v Best Practices for Successfully Transitioning a Patient Services Hub By feeds.feedblitz.com Published On :: Fri, 20 Sep 2024 10:30:00 +0000 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. Read more » Full Article Guest Post Sponsored Post
v 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 By feeds.feedblitz.com Published On :: Tue, 24 Sep 2024 10:30:00 +0000 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. Read more » Full Article Benefit Design Biosimilars Buy-and-Bill Copay Accumulator Adjustment Gross-to-Net Bubble PBMs Specialty Drugs Wholesalers
v NEW: The Drug Channels 2025 Video Webinar Series By feeds.feedblitz.com Published On :: Wed, 25 Sep 2024 10:00:00 +0000 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. Read more » Full Article Industry Trends Video
v The Pivotal Role of Technology in Delivering Effective Patient Services By feeds.feedblitz.com Published On :: Fri, 27 Sep 2024 04:00:00 +0000 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 Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage. Read on for George’s insights. Read more » Full Article Guest Post Sponsored Post
v Innovative Models for Improving Access and Visibility for Specialty-Lite and Retail Therapies By feeds.feedblitz.com Published On :: Fri, 04 Oct 2024 11:23:00 +0000 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. Read more » Full Article Guest Post Sponsored Post
v NOW AVAILABLE: 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors By feeds.feedblitz.com Published On :: Tue, 08 Oct 2024 10:30:00 +0000 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. Download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) Review pricing/license options and download the full 2024-25 report 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. Read more » Full Article Industry Trends Wholesalers
v Five Crucial Trends Facing U.S. Drug Wholesalers in 2024 and Beyond By feeds.feedblitz.com Published On :: Wed, 09 Oct 2024 10:30:00 +0000 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) Read more » Full Article Gross-to-Net Bubble Hospitals Industry Trends Mergers and Acquisitions Pharmacy Physicians Wholesalers
v As MFP Approaches, Transparency Is More Important Than Ever By feeds.feedblitz.com Published On :: Fri, 11 Oct 2024 10:30:00 +0000 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. Read more » Full Article Guest Post Sponsored Post
v The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions By feeds.feedblitz.com Published On :: Tue, 22 Oct 2024 10:30:00 +0000 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). Read more » Full Article 340B Channel Management Gross-to-Net Bubble Hospitals Inflation Reduction Act of 2022 PBMs Pharmacy Specialty Drugs
v No More Delays: Accelerating Therapy Starts by Embedding Hub Services in Provider Workflows By feeds.feedblitz.com Published On :: Fri, 25 Oct 2024 05:00:00 +0000 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 Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage. Read on for Shabbir’s insights. Read more » Full Article Guest Post Sponsored Post
v 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 By feeds.feedblitz.com Published On :: Tue, 29 Oct 2024 10:30:00 +0000 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. Read more » Full Article Average Sales Price (ASP) Biosimilars Buy-and-Bill Gross-to-Net Bubble Inflation Reduction Act of 2022 PBMs Physicians
v How Field Reimbursement Services Help Overcome Coverage Barriers and Improve Patient Outcomes By feeds.feedblitz.com Published On :: Fri, 01 Nov 2024 11:00:00 +0000 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. Read more » Full Article Guest Post Sponsored Post
v Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive By feeds.feedblitz.com Published On :: Mon, 04 Nov 2024 11:00:00 +0000 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? Read more » Full Article Average Sales Price (ASP) Biosimilars Buy-and-Bill Costs/Reimbursement Hospitals Specialty Drugs
v Drug Channels Outlook 2025 (NEW Live Video Webinar) By feeds.feedblitz.com Published On :: Tue, 12 Nov 2024 11:30:00 +0000 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: Drug Channels Outlook 2025 This event will be broadcast live onFriday, 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 » Full Article
v ACRO Announces Diversity and Inclusion Site Resource Grants Program By www.businesswire.com Published On :: Mon, 15 Apr 2024 11:00:00 +0000 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. The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO. Full Article Press Releases
v ACRO Announces Diversity and Inclusion Site Resource Grants Program By www.acrohealth.org Published On :: Wed, 17 Apr 2024 12:00:00 +0000 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. Full Article Newsletter
v What does the FDA do after drugs are approved? (15 seconds) By www.flickr.com Published On :: Mon, 12 Aug 2024 11:42:18 -0700 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). Full Article
v What does the FDA do after drugs are approved? (30 seconds) By www.flickr.com Published On :: Mon, 12 Aug 2024 11:42:19 -0700 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). Full Article
v How does the FDA approve new drugs? (15 seconds) By www.flickr.com Published On :: Mon, 12 Aug 2024 11:48:34 -0700 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). Full Article
v How does the FDA approve new drugs? (30 seconds) By www.flickr.com Published On :: Mon, 12 Aug 2024 11:48:34 -0700 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). Full Article
v ¿Cómo aprueba la FDA los medicamentos nuevos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:27 -0700 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 Full Article
v ¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:19:23 -0700 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... Full Article
v Michelle E. Tarver, M.D., Ph.D. By www.flickr.com Published On :: Wed, 21 Aug 2024 08:42:37 -0700 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/ Full Article
v FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:40:56 -0700 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 Full Article
v FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:46:59 -0700 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 Full Article
v FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:47:49 -0700 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 Full Article
v FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:48:25 -0700 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 Full Article
v FDA reopens National Forensic Chemistry Center after expansion and renovation By www.flickr.com Published On :: Wed, 02 Oct 2024 13:49:15 -0700 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 Full Article
v Off-Label Promotion: Best Resolved by Congress, Not Courts By www.fdamatters.com Published On :: Wed, 12 Dec 2012 20:25:56 +0000 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. Full Article Drug Approval and Access FDA and Congress FDA and Industry Insight on FDA-regulated Industries
v Orphan Drugs at 30: Will Success Become Too Expensive? By www.fdamatters.com Published On :: Mon, 14 Jan 2013 19:09:11 +0000 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. Full Article FDA and Congress FDA and Industry Orphan Drugs
v A Salmon on Every Plate/The Hard Road of Innovation By www.fdamatters.com Published On :: Thu, 14 Mar 2013 18:32:50 +0000 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. Full Article FDA and Congress FDA and Industry FDA Leadership Food Issues
v Revised APRA Bill Clears House Subcommittee By cohealthcom.org Published On :: Wed, 05 Jun 2024 13:51:45 +0000 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 […] Full Article Data Privacy Legislative Washington Focus APRA child data privacy consumer privacy data privacy data privacy legislation federal legislation Jim Potter
v Minnesota Becomes 18th State to Adopt Consumer Data Privacy Law By cohealthcom.org Published On :: Wed, 05 Jun 2024 15:27:53 +0000 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, […] Full Article Data Privacy Legislative consumer privacy data privacy legislation Minnesota MN Washington Privacy Act
v NY Passes Two Kids Privacy Bills to Restrict Access to Addictive Algorithmic Feeds By cohealthcom.org Published On :: Wed, 12 Jun 2024 13:03:44 +0000 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 […] Full Article Data Privacy Legislative Addictive Algorithms child data privacy data privacy legislation New York NY
v Rhode Island Governor Vetoes Consumer Data Privacy Act By cohealthcom.org Published On :: Wed, 03 Jul 2024 14:32:46 +0000 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 […] Full Article Data Privacy Legislative consumer privacy data privacy legislation Rhode Island RI veto Washington Privacy Act
v FTC Revised Health Breach Notification Rule Goes into Effect By cohealthcom.org Published On :: Mon, 29 Jul 2024 14:43:12 +0000 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 […] Full Article Regulatory/FDA Federal Trade Commission final rule FTC Good Rx HBRN Jim Potter PHI privacy
v FTC Announces Final Rule to Prohibit Deceptive Online Reviews and Testimonials By cohealthcom.org Published On :: Thu, 22 Aug 2024 18:56:13 +0000 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 […] Full Article Regulatory/FDA Endorsement Guide FAQs FTC guidance Jim Potter
v California Adopts a Bundle of AI & Privacy Laws, Most Controversial Bills Vetoed (Updated) By cohealthcom.org Published On :: Mon, 30 Sep 2024 19:05:07 +0000 Sorry, but you do not have permission to view this content. Full Article Artificial Intelligence (AI) Data Privacy Legislative child data privacy CO Colorado consumer privacy data privacy legislation Jim Potter
v Massachusetts High Court Rules Online Tracking Doesn’t Violate State Wiretap Law By cohealthcom.org Published On :: Wed, 30 Oct 2024 12:23:03 +0000 Sorry, but you do not have permission to view this content. Full Article Courts/First Amendment
v News About CardioBrief and CVCTCardioBrief By www.cardiobrief.org Published On :: Fri, 17 Jul 2020 14:49:51 +0000 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... Full Article People Places & Events CVCT
v Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease By www.cardiobrief.org Published On :: Thu, 20 Aug 2020 15:56:47 +0000 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... Full Article Interventional Cardiology & Surgery People Places & Events Policy & Ethics CABG guidelines left main disease LMCA PCI
v A COVID-19 Cardiac MRI Study: What Went Wrong? By www.cardiobrief.org Published On :: Mon, 24 Aug 2020 22:30:07 +0000 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... Full Article People Places & Events Policy & Ethics Prevention Epidemiology & Outcomes COVID-19 MRI scientific misconduct
v Should the ACC Have a Live Meeting? By www.cardiobrief.org Published On :: Mon, 25 Jan 2021 17:18:49 +0000 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... Full Article People Places & Events Policy & Ethics Prevention Epidemiology & Outcomes American College of Cardiology COVID-19 pandemic Scientific Sessions
v EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz By www.gabionline.net Published On :: Wed, 23 Oct 2024 08:39:24 +0000 <p>On 19 September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p> Full Article
v FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli By www.gabionline.net Published On :: Tue, 29 Oct 2024 09:49:30 +0000 <p>The US Food and Drug Administration (FDA) granted approval for two 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 Johnson & Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p> Full Article
v NPRA Malaysia trials new timelines for variation applications By www.gabionline.net Published On :: Tue, 05 Nov 2024 09:13:55 +0000 <p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications of registered pharmaceutical products and natural health supplements (TMHS).</p> Full Article
v EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi By www.gabionline.net Published On :: Tue, 05 Nov 2024 09:15:00 +0000 <p>The European Commission (EC) granted marketing authorization for<b> </b>three ustekinumab biosimilars<b>: </b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.</p> Full Article
v Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/ biosimilars development and market expansion By www.gabionline.net Published On :: Fri, 08 Nov 2024 13:18:16 +0000 <p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i> </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 immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p> Full Article
v RPS and pharmacy students' association call for rethink over overseas exam decision By www.pharmaceutical-journal.com Published On :: Tue, 9 Feb 2021 16:42 GMT 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. Full Article
v Government 'miscommunicated' PPE stock levels to pharmacies during first COVID-19 wave, MPs told By www.pharmaceutical-journal.com Published On :: Wed, 10 Feb 2021 12:17 GMT 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. Full Article