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Voters Just Said No to Drugs: Why legalization lost at the ballot box...


Voters Just Said No to Drugs: Why legalization lost at the ballot box...


(Third column, 4th story, link)


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ZOE WILLIAMS: Billionaires don't just think they're better than rest of us -- they hate us...


ZOE WILLIAMS: Billionaires don't just think they're better than rest of us -- they hate us...


(Second column, 6th story, link)





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Patrick Mahomes, Travis Kelce's homes burglarized during NFL game...


Patrick Mahomes, Travis Kelce's homes burglarized during NFL game...


(Second column, 3rd story, link)





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Once-big Portland tech employer lays off dozens

A year after going private in a $6.5 billion private equity deal, software maker New Relic is into its second round of layoffs this year.




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Sacramento-based Zennify buys Virginia tech firm specialized in AI development

Sacramento-based Zennify, a tech consulting firm for financial service companies, has acquired Terazo, a digital engineering firm based in Richmond, Virginia.




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LabX Media Group Acquires Discover Magazine, Expanding its Reach in Science Media

The addition of Discover to LabX’s portfolio strengthens its position as a leading voice in science and research media, bringing one of the most recognized science publications into its family.




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A Frank Assessment of Israel's Goals in Gaza From the Former Defense Minister

Israel's Defense Minister was fired last week by Prime Minster Benjamin Netanyahu who said that trust had "eroded" between them. The now former defense minister met with families of Israeli hostages held in Gaza and gave his thoughts on what Israel can still achieve in Gaza. We hear what was said.




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New Zealand formally apologizes to victims of abuse in state care

An inquiry found abuse, torture and neglect of some 200,000 people in state care over 70 years. People with disabilities or from Maori and Pacific Islander communities were especially vulnerable.




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Israeli strikes kill dozens in the Gaza Strip and Lebanon, medics say

Israeli airstrikes killed at least 46 people in the Gaza Strip in the past day, medics said. In Lebanon, warplanes struck Beirut's southern suburbs and killed 33 people in the country on Tuesday.




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The Coldest State in the U.S. Is Below Freezing on Average

The United States has a wide range of climate zones, from the subtropical to the arctic. On the low end of the thermometer, there are plenty of options for a deep winter chill. Here, we look at a couple different ways to determine the coldest state in the U.S. — and by both definitions, there's one winner.




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Amazon reportedly wants drivers to wear AR glasses for improved efficiency until robots can take over

Amazon is reportedly developing smart glasses for its delivery drivers, according to sources who spoke to Reuters. These glasses are intended to cut “seconds” from each delivery because, well, productivity or whatever. Sources say that they are an extension of the pre-existing Echo Frames smart glasses and are known by the internal code Amelia.

These seconds will be shaved off in a couple of ways. First of all, the glasses reportedly include an embedded display to guide delivery drivers around and within buildings. They will allegedly also provide drivers with “turn-by-turn navigation” instructions while driving. Finally, wearing AR glasses means that drivers won’t have to carry a handheld GPS device. You know what that means. They’ll be able to carry more packages at once. It’s a real mitzvah.

I’m being snarky, and for good reason, but there could be some actual benefit here. I’ve been a delivery driver before and often the biggest time-sink is wandering around labyrinthine building complexes like a lost puppy. I wouldn’t have minded a device that told me where the elevator was. However, I would not have liked being forced to wear cumbersome AR glasses to make that happen.

To that end, the sources tell Reuters that this project is not an absolute certainty. The glasses could be shelved if they don’t live up to the initial promise or if they’re too expensive to manufacture. Even if things go smoothly, it’ll likely be years before Amazon drivers are mandated to wear the glasses. The company is reportedly having trouble integrating a battery that can last a full eight-hour shift and settling on a design that doesn’t cause fatigue during use. There’s also the matter of collecting all of that building and neighborhood data, which is no small feat.

Amazon told Reuters that it is “continuously innovating to create an even safer and better delivery experience for drivers” but refused to comment on the existence of these AR glasses. "We otherwise don’t comment on our product roadmap,” a spokesperson said.

The Echo Frames have turned out to be a pretty big misfire for Amazon. The same report indicates that the company has sold only 10,000 units since the third-gen glasses came out last year.

This article originally appeared on Engadget at https://www.engadget.com/big-tech/amazon-reportedly-wants-drivers-to-wear-ar-glasses-for-improved-efficiency-until-robots-can-take-over-174910167.html?src=rss




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Black Friday 2024 deals: The best early sales we could find from Amazon, Best Buy, Apple, Anker and others

Black Friday may technically just be one day, but it’s evolved to consume the entire month of November in the US at this point. For the past few years, retailers like Amazon, Walmart and Target have ushered in the holiday shopping season earlier and earlier, and this year is no different.

Early Black Friday deals are already here, bringing discounts to some of our favorite tech we’ve tested this year. While it’s still advisable to wait until the week before Thanksgiving to ensure you’re getting the best of the best deals, you have plenty of opportunities to save right now if you’re eager to get a jump on your gift list this year. These are the best early Black Friday deals we could find; we’ll be updating this post regularly throughout November, so check back for the latest discounts.

Nathan Ingraham / Engadget
Cherlynn Low for Engadget
  • Audible Premium Plus (3-month) for $1 ($29 off): Those who don't currently subscribe to Audible can get three months of the audiobook service's Premium Plus plan for $1. Normally, the service costs $15 per month after a 30-day free trial. As a refresher, Premium Plus is Audible's upper tier: In addition to giving access the full Audible Plus library, it lets you keep one title from a curated selection of audiobooks each month. We wouldn't call it essential, but if you've been on the fence, this is a good way to see if it'd work for you. Just note that the plan will auto-renew until you cancel.

  • Headspace annual plan for $35 ($35 off): Our top pick for the best meditation app has tons of courses that address specific anxieties and worries, a good in-app search engine that makes it easy to find the right meditation you need and additional yoga routines, podcasts and music sessions to try out.

  • ExpressVPN two-year plan plus six extra months for $150 (82 percent off): Our top pick for best VPN for travelers provides access to tons of servers and had some of the fastest connections of any VPN service we tested. In addition to a VPN, this subscription tier gives you access to an ad blocker and password manager.

  • LG 65-inch B3 OLED smart TV for $998 ($301 off): This OLED TV has a 120Hz refresh rate, LG's a7 AI processor Gen 6, and support for NVIDIA G-Sync, AMD FreeSync Premium and VRR for an even better gaming experience.

  • Xbox Series X (1TB) with extra controller for $490 ($110 off): This bundle includes a total of two Xbox wireless controllers with the Series X console, and the built-in 1TB SSD is a good starting point for most gamers.

  • Blink Outdoor 4 (6-pack) for $180 ($300 off): The Outdoor 4 is a wireless, IP65-rated outdoor security camera we highlight in our guide to the best smart home gadgets. It captures decent (if not class-leading) 1080p video, it's relatively painless to install and it supports features like night vision, motion alerts, local storage and two-way talking. The catch is that it locks things like person detection and cloud storage behind a subscription plan. Still, it's a solid value on balance, and this deal furthers that. We've seen this price on a six-camera bundle for a few weeks, but it's still an all-time low. An eight-camera pack is also on sale for $250, another low.

  • Amazon Fire HD 10 for $75 ($65 off): No Fire HD tablet comes close to matching the performance, build quality and app support of an iPad, but they're significantly more affordable, and they still work well enough if all you need is something for casual streaming, e-reading and web browsing. At this price, the 10.1-inch Fire HD 10 is likely a better value than the smaller Fire HD 8, as it has a sharper display, it's a tick faster and it can last slightly longer on a charge. Just be ready to deal with a bunch of ads for Amazon's own apps and services. This discount ties an all-time low, and it's also available at Best Buy and Target.

  • Samsung Music Frame for $248 ($150 off): This unique smart speaker can show art or your own photos while it plays music, and it can sync with your Samsung TV speakers. Also available at Full Article



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Amazon sunsets Freevee platform for ad-supported streaming video

Amazon is closing down Freevee, its free ad-supported video on demand service. This platform was home to original programming as well as more than 100 originals from the Prime Video roster. Freevee will be phased out over the coming weeks, and its content will become available as part of Prime Video. The ad-supported tier of Prime Video is included as part of Amazon's Prime membership for $15 a month.

"To deliver a simpler viewing experience for customers, we have decided to phase out Freevee branding," an Amazon spokesperson told Variety. "There will be no change to the content available for Prime members, and a vast offering of free streaming content will still be accessible for non-Prime members, including select originals from Amazon MGM Studios, a variety of licensed movies and series, and a broad library of FAST channels – all available on Prime Video."

The free viewing platform went through several rebrands since its original launch as IMDb Freedive in January 2019. It entered its final phase as Freevee in April 2022.

This article originally appeared on Engadget at https://www.engadget.com/entertainment/streaming/amazon-sunsets-freevee-platform-for-ad-supported-streaming-video-000614080.html?src=rss




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Roy et les Islanders en visite chez McDavid

Les Islanders ont une lourde tâche qui les attend ce soir.




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Canadien 7, Sabres 5: «Les boys en avaient assez» – Martin St-Louis

Traverser une séquence de revers, ça n’a rien de plaisant. Surtout quand elle vous refoule jusqu’au dernier rang de la LNH.




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Ruby slippers from The Wizard of Oz are for sale nearly 2 decades after they were stolen

A pair of ruby slippers worn by Judy Garland in The Wizard of Oz are on the auction block nearly two decades after a thief stole the iconic shoes, convinced they were adorned with real jewels.




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Artist José González is creating an underwater universe — with an iPad

José González is an illustrator, author and animator originally from Buenos Aires now living in English Harbour. González was selected to be one of the Artists in Residence at Business and Arts N.L. (Un)Common Threads Creativity and Innovation Summit happening on Nov. 7. In advance of the summit, González has been busy preparing for his installation, which will feature a large-scale fish tank with animated sea creatures brought to life through projections and augmented reality.




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'No happy paintings': Dozens of art works by Canadian war artist at Calgary exhibit

Bill MacDonnell's paintings are on display at the Military Museums in Calgary through Remembrance Day and into 2025.



  • News/Canada/Calgary

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Elliot Page among 2SLGBTQ+ stars recognized at PTP Pink Awards

Actor Elliot Page and musician Rufus Wainwright were among the stars who honoured 2SLGBTQ+ charities at the inaugural PTP Pink Awards in Toronto Thursday, in the shadow of a U.S. election that has many worried about queer and trans rights.




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Mattel apologizes for mistakenly printing porn website on Wicked toy doll packaging

Toy giant Mattel says it "deeply" regrets an error on the packaging of its Wicked movie-themed dolls, which mistakenly links toy buyers to a pornographic website.




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Blitz recalls a long line of war movies going back decades, but that doesn't mean it's not relevant

Following a mother and son during the the Blitz, Nazi Germany's bombing campaign on London during the Second World War, director Steve McQueen's new drama understands the war film — perhaps a bit too well.




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Vers un lock-out dès vendredi chez Postes Canada?

Le syndicat des facteurs de Postes Canada a remis un préavis de grève de 72 heures à l’employeur, qui a répliqué aussitôt avec un avis de lock-out.




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Vivez l’expérience de l’Université de Sherbrooke sur la Rive-Sud

Depuis 35 ans, l’Université de Sherbrooke est présente à Longueuil.




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Lock-out dans les ports: Ottawa n’aurait pas été assez «proactif», selon un expert

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




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Attaque à la voiture-bélier en Chine: 35 morts et des dizaines de blessés

Attaque avec une voiture en Chine: 35 morts et des dizaines de blessés.




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Trump est fasciste, mais c’est le Canada qui protège les nazis!

Les progressistes s’inquiètent de voir les États-Unis basculer dans le fascisme depuis l’élection de Donald Trump.




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Un modeste conseil au PLQ: laissez les beaux-pères au chalet...

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




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Canada, prepare for the big squeeze. Trump will press on several sensitive fronts

Donald Trump's second term as U.S. president carries implications at home and abroad. That includes potentially wreaking havoc on global economies through the aggressive use of tariffs.




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CSIS had concerns about Abdelrazik's motives ahead of trip to Sudan, investigator testifies

Canada's intelligence agency amassed a sizable file on Abousfian Abdelrazik's suspected terrorism ties in the early 2000s, although the validity of that intelligence was called into question during the Montreal man's Federal Court case.




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Modern gizmos take some licking

You humans might be amazed to know what we dogs have figured out.




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Zach Bryan aurait offert 12 millions $ à son ex pour acheter son silence après leur rupture

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.




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Le film «Monsieur Aznavour» présenté à Montréal samedi: une première «symbolique» pour le réalisateur Grand Corps Malade

Gros succès en France, le drame biographique est présenté samedi au Festival Cinemania.




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Découvrez l’étrange rituel du chanteur de Coldplay

Chris Martin a intrigué les badauds lundi en embrassant le tarmac de l’aéroport de Sydney.




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Rare ‘Morning Glory’ cloud dazzles Virgin flyers

ONE of the world’s most spectacular clouds made a dramatic entrance for passengers on an Adelaide-bound jet.




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‘Everyone wants to be Suarez’

HE was spotted playing soccer in a park by a talent scout on holiday in Uruguay at age 15. Now Andrew Alvarenga has made the first grade side at top division soccer’s Club Atletico Cerro.




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DGFT to organize EODC Camp from November 11 to 22 in New Delhi to expedite pending export obligations

The office of the Additional Director General of Foreign Trade (CLA DGFT) has announced an Export Obligation Discharge Certificate (EODC) Camp scheduled from November 11 to 22, 2024. The camp is




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KPPA to organize webinar series from November 17 to 23 as part of NPW celebration

As part of the National Pharmacy Week (NPW) celebration, the Kerala Private Pharmacist Association (KPPA) is organizing a high─impact webinar series from November 17th to 23rd, connected by the common




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Schultz Medical to exhibit at MEDICA 2024 with Medilink UK

Schultz Medical, a single use instrument company based in Southport, Merseyside have announced they will be exhibiting at MEDICA 2024 in Germany and on the UK Pavilion in Hall 15 hosted by Medilink UK.




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How to Make Your Own Zoetrope

Put your own spin on a zoetrope with homemade drawings—or carve one into a pumpkin




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What Made This Bizarre ‘Dandelion’ Supernova?

A strange supernova remnant first appeared as a “guest star” seen in 1181 by sky watchers in China and Japan




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The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions

Reality has again failed to support the spin surrounding the 340B Drug Pricing Program.

For 2023, discounted purchases under the 340B program reached a record $66.3 billion—an astounding $12.6 billion (+23.4%) higher than its 2022 counterpart. The gross-to-net difference between list prices and discounted 340B purchases also grew, to $57.8 billion (+$5.5 billion). 340B purchases are now almost 40% larger than Medicaid’s prescription drug purchases.

Hospitals again accounted for 87% of 340B purchases for 2023. Purchases at every 340B covered entity type grew, despite drug prices that grew more slowly than overall inflation.

Lobbyists claim that manufacturers’ 340B contract pharmacy changes are “stripping billions of dollars from the healthcare safety net.” But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.

Read on for full details and our analysis, along with fresh details of troubling behavior by the Health Resources and Services Administration (HRSA).
Read more »
       




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FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships

Sorry, but you do not have permission to view this content.




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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>




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Regulatory update for post-registration of biological products in Brazil

<p>On 3<sup>&nbsp;</sup>June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>




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FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>




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Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>




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Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?
He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues


In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:


  • Phase 3 trial completes January 2010
  • Certification of delayed results obtained December 2010 (compliant)
  • FDA approval June 2013
  • Results posted July 2013 (compliant)


In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency


The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.

[Image credit: Shamless lawlessness via Flikr user willytronics.]


Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577