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Brianna Ghey's mother, Esther Ghey, is now campaigning to raise awareness about the dangers of social media and the "toxic" online world which her daughter came to inhabit. She wants tighter regulation on internet access and more parental controls.

Stock index switch-up reflects symbolic market shift as chip industry refocuses around AI.

Industry Minister François-Philippe Champagne said the decision to dissolve TikTok of its Canadian business is meant to address risks perceived to be related to TikTok's Chinese parent company.

If the legislation is passed, social media platforms including X, TikTok, Instagram and Facebook would have one year to work out how to exclude Australian children.

1. Magnus Carlsen returns to Kolkata after almost five years at Tata Steel India Rapid and Blitz 2024  ChessBase India
2. "It's Chaotic": Chess World No. 1 Magnus Carlsen Reveals Why He Does Not Play In India  NDTV Sports
3. King Carlsen hails growth of Indian chess, praises Praggnanandhaa's fighting spirit  Telegraph India
4. Tata Steel Chess set for a Carlsen-Pragg opening  Hindustan Times
5. Tata Steel Chess India Rapid & Blitz 2024: Schedule, Venue, Players, Tickets, Prize Money  Firstpost

1. Netflix's The Great Indian Kapil Show: Navjot Singh Sidhu is back after 5 years of exit, Archana Puran Singh says, 'He’s taken over my...'  Firstpost
2. Did you know! Navjot Singh Sidhu was ousted from The Kapil Sharma Show for this reason  The Times of India
3. Navjot Singh Sidhu makes a roaring comeback; Archana Puran Singh worried about her The Great Indian Kapil Show throne  Hindustan Times
4. The Great Kapil Sharma Show: Navjot Sidhu shares his fast-track fatherhood plan. Kapil’s response is too f  The Economic Times
5. Navjot Singh Sidhu shares BTS pics from The Great Indian Kapil's show set with Archana Puran Singh and...  Moneycontrol

1. Security beefed up at Ram temple in Ayodhya after Pannun's threat message  The Times of India
2. Security beefed up around Ram Mandir in Ayodhya after Gurpatwant Pannun’s ‘threat’  Hindustan Times
3. Pannun Announces New Dates Of Temple Attacks In Canada, India Terms Threats ‘Terror Acts’: Intel Sources  News18
4. Khalistani terrorist Pannun warns of ‘shaking Ayodhya's foundations’  The Economic Times
5. Security beefed up in Ayodhya after Khalistan`s threat  Zee News

1. Bulldozer justice: SC lays down pan-India guidelines for demolition of properties, says Executive can’t become judge and accused, convicts have certain rights  The Hindu
2. "House Embodies Hope": Supreme Court Demolishes 'Bulldozer Justice' Idea  NDTV
3. Unconstitutional to demolish house without following due process merely because they are involved in a crime: SC  The Indian Express
4. Supreme Court on bulldozer action: ‘No demolition without following guidelines, 15-day notice’  Hindustan Times
5. Bulldozer justice: Executive can't become judge, demolish house of accused, SC says  The Times of India

Tickets for the event will go on sale on November 10, 2024, via BookMyShow

The launch event will see the YouTubers partnering with Ajey Nagar, known as CarryMinati, for a special fan interaction in Mumbai

Tamannaah Bhatia, Avinash Tiwary and Rajiv Mehta play three unlikely suspects in director Neeraj Pandey’s latest

The actor, who stars in the upcoming film ‘The Sabarmati Report’, based on the 2002 Godhra train burning incident, emphasised his secular credentials while saying that his perspective on the state of the nation has shifted in the last ten years

Canadian soccer great Christine Sinclair played her final pro game on Sunday when her Portland Thorns were eliminated from the NWSL playoffs by Gotham FC.

AthletesCAN in partnership with CBC Sports presents the Most Trending Moment Award as part of the 47th Canadian Sport Awards.

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.

But the streaming gaming revolution "is not going to happen overnight."

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.

NVIDIA has been testing a single app that merges the GeForce Experience and Control Panel over the past year. After rolling out several betas to make sure it works as intended, the company has officially launched the NVIDIA application, which is now available to download for users with its GPUs in their PCs and laptops. 

The company says the app is meant to make it easy to keep their NVIDIA Studio and GeForce Game Ready drivers updated and to give users quick access to its latest programs. In its home screen, users will find a prominently displayed section that will lead them to the latest driver downloads, as well as sections that will take them to other NVIDIA applications. At the bottom, they'll find a Library section showing their most recently opened games and programs that they can launch from there. 

Since it's supposed to provide a unified experience, users will be able to fine-tune the settings for their games and programs from within the app. Users will be able to access Optimal Playable Settings with relevant Control Panel options, and they'll be able to configure their displays, enable G-SYNC, enhance videos with AI and fine-tune their GPU's performance from within its interface. 

NVIDIA explains that it designed the unified application to be 50 percent more responsive than the GeForce Experience. It also installs in half the time. It's also worth noting that app will introduce a redesigned in-game overlay that simplifies access to gameplay recording tools capable of capturing video in 4K at 120 FPS, as well as AI-powered filters for those with RTX GPUs. They'll then be able to view their screenshots and new videos in the app's Gallery. 

This article originally appeared on Engadget at https://www.engadget.com/computing/nvidias-new-all-in-one-pc-app-launches-out-of-beta-today-140040945.html?src=rss

Mumbai (AFP) Nov 2, 2024
Indian security forces killed three suspected militants in two separate firefights in disputed Kashmir, the army and a senior police official said Saturday. Muslim-majority Kashmir has been divided between rivals India and Pakistan since their independence from British rule in 1947 and is home to a long-running insurgency. The first firefight broke out after Indian troops moved to check

New Delhi (AFP) Nov 5, 2024
The toxic smog season in India's capital has just begun, but those unable to escape cancer-causing poisonous fumes say the hazardous impact on health is already taking its toll. New Delhi regularly ranks among the world's most polluted capitals, with a melange of factory and vehicle emissions exacerbated by agricultural fires blanketing the city each winter, stretching from mid-October until

New Delhi (AFP) Nov 7, 2024
Sweeping aside thick toxic scum, thousands of Hindu devotees ignored court warnings Thursday against bathing in the sacred but sewage-filled Yamuna river, a grim display of environmental degradation in India's capital. Thousands celebrated the festival of Chhath Puja for the Hindu sun god Surya, entering the stinking waters to pray as the evening rays set in the sky. A parliamentary repo

Barsana, India (AFP) Nov 8, 2024
Venerated as incarnations of Hindu deities, India's sacred cows are also being touted as agents of energy transition by a government determined to promote biogas production to cut its dependence on coal. It is an understatement to say that Nakul Kumar Sardana is proud of his new plant at Barsana, in India's northern Uttar Pradesh state. Firstly, says the vice-president of a biomass joint

New Delhi (AFP) Nov 8, 2024
India's capital unveiled plans Friday to fly special drones to clear pollution from its smog-choked skies - a plan derided by experts as another "band-aid" solution to a public health crisis. New Delhi and the surrounding metropolitan area, home to more than 30 million people, consistently tops world rankings for air pollution in winter. The smog is blamed for thousands of premature de

Paris, France (SPX) Nov 03, 2024
ESA's Proba-3 mission, designed to create a solar eclipse in space, is leaving Europe to head to its Indian launch site. The mission's two spacecraft, designed to align precisely in orbit so one will block the Sun for the other, have departed from Redwire Space's facilities in Kruibeke, Belgium. The pair will be transported to the Satish Dhawan Space Centre near Chennai, India, to prepare for th

Billionaire and social media mogul Kim Kardashian finally wore the Princess Diana-owned pendant she bought last year. She debuted the amethyst and diamond cross, purchased in January 2023 for £163,800 (roughly $265,000 Cdn), at the LACMA Art+Film Gala in Los Angeles on Saturday. 

Bill MacDonnell's paintings are on display at the Military Museums in Calgary through Remembrance Day and into 2025.

Citing national security concerns, the federal government has ordered TikTok to shutter its Canadian operations — but users will still be able to access the popular video app.

Donald Trump is returning to the White House with big plans to remake the global trade landscape. That could be a disaster for Canada's economy. But key players of the last trade war believe they can mitigate the damage.

The federal government ordered an end to TikTok's Canadian operations on Wednesday, citing national security concerns. But its decision to keep the app itself available has privacy experts puzzled.

As people gather to remember those who fought and died to protect this country in past wars, a new poll suggests many Canadians know little about their country's history.

Donald Trump's former commerce secretary says he 'can't imagine' the U.S. president-elect would want to tax Canadian energy, despite campaign promises about imposing a global tariff when he takes office in January.

A Canada Border Services Agency superintendent is speaking out after being targeted by the Indian government with allegations of murder and terrorism — allegations Canadian authorities say are not backed by any evidence.

Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller

The Federation of Pharmaceutical Entrepreneurs (FOPE) has identified potential opportunities for Indian pharmaceutical companies to expand in Australia. Further, the India─Australia Economic Cooperation and Trade

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

Indian pharma and biotech companies are confident that under the new US President Donald Trump, its strengths in high quality generics manufacture and export will continue to command respect. This view is

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

The Indian pharmaceutical industry is advocating for enhanced fire safety measures and improved insurance coverage for employees working in pharmaceutical facilities.

Researchers at the Wyss Institute at Harvard University have developed a microfluidic chip that can recreate some of the features of radiation-induced lung injury. The lungs are very sensitive to radiation, and this can limit the application of radiotherapy to treat cancer. Accurately modeling radiation-induced lung injury could assist in developing new methods to prevent […]

Researchers at the National University of Singapore have developed a magneto-responsive hydrogel wound dressing that also contains two different regenerative cell types. The hydrogel is also embedded with magnetic particles that can be stimulated using an external magnetic field. The action of the magnetic field on the gel-encapsulated particles causes mechanical stresses within the gel […]

Prepare to witness the convergence of strategy and science at the highly anticipated the DIA 2024 Global Annual Meeting! Immerse yourself in four days of conversations that don’t happen anywhere else, where strategic thinking seamlessly intertwines with scientific innovation: Elevate Your Professional Profile Expand your knowledge base with continuing education opportunities available virtually from June […]

The post Science Meets Strategy at DIA 2024 first appeared on ACRO.

We still don’t know what COVID-19 is doing to the heart or how we should be investigating it and treating it. Last month JAMA Cardiology published a German cohort study of 100 patients recently recovered from COVID-19… A number of striking problems with the study were noted on Twitter…...

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The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found.

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:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

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”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

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.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

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.

[Fair Warning: I have generally tried to keep this blog separate from my corporate existence, but am making an exception for two quick posts about the upcoming DIA 2013 Annual Meeting.]

Improving Enrollment in Pediatric Clinical Trials

Logistically, ethically, and emotionally, involving children in medical research is greatly different from the same research in adults. Some of the toughest clinical trials I've worked on, across a number of therapeutic areas, have been pediatric ones. They challenge you to come up with different approaches to introducing and explaining clinical research – approaches that have to work for doctors, kids, and parents simultaneously.

On Thursday June 27, Don Sickler, one of my team members, will be chairing a session titled “Parents as Partners: Engaging Caregivers for Pediatric Trials”. It should be a good session.

Joining Don are 2 people I've had the pleasure of working with in the past. Both of them combine strong knowledge of clinical research with a massive amount of positive energy and enthusiasm (no doubt a big part of what makes them successful).

However, they also differ in one key aspect: what they work on. One of them – Tristen Moors from Hyperion Therapeutics - works on an ultra-rare condition, Urea Cycle Disorder, a disease affecting only a few hundred children every year. On the other hand, Dr. Ann Edmunds is an ENT working in a thriving private practice. I met her because she was consistently the top enroller in a number of trials relating to tympanostomy tube insertion. Surgery to place “t-tubes” is one of the most common and routine outpatients surgeries there is, with an estimated half million kids getting tubes each year.

Each presents a special challenge: for rare conditions, how do you even find enough patients? For routine procedures, how do you convince parents to complicate their (and their children’s) lives by signing up for a multi-visit, multi-procedure trial?

Ann and Tristen have spent a lot of time tackling these issues, and should have some great advice to give.

For more information on the session, here’s Don’s posting on our news blog.

Are we looking at our enrollment data in the right way?

Session Details:

June 25, 1:45PM - 3:15PM

• Session Number: 241
• Room Number: 205B

1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead
3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

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.