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My Little Pony, Transformers, Phase 10 join the National Toy Hall of Fame

The three 1980s staples are new National Toy Hall of Fame inductees. Hess Toy Trucks, the Pokémon Trading Card Game, the trampoline, and balloons were among the finalists.




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Supreme Court refuses legal lifesaver for former Trump chief of staff

The Supreme Court dealt a major legal blow to former White House Chief of Staff Mark Meadows on Tuesday, refusing to move the Georgia election interference charges against him to federal court.




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President-Elect Donald Trump Names Former Rep. John Ratcliffe as CIA Director


President-elect Donald Trump on Wednesday announced that former Rep. John Ratcliffe (R-TX) will serve as his director of the Central Intelligence Agency (CIA).

The post President-Elect Donald Trump Names Former Rep. John Ratcliffe as CIA Director appeared first on Breitbart.




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Driving AI Transformation

As we head into 2025, CEOs are focused on a clear set of priorities—AI-enabled growth, dynamic capacity, risk management, and human-machine integration.

The post Driving AI Transformation appeared first on Gigaom.




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Unleashing Transformation

AI isn’t just another tool in the technology toolkit; it’s a revolution waiting to be led. As tech leaders, this is your

The post Unleashing Transformation appeared first on Gigaom.




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Martin Garrix set to perform in ‘world’s biggest Holi celebration’ in India

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




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‘Mura’ movie review: This revenge drama packs a punch with its terrific performances

Muhammad Musthafa’s sophomore directorial ‘Mura’ is a gangster drama that revolves around revenge and friendship starring a bunch of new as well as seasoned performers




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Former CFL commissioner Mark Cohon joins Northern Super League as board chair

Mark Cohon, who brought the CFL back to Ottawa with the Redblacks as CFL commissioner, is joining the new Northern Super League as chair of its board of directors.




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A former DACA 'Dreamer' has won elected office in New Mexico

NPR's Juana Summers talks with Cindy Nava, a Democrat, who will be joining the New Mexico state senate in Albuquerque. She is one of the millions of "Dreamers" who are protected by DACA.




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Former Salesforce president named Amperity CEO

He replaces interim CEO Chris Jones, who had been filling in since the previous CEO stepped down in June.




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Keke Palmer calls out former Scream Queens co-star for racist remark

The ‘Scream Queens’ actor revealed her white co-star made a ‘weighted’ reference to Martin Luther King




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Trump to name former Arkansas Gov. Mike Huckabee as ambassador to Israel

In the midst of the Israel-Hamas war, President-elect Donald Trump announced he will nominate Huckabee, a loyalist and former Republican governor, to serve in the key post as ambassador to Israel.




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A U.S. jury awards former Iraqi detainees $42 million for Abu Ghraib prison abuse

The jury also decided to hold a Virginia-based military contractor responsible for contributing to the torture and mistreatment of detainees at the notorious Iraqi prison two decades ago.




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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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New Zealand formally apologizes to victims of abuse in state care

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.




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Fujifilm is developing a 102MP medium format cinema camera

Fujifilm is developing a medium-format, 102-megapixel cinema camera, the company said in a surprise announcement. Due next year, the GFX Eterna will carry a boxy, modular design reminiscent of Sony's FX6 or the new Blackmagic Pyxis and will likely be launched with a top handle, electronic viewfinder and other optional accessories.

The new camera will have a medium format GFX 102-megapixel (MP) CMOS II HS sensor, the same one used on the GFX100 II. That sensor is 43.8mm x 32.9 mm in size, or 1.7 times larger than the full-frame sensor found on the aforementioned FX or Pyxis. That will be one of the largest cinema camera sensors available, even bigger than RED's V-Raptor XL sensor.

The benefits will be extra dynamic range, potentially high resolution and a very shallow depth of field that should allow for cinematic shots when paired with the right lens. That does bring up the fact that Fujifilm currently has no GFX glass designed specifically for film production. However, the company said it's developing a 32-90mm power zoom lens (24-70mm full-frame equivalent) and will have a mount adapter for GFX to PL lenses, which are widely used in cinema. 

One other concern might be rolling shutter distortion. RED's V-Raptor XL uses a global shutter that has zero distortion, but the sensor Fujifilm will employ has a fair bit of it . In addition, the GFX100 II captures 8K with a 1.53x crop, negating many of the benefits of a medium format sensor — so, hopefully Fujifilm will resolve those issues with its cinema camera. 

Fujifilm will show off the GFX Eterna starting tomorrow at the InterBEE 2024 media exhibition in Chiba City, Japan. It's set to be released sometime in 2025, with an exact date and pricing yet to be announced.

This article originally appeared on Engadget at https://www.engadget.com/cameras/fujifilm-is-developing-a-102mp-medium-format-cinema-camera-130027537.html?src=rss




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Amazon sunsets Freevee platform for ad-supported streaming video

Amazon is closing down Freevee, its free ad-supported video on demand service. This platform was home to original programming as well as more than 100 originals from the Prime Video roster. Freevee will be phased out over the coming weeks, and its content will become available as part of Prime Video. The ad-supported tier of Prime Video is included as part of Amazon's Prime membership for $15 a month.

"To deliver a simpler viewing experience for customers, we have decided to phase out Freevee branding," an Amazon spokesperson told Variety. "There will be no change to the content available for Prime members, and a vast offering of free streaming content will still be accessible for non-Prime members, including select originals from Amazon MGM Studios, a variety of licensed movies and series, and a broad library of FAST channels – all available on Prime Video."

The free viewing platform went through several rebrands since its original launch as IMDb Freedive in January 2019. It entered its final phase as Freevee in April 2022.

This article originally appeared on Engadget at https://www.engadget.com/entertainment/streaming/amazon-sunsets-freevee-platform-for-ad-supported-streaming-video-000614080.html?src=rss




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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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Former U.S. commerce secretary says he 'can't imagine' Trump would tax Canadian energy

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.




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Former B.C. premier John Horgan, Canada's ambassador to Germany, dead at 65

Former B.C. premier John Horgan has died at the age of 65, CBC News has confirmed. In June this year, Horgan told CBC that he had been diagnosed with cancer for the third time during a routine followup appointment for his previous throat cancer.



  • News/Canada/British Columbia

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Pharmaceutical water systems in transformation mode with advanced processes & shift towards analytics

Indian and multinational pharma companies are leading the charge by investing in digital transformation and aligning Indian operations with global standards. Essentially, pharmaceutical water systems are




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Transforming pre-surgical planning

Rob Pitts, sales manager at Tri-Tech 3D, UK provider of Stratasys 3D printing solutions, explores how additive manufacturing (AM) can help speed up surgical workflows and reduce costs by transforming anatomical modelling.




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Misinformation Really Does Spread like a Virus, Epidemiology Shows

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




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Informa Connnect's Pharma/Biotech GTN Summit

Informa Connnect's Pharma/Biotech GTN Summit
November 18-20, 2024 | W Philadelphia Hotel, Philadelphia, PA
Drug Channels Readers Receive 15% Off* with Code 24DGC15.

View the Complete Agenda

Book Your Place

The complex components of gross-to-net management requires cross-functional collaboration in order to effectively develop sound accrual estimates, proper forecasting, optimized pricing and contracting models and accurate financial reporting, all with minimal disruption to market access strategies.

The CPE-accredited Pharma/Biotech GTN Summit is the ideal opportunity to engage in comprehensive sessions for end-to-end GTN excellence, connect with peers to exchange experiences and solutions to common challenges, and participate in interactive discussions that address real-world scenarios to enhance GTN accuracy and efficiency.

Featured Thought-Leaders Leading the Dialogue Include:
  • Nancy Bell, Vice President, Head of US Patient Value & Access, Takeda Oncology
  • Chris Boneham, Vice President, Market Access US, Y-mAbs Therapeutics
  • Prakash Chainani, Vice President – Finance, HR & IT, Lifestar Pharma LLC (a Mankind Group Company)
  • George Kappus, Associate Director, M&S Controlling (GtN, Boehringer Ingelheim
  • Sherri Cirota, Executive Director, Contracts & Pricing, Alkermes
  • Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK
  • Rosalind Davis, Director, Government Pricing & Contracts, CSL Vifor
  • Dan Sacchetta, Director Managed Markets Finance- Gross-to-Net, Novartis
  • Eckart Beuttenmueller, Director, Gross-to-Net Execution, Bayer
  • Kinneret Klein, Executive Director, Commercial Financial Planning & Analysis, Biocryst
  • James Engel, Controller, Finance, Collegium Pharmaceuticals
  • Brett Nussbaum, Head of Gross to Net Accounting, Novartis
  • Timothy Kocses, Executive Director, US Commercial Controller, Bristol Myers Squibb
  • Robert Lucchesi, Director, FP&A Sales Reporting & Forecasting, Novo Nordisk
  • Funso Olufade, PhD, MBA, Sr. Director – Head, Commercial Finance, Ascendis Pharma
  • Amy Ramazio, Contract Forecasting & Analytics Director, GSK US Market Access
  • Ranish Singhvi, Vice President, Finance, Accord Healthcare
  • Jeffrey Miller, Assistant Vice President & Corporate Controller, Lannett Company
  • Bal Ram, SVP Finance, US Operations, Indivior
  • Matthew Pellegrini, Sr. Director - Revenue Optimization Contracting & Compliance N.A, Teva Pharmaceuticals
  • Michael Domanico, Vice President Finance, Revenue, Sandoz
  • Christopher Wang, Corporate Controller, Revance Therapeutics
  • Melissa Norton, Assistant Controller, Revenue, Tolmar
  • Michael Christiano, Director, Revenue, Ardelyx
Learn more and see why the GTN Summit remains a great choice for education and benchmarking on strategic forecasting, estimates, analytics and reporting through best practices for gross-to-net management.

Drug Channels subscribers — Save 15% when you reserve your place using the VIP code 24DGC15.

*Offer applies to the current rate and maybe not be applied to existing registrations; additional terms may apply, see website for full details.


The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).
       




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Informa Connect's Copay, Reimbursement and Access Congress

Informa Connect's Copay, Reimbursement and Access Congress
November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA
Drug Channels readers save 10% with code USAVE24*

The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready?

A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward.

Why attend the Copay, Reimbursement and Access Congress?

Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals.
  • Is your program sustainable and innovative to better support patients?
  • Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies?
  • In an election year, what is the future of health policy?
Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more.

Content highlights:
  • Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation
  • Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more
  • Insights direct from enforcement agents on the top trends and actions within the copay and patient services space
  • Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics
  • 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships
  • Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure
  • And more!
Download the agenda and register today—Be sure to use your exclusive promo USAVE24 to save 10% off* of your registration

See you there!

*Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.
**Pending speaker permissions



The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).

       




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Informa Connect’s PBM Contracting Summit

Informa Connect’s PBM Contracting Summit
December 10-11, 2024 | Chicago, IL
Drug Channels readers save 10% with code 24DRCH10*

Experts from across the US come together each year at the PBM Contracting Summit to gain innovative and practical contracting strategies, master PBM innovation and design, improve patient care management and rising costs, understand the current legislative issues impacting contract negotiations and more. Join us in Chicago (or virtually) where you’ll benefit from two days of learning, education and networking, and will return to the office having mastered the complex PBM landscape.

You’ll hear from Matthew Gibbs, Pharm.D., Pharmacy Transformation Leader of Blue Shield of California as he leads a comprehensive discussion on the PBM landscape over the last year, and delves into the evolving trends and emerging challenges shaping the current industry today.

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions:
  • What are the latest legislative updates and proposed federal bills impacting PBM operations?
  • What's on the horizon for alternative PBMs? What are the top intricacies of rebate eligibility? What are the market impacts of innovative models such as Mark Cuban's Cost Plus Drugs and Amazon's pharmacy model?
  • What can be learned from the J&J lawsuit? Review the expansion of data access and the importance of employer's fiduciary duties.
  • What are the challenges of vertical integration?
  • How do PBMs manage their contracting processes with plan sponsors to create successful contracts?
  • What are the most effective strategies for spread pricing and reimbursement models?
  • What is the best solution to navigate the challenges of the 340B drug pricing program and PBM contracting?
  • What is the best way to design and optimize benefits for covering GLP-1s?
  • How can I ensure compliance with ERISA requirements?
  • What are the latest developments in copay maximizer and accumulator programs?
  • What market dynamics and barriers are impacting pricing and demand?
  • What can be learned from the economic landscape of biosimilars and specialty therapeutics?
  • And much more!

View the agenda for the PBM Contracting Summit to see the complete picture – the program, speakers, and more, visit www.informaconnect.com/pbm-contracting for further details and to register. Drug Channels readers will save 10% off when they use code 24DRCH10 and register prior to November 8, 2024.*

*Cannot be combined with other offers or used towards a current registration. Cannot be combined with special category rates or other offers. Other restrictions may apply.


The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).
       




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Informa Connect’s Trade and Channel Strategies

Informa Connect’s Trade and Channel Strategies
December 10-12, 2024 at the W Hotel in Philadelphia, PA
Drug Channels readers save 10% with code 24DC10*

Pharmacy and distribution models are growing increasingly complex. Stop running in circles—It’s time to unlock proven strategies to propel market access.

What is the secret to success? Trade and Channel Strategies is bringing together industry experts to deliver specific strategies and talk best practices in tackling the latest industry challenges.

As the landscape rapidly evolves, there are only two choices—Adapt or risk falling behind. With policy changes and market fluctuations, specifically surrounding the DSCSA and IRA, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of innovations within the pharmacy sector, there has never been a more important time for industry to unite. A program driven by market dynamics and led by champions of channel strategy, join your peers now to master the complexities of pharmacy and distribution models to accelerate market access—It's all happening December 10-12.

Why do trade and channel professionals choose this pivotal event?

The challenge of staying viable among shifting market dynamics while meeting business objectives is heavy. Professionals are left with many questions, including:
  • How will the new administration affect the distribution channel?
  • Is my organization haemorrhaging money to stay afloat with the shift to alternative distribution and pharmacy models?
  • Does the DSCSA deadline change affect my organization? Am I still prepared?
Join the experts for three dedicated days of collaborative discussions that will give you the answers to these questions and so many more. Leaders in the landscape are uniting and will dive into the top trends for innovative distribution, integrated pharmacy models and talk the truth about the future of trade.

WHAT CAN YOU EXPECT?

Vital insights from industry’s leading pharmacy and distribution experts, including:
  • Bill Roth, Senior Vice President of Consulting, Blue Fin Group, An IntegriChain Company
  • Patrick Lupo Group Vice President, Pharmacy Trade and Specialty, Walgreens
  • Amanda Salindong, Associate Director, Channel & Distribution, Alnylam Pharmaceuticals
  • Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK
  • Eliane Maalouf, Director Trade and Fulfillment, Mass General Brigham Specialty Pharmacy
  • Stephanie Wirkes, Head of Distribution and Strategy Execution, Bayer
  • John Harlow, Chief Commercial Officer, Melinta Therapeutics
  • Aria Cohen, Vice President, Head of Market Access, Alkeus Pharmaceuticals, Inc.
  • Elizabeth Cherry, Program Director for Trade Relations, Vanderbilt Specialty Pharmacy
  • Danielle Bryan, PharmD, CSP, Program Director, Specialty Pharmacy Trade Relations, Vanderbilt University Medical Center
  • Thomas Scalone, Director, Trade Strategy and Operations, Bristol Myers Squibb
  • Dina Lynch, VP, Market Access and Reimbursement, Renibus Therapeutics
  • And more!
Tackle the hottest topics facing industry right now, including:
  • Keynote Address: Access and Channel 2024 In-Review and Preview of 2025
  • Pharmacy Evolved—Aligning Commercialization to the Changing Pharmacy Channel
  • Advanced Trade Leaders Executive Session
  • Navigate and Operationalize the IRA
  • Focused Multi-Track Offerings:
    • Supply Chain, Distribution and Logistics
    • Pharmacy Models and Reimbursement Strategies
    • Data, Innovation and Analytics
    • Health Systems and Pharma Partnering Symposium
  • Balancing the GTN Bubble with Market Access Priorities
  • What’s Happening in Retail—Brick and Morter, Home Delivery and Cash Pay Pharmacies
  • Navigating Post Deadline Challenges—DSCSA Compliance and Serialization Updates
  • Four Roundtable Breakout Discussions:
    • What Good Looks Like in a 3PL/Manufacturer Partnership
    • Optimizing Healthcare Partnerships
    • Women in Trade
    • GLP-1s and New Product Archetypes
  • Actions Needed to Mitigate and Prevent Drug Shortages
  • Case Study: Master Your Organization Chart—Ensuring Higher Cross Functional Interactions
  • Three Interactive Workshops:
    • Trade 101
    • Advanced Trade Leaders Executive Session
    • Health Systems Fundamentals
  • And more!
Exclusive Offer—Download the agenda and register today—Be sure to use your exclusive promo 24DC10 to save 10% off* of your registration.

See you there!

* Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply.


The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net).
       




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New On-Demand Training Platform




I am pleased to announce the availability of on-demand training about FDA's regulation of advertising and promotion. So, you are now able to learn about the wonderful world of FDA ad-promo from the comfort of your home, office, or campsite. 

At PhillyCooke.Thinkific.com, you can see the courses that are currently available and sign up. In the video above, there's a special discount code to celebrate the launch of this new platform.

If you are interested in providing access to the training for your full team, then please email me at DCooke@PhillyCooke.com or fill out the contact form on the website. I can provide all of the information about the corporate licensing.
 
Every course comes with access for a full year. You can view, and review, the content as often as you like. In addition, every module on the platform is reviewed in its entirety at least twice per year. If something changes, new modules will replace the old ones, and students will be notified of the update. Those new modules will be available at no additional cost! That way you can rest assured that the information you are learning is always current with the latest developments in the world of ad-promo.




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Former CHC Board Chairs Sharon Callahan and Nick Colucci Named as 2025 MAHF Inductees

Two former board chairs of the Coalition for Healthcare Communication (CHC) were named as the Medical Advertising Hall of Fame (MAHF) 2025 inductees – Sharon Callahan, former Chief Client Officer at Omnicom Health Group (OHG), and Nick Colucci, former Chairman and CEO of Publicis Health/COO of Publicis Groupe North America. The inductees will be honored […]




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Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/ biosimilars development and market expansion

<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>




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Mariana Oncology’s Radiopharm Platform Acquired By Novartis

Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.




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Biotech Risk Cycles: Assets And Platforms

Today’s market likes products. Platforms aren’t in vogue anymore. Investors, especially in the public markets, only want late stage de-risked assets. Pharma only seems to be buying these kinds of asset. VCs need to focus on clinical stage companies. Or

The post Biotech Risk Cycles: Assets And Platforms appeared first on LifeSciVC.




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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.




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Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21st Century Cures Act:


In another tweet, he suggests that the act will "decimate" informed consent in drug trials. Subsequent responses and retweets  did nothing to clarify the situation, and if anything tended to spread, rather than address, Feuerstein's confusion.

Below is a quick recap of the current regulatory context and a real-life example of where the new wording may be helpful. In short, though, I think it's safe to say:


  1. Waiving informed consent is not new; it's already permitted under current regs
  2. The standards for obtaining a waiver of consent are stringent
  3. They may, in fact, be too stringent in a small number of situations
  4. The act may, in fact, be helpful in those situations
  5. Feuerstein may, in fact, need to chill out a little bit


(For the purposes of this discussion, I’m talking about drug trials, but I believe the device trial situation is parallel.)

Section 505(i) - the section this act proposes to amend - instructs the Secretary of Health and Human Services to propagate rules regarding clinical research. Subsection 4 addresses informed consent:

…the manufacturer, or the sponsor of the investigation, require[e] that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings.

[emphasis  mine]

Note that this section already recognizes situations where informed consent may be waived for practical or ethical reasons.

These rules were in fact promulgated under 45 CFR part 46, section 116. The relevant bit – as far as this conversation goes – regards circumstances under which informed consent might be fully or partially waived. Specifically, there are 4 criteria, all of which need to be met:

 (1) The research involves no more than minimal risk to the subjects;
 (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
 (3) The research could not practicably be carried out without the waiver or alteration; and
 (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

In practice, this is an especially difficult set of criteria to meet for most studies. Criterion (1) rules out most “conventional” clinical trials, because the hallmarks of those trials (use of an investigational medicine, randomization of treatment, blinding of treatment allocation) are all deemed to be more than “minimal risk”. That leaves observational studies – but even many of these cannot clear the bar of criterion (3).

That word “practicably” is a doozy.

Here’s an all-too-real example from recent personal experience. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. It seems – but there is little hard data – that a lot of physicians do not strictly follow guidelines on when to perform the procedure. So we devise a study: whenever the procedure is performed, we ask the physician to complete a quick form categorizing why they made their decision. We also ask him or her to transcribe a few pieces of data from the patient chart.

Even though the patients aren’t personally identifiable, the collection of medical data qualifies this as a clinical trial.

It’s a minimal risk trial, definitely: the trial doesn’t dictate at all what the doctor should do, it just asks him or her to record what they did and why, and supply a bit of medical context for the decision. All told, we estimated 15 minutes of physician time to complete the form.

The IRB monitoring the trial, however, denied our request for a waiver of informed consent, since it was “practicable” (not easy, but possible) to obtain informed consent from the patient.  Informed consent – even with a slimmed-down form – was going to take a minimum of 30 minutes, so the length of the physician’s involvement tripled. In addition, many physicians opted out of the trial because they felt that the informed consent process added unnecessary anxiety and alarm for their patients, and provided no corresponding benefit.

The end result was not surprising: the budget for the trial more than doubled, and enrollment was far below expectations.

Which leads to two questions:

1.       Did the informed consent appreciably help a single patient in the trial? Very arguably, no. Consenting to being “in” the trial made zero difference in the patients’ care, added time to their stay in the clinic, and possibly added to their anxiety.
2.       Was less knowledge collected as a result? Absolutely, yes. The sponsor could have run two studies for the same cost. Instead, they ultimately reduced the power of the trial in order to cut losses.


Bottom line, it appears that the modifications proposed in the 21st Century Cures Act really only targets trials like the one in the example. The language clearly retains criteria 1 and 2 of the current HHS regs, which are the most important from a patient safety perspective, but cuts down the “practicability” requirement, potentially permitting high quality studies to be run with less time and cost.

Ultimately, it looks like a very small, but positive, change to the current rules.

The rest of the act appears to be a mash-up of some very good and some very bad (or at least not fully thought out) ideas. However, this clause should not be cause for alarm.




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Is AI Search a Medical Misinformation Disaster?



Last month when Google introduced its new AI search tool, called AI Overviews, the company seemed confident that it had tested the tool sufficiently, noting in the announcement that “people have already used AI Overviews billions of times through our experiment in Search Labs.” The tool doesn’t just return links to Web pages, as in a typical Google search, but returns an answer that it has generated based on various sources, which it links to below the answer. But immediately after the launch users began posting examples of extremely wrong answers, including a pizza recipe that included glue and the interesting fact that a dog has played in the NBA.

Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory.

While the pizza recipe is unlikely to convince anyone to squeeze on the Elmer’s, not all of AI Overview’s extremely wrong answers are so obvious—and some have the potential to be quite harmful. Renée DiResta has been tracking online misinformation for many years as the technical research manager at Stanford’s Internet Observatory and has a new book out about the online propagandists who “turn lies into reality.” She has studied the spread of medical misinformation via social media, so IEEE Spectrum spoke to her about whether AI search is likely to bring an onslaught of erroneous medical advice to unwary users.

I know you’ve been tracking disinformation on the Web for many years. Do you expect the introduction of AI-augmented search tools like Google’s AI Overviews to make the situation worse or better?

Renée DiResta: It’s a really interesting question. There are a couple of policies that Google has had in place for a long time that appear to be in tension with what’s coming out of AI-generated search. That’s made me feel like part of this is Google trying to keep up with where the market has gone. There’s been an incredible acceleration in the release of generative AI tools, and we are seeing Big Tech incumbents trying to make sure that they stay competitive. I think that’s one of the things that’s happening here.

We have long known that hallucinations are a thing that happens with large language models. That’s not new. It’s the deployment of them in a search capacity that I think has been rushed and ill-considered because people expect search engines to give them authoritative information. That’s the expectation you have on search, whereas you might not have that expectation on social media.

There are plenty of examples of comically poor results from AI search, things like how many rocks we should eat per day [a response that was drawn for an Onion article]. But I’m wondering if we should be worried about more serious medical misinformation. I came across one blog post about Google’s AI Overviews responses about stem-cell treatments. The problem there seemed to be that the AI search tool was sourcing its answers from disreputable clinics that were offering unproven treatments. Have you seen other examples of that kind of thing?

DiResta: I have. It’s returning information synthesized from the data that it’s trained on. The problem is that it does not seem to be adhering to the same standards that have long gone into how Google thinks about returning search results for health information. So what I mean by that is Google has, for upwards of 10 years at this point, had a search policy called Your Money or Your Life. Are you familiar with that?

I don’t think so.

DiResta: Your Money or Your Life acknowledges that for queries related to finance and health, Google has a responsibility to hold search results to a very high standard of care, and it’s paramount to get the information correct. People are coming to Google with sensitive questions and they’re looking for information to make materially impactful decisions about their lives. They’re not there for entertainment when they’re asking a question about how to respond to a new cancer diagnosis, for example, or what sort of retirement plan they should be subscribing to. So you don’t want content farms and random Reddit posts and garbage to be the results that are returned. You want to have reputable search results.

That framework of Your Money or Your Life has informed Google’s work on these high-stakes topics for quite some time. And that’s why I think it’s disturbing for people to see the AI-generated search results regurgitating clearly wrong health information from low-quality sites that perhaps happened to be in the training data.

So it seems like AI overviews is not following that same policy—or that’s what it appears like from the outside?

DiResta: That’s how it appears from the outside. I don’t know how they’re thinking about it internally. But those screenshots you’re seeing—a lot of these instances are being traced back to an isolated social media post or a clinic that’s disreputable but exists—are out there on the Internet. It’s not simply making things up. But it’s also not returning what we would consider to be a high-quality result in formulating its response.

I saw that Google responded to some of the problems with a blog post saying that it is aware of these poor results and it’s trying to make improvements. And I can read you the one bullet point that addressed health. It said, “For topics like news and health, we already have strong guardrails in place. In the case of health, we launched additional triggering refinements to enhance our quality protections.” Do you know what that means?

DiResta: That blog posts is an explanation that [AI Overviews] isn’t simply hallucinating—the fact that it’s pointing to URLs is supposed to be a guardrail because that enables the user to go and follow the result to its source. This is a good thing. They should be including those sources for transparency and so that outsiders can review them. However, it is also a fair bit of onus to put on the audience, given the trust that Google has built up over time by returning high-quality results in its health information search rankings.

I know one topic that you’ve tracked over the years has been disinformation about vaccine safety. Have you seen any evidence of that kind of disinformation making its way into AI search?

DiResta: I haven’t, though I imagine outside research teams are now testing results to see what appears. Vaccines have been so much a focus of the conversation around health misinformation for quite some time, I imagine that Google has had people looking specifically at that topic in internal reviews, whereas some of these other topics might be less in the forefront of the minds of the quality teams that are tasked with checking if there are bad results being returned.

What do you think Google’s next moves should be to prevent medical misinformation in AI search?

DiResta: Google has a perfectly good policy to pursue. Your Money or Your Life is a solid ethical guideline to incorporate into this manifestation of the future of search. So it’s not that I think there’s a new and novel ethical grounding that needs to happen. I think it’s more ensuring that the ethical grounding that exists remains foundational to the new AI search tools.




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Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement

Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last.

The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News.




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An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance

Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes.

The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News.




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Do People Believe Misinformation on Vaccines?

Social media has become a significant source of health-related content. But while it connects people to news, updates, […]

The post Do People Believe Misinformation on Vaccines? appeared first on World of DTC Marketing.



  • As I See It
  • Focus on patients
  • Health information online
  • Misinformation on vaccines

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SAS/STAT Users Still Moving to the SAS 9.4 Platform?

 We introduced a Topics tab in the online documentation a few releases ago, and there are corresponding pages in our focus area that briefly describe the topic areas and the procedures that perform analyses for those areas.




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Trump names Musk to co-lead newly formed Department of Government Efficiency

WASHINGTON — US President-elect Donald Trump said on Nov 12 that Elon Musk and former Republican presidential hopeful Vivek Ramaswamy will lead the newly created Department of Government Efficiency. Musk and Ramaswamy "will pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies", Trump said in a statement. Trump said their work would conclude by July 4, 2026, adding that a smaller and more efficient government would be a "gift" to the country on the 250th anniversary of the signing of the Declaration of Independence. Businessman and former Republican presidential candidate Vivek Ramaswamy attends Donald Trump's campaign event sponsored by conservative group Turning Point Action, in Las Vegas, Nevada, US, Oct 24, 2024. PHOTO: Reuters file The appointments reward two Trump supporters from the private sector.




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Social media magic: How a former chef became Bobby Saputra, the internet's favourite billionaire playboy

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.




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A US Ambassador Working for Cuba? Charges Against Former Diplomat Victor Manuel Rocha Spotlight Havana's Importance in the World of Spying

Calder Walton writes that if proved, Victor Manuel Rocha's espionage would place him among the longest-serving spies in modern times. Allowing him to operate as a spy in the senior echelons of the U.S. government for so long would represent a staggering U.S. security failure.




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185384: Menon says India to decide on information-sharing with Pakistan

Menon emphasized that India had been tough on Pakistan with regard to accountability, but restrained in its rhetoric and actions.




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221726: Indian information inadequate to warrant listing of three Pakistan-based individuals

Chinese officials had approached the Indian government for more information but had since been reportedly told by the Indian government that the information presented was sufficient to justify the listing.




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Former Colombian President Iván Duque Discusses Resurgent Left Wing in Latin America at Kennedy School Event

Former Colombian President Iván Duque discussed Latin America’s resurgent left wing and advocated for environmental action at the Harvard Kennedy School on Thursday afternoon.




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Enabling an Economic Transformation of Ukraine: Recovery, Reconstruction, and Modernization

The aim of the report is to focus specifically on the critical role of private sector investment in Ukraine’s economic reconstruction, and how the private sector, both within Ukraine and internationally, can enable Ukraine to win the peace. It provides a short overview of the economic challenges facing Ukraine, including governance, the sectors that will be critical to Ukraine's reconstruction, the roles and responsibilities for the G7, EU, IFIs, and DFIs, and then recommendations for how Ukraine and its partners can best attract private sector investment.




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Local Start-ups Hold the Key to Transforming Africa's Seed Industry

"The seed industry in sub-Saharan Africa is informal in nature, with approximately 80% of farmers saving and replanting seeds from year to year. This gives them security of access. But improved varieties — including high-yielding and hybrid crops — will increase productivity and income. To get these seeds into the hands of farmers, a better marketing and distribution system is needed. Local small and medium-sized seed enterprises have a comparative advantage in reaching this underserved market due to their size and market reach."




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Education, Research, and Innovation in Africa: Forging Strategic Linkages for Economic Transformation

Africa is a youthful continent: nearly 41% of its population is under the age of 18. To address the unique challenges of this demographic structure, the African Union (AU) hopes to reposition the continent as a strategic player in the global economy through improved education and application of science and technology in development. The paper proposes the creation of “Innovation Universities” that combine research, teaching, community service and commercialization in their missions and operations. They would depart from the common practice where teaching is carried out in universities that do little research, and where research is done in national research institutes that do not undertake teaching. Under this model, there is little connection with productive sectors. The idea therefore is not just to create linkages between those activities but to pursue them in a coordinated way under the same university structure. Innovation universities can be created in diverse fields such as agriculture, health, industry, services, and environment to advance sustainable development and inclusive growth.




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If We Develop Africa's Bioeconomy It Will Be as Transformative for Us as Digital Has Been

"Unlike the digital revolution that relied on pre-existing technologies, the new bioeconomy will involve more local research, teaching and commercialization. This will require greater involvement of local universities, especially those with an entrepreneurial inclination."




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The Historical Puzzle of US Economic Performance under Democrats vs. Republicans

We have heard much about the puzzle that US economic performance under President Joe Biden has been much stronger than voters perceive it to be.  But the current episode is just one instance of a bigger historical puzzle:  the US economy has since World War II consistently done better under Democratic presidents than under Republican presidents.  This fact is even less widely known, including among Democratic voters, than the truth about Biden’s term.  Indeed, some poll results suggest that more Americans believe the reverse, that Republican presidents are better stewards of the economy than Democrats.