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

The show will premiere in January 2025

Nintendo is set to show off the Donkey Kong Country expansion of its Super Nintendo World theme park today (Monday, November 11) at 5PM ET, the company revealed in a post on X. That means the new Universal Studios Japan area might finally open soon, after being delayed from the previously announced launch window of Spring 2024. 

The new park attraction featuring Mario's barrel-throwing nemesis was first revealed in 2021. The centerpiece is a ride called Mine Cart Madness, named after the best level in the 1994 SNES game Donkey Kong Country. After being blasted out of a barrel cannon, you'll take a mine cart ride through the jungle that includes a "leap across a collapsed track" as Nintendo showed in a render earlier this year.  

The direct livestream appears to be focused on Donkey Kong world alone, and Nintendo specifically pointed out that "no game information will be featured" — so don't expect any news on the next-gen Switch 2 console either. 

Donkey Kong Country will expand the park size by up to 70 percent, Nintendo said when it was announced. Current attractions at the Japan park are the Mario Kart: Kuppa's Challenge rollercoaster and Yoshi Adventure. Nintendo recently announced that it would open a Super Nintendo World attraction at Universal Studios Orlando on May 22nd, 2025 with the same attractions as the park in Osaka. 

This article originally appeared on Engadget at https://www.engadget.com/gaming/nintendo/nintendo-will-show-off-donkey-kong-country-theme-park-expansion-at-live-event-today-130015655.html?src=rss

THE soap opera continues for SurfStitch as the surfwear brand sheds 40 jobs in a bid to return to profit.

CBC has announced it's investing more in local and regional news. The coverage includes up to 25 journalists in more than a dozen communities and four new daily local podcasts.

Via Rail's service standards have eroded substantially over the last decade, with many more trains arriving late.

The union representing Canada Post workers said it will be in a legal strike position on Friday, exactly one year after talks on a new contract began. But the union is holding back on deciding whether a job action will take place immediately.

Selon une étude, l’activité physique régulière pourrait atténuer le risque de développer un cancer du pancréas, qui touche les personnes obèses.

The Embassy of India in Iraq has extended an invitation to Indian businesses to participate in the "Medico Expo," officially known as the Erbil International Health Exhibition. This prestigious event, set to be the

The U.S. Food and Drug Administration posted a photo:

Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The U.S. Food and Drug Administration posted a photo:

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

Early in the pandemic there was a widespread belief that science would be our salvation. With the help of science we would be spared the worst consequences, such as occurred during the 1918 Spanish flu pandemic. A vaccine would arrive, reliably, after a few hard months of research, and in short order the problem would...

Click here to continue reading...

At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...

Click here to continue reading...

I recently posted the following thread on Twitter: I am so disappointed by the large number of pre-pandemic medical skeptics who have now turned into mask/vaccine skeptics. I largely agreed with many of them back in the day. /1 Pre-pandemic they used their skills and intelligence to rightfully question whether, say, a stent should be inserted...

Click here to continue reading...

<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>

The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.

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

But while we can all agree that "patient engagement is good" in a highly general sense, we don't have much consensus on what the implications of that idea might be. There is precious little hard evidence about how to either attract engaged patients, or how we might effectively turn "regular patients" into "engaged patients".

Habanero tidak hanya menyajikan game slot biasa, melainkan sebuah petualangan menang tanpa batas. Dengan tema-tema yang beragam, mulai dari petualangan antariksa hingga ke dunia mitologi, setiap game Habanero memiliki keunikan…

The post Game Slot Gacor Gampang Menang Habanero appeared first on Biosimilarnews.

Keuntungan besar dan kegembiraan yang ditawarkan oleh mesin slot online membuatnya semakin populer. Namun, dalam lautan situs slot yang ada, bagaimana Anda bisa menemukan situs slot terbaik yang dapat memberikan…

The post Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini appeared first on Biosimilarnews.

Fort Health’s $5.5 million in funding was led by Twelve Below and Vanterra and included participation from Redesign Health, Blue Venture Fund and True Wealth Ventures.

The post Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care appeared first on MedCity News.

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.

Research has consistently demonstrated strong links between people’s health and societal sectors such as employment, community development, education, housing, and transportation.

As the coronavirus pandemic grips the world, the opioid epidemic continues to affect millions of Americans. Several states are developing innovative ways to tackle this public health issue. In this episode, we speak with Beth Connolly, who leads Pew’s research on substance use disorders, and Louisiana Representative Paula Davis, who helped ensure effective treatment in her state.

We’re seeing an alarming increase in the number of failed biotech companies. While the biotechnology industry holds enormous […]

The post Why Biotech Companies Fail: Lessons for CEOs appeared first on World of DTC Marketing.

Watch the video and learn basic principles of modeling panel data using SAS/ETS.

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

LONDON — The world's biggest food and beverage companies on average sell products in low-income countries that are less healthy than what they sell in high-income countries, according to a new report. Products sold by companies including Nestle, Pepsico and Unilever were assessed as part of a global index published by the Access to Nutrition Initiative (ATNI), its first since 2021. The non-profit group found that across 30 companies, the products sold in low-income countries scored lower on a star rating system developed in Australia and New Zealand than those sold in high-income countries. In the Health Star Rating system, products are ranked out of five on their healthiness, with five the best, and a score above 3.5 considered to be a healthier choice.

Denzel Washington has confirmed he will star in Black Panther 3 before his retirement. The 69-year-old actor is the first to talk about the existence of a third film in the blockbuster Marvel franchise — which will follow the 2018 original and 2022 sequel Black Panther: Wakanda Forever — and has also revealed the film will be among a handful of roles he will take on before he bows out of acting after a career spanning four decades. Confirming director Ryan Coogler has written a role just for the Oscar-winner for the third instalment, Denzel told Australia's Today show: "At this point in my career, I'm only interested in working with the best, I don't know how many more films I will make, probably not that many. I want to do things that I haven't done." Sharing the roles he has lined up before he bids farewell to his Hollywood career, he said: "I played Othello at 22, I'm now going to play it at 70. After that, I'm playing Hannibal. After that, I've been talking with Steve McQueen about a film. After that, Ryan Coogler is writing a part for me in the next Black Panther.

SEOUL - South Korea's military said it will hold a three-day joint exercise with the United States and Japan starting on Wednesday (Nov 13), featuring fighter jets and marine patrol aircraft as well as the US nuclear-powered aircraft carrier USS George Washington. The Freedom Edge exercise is a response to what the South Korean military said were threats from North Korea, which recently conducted an intercontinental ballistic missile test, drawing condemnation from Seoul, Tokyo and Washington. It also comes as the US State Department said North Korean troops have started engaging in combat operations in Russia's war with Ukraine. The exercise will include South Korean and Japanese fighter jets and maritime patrol aircraft, as well as the USS George Washington, Seoul's Joint Chiefs of Staff (JCS) said in a statement. The trilateral exercise follows a first round held earlier this year after the leaders of the three countries agreed at a summit in 2023 to hold annual training drills. Pyongyang has long condemned joint drills between South Korea and the United States, calling them a rehearsal for invasion.

Aug 12, 2022

Companies that rely on certain countries in Asia for their supply lines will face continued challenges as geopolitical stresses, let alone global pandemics, cause supply shortages. Beyond causing economic harm, these shortages pose a direct threat to U.S. national security interests.

Nov 15, 2023

Efforts around and impacts of global methane-emissions abatement will be the focus at an official side event on December 6 co-sponsored by the Harvard Project on Climate Agreements at the 28th Conference of the Parties (COP-28) of the United Nations Framework Convention on Climate Change (UNFCCC) in Dubai. Harvard Project Director Robert Stavins will also participate in a number of other events at COP-28.

Jul 11, 2024

Efforts to measure and mitigate the impact of methane emissions was the topic of discussion last Monday (June 10, 2024) at a panel convened as part of Climate Action Week in the Northwest Building, sponsored by Harvard’s Salata Institute for Climate and Sustainability and moderated by Harvard Environmental Economics Program and Harvard Project Director Robert Stavins.

Aug 5, 2024

This original primer, conducted as research for The Africa Futures Project, is an initial exploration into the evolving roles and increasing influence of “middle powers” in Africa. It covers a diverse array of existing and aspiring middle powers, presenting key points for each nation under four distinct analytical lenses.

CrissCross Representative Payee Services

Vanilla Reload Swipe Load is a quick, safe and easy way to load cash on to your prepaid card.

Growth Unlocked: Closing the Strategy-to-Execution Gap

The Investor Desk - Featured Company - US Highland - UHLN

CEPSA's logo installation