Dispute risks damage to Canada's reputation as reliable trade partner, says Steven Mackinnon

Fox News host Sean Hannity says the "decentralization of power as our founders intended is very much on its way to DC."

If you’ve ever tried to make a portrait that looks like the person you’re sketching, you know it’s no walk in the park. Maybe you’ve got the eyes perfectly, but then the mouth looks… well, let’s say “abstract.” So, how do the pros do it? What tools, materials, and techniques help bring out that jaw-dropping […]

The post Draw Portraits Like a Pro – Essential Tools and Materials for Photo-Realistic Results appeared first on Chart Attack.

Researchers in Montreal are pointing to the benefits of bilingualism for the brain's health and efficiency — suggesting it could even help prevent diseases associated with aging, including Alzheimer's.

The Pennsylvania Senate race is over.

The employers' association is threatening to lock out workers at 9 p.m. Sunday if a deal isn't reached.

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.

“Going viral” appears to be more than just a catchphrase when it comes to the rampant spread of misinformation

Understanding the psychology of ambiguous loss can help people struggling with grief and depression in the wake of the 2024 election results

Focusing on size in health care might be doing more harm than good.

Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
Read more »

By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow.  I’ve found

The post Keeping It Simple: What Really Matters For Emerging Enterprises   appeared first on LifeSciVC.

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.
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

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.

Sep 5, 2023

Stephen Walt critiques Vivek Ramaswamy's claim of being a foreign policy realist.

May 21, 2024

Stephen Walt argues that realists oppose Israel's actions in Gaza (and U.S. complicity in them) because the combination is undermining the United States' global position and bringing the United States precisely zero strategic benefits.

The �Design Smart, Live Beautifully� Home Tour coincides with the launch of the 2014 model of Blu�s award-winning�Breezehouse, which is�packed with luxurious features and an even more spacious floor plan

Blu Homes Breezehouse is the Real Simple and This Old House "2014 Dream Home of the Year."

Get help with student loans today!

Closing Bell Opens Doors for Students

Farmers Insurance "We Know From Experience" Ad Campaign Spot

A New Campaign Inspiring Women to Share Something They Believe is Worth Saying, Launching During The Golden Globes

Snack bar maker Larabar teams up with Feeding America� to make simple and wholesome food accessible for all and empower their community to take action to #ShareRealFood across America.

Altimetrik defines future of the Enterprise Internet of Things

From unique cereal recipes by Chef Justin Warner to simply enjoying a favorite bowl, cereal lovers of all ages are encouraged to share how they are enjoying cereal again on #NationalCerealDay.

Praised as the most beautiful countryside in China, the unique view of shaiqiu can only be found in Huangling village where baskets of colorful harvest bask in the sunshine.

Professional lumberjack Adrian Flygt teaches a dedicated team of off-the-street lumbersexuals on how to use the �misery whip� saw during their training in Stillwater, Minn.

Eva Longoria :30 English

Institut Marqu�s

Are you aware of a SimCity 2000 release that came on A LOT OF FLOPPIES? As in, ten or more 3.5" disks? Because I spent the better part of an afternoon watching my friend install it in the mid 90s. Yet there's no record that this version of the game existed.

I'm so very happy to announce that my next Graceling Realm book, Seasparrow, will release on November 1, 2022. Scroll down for my beautiful covers in the US and the UK! I'll also include links for pre-ordering at the bottom of this post.

Seasparrow is told from the point of view of Hava, Queen Bitterblue's secret sister and spy, who has the Grace of changing what you think you see when you look at her. In other words, the Grace of hiding in plain sight. In Seasparrow, Hava sails across the sea toward Monsea with her sister, the royal entourage, and the world's only copies of the formulas for the zilfium weapon Hava saved at the end of Winterkeep. As in all of my books, adventure ensues — the kind of adventure that will cause Hava to do some soul-searching. While Bitterblue grapples with how to carry the responsibility of a weapon that will change the world, Hava has a few mysteries to solve — and a decision to make about who she wants to be in the new world Bitterblue will build. Seasparrow was edited by Andrew Karre. Thank you, Andrew, for helping me help Hava find her wings!

Prior to today, I've only been talking about this book on Twitter, where I don't have a lot of space to say meaningful things. I have space on this blog, so here are a few non-spoilery bits of info about Seasparrow.

* Unlike my other Graceling Realm books, this one is told from the first-person point of view. Why? Because it was right for this book. Hava is a character who's so internal that often other people don't even know she's there. I suppose I can't entirely explain why, when I started writing, I knew I needed to write in first person, but maybe it's because in order to write about Hava, I needed to get deep inside, where she was. I don't think I've ever written a book from the perspective of someone so hidden before. And yet, from the start, Hava let me in. It felt like she was the one making the decision about what point of view we needed.

* Though the page count is higher (624!), the word count is not higher than any of my other Graceling Realm books. That's because Hava's story is told in a lot of pretty short chapters. That felt right for Hava and the way she processes things; again, it felt like she was the one making this decision. Short chapters have a way of creating a sense of empty space inside a printed book, which is an effect I've always liked, so I went with it.

* The interior art that Ian Schoenherr created for Seasparrow is spectacular. Maybe more than any of my books prior to this, I'm excited for the day when I'll have the finished product in my hands.

* Four years ago, I spent some time in the Arctic on a tall ship. I planned this book while I was on that trip. I started writing it the moment I got back. I could not have written this book were it not for my experience doing an artist residency with the organization The Arctic Circle. Here's a link to the blog posts I wrote about my Arctic experience, which are mostly compilations of pictures. Click on "More Posts" at the bottom to see them all.

 

And now for the covers! Here's the US/Canada cover for Seasparrow, which will be published by Dutton/Penguin Random House. Kuri Huang is the cover artist. Jessica Jenkins is the cover designer. And as I've already said, the interior will include beautiful art by Ian Schoenherr.

 

And here is the UK/Australia/New Zealand cover for Seasparrow. My editor at Gollancz is Gillian Redfearn. Micaela Alcaino is the cover artist and Tomás Almeida is the in-house designer.

Finally, here are some direct pre-ordering links! Seasparrow can be ordered in the US at:

Bookshop.org

barnesandnoble.com

Target

Amazon

 

And in the UK at:

UK.Bookshop.org

Waterstones

Blackwells

 

...and wherever books are sold.

 

Happy holiday weekend for those celebrating. And happy reading!

The internet has been buzzing with excitement over what many fans initially thought was an official Agent Venom trailer from Sony. The clip, featuring Tony Revolori as Flash Thompson transforming into Agent Venom, quickly went viral and sparked discussions about a possible new Venom movie. Fans seem to be excited about the prospect of seeing […]

The post Why Fans Think Sony’s Agent Venom Trailer Is Real appeared first on ComingSoon.net - Movie Trailers, TV & Streaming News, and More.

Dutch Palestinian analyst Mouin Rabbani discusses the violence that broke out last week between visiting Israeli soccer fans and pro-Palestinian protesters in Amsterdam. The Dutch authorities made over 60 arrests, and at least five people were hospitalized as a result of the clashes, which local and international leaders were quick to brand as antisemitic, even though observers in Amsterdam have said it was Israeli hooligans who instigated much of the violence. Rabbani says that while it’s common for rival teams’ fans to get into skirmishes, what happened in Amsterdam was different. “What we’re talking about here in Amsterdam is not a clash between the hooligans of two opposing sides, but rather these Israeli thugs attacking people who, in principle, had nothing to do with the game, and then afterwards being confronted by their victims,” Rabbani says.

Over the next few weeks and months, you'll see social media posts discussing how companies cannot offer holiday bonuses or will have to cut employees due to Trump's tariffs (proposed or enacted).

 

Some of these stories may be fiction or cautionary tales that illustrate the price the average American pays for a politician's decision.

 

But I can 100% tell you this is a reality many business owners in the manufacturing sector now face.

 

If you aren't aware of how tariffs work, it's relatively simple. The company importing the goods from a foreign country pays the fee. If a company has to pay 20%, 60%, or 200% more to bring that item into the United States, who ultimately bears that cost? The American people.

 

Over the last few days, I have been talking at length with my factory representatives, figuring out how much of an item I need to order now to offset any expanded costs later. In addition, we are looking at where we can move manufacturing to outside of China (hard mode, not a lot of places outside of China or Europe produce boardgame components at the scale our industry uses).

 

I've been speaking with my shipping representatives about the increasing freight costs we expect to see with a rise in tariffs. We're already paying extreme freight prices, which will only go up as demand increases. The last time tariffs were levied on Chinese manufactured goods, freight costs went up.

 

Now I am in a position that forces me to examine how much we may need to raise prices if the most extreme of the proposed tariffs goes into effect.

 

I'm also trying to do right by my staff. But I can only do so much, you know? How long can business owners incur these costs, protect our staff, and not have consumers pay through the nose? Can I accept breaking even for the time being to keep my people employed and our games affordable? But what happens when the company starts losing money?

 

Many CEOs and business owners are staring down this reality right now. This isn't just a theoretical exercise. We have to plan for the worst.

 

So, what do I plan to do about this? I will be even more present in my local and state business associations that have direct links to policy makers in D.C. I will take every opportunity to speak directly to those who have a say in this new administration about why this isn't good for the economy. I'm just a tiny player in the world of manufacturing. But I do know the power of my voice. And more importantly, I know the power your voice holds as well.

 

You can start putting pressure on your elected (or newly elected) officials by writing, calling, or contacting them through their open channels (many of them love social media). Tell them you do not want these proposed tariffs, and let them know how these cost increases will impact you. Hold them to their promises. Make your voice heard. 

We are all in this together. 

– Meredith Placko

Warehouse 23 News: A Great Deal Of Adventure!

Excitement is in the cards with the Decks of Destiny for The Fantasy Trip. This collection of resources and reference material contains adversaries, rumors, combat options, and more to make your games of TFT fast and furious. Download this set today from Warehouse 23!

Four-legged robot dogs learned to perform new tricks by practising in a virtual platform that mimics real-world obstacles – a possible shortcut for training robots faster and more accurately

Once upon a time a man named Barry Goldwater appeared on the political scene. And the radical cried, “Danger! A fascist!” And the people came running, but they saw that, actually, he was just a right-wing authoritarian, and he was making no effort to build a mass movement based on violence and terror in order … Continue reading A Totally Original Parable Not Derived From Anything Else Really

It may not be rain on your wedding day, but these cakes are still a little too ironic.

[grabbing microphone]

HIT IT!

 

It's like loving journalism

... but not kerning!

It's a "good job"

that needs some learning.

It's the winner's cake

that SHOULD be burning!

And who would have thought? It figures!

It's calling someone "dumb"

When you can't spell the word

It's trying to show you care

While giving a beautiful turd

Heh.

And isn't it ironic, don't you think?

Thanks to Tracey, Julie, Dorothy S., Tony W., & Stacey, who really DO think.

 *****

Hang on, you know what ELSE has delicious irony? A fully armed and operational battle station with an exposed exhaust port.

Death Star Waffle Iron

Thanks to this waffle iron, you can recreate the Death Star's catastrophic destruction every morning with butter and syrup. Nomz. Just remember: Use the forks.

Tolerability

two girls, a guy, and a robot, sitting on a couch, playing video games. it's 2002 babey

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