Soderlund died from complications due to Alzheimer's disease.

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Last year, FDA advisers unanimously voted that oral phenylephrine is ineffective.

"You’ve taken this idea way too far," a mentor told Prof. Fei-Fei Li.

A now nine-year-old girl who says she was sexually assaulted by a priest last year in Little Grand Rapids First Nation told court on Tuesday she remembers feeling scared as the priest allegedly walked her to his bedroom inside the church that day.

The pedigree of the producers and writers involved is cause for concern, though.

The film will mark Geetu’s third directorial after ‘Liar’s Dice’ and ‘Moothon’

The announcement was made in a video unveiled at Disney’s D23 event in Brazil, featuring the returning stars in a reveal

Megan Fox has announced pregnancy with Machine Gun Kelly after experiencing a pregnancy loss in 2023

Tampa Bay Rays shortstop Wander Franco was charged with illegally carrying a gun in his vehicle during the altercation in a parking lot that led to his arrest in the Dominican Republic over the weekend, prosecutors said Tuesday.

Playtonic Friends just announced that Victory Heat Rally from developer Skydevilpalm is coming to mobile through Crunchyroll and also on …

Continue reading "‘Victory Heat Rally’ From Skydevilpalm and Playtonic Friends Is Coming to PC and Crunchyroll for Mobile on October 3rd"

In this week’s episode of The TouchArcade Show I talk about how I finally ended up getting sick after weeks …

Continue reading "Ok I’m Actually Sick Now – The TouchArcade Show #601"

Are there hidden planets in our solar system? New technologies, like the powerful Rubin Observatory, brings us closer to answers.

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

Rachelle and Kelly Swan bought their house in Spiritwood two years ago. They gave up their keys to the bank voluntarily in May, closing the door on the bat-infested house.  

Scientists warn that this year could end 1.5 C hotter than pre-industrial times, surpassing the current record of 1.48 C set just last year. Some experts now fear Donald Trump’s less-than-friendly stance on climate change could make the crisis even worse.

There are not many usable precedents for what J. D. Vance can do with a one-term vice presidency.

While public transit in many Canadian cities is struggling with rising fares and falling ridership, one Ontario community has more than doubled its transit use in the past two years. Orangeville has made its buses free, joining a list of much larger communities that have gone fare-free.

Megan Fox et son petit ami Machine Gun Kelly seront bientôt parents.

SOME volunteer firefighters feel left in the dark after the Country Fire Authority’s board and chief executive were replaced within 24 hours.

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

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

Researchers at Rice University have developed a magnetoelectric material that converts a magnetic field into an electric field. The material can be formulated such that it can be injected into the body, near a neuron, and then an alternating magnetic field can be applied to the area from outside the body. Magnetic fields are very […]

Today’s guest post comes from Josh Marsh, Vice President and General Manager, Sonexus™ Access and Patient Support at Cardinal Health

Josh discusses challenges manufacturers may face when outsourcing patient support programs. He outlines a process that smoothly transitions hubs and minimizes disruptions for patients and healthcare providers.

To learn more, download the 3-step guide to patient hub transitions.

Read on for Josh’s insights.
Read more »

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

Megan Fox is pregnant. The 38-year-old actress — who has Noah, 12, Bodhi, ten, and Journey, eight, with her ex-husband Brian Austin Green — has confirmed via social media that she's expecting her first child with Machine Gun Kelly.

Apr 2, 2024

Stephen Walt argues that because no one knows what Putin might do, NATO's European members should increase their defense capabilities and correct any obvious vulnerabilities. At the same time, however, the United States and its NATO allies should acknowledge Russia's legitimate security concerns and consider what they can do to allay them.

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

T. Rowe Price Survey Key Findings

Homewood Suites by Hilton Business Traveler B-Roll

hello products are a solution to the struggle at the sink. This advertisement shows the frustrations moms and dads can face when it�s brush time and they need to negotiate with their kids to brush.

Joining Forces Event at Fort Leonard Wood, MO

Chef Giorgio Rapicavoli de Eating House Miami nos invita participar en el concurso de milk life Somos Fuertes

Abbott is asking a million people what living fully means to them. See how some people in the U.S. respond.

Sunscreen is FDA regulated as an over the counter drug and thus restricted from schools, playgrounds & practice fields. Give your child the right to bring sunscreen to school with a simple permission slip.

Institut Marqu�s

The Wheels Up Pink Plane is the first-ever pink Beechcraft King Air 350i. Proceeds benefit the Dubin Breast Center at Mount Sinai in New York City. Westchester County Airport, White Plains, NY

Video of legally-blind photographer living his Whole Day, as he captures a celebration of senses and movement

Hi Sir Could I know the difference between Stock Group and Stock category in Tally prime Under What circumstances they Use in plant accounting Whether Raw material,Finished goods, Packing materials come under Stock group or Stock category Please advise Thanks

Members, bestow yourselves with back pats of honor, for everything is going exactly as planned!

Sick of poverty, riots and insanity? So were your ancestors when THEY got lost in pulp magazines! Brush away the summer insanity with colorful madness, this week in the Comedy Goldmine!

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.

Ready to welcome a steady incoming flow of conference attendees, introduce the world to a host of new industry innovations and provide a full lineup of fun events all week long, ProMat 2023 opened its doors to the world at 10 a.m. CST this morning.

TikTok’s “sleepy girl mocktails” remind us how important magnesium is for sleep and health

The Regal North Hollywood is holding a showing of the new feature-length anime The Lord of the Rings: The War of the Rohirrim from 1.00pm on this Saturday (November 9) open to children aged nine to 14, and their parents. It's not entirely clear whether adult-without-kids can also attend, but I took a few moments to run through their pre-booking survey and it does seem that you get screened out if you state you're attending without kids.

T&Cs also state that no-one under the age of nine will be admitted (presumably because of MPAA ratings).

If this tickles your fancy (and you have kids 9 to 14), you can reserve (free!) your tickets here.

If you're unaware of the story, The War of the Rohirrim is set many years before the events of The Lord of the Rings and follows a historic event described by J.R.R. Tolkien in Appendix A of the book. As the filmmakers describe it, "...a sudden attack by Wulf, a clever and ruthless Dunlending lord seeking vengeance for the death of his father, forces Helm Hammerhand, the King of Rohan, and his people to make a daring last stand in the ancient stronghold of the Hornburg."

The anime debuts worldwide (in most locations) on December 13.

Early free screening details

Saturday, November 9th, 2024
Regal North Hollywood
6150 Laurel Canyon Blvd # 200, North Hollywood, CA 91606

1:00 pm. Open to children 9-14 and their parents
No one under 9 will be admitted.
Check-in will begin 60 minutes before the start of the show.

RESERVE YOUR TICKETS