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Roguelite ‘Coromon: Rogue Planet’ in Development for Release on iOS, Android, Switch, and Steam in 2025

Following developer TRAGsoft bringing monster collecting game Coromon to mobile after it debuted on PC and Switch, we are getting …





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SwitchArcade Round-Up: Reviews Featuring ‘Bakeru’ & ‘Peglin’, Plus Highlights From Nintendo’s Blockbuster Sale

Hello gentle readers, and welcome to the SwitchArcade Round-Up for September 2nd, 2024. I think it’s a holiday today in …




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The Best Switch Visual Novels and Adventure Games in 2024 – From Fata Morgana and VA-11 Hall-A to Famicom Detective Club and Gnosia

After tackling the best party games on Switch in 2024, the recent release of Emio – The Smiling Man: Famicom …




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‘Total War: Empire’ Is Coming to iOS and Android This Fall From Feral Interactive

Feral Interactive’s tease seemingly was about Total War: Empire from Creative Assembly and SEGA because the developer just announced that …






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The short and sweet bursts of exercise that could save your brain from dementia...


The short and sweet bursts of exercise that could save your brain from dementia...


(Third column, 17th story, link)





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More women seek testosterone therapy, prompted by influencers, docs say...


More women seek testosterone therapy, prompted by influencers, docs say...


(Third column, 11th story, link)







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Mesopotamia Artifacts Help Explain How Language Evolved from Pictures to Words

By comparing early markings used for business purposes to 'proto' cuneiform, we can say language transitioned from symbols to writing.




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How to Remove a Tick From a Dog

Protect your dog from ticks with these easy steps for safe removal and prevention. Learn how to spot, remove, and keep ticks at bay.




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BBC confirms exit of ‘world-class’ Gary Lineker from Match of the Day

The former striker will depart the programme at the end of the 2024/25 season




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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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US prohibits airlines from flying to Haiti after planes were shot by gangs

The shootings were part of a wave of violence that erupted as the country plagued by gang violence swore in its new prime minister after a politically tumultuous process.




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First ferret babies born from a clone bring new hope for their species

Sibert and Red Cloud, black-footed ferret siblings at the Smithsonian’s National Zoo and Conservation Biology Institute, are the first members of an endangered species born to a cloned animal.



  • Radio/As It Happens

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Agate Stone: Meaning, Uses, and How to Benefit from Its Energy

Discover agate meaning: learn how this beautiful crystal supports emotional healing, balance, and grounding energy, making it a must-have for spiritual wellness.




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Trump Might Not Lead a U.S. Retreat from the World Stage After All

His early personnel choices indicate his incoming administration would be willing to use sticks as well as carrots to deal with Russia.




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LG's new display stretches from 12 to 18 inches

Today's edition of things I suddenly really really need comes courtesy of LG Display. The company has developed what it claims to be the first display capable of stretching up to 50 percent. The screen is able to expand from 12 inches to 18 inches and can bend, twist and stretch — basically the Bop It of the tech world. LG Display unveiled another model in 2022, which stretched from 12 inches to 14 inches — about 20 percent longer.

 So, how did it go from 20 percent to 50 percent stretch capabilities? According to the company, "By applying a number of new technologies, such as improving the properties of a special silicon material substrate used in contact lenses and developing a new wiring design structure, LG Display improved the panel’s stretchability and flexibility, exceeding the original national project’s target of 20 percent elongation."

The free-form screen technology, as LG Display calls it, has full red, green and blue color with a resolution of 100ppi. The display also uses a micro-LED light source smaller than 40 micrometers, allowing the screen to be stretched over 10,000 times. The company claims it should still have high quality images even if it undergoes an external shock or is in more extreme temperatures than normal. 

Unfortunately for me (though certainly good for my wallet), the stretchable display is currently just a prototype. However, it could be used for flexible items like clothing, car panels and more in the future. 

This article originally appeared on Engadget at https://www.engadget.com/lgs-new-display-stretches-from-12-to-18-inches-124504018.html?src=rss




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Rogue Point is a tactical shooter from the teams behind Worms and Black Mesa

Team17, the developer of the Worms and publisher of Dredge, Blasphemous and more, is working on Rogue Point, a new rogue-lite tactical FPS game. The studio has enlisted the help of Crowbar Collective, the team behind Black Mesa, the fan-made and Valve-approved Half-Life remake that needs no further introduction. Rogue Point is currently in development and slated to enter early access soon.

Rogue Point is set in a dystopian future where a single CEO had controlled everything. After his death, competing companies work to carve up his empire. To achieve this, they hire mercenaries using the MERX app, and it’s as simple as getting food using Uber Eats. Currently, only Rogue Point, a team of vigilantes, is fighting back against this dystopian state of affairs.

Team17/Crowbar Collective

The game pits teams of four against computer-controlled enemies of different classes, each offering unique challenges. Players must strategize and play with the right loadouts or risk losing. There’s plenty of gear to acquire, too, with some weapons only available in the mission field.

Maps are procedurally generated to ensure no two playthroughs are the same. Unlocked equipment may also be used in future runs. Besides the standard campaign missions where “high-octane tactical combat meets strategic planning,” there’s an endgame mission with maxed-out difficulty, promising a challenge for those craving it.

The developers have a rather extensive wishlist of features they hope to add to the game down the road. Those include new weapons (who doesn’t like new gear?), improved AI and new maps. There are currently four maps announced, but the procedural generation should make things less repetitive.

Rogue Point isn’t in early access yet, but you can wishlist it on Steam. The game is set to come out in 2025, but the developers have yet to announce a final release date.

This article originally appeared on Engadget at https://www.engadget.com/gaming/pc/rogue-point-is-a-tactical-shooter-from-the-teams-behind-worms-and-black-mesa-142959920.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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Chrome for iOS now lets you add text to Google Lens visual searches

If you use Chrome on your iPhone, you’re about to see some features sliding over from the Android version. Google Lens will let you add text to your image searches, and you can save files and pictures directly to Google Drive and Photos. You can get “Shopping Insights” for products you’re browsing.

Chrome for iOS now lets you add words to your Google Lens visual searches, allowing you to add nuance to your query or “perform more complex and specific searches,” as Chrome Product Manager Katia Muradyan wrote in a blog post. After activating Lens by tapping the camera icon in the Chrome search bar, you can ask questions about the object you’re snapping a pic of, and it will produce corresponding results. Google says AI Overviews will also appear for some of these search results.

The feature shares some common ground with an Apple Intelligence feature for iPhone 16 owners in iOS 18.2, which is currently in beta. Visual Intelligence lets you point your camera at something and get info about it, including asking ChatGPT questions about it or searching for it on Google.

Chrome for iPhone now has a feature that lets you save a file directly to Google Drive or Google Photos, sparing you from using your phone’s internal storage. When saving files from Chrome, you’ll see a new option to save the file to Drive. Similarly, when browsing a photo you want to save, long-press on it, and you’ll see a new “Save in Google Photos” option in the context menu. Of course, the feature requires you to be signed into a Google account.

Chrome for iOS also adds a feature that pops up a mini-map when you click on an address. Look for an underlined link to specific addresses; clicking on it will take you to the mini-map without leaving the browser.

Finally, Google is adding Shopping Insights for US users. The company frames it as a way to help you find great prices on items you’re shopping for, but it’s hard to imagine this feature exists strictly from the kindness of Google's heart. Regardless, you’ll soon see a “Good Deal Now” alert in Chrome’s address bar when browsing for products for which it’s available. You’ll see details like price history / tracking and buying options if you tap it.

This article originally appeared on Engadget at https://www.engadget.com/mobile/smartphones/chrome-for-ios-now-lets-you-add-text-to-google-lens-visual-searches-170920556.html?src=rss




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Paradigm Shift in Science: From Big Data to Autonomous Robot Scientists

Sydney, Australia (SPX) Nov 04, 2024
In a recent study led by Professor Xin Li and Dr. Yanlong Guo of the Institute of Tibetan Plateau Research, Chinese Academy of Sciences, researchers analyze how scientific research is evolving through the power of big data and artificial intelligence (AI). The paper discusses how the traditional "correlation supersedes causation" model is being increasingly challenged by new "data-intensive scie




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Ruby slippers from The Wizard of Oz are for sale nearly 2 decades after they were stolen

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.




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From Beyoncé to brat summer, celeb endorsements and viral moments didn't matter much in this U.S. election

While buzzy social media moments, massive celebrity endorsements and viral memes were everywhere during the U.S. election campaign, those who study social media and pop culture say it's likely that smaller social media interactions had a larger impact on the outcome.




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Via Rail's performance has gone from bad to worse — and it's costing the company millions

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




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Trudeau government bans TikTok from operating in Canada — but Canadians can still use it

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.




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Emissions from oilsands forecast to continue rising as oil production increases, says report

Total greenhouse gas emissions from Alberta's oilsands have remained relatively flat for the last few years but could climb yet again in 2024 as the industry ratchets up oil production, according to a new report released Thursday.



  • News/Canada/Calgary

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Ottawa to reinstate Arctic ambassador as it faces challenges from U.S., Russia and China in region

Ottawa is finalizing its long-awaited Arctic foreign policy with Inuit leaders for release before the end of the year, as Canada braces for a second Trump presidency and increasing threats to its sovereignty from China and Russia.




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National chief says ICC should probe disappearances of children from residential schools

The national chief of the Assembly of First Nations says the International Criminal Court should investigate the disappearance of Indigenous children from Canadian residential schools.




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Baby milk price promotion ban should end, watchdog suggests

Many parents opt for more expensive baby milk, equating higher costs with better quality, the watchdog found.




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Les fromages en portions individuelles au banc d’essai

Les fromages vendus en portions individuelles sont des plus pratiques pour l’école et le bureau.




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DGFT to organize EODC Camp from November 11 to 22 in New Delhi to expedite pending export obligations

The office of the Additional Director General of Foreign Trade (CLA DGFT) has announced an Export Obligation Discharge Certificate (EODC) Camp scheduled from November 11 to 22, 2024. The camp is




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Indian health, pharma companies invited to participate in Iraq's 'Medico Expo' from Feb 5─8, 2025

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




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KPPA to organize webinar series from November 17 to 23 as part of NPW celebration

As part of the National Pharmacy Week (NPW) celebration, the Kerala Private Pharmacist Association (KPPA) is organizing a high─impact webinar series from November 17th to 23rd, connected by the common




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National online certificate course for pathologists on cervical cancer screening to begin from November 25

The Indian Council of Medical Research─National Institute of Cancer Prevention and Research (ICMR─NICPR) is set to launch its first─ever DHR─funded National NICPR─ECHO online certificate course on cervical




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DGTR releases list of registered parties on anti─dumping investigation on sodium citrate imports from China

The Directorate General of Trade Remedies (DGTR), under the ministry of commerce and industry, has released a list of registered interested parties regarding the ongoing Second Sunset Review anti─dumping




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DGTR issues directive for sunset review anti─dumping investigation on Aniline imports from China

The Directorate General of Trade Remedies (DGTR), under the Ministry of Commerce and Industry, has issued a notice to all interested parties involved in the sunset review of the anti─dumping investigation




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Accumold showcases micromoulding innovation at Compamed

Accumold, with over 40 years of experience in micromoulding technology, is set to participate at Compamed, taking place in Düsseldorf, Germany, from 11-14 November. The company will highlight its small and complex parts for medical device OEMs.




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Trump’s Administration Will Attack Health Care from Multiple Angles

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




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Glasses Provide Audible Prompts for Blind Wearers

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 […]




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The Promise of a Direct-to-Patient Model—Breaking Down What’s Really Needed for Better Patient Access

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 »
       




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Recap of FDLI #AdPromo2023

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available on-demand at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/


The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.




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Off-Label Promotion: Best Resolved by Congress, Not Courts

On December 3, a federal appeals court ruled against one of the FDA’s untouchable restrictions on industry—thou shalt not promote the off-label use of pharmaceutical products. An industry that is little interested in constitutional law suddenly finds itself talking about the First Amendment and whether, and on what grounds, the case will be appealed. Meantime, the court’s decision left FDA Matters torn between cheering and booing. Patients are poorly served if their doctor is prescribing drugs without being able to tap into all sources of relevant knowledge. However, permitting off-label promotion undercuts the incentive for companies to thoroughly investigate the safety and efficacy of a drug for a second or third use.



  • Drug Approval and Access
  • FDA and Congress
  • FDA and Industry
  • Insight on FDA-regulated Industries

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Lessons From A Private Funding Round: Science, Relationships, And Experience

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “refreshing burst of enthusiasm” in the biotech sector. It’s true

The post Lessons From A Private Funding Round: Science, Relationships, And Experience appeared first on LifeSciVC.




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Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In the last decade, our industry has made great strides in combating cancer by harnessing the body’s own immune system. As it was

The post Neuro-Immunology: The Promise Of A Differentiated Approach To Neurodegenerative Disease appeared first on LifeSciVC.




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Pediatric Trial Enrollment (Shameless DIA Self-Promotion, Part 1)


[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.




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Preview of Enrollment Analytics: Moving Beyond the Funnel (Shameless DIA Self-Promotion, Part 2)


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


I will be chairing a session on Tuesday on this topic, joined by a couple of great presenters (Diana Chung from Gilead and Gretchen Goller from PRA).

Here's a short preview of the session:



Hope to see you there. It should be a great discussion.

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





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Can a Form Letter from FDA "Blow Your Mind"?

Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information.


However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic.


However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA.


He claims that the contents of the letter will "blow your mind". To him, the key passage is:


We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular.


Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!"
Adam Feuerstein: This time,
too much froth, not enough coffee?


I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review.


It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples.


A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications.

Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval.

We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process.