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Best Practices for Successfully Transitioning a Patient Services Hub

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

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

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

Read on for Josh’s insights.
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Drug Channels News Roundup, September 2024: Inside JNJ’s Gross-to-Net Bubble, Optum Rx’s Private Label Biosimilars, Where Biosimilars Boom, Accumulators vs. Patients, and Steve Collis Retires

Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you:
  • Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble
  • Optum Rx joins the private label biosimilar bandwagon
  • Biosimilars boom for provider-administered drugs
  • Fresh evidence of how copay accumulators hurt patients
Plus, words of wisdom from Cencora's soon-to-be-former CEO Steve Collis.

P.S. Join my more than 58,000 LinkedIn followers for daily links to neat stuff along with thoughtful and provocative commentary from the DCI community.

There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

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NEW: The Drug Channels 2025 Video Webinar Series

Drug Channel Institute is pleased to announce The Drug Channels 2025 Video Webinar Series.

Join Dr. Adam J. Fein for three live video webinars during 2025. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia.

During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel. Topics will be determined based on what’s happening—trends, policy changes, company announcements, and more. He’ll share DCI’s latest market data to help you stay on top of new developments. You will be able to use these events as both a capstone of your current learning and a touchpoint for the future.

The three events are scheduled for 12:00 p.m. to 1:30 p.m. ET on the following dates:
  • April 4, 2025
  • June 20, 2025
  • December 12, 2025 (Drug Channels Outlook 2026)
For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price. Please contact Paula Fein (paula@drugchannels.net) for details.

Read on for full details on pricing, including substantial discounts for multiple sites.

P.S. If you're not familiar with our webinars, click here to watch brief excerpts from our video webinars.
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The Pivotal Role of Technology in Delivering Effective Patient Services

Today’s guest post comes from George Moore, Chief Information Technology Officer at CareMetx.

As George explains using novel survey data, manufacturers view new technologies  as crucial for patient services. He then explains how digital technology, artificial intelligence (AI), and machine learning (ML) can be used to improve patient adherence and increase hub efficiencies.

To learn more, download CareMetx’s new 2024 Patient Services ReportRevealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for George’s insights.
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Innovative Models for Improving Access and Visibility for Specialty-Lite and Retail Therapies

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
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NOW AVAILABLE: 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

I am pleased to announce Drug Channels Institute's new 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, available for purchase and immediate download.
We’re offering special discounted pricing if you order before October 23, 2024.

2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our 15th edition--remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. This 2024-25 edition includes substantial new material—outlined on page vii of the report overview.

9 chapters, 380+ pages, 178 exhibits, more than 750 endnotes: There is nothing else available that comes close to this valuable resource.

You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.

Email Paula Fein (paula@drugchannels.net) if you’d like to bundle your report purchase with access to DCI’s video webinars.

If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive your email.

Read on for some additional details.
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Five Crucial Trends Facing U.S. Drug Wholesalers in 2024 and Beyond

As regular readers of Drug Channels know, U.S. distribution and dispensing channels for prescription drugs are undergoing significant evolution and consolidation as the changing economics of pharmaceuticals challenge conventional business models.

During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact. Put simply: Buy low, sell high, collect early, and pay late.

But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their industry position and strengthening their economic fundamentals.

Read on for five key pricing, pharmacy, provider, and manufacturer trends that are driving the U.S. drug wholesaling industry.

For even more, check out DCI's new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, the fifteenth edition of our deep dive into wholesale distribution channels.Click here to download a free report overview (including key industry trends, the table of contents, and a list of exhibits)
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As MFP Approaches, Transparency Is More Important Than Ever

Today’s guest post comes from Angie Franks, Chief Executive Officer of Kalderos.

Angie discusses how the Maximum Fair Price provision of the Inflation Reduction Act of 2022 will challenge providers, pharmacies, and manufacturers. She explains how Kalderos’ Truzo platform could reduce duplicate claims and address compliance issues.

To learn more, register for Kalderos’ October 25 webinar Cracking the MFP Code: How Flexible Technology Helps You Navigate an Evolving Landscape.

Read on for Angie’s insights.
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The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions

Reality has again failed to support the spin surrounding the 340B Drug Pricing Program.

For 2023, discounted purchases under the 340B program reached a record $66.3 billion—an astounding $12.6 billion (+23.4%) higher than its 2022 counterpart. The gross-to-net difference between list prices and discounted 340B purchases also grew, to $57.8 billion (+$5.5 billion). 340B purchases are now almost 40% larger than Medicaid’s prescription drug purchases.

Hospitals again accounted for 87% of 340B purchases for 2023. Purchases at every 340B covered entity type grew, despite drug prices that grew more slowly than overall inflation.

Lobbyists claim that manufacturers’ 340B contract pharmacy changes are “stripping billions of dollars from the healthcare safety net.” But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.

Read on for full details and our analysis, along with fresh details of troubling behavior by the Health Resources and Services Administration (HRSA).
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No More Delays: Accelerating Therapy Starts by Embedding Hub Services in Provider Workflows

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services ReportRevealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
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Drug Channels News Roundup, October 2024: Humira Price War Update, PA vs. Providers, IRA vs. Physicians, My AI Podcast, New DCI Jobs, and Dr. G on Copayments

Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:
  • Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy
  • Vampiric! Prior authorization sinks its fangs into providers’ time
  • Wicked! How the IRA will put a stake through specialty physician practices
  • Eerie! Google’s monstrous AI podcasts leave me petrified
  • Zoinks! Join the vampire hunters at Drug Channels Institute
Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
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How Field Reimbursement Services Help Overcome Coverage Barriers and Improve Patient Outcomes

Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds

Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services.

To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients.

Read on for Kimberley’s insights.
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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
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Drug Channels Outlook 2025 (NEW Live Video Webinar)

Adam J. Fein, Ph.D., president of Drug Channels Institute (DCI) and the author of Drug Channels, invites you to join him for DCI’s new live video webinar:


This event will be broadcast live on
Friday, December 13, 2024,
from 12:00 p.m. to 1:30 p.m. ET

This post describes the event and explains how to purchase a registration. (Or, just click here to order.) The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

This event is part of The Drug Channels 2024 Video Webinar Series. (Please note that our December 2024 webinar is *not* included with next year’s 2025 Video Webinar Series.)

WHAT YOU WILL LEARN

Join Dr. Fein as he helps you and your team get ready for 2025 by outlining key issues and uncertainties that will surely affect your planning. This event can be both a capstone of your annual learning and a touchpoint for the future. DCI’s Outlook webinars have proven to be reliable and informative guides to crucial aspects of the ever-evolving healthcare industry.

During the event, Dr. Fein will share his latest thinking and projections on a wide range of topics, including:
  • Latest predictions for the Inflation Reduction Act
  • Expectations for the Medicare Part D market in 2025 and beyond
  • Update on 340B Drug Pricing Program’s controversies
  • Impact of the new Trump administration and Congress on the drug channel
  • Vertical integration and consolidation trends—and prospects for dis-integration and de-consolidation
  • The state of biosimilar markets
  • What’s next for PBMs’ private label products and GPOs
  • Retail pharmacy’s future
  • Prospects for direct-to-patient channels
  • What’s ahead for discount cards and cash-pay pharmacies
  • The outlook for state and federal legislation on PBMs and the drug channel
  • Gross-to-net bubble developments
  • And much more!
PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions. The webinar will last at least 90 minutes to accommodate audience questions.

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data. He will draw from exclusive information found in DCI's economic reports .

Read on for full details on pricing and registration.
Read more »
       





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ACRO Announces Diversity and Inclusion Site Resource Grants Program

ACRO is pleased to announce the launch of the ACRO Diversity and Inclusion Site Resource Grants Program! The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities. “We are excited to invite […]

The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO.




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What does the FDA do after drugs are approved? (15 seconds)

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

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What does the FDA do after drugs are approved? (30 seconds)

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

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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How does the FDA approve new drugs? (15 seconds)

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

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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How does the FDA approve new drugs? (30 seconds)

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

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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¿Cómo aprueba la FDA los medicamentos nuevos?

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...

Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546




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¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos)

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

Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin.

Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug...




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Michelle E. Tarver, M.D., Ph.D.

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

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Center Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.

Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Learn more at www.fda.gov

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required. For more privacy and use information visit: www.flickr.com/people/fdaphotos/




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FDA reopens National Forensic Chemistry Center after expansion and renovation

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

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

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

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

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

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

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

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

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

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

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

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

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

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

FDA photo by Matthew MacRoberts




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FDA reopens National Forensic Chemistry Center after expansion and renovation

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

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

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

FDA photo by Matthew MacRoberts




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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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Orphan Drugs at 30: Will Success Become Too Expensive?

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.




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A Salmon on Every Plate/The Hard Road of Innovation

Chicken was once an expensive delicacy. In 1928, America’s quest for a better diet and a better standard of living was summarized by the campaign promise of “a chicken in every pot.” Today, chicken is a ubiquitous, low-cost source of protein, which we largely take for granted. Despite depletion of ocean-based stocks, fish hold similar potential. To begin this transformation, FDA must approve a scientifically-based innovative product—a faster growing genetically-engineered (GE) Atlantic salmon. When FDA Matters wrote about this subject 18 months ago, I believed the agency was near to approval of this first-ever food product from a GE animal. It is still not resolved and there are implications for all innovations that require FDA approval.




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Revised APRA Bill Clears House Subcommittee

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]




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Minnesota Becomes 18th State to Adopt Consumer Data Privacy Law

On May 24, Governor Tim Walz signed into law Minnesota’s new comprehensive data privacy law, the Minnesota Consumer Data Privacy Act (HF 4757 referenced as the MCDPA). The MCDPA goes into effect on July 31, 2025, with some exceptions for colleges and universities (who have until 2029). The MCDPA is similar to other state privacy laws, […]




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NY Passes Two Kids Privacy Bills to Restrict Access to Addictive Algorithmic Feeds

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]




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Rhode Island Governor Vetoes Consumer Data Privacy Act

On June 25th, Rhode Island Governor Daniel McKee transmitted without signature (effectively a pocket veto) the Rhode Island Data Transparency and Privacy Protection Act (SB 2500 / HB 7787). The act is based on the Washington Privacy Act model but diverges from the prevalent forms of that model in two ways. First, the act contains a unique […]




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FTC Revised Health Breach Notification Rule Goes into Effect

Agencies with healthcare clients in pharmaceuticals, healthcare services, digital health apps, or health-related connected devices such as wearables should take note that the Federal Trade Commission (FTC) final rule updating its Health Breach Notification Rule (HBNR) that took effect on July 29, 2024. The FTC considers a breach to include a covered entity’s unauthorized disclosure […]




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FTC Announces Final Rule to Prohibit Deceptive Online Reviews and Testimonials

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]




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California Adopts a Bundle of AI & Privacy Laws, Most Controversial Bills Vetoed (Updated)

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Massachusetts High Court Rules Online Tracking Doesn’t Violate State Wiretap Law

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  • Courts/First Amendment

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News About CardioBrief and CVCTCardioBrief

Note to readers: After a period of inactivity CardioBrief is coming back, but with some big differences. This website, CardioBrief.Org, will remain my personal website. A new website, CVCTCardiobrief.com, will be the new home for my “professional” blogging activities. To develop this website I have joined forces with the global CVCT Forum. I look forward to...

Click here to continue reading...




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Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease

It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...

Click here to continue reading...




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A COVID-19 Cardiac MRI Study: What Went Wrong?

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

Click here to continue reading...




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Should the ACC Have a Live Meeting?

I was surprised to learn from a recent press release that the American College of Cardiology is planning to have some live participants at its annual scientific sessions meeting in May. The college said it is also partnering with a technology company to offer these participants a wearable monitoring device “as an added safety measure...

Click here to continue reading...




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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>




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FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>




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NPRA Malaysia trials new timelines for variation applications

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>




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EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>




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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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RPS and pharmacy students' association call for rethink over overseas exam decision

The Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries.




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Government 'miscommunicated' PPE stock levels to pharmacies during first COVID-19 wave, MPs told

The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said.