and How the 2024 Election Could Change Access to Education in the U.S. and Influence Global Climate Change Decisions By www.scientificamerican.com Published On :: Mon, 04 Nov 2024 11:00:00 +0000 The outcome of the 2024 U.S. presidential election could set the climate agenda, reshape public education and shift the dynamics of global science collaboration. Full Article
and Rainwater Could Help Satisfy AI’s Water Demands By www.scientificamerican.com Published On :: Thu, 07 Nov 2024 13:00:00 +0000 A few dozen ChatGPT queries cost a bottle’s worth of water. Tech firms should consider simpler solutions, such as harvesting rainwater, to meet AI’s needs Full Article
and What Trump Can—And Probably Can’t—Do to Reverse U.S. Climate Policy By www.scientificamerican.com Published On :: Fri, 08 Nov 2024 17:30:00 +0000 The new president-elect can go beyond just pulling out of the Paris Agreement. But it may be more difficult to roll back clean energy policies Full Article
and Water under Threat, Wooden Satellites and a Mud Bath for Baseballs By www.scientificamerican.com Published On :: Mon, 11 Nov 2024 11:00:00 +0000 Droughts in 48 of 50 U.S. states, evidence of microplastics mucking up wastewater recycling and the science of a baseball mud bath in this week’s news roundup. Full Article
and Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors By feeds.feedblitz.com Published On :: Tue, 17 Sep 2024 10:30:00 +0000 On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. 9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8. Review pricing/license options and place a preorder Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) 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. Special preorder and launch pricing discounts will be valid through October 23, 2024. Read on for more details. Read more » Full Article Biosimilars Buy-and-Bill Channel Management Group Purchasing Organizations (GPOs) Industry Trends Inflation Reduction Act of 2022 Physicians Specialty Drugs Wholesalers
and 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
and Informa Connect's Copay, Reimbursement and Access Congress By feeds.feedblitz.com Published On :: Mon, 30 Sep 2024 04:30:00 +0000 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). Full Article Sponsored Post
and Why PBMs and Payers Are Embracing Insulin Biosimilars with Higher Prices—And What That Means for Humira (rerun with an FTC update) By feeds.feedblitz.com Published On :: Tue, 01 Oct 2024 10:30:00 +0000 This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs). The FTC rightly calls out how the gross-to-net bubble can raise patients’ out-of-pocket costs, while also acknowledging how rebates can reduce a plan's (but not the patient’s) costs. Apparently, the FTC believes that PBMs’ customers are pretty dumb, because PBMs are able to prevent plans from “appreciating” such healthcare financing dynamics. Section V.E. of the complaint (starting on page 23) focuses on the PBMs’ alleged unlawful conduct related to preferring high-list/high-rebate insulin products over versions with lower list prices. I thought it would therefore be fun to take the Wayback Machine to November 2021, when I wrote about this specific topic.Below, you can review my commentary about the warped incentives behind Viatris’ dual-pricing strategy for its interchangeable biosimilar of Lantus. Much of the FTC’s description of the drug channel aligns with my commentary. But before you fist pump too hard for Ms. Khan’s FTC, you should pause to reflect on the agency’s legal theories in light of plans’ revealed preferences. The Food & Drug Administration (FDA) recently approved the first interchangeable biosimilar insulin product: the insulin glargine-yfgn injection from Viatris. Read the FDA’s press release. Alas, I’m sad to report that the warped incentives baked into the U.S. drug channel will limit the impact of this impressive breakthrough. Viatris is being forced to launch both a high-priced and a low-priced version of the biosimilar. However, only the high-list/high-rebate, branded version will be available on Express Scripts’ largest commercial formulary. Express Scripts will block both the branded reference product and the lower-priced, unbranded—but also interchangeable—version. Meanwhile, Prime Therapeutics will place both versions on its formularies, leaving the choice up to its plan sponsor clients. Consequently, many commercial payers will adopt the more expensive product instead of the identical—but cheaper—version. As usual, patients will be the ultimate victims of our current drug pricing system. Below, I explain the weird economics behind this decision, highlight the negative impact on patients, and speculate on what this all could mean for biosimilars’ future. Until plan sponsors break their addiction to rebates, today’s U.S. drug channel problems will remain. Read more » Full Article Benefit Design Biosimilars Costs/Reimbursement Gross-to-Net Bubble PBMs
and 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
and 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
and 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
and Informa Connect’s Trade and Channel Strategies By feeds.feedblitz.com Published On :: Mon, 21 Oct 2024 11:00:00 +0000 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). Full Article
and 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
and 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
and 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
and 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
and How the Perfect Storm Will Impact Patient Support Programming in 2025 and Beyond By feeds.feedblitz.com Published On :: Fri, 08 Nov 2024 05:23:00 +0000 Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx. Chris examines three key trends that will affect patient support programs: the Inflation Reduction Act (IRA), legal/regulatory battles over copay adjustment programs, and uncertainties following a national election. He then outlines three actions that should guide manufacturers' preparation. To learn more, register for ConnectiveRx’s free webinar on December 11: The Perfect Storm? Patient Support Programming in 2025 and Beyond. Read on for Chris’s insights. Read more » Full Article Guest Post Sponsored Post
and 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
and 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
and 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
and 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
and 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
and 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
and 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
and New On-Demand Training Platform By regulatoryrx.blogspot.com Published On :: Mon, 02 May 2022 12:00:00 +0000 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. Full Article APLB FDA On-demand OPDP SEM SEO training
and FDA Post-Election: Continuity and Progress Likely to Mark 2013 By www.fdamatters.com Published On :: Tue, 29 Jan 2013 22:51:00 +0000 Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad. In particular, medical innovation seems poised to flourish in an FDA environment where there is continuity of policy and leadership, instead of a new team learning the ropes. I explore this and other themes in the latest issue of Pharmaphorum.com. You can read my thoughts at: http://www.pharmaphorum.com/2013/01/29/fda-post-election-continuity-and-progress-likely-to-mark-2013/. Full Article Drug Approval and Access FDA Appropriations FDA Leadership Planning for FDA's Future
and 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
and 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
and FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships By cohealthcom.org Published On :: Fri, 18 Oct 2024 20:56:52 +0000 Sorry, but you do not have permission to view this content. Full Article Regulatory/FDA Federal Trade Commission final rule FTC Good Rx HBRN Jim Potter PHI privacy
and Former CHC Board Chairs Sharon Callahan and Nick Colucci Named as 2025 MAHF Inductees By cohealthcom.org Published On :: Fri, 25 Oct 2024 20:39:55 +0000 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 […] Full Article CHC News chc MAHF Nick Colucci Sharon Callahan
and 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
and 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
and The Decline of Science In the Pandemic By www.cardiobrief.org Published On :: Wed, 16 Sep 2020 14:13:24 +0000 Early in the pandemic there was a widespread belief that science would be our salvation. With the help of science we would be spared the worst consequences, such as occurred during the 1918 Spanish flu pandemic. A vaccine would arrive, reliably, after a few hard months of research, and in short order the problem would...Click here to continue reading... Full Article Policy & Ethics COVID-19 pandemic science
and Cardiology Research: Business As Usual During the Pandemic By www.cardiobrief.org Published On :: Thu, 29 Oct 2020 16:33:14 +0000 At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...Click here to continue reading... Full Article Epidemiology & Outcomes People Places & Events Policy & Ethics coronavirus COVID-19 pandemic research agenda
and Skeptics and the Pandemic By www.cardiobrief.org Published On :: Mon, 06 Sep 2021 13:31:09 +0000 I recently posted the following thread on Twitter: I am so disappointed by the large number of pre-pandemic medical skeptics who have now turned into mask/vaccine skeptics. I largely agreed with many of them back in the day. /1 Pre-pandemic they used their skills and intelligence to rightfully question whether, say, a stent should be inserted...Click here to continue reading... Full Article People Places & Events Policy & Ethics Prevention Epidemiology & Outcomes COVID-19 masks pandemic skeptics vaccines
and 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
and 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
and Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206 By www.gabionline.net Published On :: Tue, 05 Nov 2024 09:14:16 +0000 <p>In October 2024, China based Bio-Thera Solutions (Bio-Thera) and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab).</p> Full Article
and 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
and 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
and Regulator looking at 'flexibility' that would allow overseas candidates to sit registration assessment By www.pharmaceutical-journal.com Published On :: Thu, 11 Feb 2021 14:53 GMT The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence. Full Article
and Nearly 200 women were prescribed valproate during pregnancy between April 2018 and September 2020 By www.pharmaceutical-journal.com Published On :: Fri, 12 Feb 2021 15:47 GMT Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed. Full Article
and Everything you should know about the coronavirus pandemic By www.pharmaceutical-journal.com Published On :: Mon, 15 Feb 2021 11:25 GMT The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public. Full Article
and Overseas candidates will be allowed to sit registration assessment remotely, regulator says By www.pharmaceutical-journal.com Published On :: Tue, 16 Feb 2021 12:05 GMT The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home. Full Article
and NHS England lowers threshold for COVID-19 vaccination site applications By www.pharmaceutical-journal.com Published On :: Wed, 17 Feb 2021 12:13 GMT Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said. Full Article
and RPS pays tribute to pharmacy law and ethics pioneer Joy Wingfield By www.pharmaceutical-journal.com Published On :: Fri, 19 Feb 2021 16:10 GMT The Royal Pharmaceutical Society has expressed its sadness at the death of Joy Wingfield, honorary professor of Pharmacy Law and Ethics at the University of Nottingham. Full Article
and IFM’s Hat Trick and Reflections On Option-To-Buy M&A By lifescivc.com Published On :: Wed, 13 Mar 2024 11:00:37 +0000 Today IFM Therapeutics announced the acquisition of IFM Due, one of its subsidiaries, by Novartis. Back in Sept 2019, IFM granted Novartis the right to acquire IFM Due as part of an “option to buy” collaboration around cGAS-STING antagonists for The post IFM’s Hat Trick and Reflections On Option-To-Buy M&A appeared first on LifeSciVC. Full Article Capital efficiency Exits IPOs M&As External R&D IFM option deals Option To Buy
and Lessons From A Private Funding Round: Science, Relationships, And Experience By lifescivc.com Published On :: Tue, 02 Apr 2024 11:00:46 +0000 By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “refreshing burst of enthusiasm” in the biotech sector. It’s true The post Lessons From A Private Funding Round: Science, Relationships, And Experience appeared first on LifeSciVC. Full Article Biotech financing From The Trenches Fundraising CFTR Sionna Therapeutics
and The Biotech Startup Contraction Continues… And That’s A Good Thing By lifescivc.com Published On :: Fri, 26 Apr 2024 11:00:38 +0000 Venture creation in biotech is witnessing a sustained contraction. After the pandemic bubble’s over-indulgence, the venture ecosystem appears to have reset its pace of launching new startups. According to the latest Pitchbook data, venture creation in biotech hit its slowest The post The Biotech Startup Contraction Continues… And That’s A Good Thing appeared first on LifeSciVC. Full Article Biotech financing Biotech investment themes Capital markets Fundraising Biotech startups venture creation
and Stars and Scars… Some Lessons Learned About Leadership By lifescivc.com Published On :: Thu, 02 May 2024 11:00:41 +0000 By Arthur O. Tzianabos, PhD, CEO of Lifordi Immunotherapeutics, as part of the From the Trenches feature of LifeSciVC As the biotech industry continues to pick up steam, I have been getting a number of phone calls from folks in The post Stars and Scars… Some Lessons Learned About Leadership appeared first on LifeSciVC. Full Article Corporate Culture From The Trenches Leadership