer a couple reasons. First,

[D]ebt financing can be structured to be more “patient” than private or public equity by specifying longer maturities; 10- to 20-year maturities are not atypical for corporate bonds. ... Such long horizons contrast sharply with the considerably shorter horizons of venture capitalists, and the even shorter quarterly earnings cycle and intra-daily price fluctuations faced by public companies.

I'm not sure where this line of though is coming from. Certainly all big pharma companies' plans extend decades into the future - there may be quarterly earnings reports to file, but that's a force exerted far more on sales and marketing teams than on drug development. The financing of pharmaceutical development is already extremely long term.

Even in the venture-backed world, Stein and team are wrong if they believe there is pervasive pressure to magically deliver drugs in record time. Investors and biotech management are both keenly aware of the tradeoffs between speed and regulatory success. Even this week's came-from-nowhere Cinderella story, Intercept Pharmaceuticals, was founded with venture money over a decade ago - these "longer maturities" are standard issue in biotech. We aren't making iPhone apps here, guys.

Second,

Although big pharma companies are central to the later stages of drug development and the marketing and distributing of approved drugs, they do not currently play as active a role at the riskier preclinical and early stages of development

Again, I'm unsure why this is supposed to be so. Of Pfizer's 81 pipeline compounds, 55 are in Phase 1 or 2 - a ratio that's pretty heavy on early, risky project, and that's not too different from industry as a whole. Pfizer does not publish data on the number of compounds it currently has undergoing preclinical testing, but there's no clear reason I can think of to assume it's a small number.

So, is Megafund truly a revolutionary idea, or is it basically a mathematical deck-chair-rearrangement for the "efficiencies of scale" behemoths we've already got?

[Image: the world's first known dino, Megalosaurus, via Wikipedia.]

Tech startups are stepping up to meet the needs of 60 million people worldwide who use opioids, representing about 1 percent of the world’s adult population. In the United States, deaths involving synthetic opioids have risen 1,040 percent from 2013 to 2019. The COVID-19 pandemic and continued prevalence of fentanyl have since worsened the toll, with an estimated 81,083 fatal overdoses in 2023 alone.

Innovations include biometric monitoring systems that help doctors determine proper medication dosages, nerve stimulators that relieve withdrawal symptoms, wearable and ingestible systems that watch for signs of an overdose, and autonomous drug delivery systems that could prevent overdose deaths.

Helping Patients Get the Dosage They Need

For decades, opioid blockers and other medications that suppress cravings have been the primary treatment tool for opioid addiction. However, despite its clinical dominance, this approach remains underutilized. In the United States, only about 22 percent of the 2.5 million adults with opioid use disorder receive medication-assisted therapy such as methadone, Suboxone, and similar drugs.

Determining patients’ ideal dosage during the early stages of treatment is crucial for keeping them in recovery programs. The shift from heroin to potent synthetic opioids, like fentanyl, has complicated this process, as the typical recommended medication doses can be too low for those with a high fentanyl tolerance.

A North Carolina-based startup is developing a predictive algorithm to help clinicians tailor these protocols and track real-time progress with biometric data. OpiAID, which is currently working with 1,000 patients across three clinical sites, recently launched a research pilot with virtual treatment provider Bicycle Health. Patients taking Suboxone will wear a Samsung Galaxy Watch6 to measure their heart rate, body movements, and skin temperature. OpiAID CEO David Reeser says clinicians can derive unique stress indications from this data, particularly during withdrawal. (He declined to share specifics on how the algorithm works.)

“Identifying stress biometrically plays a role in how resilient someone will be,” Reeser adds. “For instance, poor heart rate variability during sleep could indicate that a patient may be more susceptible that day. In the presence of measurable amounts of withdrawal, the potential for relapse on illicit medications may be more likely.”

Nerve Stimulators Provide Opioid Withdrawal Relief

While OpiAID’s software solution relies on monitoring patients, electrical nerve stimulation devices take direct action. These behind-the-ear wearables distribute electrodes at nerve endings around the ear and send electrical pulses to block pain signals and relieve withdrawal symptoms like anxiety and nausea.

The U.S. Food and Drug Administration (FDA) has cleared several nerve stimulator devices, such as DyAnsys’ Drug Relief, which periodically administers low-level electrical pulses to the ear’s cranial nerves. Others include Spark Biomedical’s Sparrow system and NET Recovery’s NETNeuro device.

Masimo’s behind-the-ear Bridge device costs US $595 for treatment providers.Masimo

Similarly, Masimo’s Bridge relieves withdrawal symptoms by stimulating the brain and spinal cord via electrodes. The device is intended to help patients initiating, transitioning into, or tapering off medication-assisted treatment. In a clinical trial, Bridge reduced symptom severity by 85 percent in the first hour and 97 percent by the fifth day. A Masimo spokesperson said the company’s typical customers are treatment providers and correctional facilities, though it’s also seeing interest from emergency room physicians.

Devices Monitor Blood Oxygen to Prevent Overdose Deaths

In 2023, the FDA cleared Masimo’s Opioid Halo device to monitor blood oxygen levels and alert emergency contacts if it detects opioid-induced respiratory depression, the leading cause of overdose deaths. The product includes a pulse oximeter cable and disposable sensors connected to a mobile app.

Opioid Halo utilizes Masimo’s signal extraction technology, first developed in the 1990s, which improves upon conventional oxygen monitoring techniques by filtering out artifacts caused by blood movement. Masimo employs four signal-processing engines to distinguish the true signal from noise that can lead to false alarms; for example, they distinguish between arterial blood and low-oxygen venous blood.

Masimo’s Opioid Halo system is available over-the-counter without a prescription. Masimo

Opioid Halo is available over-the-counter for US $250. A spokesperson says sales have continued to show promise as more healthcare providers recommend it to high-risk patients.

An Ingestible Sensor to Watch Over Patients

Last year, in a first-in-human clinical study, doctors used an ingestible sensor to monitor vital signs from patients’ stomachs. Researchers analyzed the breathing patterns and heart rates of 10 sleep study patients at West Virginia University. Some participants had episodes of central sleep apnea, which can be a proxy for opioid-induced respiratory depression. The capsule transmitted this data wirelessly to external equipment linked to the cloud.

Celero’s Rescue-Rx capsule would reside in a user’s stomach for one week.Benjamin Pless/Celero Systems

“To our knowledge, this is the first time anyone has demonstrated the ability to accurately monitor human cardiac and respiratory signals from an ingestible device,” says Benjamin Pless, one of the study’s co-authors. “This was done using very low-power circuitry including a radio, microprocessor, and accelerometer along with software for distinguishing various physiological signals.”

Pless and colleagues from MIT and Harvard Medical School started Celero Systems to commercialize a modified version of that capsule, one that will also release an opioid antagonist after detecting respiratory depression. Pless, Celero’s CEO, says the team has successfully demonstrated the delivery of nalmefene, an opioid antagonist similar to Narcan, to rapidly reverse overdoses.

Celero’s next step is integrating the vitals-monitoring feature for human trials. The company’s final device, Rescue-Rx, is intended to stay in the stomach for one week before passing naturally. Pless says Rescue-Rx’s ingestible format will make the therapy cheaper and more accessible than wearable autoinjectors or implants.

Celero’s capsule can detect vital signs from within the stomach. www.youtube.com

Autonomous Delivery of Overdose Medication

Rescue-Rx isn’t the only autonomous drug-delivery project under development. A recent IEEE Transactions on Biomedical Circuits and Systems paper introduced a wrist-worn near-infrared spectroscopy sensor to detect low blood oxygen levels related to an overdose.

Purdue University biomedical engineering professor Hugh Lee and graduate student Juan Mesa, who both co-authored the study, say that while additional human experiments are necessary, the findings represent a valuable tool in counteracting the epidemic. “Our wearable device consistently detected low-oxygenation events, triggered alarms, and activated the circuitry designed to release the antidote through the implantable capsule,” they wrote in an email.

Lee and Purdue colleagues founded Rescue Biomedical to commercialize the A2D2 system, which includes a wristband and an implanted naloxone capsule that releases the drug if oxygen levels drop below 90 percent. Next, the team will evaluate the closed-loop system in mice.

This story was updated on 27 August 2024 to correct the name of Masimo’s Opioid Halo device.

As a leader who has committed much of his career to improving healthcare — an industry that holds millions of people’s lives in its hands — I took from this terrifying incident a new guiding principle. Healthcare needs to pursue a zero-failure rate.

The post What My Daughter’s Harrowing Alaska Airlines Flight Taught Me About Healthcare appeared first on MedCity News.

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

GLP-1 receptor agonists, used to treat Type 2 diabetes and now widely prescribed for weight loss, have seen […]

The post Will an Anti-Nausea Drug Boost GLP-1 Sales? appeared first on World of DTC Marketing.

Johnson & Johnson must pay US$15 million (S$19.6 million) to a Connecticut man who alleges that he developed mesothelioma, a rare form of cancer, as a result of using the company's talc powder for decades, a jury found on Tuesday (Oct 15). Plaintiff Evan Plotkin sued the company in 2021 soon after his diagnosis, saying he was sickened by inhaling J&J's baby powder. The jury in Fairfield County, Connecticut Superior Court also found that the company should pay additional punitive damages, which will be determined later by the judge overseeing the case. "Evan Plotkin and his trial team are thrilled that a jury once again decided to hold Johnson & Johnson accountable for their marketing and sale of a baby powder product that they knew contained asbestos," Ben Braly, a lawyer for Plotkin, said in an email. Erik Haas, J&J's worldwide vice president of litigation, said in a statement that the company would appeal "erroneous" rulings by the trial judge that kept the jury from hearing critical facts about the case.

The quest for realism in Thai drama The Empress of Ayodhaya went too far when a cat was reportedly drugged in a poisoning scene. In episode five of the show, the character Indravedi (Fern Nopjira Lerkkajornnamkul) suspects her drink has been drugged, so she asks nanny Thongdee (Ja Molywon Phantara) to test it out on the black feline. The cat can be seen convulsing and retching, and the camera moves to show Indravedi looking concerned, while Thongdee declares that it is dead. The scene caused public outrage with fears that the cat had actually been killed, and calls to ban the period drama were trending on X. On Nov 7, a now-deleted X account reportedly belonging to Ja posted: "The cat didn't actually die. We put it under anaesthesia, but while filming, the cat retched and seized." She and Fern initially thought the cat had actually died while filming and their faces "turned pale", she added.

Sir Elton John has overhauled his diet after suffering a health scare. The 77-year-old singer has made a concerted effort to control his blood sugar levels in recent times, after being diagnosed with type 2 diabetes in the early 2000s and battling a "severe eye infection" earlier this year. Elton said on Ruthie's Table 4 podcast: "I can have an apple, I can eat a bit of melon. As long as you're sensible about it, it doesn't shoot your blood sugar up. But what I crave is chocolate and ice cream — I can't have any ice cream." Despite this, Elton revealed that his dream meal would still be full of sugar-filled desserts. The award-winning star — who is married to filmmaker David Furnish — said: "If I had a death row meal, it wouldn't contain anything except sweets, because I can't eat them now. So, I'd have ice cream, doughnuts, apple pie, rhubarb crumble." Elton has dealt with various health issues over the years, including having surgery for prostate cancer and battling a "severe eye infection". The singer detailed his most-recent problem in an Instagram post in September.

Dec 5, 2023

David W. Kearn argues that deployment of nuclear weapons cannot rectify a perceived imbalance in conventional forces in the western Pacific.