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Sinner beats Fritz at ATP Finals in rematch of U.S. Open championship

Top-ranked Jannik Sinner made it two wins in two matches before his home fans at the ATP Finals, beating Taylor Fritz 6-4, 6-4 on Tuesday. Earlier, Daniil Medvedev moved back into contention with a 6-2, 6-4 victory over Alex De Minaur.



  • Sports/Olympics/Summer Sports/Tennis

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Fernandez, Dabrowski headline Canadian lineup for Billie Jean King Cup Finals

Singles star Leylah Fernandez and doubles specialist Gabriela Dabrowski will anchor Canada's five-player lineup this week when the team tries to defend its Billie Jean King Cup title in Malaga, Spain.




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Open World Dress Up Game ‘Infinity Nikki’ Gets New Trailer With Closed Beta Sign Ups Now Live, Pre-Registrations Also Available

Another mobile reveal from Gamescom Opening Night Live 2024 was the latest trailer for the open world dress up game …




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‘Balatro’ Is Coming to Apple Arcade and Also iOS as a Standalone Premium Release Beginning September 26th

Balatro from developer LocalThunk and publisher Playstack is finally coming to mobile later this month on iOS, Android, and also …




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Kennedy's FDA Wish List: Raw Milk, Stem Cells, Heavy Metals...


Kennedy's FDA Wish List: Raw Milk, Stem Cells, Heavy Metals...


(First column, 9th story, link)


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20 of the Most Adorable Animals To Help Make Anyone's Day

From a monkey that weighs only a few ounces to a 100-pound rodent, get to know some of these adorable creatures.




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SNL cast member reveals Elon Musk made her cry when he hosted the show

‘I’m gonna come out and say it at long last,’ sketch show star said




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Dutch appeals court overturns landmark climate ruling against Shell

The original 2021 ruling ordered Shell to cut its carbon emissions by 45% by 2030 compared to 2019 levels. The appeals court said there is "insufficient consensus" on a specific reduction percentage.




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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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Move aside, moose — a new study has found the most distinct animals in Canada

When we think of Canadian animals, the moose or beaver probably come to mind first — but according to a new study, the most distinct animals in Canada are creatures like the spiny softshell turtle and the mudpuppy, which both embody more than 150 million years of evolution.




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Headspace's Black Friday deals discounts subscriptions by 50 percent

The winter holidays are upon us and despite the festive feelings we might be hoping for, this time of year is often paired with increased stress, worry and anxiety. Fortunately, there are some great tools for helping to manage those negative emotions while promoting positive ones. One of those tools is the Headspace mental health app, which is running a three-week Black Friday deal. From November 12 through December 4, you can snag a Headspace annual plan for half off. This subscription normally costs $70 a year, but during this promotion, you can access the service for $35 billed annually. And what better time than the holiday chaos to gift someone (or heck, to gift yourself) a little bit of mindfulness?

Headspace's service has features to help users with meditation, sleep tools, mindfulness and general mental health. Its holistic approach made Headspace stand out as one of our top picks for meditation apps. Reviewer Lawrence Bonk appreciated how well Headspace created progression across its courses, as well as the chance to pick from different instructors so that any user can find the meditation guidance that will work best for their individual brains. This app is also getting the AI treatment. Headspace has introduced an AI companion named Ebb that can help users by recommending meditations and activities to best match their current challenges. 

Since this is a year-long subscription, it's a gift that keeps on giving for whoever you choose to buy this plan for. Having a happier brain is a present anyone can appreciate.

Follow @EngadgetDeals on Twitter and subscribe to the Engadget Deals newsletter for the latest tech deals and buying advice.

This article originally appeared on Engadget at https://www.engadget.com/deals/headspaces-black-friday-deals-discounts-subscriptions-by-50-percent-140026483.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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Cadillac reveals the 2026 Vistiq EV SUV

Cadillac is adding to its fleet of EVs with a new luxury SUV. The 2026 Cadillac Vistiq is a three-row, all-electric SUV that will hit showrooms and dealerships sometime next summer with a starting price of $78,790.

The Vistiq’s dual-motor, all-wheel drive system runs on a 102 kWh battery pack with a range of 300 miles that produces 615 horsepower and 650 pound-feet of torque. The Vistiq also supports vehicle-to-home (V2H) bidirectional charging capabilities: it can charge at home, and also deliver electricity to your house during a power outage. Using the features requires buying the GM Energy V2H bundle though.

The SUV’s design borrows aesthetically from other Cadillac EVs. Like the Lyriq, it has flush door handles, and features similar looking lights and side panels. It also matches the Lyriq’s 300 mile range. The “swept-back windshield” and “Black Crystal Shield grill” evoke the Escalade IQ.

Of course, the Vistiq's power and price are different from its Cadillac EV's. The new Cadillac EV SUV is less expensive than an Escalade IQ ($129,990) but more than a Lyriq ($58,595), and the Escalade IQ has a higher peak battery range at 450 miles.

The Vistiq comes with a 23-speaker AKG7 Studio Audio system with Dolby Atmos. The Android-powered infotainment system is baked into a 33-inch high resolution LED display. The Verge also reported that the new EV’s navigation system uses Google Maps and can run other apps from the Google Play Store.

Apple CarPlay and Android Auto won’t be available in Cadillac’s newest EV. General Motors is phasing out Apple CarPlay and Android Auto from its EVs and plans to go with Android Automotive. GM’s Executive Director of Digital Cockpit Experience Edward Kummer said in a Reuters interview that the carmaker didn’t want any features in its EVs “that are dependent on a person having a cellphone.”

This article originally appeared on Engadget at https://www.engadget.com/transportation/evs/cadillac-reveals-the-2026-vistiq-ev-suv-191557412.html?src=rss




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Time limits for trials were meant to speed up justice. They've also halted hundreds of criminal cases

Supporters say the Supreme Court of Canada's so-called Jordan ruling in 2016 has sped up proceedings and strengthened Charter rights for prompt justice. But some victims say the time limits for trials work in criminals' favour and cases continue to collapse because those limits are breached. 



  • News/Canada/British Columbia

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Linksys reveals mesh wi-fi router

Multiple routers with multiple networks for your home are coming to Australia.




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ICMR announces call for CAR proposals under extramural research programme

The Indian Council of Medical Research (ICMR) has issued a call for proposals for its Centre for Advanced Research (CAR) initiative under the Extramural Research Programme, inviting experienced research teams to




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Inter─ministerial committee calls for amendment in FSSAI Act on nutraceuticals

An inter─ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of




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Telangana DCA warns private hospitals of stern action for illegal sale of narcotic drugs

Finding regulatory violations in two private hospitals operating in the twin cities of Hyderabad and Secunderabad, the Telangana drugs control administration (DCA) has issued advisories to all the private hospitals in the state mandating strict obtainment of NDPS licence (NDPS Form II) from the DCA to purchase and sell NDPS drugs.




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Hospitals Are Relying More on PBMs to Manage Manufacturers' 340B Contract Pharmacy Restrictions: DCI's 2024 Market Analysis (rerun)

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Click here to see the original post from June 2024.



The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:
  • About 33,000 pharmacy locations—more than half of the entire U.S. pharmacy industry—act as contract pharmacies for the hospitals and federal grantees that participate in the 340B program. 
  • Five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market.
  • Federal grantees are aligned primarily with the vertically intergated organizations' retail pharmacies, while hospitals rely on mail and specialty pharmacies.
Over the past four years, manufacturers’ restrictions on 340B contract pharmacies have led hospitals to deepen their relationships with the largest PBMs—even as those PBMs have simultaneously limited hospitals’ direct participation in specialty pharmacy networks.

For an updated look at what’s next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D., on June 21 for his latest live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook.
Read more »
       




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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »
       




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FTC Announces Final Rule to Prohibit Deceptive Online Reviews and Testimonials

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]




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NPRA Malaysia trials new timelines for variation applications

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>




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Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/ biosimilars development and market expansion

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>




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Everything you need to know about the COVID-19 therapy trials

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19, from investigating the possibility of repurposing existing drugs to searching for novel therapies against the virus.




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UK universities and NHS trusts that flout the rules on clinical trials identified in report to Parliament

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]




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AllTrials guide to asking academic institutions about missing results

When university and hospital trusts were called to the UK parliament last year to answer questions on why they were not following the rules on reporting results, we saw how effective the questioning from politicians was. Those of you who watched the parliamentary session saw the pressure the university representatives were put under. Because the politicians asked […]




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Half of US clinical trials are breaking the law on reporting results

New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […]




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Hundreds of clinical trials ruled to be breaking the law

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]




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Counterfeit Drugs in Clinical Trials?

This morning I ran across a bit of a coffee-spitter: in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their

Counterfeits flooding
the market? Really?
"Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms -  the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote:

"Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs.  With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

[Emphasis added.]

I have to admit to being a little floored by the idea that there is any sort of risk, in industry-run clinical trials, of counterfeit medication "infiltration".

Does Gill know something that the rest of us don't? Or is this just an awkward slap at perceived competition – innuendo against the companies that currently manage clinical trial comparator drug supply? Or an attempt at depicting the trials of non-Transcelerate members as risky and prone to fraud?

Either way, it could use some explaining. Thinking I might have missed something, I did do a quick literature search to see if I could come across any references to counterfeits in trials. Google Scholar and PubMed produced no useful results, but Wikipedia helpfully noted in its entry on counterfeit medications:

Counterfeit drugs have even been known to have been involved in clinical drug trials.[citation needed]


And on that point, I think we can agree: Citation needed. I hope the folks at Transcelerate will oblige.




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Half of All Trials Unpublished*

(*For certain possibly nonstandard uses of the word "unpublished")

This is an odd little study. Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals
Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, Philippe Ravaud



But here the authors are concerned with publication in medical journals, and they were only able to locate journal articles covering about half (297/594) of trials with registered results. 

It's hard to know what to make of these results, exactly. Some of the "missing" trials may be published in the future (a possibility the authors acknowledge), some may have been rejected by one or more journals (FDAAA requires posting the results to ClinicalTrials.gov, but it certainly doesn't require journals to accept trial reports), and some may be pre-FDAAA trials that sponsors have retroactively added to ClinicalTrials.gov even though development on the drug has ceased.

It would have been helpful had the authors reported journal publication rates stratified by the year the trials completed - this would have at least given us some hints regarding the above. More than anything I still find it absolutely bizarre that in a study this small, the entire dataset is not published for review.

One potential concern is the search methodology used by the authors to match posted and published trials. If the easy routes (link to article already provided in ClinicalTrials.gov, or NCT number found in a PubMed search) failed, a manual search was performed:
The articles identified through the search had to match the corresponding trial in terms of the information registered at ClinicalTrials.gov (i.e., same objective, same sample size, same primary outcome, same location, same responsible party, same trial phase, and same sponsor) and had to present results for the primary outcome. 
So it appears that a reviewed had to score the journal article as an exact match on 8 criteria in order for the trial to be considered the same. That could easily lead to exclusion of journal articles on the basis of very insubstantial differences. The authors provide no detail on this; and again, that would be easy to verify if the study dataset was published. 

The reason I harp on this, and worry about the matching methodology, is that two of the authors of this study were also involved in a methodologically opaque and flawed study about clinical trial results posted in the JCO. In that study, as well, the authors appeared to use an incorrect methodology to identify published clinical trials. When I pointed the issues out, the corresponding author merely reiterated what was already (insufficiently) in the paper's Methodology section.

I find it strange beyond belief, and more than a little hypocritical, that researchers would use a public, taxpayer-funded database as the basis of their studies, and yet refuse to provide their data for public review. There are no technological or logistical issues preventing this kind of sharing, and there is an obvious ethical point in favor of transparency.

But if the authors are reasonably close to correct in their results, I'm not sure what to make of this study. 

The Nature article covering this study contend that
[T]he [ClinicalTrials.gov] database was never meant to replace journal publications, which often contain longer descriptions of methods and results and are the basis for big reviews of research on a given drug.
I suppose that some journal articles have better methodology sections, although this is far from universally true (and, like this study here, these methods are often quite opaquely described and don't support replication). As for results, I don't believe that's the case. In this study, the opposite was true: ClinicalTrial.gov results were generally more complete than journal results. And I have no idea why the registry wouldn't surpass journals as a more reliable and complete source of information for "big reviews".

Perhaps it is a function of my love of getting my hands dirty digging into the data, but if we are witnessing a turning point where journal articles take a distant back seat to the ClinicalTrials.gov registry, I'm enthused. ClinicalTrials.gov is public, free, and contains structured data; journal articles are expensive, unparsable, and generally written in painfully unclear language. To me, there's really no contest. 

Carolina Riveros, Agnes Dechartres, Elodie Perrodeau, Romana Haneef, Isabelle Boutron, & Philippe Ravaud (2013). Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals PLoS Medicine DOI: 10.1371/journal.pmed.1001566




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Patient Centered Trials - Your Thoughts Needed

The good folks down at eyeforpharma have asked me to write a few blog posts in the run-up to their Patient Centered Clinical Trials conference in Boston this September. In my second article -Buzzword Innovation: The Patient Centricity “Fad” and the Token Patient - I went over some concerns I have regarding the sudden burst of enthusiasm for patient centricity in the clinical trial world.

Apparently, that hit a nerve – in an email, Ulrich Neumann tells me that “your last post elicited quite a few responses in my inbox (varied, some denouncing it as a fad, others strongly protesting the notion, hailing it as the future).”

In preparing my follow up post, I’ve spoken to a couple people on the leading edge of patient engagement:


In addition to their thoughts, eyeforpharma is keenly interested in hearing from more people. They've even posted a survey – from Ulrich:
To get a better idea of what other folks think of the idea, I am sending out a little ad hoc survey. Only 4 questions (so people hopefully do it). Added benefit: There is a massive 50% one-time discount for completed surveys until Friday connected to it as an incentive).
So, here are two things for you to do:

  1. Complete the survey and share your thoughts
  2. Come to the conference and tell us all exactly what you think

Look forward to seeing you there.

[Conflict of Interest Disclosure: I am attending the Patient Centered Clinical Trials conference. Having everyone saying the same thing at such conferences conflicts with my ability to find them interesting.]





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The Streetlight Effect and 505(b)(2) approvals

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:


This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:
My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?
That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:
What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?
This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs
Extreme qualitative differences of 505(b)(2) drugs.
Source: Thomson Reuters analysis via RAPS
are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:
What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?
This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.
  • Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
  • Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 
But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:
The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.
This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]




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REMOTE Redux: DTP trials are still hard

Maybe those pesky sites are good for something after all. 

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work.

The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.)

However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study.

In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE.

TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance.

And the results after a full two years of active enrollment?

  • Traditional sites: 49 enrolled
  • Patient centric: 10 enrolled
Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients.

Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short.


Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067




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Hospitals face months of IV fluid shortages after Helene damages N.C. factory

Hospitals have been forced to innovate with new ways of hydrating patients and giving them medications, after a key factory that produces IV fluid bags flooded during Hurricane Helene. (This story first aired on Morning Edition on Nov. 7, 2024.)




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Bluetooth Microscope Reveals the Inner Workings of Mice



This article is part of our exclusive IEEE Journal Watch series in partnership with IEEE Xplore.

Any imaging technique that allows scientists to observe the inner workings of a living organism, in real-time, provides a wealth of information compared to experiments in a test tube. While there are many such imaging approaches in existence, they require test subjects—in this case rodents—to be tethered to the monitoring device. This limits the ability of animals under study to roam freely during experiments.

Researchers have recently designed a new microscope with a unique feature: It’s capable of transmitting real-time imaging from inside live mice via Bluetooth to a nearby phone or laptop. Once the device has been further miniaturized, the wireless connection will allow mice and other test subject animals to roam freely, making it easier to observe them in a more natural state.

“To the best of our knowledge, this is the first Bluetooth wireless microscope,” says Arvind Pathak, a professor at the Johns Hopkins University School of Medicine.

Through a series of experiments, Pathak and his colleagues demonstrate how the novel wireless microscope, called BLEscope, offers continuous monitoring of blood vessels and tumors in the brains of mice. The results are described in a study published 24 September in IEEE Transactions on Biomedical Engineering.

Microscopes have helped shed light on many biological mysteries, but the devices typically require that cells be removed from an organism and studied in a test tube. Any opportunity to study the biological process as it naturally occurs in the in the body (“in vivo”) tends to offer more useful and thorough information.

Several different miniature microscopes designed for in vivo experiments in animals exist. However, Pathak notes that these often require high power consumption or a wire to be tethered to the device to transmit the data—or both—which may restrict an animal’s natural movements and behavior.

“To overcome these hurdles, [Johns Hopkins University Ph.D. candidate] Subhrajit Das and our team designed an imaging system that operates with ultra-low power consumption—below 50 milliwatts—while enabling wireless data transmission and continuous, functional imaging at spatial resolutions of 5 to 10 micrometers in [rodents],” says Pathak.

The researchers created BLEscope using an off-the-shelf, low-power image sensor and microcontroller, which are integrated on a printed circuit board. Importantly, it has two LED lights of different colors—green and blue—that help create contrast during imaging.

“The BLE protocol enabled wireless control of the BLEscope, which then captures and transmits images wirelessly to a laptop or phone,” Pathak explains. “Its low power consumption and portability make it ideal for remote, real-time imaging.”

Pathak and his colleagues tested BLEscope in live mice through two experiments. In the first scenario, they added a fluorescent marker into the blood of mice and used BLEscope to characterize blood flow within the animals’ brains in real-time. In the second experiment, the researchers altered the oxygen and carbon dioxide ratios of the air being breathed in by mice with brain tumors, and were able to observe blood vessel changes in the fluorescently marked tumors.

“The BLEscope’s key strength is its ability to wirelessly conduct high-resolution, multi-contrast imaging for up to 1.5 hours, without the need for a tethered power supply,” Pathak says.

However, Pathak points out that the current prototype is limited by its size and weight. BLEscope will need to be further miniaturized, so that it doesn’t interfere with animals’ abilities to roam freely during experiments.

“We’re planning to miniaturize the necessary electronic components onto a flexible light-weight printed circuit board, which would reduce weight and footprint of the BLEscope to make it suitable for use on freely moving animals,” says Pathak.

This story was updated on 14 October 2024, to correct a statement about the size of the BLEscope.




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Antibiotic Sales for Use in Food Animals Increased Again in 2019

Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs.




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FDA Proposal Will Not Sufficiently Curb Injudicious Use of Antibiotics in Food Animals

The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics.




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Pain Management in Crisis: Why Hospitals Are Limiting Pain Medications and What This Means for Patients

Hospitals across the U.S. have significantly restricted the use of pain medications containing narcotics. This shift comes amid […]

The post Pain Management in Crisis: Why Hospitals Are Limiting Pain Medications and What This Means for Patients appeared first on World of DTC Marketing.




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McDonald's E. coli crisis reveals why vegetable contamination is harder problem than tainted beef

NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say.




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Taiwan businessman Tsao to sue Chinese officials over sanctions

TAIPEI — Taiwanese businessman Robert Tsao said on Nov 11 that he would sue in a Taiwan court senior Chinese officials over sanctions they had placed on him, saying he was seeking to counter China's intimidation of lawful activity. China, which claims Taiwan as its own territory, said in October it would punish and sanction Tsao, the retired founder of chipmaker United Microelectronics Corp (UMC), for alleged criminal and pro-Taiwan independence activities. China's Taiwan Affairs Office said the "Black Bear Academy" that Tsao has helped fund was seeking to incite separatism that would endanger cross-strait ties. Tsao, one of Taiwan's richest men who has pledged to provide millions to two civilian defence training programmes, told a press conference that China was threatening the lawful holding of political views in Taiwan and his personal safety. The lawsuit will be lodged in a Taipei court against Song Tao, head of China's Taiwan Affairs Office, and also the office's spokesman Chen Binhua. Taiwan courts have no jurisdiction in China and senior Chinese officials do not visit the island.




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221726: Indian information inadequate to warrant listing of three Pakistan-based individuals

Chinese officials had approached the Indian government for more information but had since been reportedly told by the Indian government that the information presented was sufficient to justify the listing.




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213853: China thanked for support of nominations of 3 Pakistan-based individuals for UNSCR 1267 designation

Deputy Director Shen acknowledged the message but offered no further comment.




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Writing Policy Recommendations for Academic Journals: A Guide for the Perplexed

How can scholars write effective policy recommendations? Despite the potential importance of academic work to the policy debate, many scholars receive little training on why and how to make policy recommendations. To remedy this problem, here are steps to guide scholars as they begin developing policy recommendations for their articles. 






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Heat Pumps Can Help Meet Climate Goals but Can Hurt Pocketbooks

Massachusetts has set aggressive targets for heat pump installations for over 100,000 homes by 2025 and over 500,000 homes by 2030. But the high price of electricity in Massachusetts — the fourth highest in the nation — relative to natural gas or oil makes achieving these targets very challenging unless there is a major change in electricity policy.







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Actor/Comedian Rob Riggle Joins Easter Seals Dixon Center to Reinforce Value of Employing Veterans - What to Wear

Rob Riggle Stars alongside Brice Williams in the newest Easter Seals Dixon Center PSA, directed by Jim Fabio with support from Judd Apatow