Spare Us, Senator Murphy
The Connecticut Democrat suddenly thinks Democrats need to listen to people outside their coalition.
The Connecticut Democrat suddenly thinks Democrats need to listen to people outside their coalition.
There is already a bunch of early Black Friday deals to check out, but if you're on the lookout for a great set of wireless headphones for yourself or a loved one, here's one that's absolutely worth your attention. Sony's WH-1000XM5 headphones have dropped to $298. That's a $102 discount.
This isn't quite the lowest price we've seen for the over-ear XM5s. They dropped to $280 at one point earlier this year. However, the headphones haven't gone back down to that point since, and this is still a great deal.
The XM5s are our pick for the best wireless headphones overall. We've long been recommending Sony's 1000X line and this is the best iteration to date. They earned a score of 95 in our review.
The redesigned headphones are much more comfortable to wear for extended periods than previous models. Sony has improved the active noise cancellation (ANC) feature as well, thanks to the addition of a new chip and four more microphones. We feel that the company's current flagship headphones do a better job of blocking out high frequencies and background noise (and even human voices) than the XM4s.
The XM5s can switch between noise modes depending on your location or activity, and they can pause audio automatically when you start speaking. They deliver better call quality than rival models and, in general, you'll get clear, crisp sound, including punchy bass. You won't need to charge the XM5s too often either, as they have a 30-hour battery life.
Check out all of the latest Black Friday and Cyber Monday deals here.
This article originally appeared on Engadget at https://www.engadget.com/deals/sonys-wh-1000xm5-headphones-are-100-off-in-this-black-friday-deal-192016343.html?src=rssNintendo has filed a lawsuit against a streamer called EveryGameGuru, accused of streaming gameplays of pirated games before they were even released — and of providing viewers access to piracy tools and illegal copies of the games.
EveryGameGuru allegedly streamed Mario & Luigi: Brothership across five days, weeks before its official release on November 7. After Nintendo had the videos taken down from various platforms, including YouTube, they continued live streaming on Loco and even included a QR code for their CashApp handle.
Nintendo said EveryGameGuru sent the company an email, saying it has “a thousand burner channels” and “can do this all day.”
Don’t anger the house of Mario! The company is asking for $150,000 in damages per violation of its copyright. 404media did the math: That could add up to millions, seeing as the suit cites at least 10 games, streamed on at least 50 occasions.
— Mat Smith
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Sure, it’s not for most of us. The Vive Focus Vision isn’t for the same people as the PSVR2 or Meta Quest 3. This is meant to be high-end VR for businesses and creators: a cross between the Focus 3 and last year’s goggle-like XR Elite. The build quality is excellent, but it’s running on aging hardware. Worse, it’s riddled with software issues and is rather expensive compared to the Meta Quest 3.
If you’re aged 30 and up, you know the voice of Elwood Edwards, realize it or not. He recorded the phrase, “You’ve got mail!” and three other lines for Quantum Computer Services in 1989. That company became America Online (AOL), Meg Ryan made the movie with Tom Hanks and everything else. (AOL is currently owned by Yahoo, Engadget’s parent company.)
The latest patch for the PS5 version of God of War Ragnarok adds the option first seen in the PC port to tone down the boy’s excessive and unsolicited hints when Kratos is contemplating the game’s many puzzles. Enough, Atreus! (The patch also includes PS5 Pro upgrades, for smooth 60 fps and better visuals. But that’s not as funny.)
This article originally appeared on Engadget at https://www.engadget.com/general/the-morning-after-nintendo-sues-pirated-software-streamer-for-millions-121630229.html?src=rssWhile reading through the list of Grammy nominees earlier I came across quite a surprise. There, competing for record of the year alongside the likes of Beyoncé's Texas Hold 'Em and Chappell Roan's Good Luck Babe, was Now and Then by The Beatles. No, to my dismay, this isn't a time travel situation, but the result of AI.
So, here's the story of how The Beatles got nominated for two Grammys — they also snagged a best rock performance nod — 50 years after formally breaking up. It starts with a demo John Lennon recorded in the 1970s that was given to Paul McCartney, Ringo Starr and George Harrison for inclusion on the The Beatles Anthology, released in 1995. While other tracks like Free as a Bird and Real Love made it on, technology wasn't advanced enough to separate Lennon's vocals and piano without reducing the recording's quality.
But, last year McCartney and Starr used modern machine learning technology to pull Lennon's vocals for a new track. Now and Then, released in November 2023, includes McCartney on bass, Starr on the drums, Lennon's vocals and a guitar in Harrison's style (a 1995 recording of him makes up some of the background rhythm guitar. You can watch a documentary about making the track here.
Unsurprisingly, the song is said to be the last from the Beatles. We'll have to wait until the awards show in February to see whether or not AI will help them win another Grammy.
This article originally appeared on Engadget at https://www.engadget.com/ai/the-beatles-are-nominated-for-two-grammys-thanks-to-ai-150004467.html?src=rssWaymo has announced expanded availability of its driverless rideshare service throughout Los Angeles. That’s right. Waymo One is now available to all customers anywhere in LA county, which is 80 square miles. The company has dropped the waitlist for area residents. Now LA residents will get to experience sitting in endless traffic with a series of cameras and navigational algos leading the way instead of a person.
This expanded service starts today and it offers “fully autonomous rides” at any time of the day or night. Let’s hear it for some drunken late night bonding with an algorithm. Waymo also says it’ll further expand the service area in the future. After all, Los Angeles comprises five counties.
It’s been offering driverless rides to LA customers for a while now, but with a mandatory waitlist. Waymo One also started small in San Francisco and Phoenix before announcing similar expansions. The service will be coming to Austin and Atlanta in the near future.
All told, the company says over 300,000 Los Angeles residents have joined the waitlist for the service and Waymo One has completed “hundreds of thousands of paid trips across the city.” Waymo says these driverless rides are also highly rated, with an average rating of 4.7 stars out of five. A recent survey indicated that 98 percent of customers are satisfied with the service.
This article originally appeared on Engadget at https://www.engadget.com/transportation/waymos-driverless-cars-in-la-county-are-now-available-to-everyone-173237519.html?src=rssCarey Price aura vraisemblablement la faveur du comité qui est appelé à décider qui sera intronisé chaque année.
OPINION: Queensland, we can’t have it all. The state is stuck with staggering debt and leaders — on both sides — refuse to accept an even half-decent strategy to reduce it. Join the Cage Fight from 7am.
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.
Depuis quelques années, et avec une plus grande intensité au cours des derniers jours, plusieurs proposent la création d’une commission Parent 2.0.
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.
Deputy Prime Minister Chrystia Freeland is reassuring Canadians as officials worry president-elect Donald Trump’s promise to deport millions of undocumented immigrants could send them northward.
THOUSANDS of fans stay up late to watch the English Premier League. But the UK leaving the EU could change all that.
DOCTORS from a top Australian university say they too were hit with erroneous Centrelink debt notices — and even a PhD can’t sort out the mess.
ONE of the world’s most spectacular clouds made a dramatic entrance for passengers on an Adelaide-bound jet.
The car finance industry is setting aside billions to pay for potential claims after a test case.
The way firms deal with fare evasion will be examined amid concern about how passengers are treated.
Four workers red-flagged in a 2014 review of SA’s troubled child protection agency remain suspended on full pay.
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.
The Indian healthcare industry is looking to invest further in computational infrastructure as data integration frameworks and regulatory compliance are pivotal to ensure intelligent clinical support
TekniPlex Healthcare is set to unveil its strongest-ever reinforced paper for medical device packaging applications at Pack Expo 2024, 3-6 November in Chicago.
In this episode of The FemTech series Olivia Friett is joined by Jane Kennedy and Dr. MaryAnn Ferreux where we will discuss the inequality in women's health and how we can overcome the obstacles that come with this.
Nick Guerin, CSP, director of environmental, health & safety at Tessy Plastics highlights how contract manufacturers are driving sustainability in the medical plastics industry.
Scientific American staff and sleep experts share advice on how to get better sleep in the stressful days leading up to the U.S. presidential election—and those that come after
The outcome of the 2024 U.S. presidential election could reshape policies from health care at home to nuclear proliferation abroad
Famous people who die at age 27, such as Janis Joplin, Jimi Hendrix and Amy Winehouse, get even more famous because of the mythology surrounding that number—an example of how modern folklore emerges
It is difficult to disentangle Russian and Chinese scientists from international science cooperation. That is a good thing
The new Trump administration is likely to reduce subsidies for Affordable Care Act insurance plans and roll back Medicaid coverage. Public health authorities worry that antivaccine activist Robert F. Kennedy, Jr., will be empowered
A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer […]
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.
Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). The FTC rightly calls out how the gross-to-net bubble can raise patients’ out-of-pocket costs, while also acknowledging how rebates can reduce a plan's (but not the patient’s) costs. Apparently, the FTC believes that PBMs’ customers are pretty dumb, because PBMs are able to prevent plans from “appreciating” such healthcare financing dynamics.
Section V.E. of the complaint (starting on page 23) focuses on the PBMs’ alleged unlawful conduct related to preferring high-list/high-rebate insulin products over versions with lower list prices. I thought it would therefore be fun to take the Wayback Machine to November 2021, when I wrote about this specific topic.
Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Much of the FTC’s description of the drug channel aligns with my commentary. But before you fist pump too hard for Ms. Khan’s FTC, you should pause to reflect on the agency’s legal theories in light of plans’ revealed preferences.
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.
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.
The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024.
Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos.
The U.S. Food and Drug Administration posted a video:
What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
The U.S. Food and Drug Administration posted a video:
What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).
The U.S. Food and Drug Administration posted a video:
¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars
<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i> </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 immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>
The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care.
A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.
By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets. Identifying
The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.
The UK body that oversees health research is writing a new strategy on clinical trial transparency and it wants to hear opinions on it. The Health Research Authority (HRA) says its strategy aims to “make transparency easy, make compliance clear and make information public.” It has opened a public consultation on the strategy and some […]
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 […]
PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.
I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.
However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.
Two words that make us mistrust Duke: |
I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research.(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)
When they're frothing at the mouth, even Atticus doesn't let them publish a review |
A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.(Emphasis mine.)
In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.
There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products.
At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making.I agree, and hope she can pull it off.]
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? |
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.
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.
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?