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How Superman Helped Launch the Hubble Space Telescope

Long before it orbited Earth, the Hubble Space Telescope starred in a famous Superman comic




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New Prime Number, 41 Million Digits Long, Breaks Math Records

The discovery of a new prime number highlights the rising price of mathematical gold




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How the 2024 Election Could Change Access to Education in the U.S. and Influence Global Climate Change Decisions

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.




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Election Grief Is Real. Here’s How to Cope

Understanding the psychology of ambiguous loss can help people struggling with grief and depression in the wake of the 2024 election results




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Rainwater Could Help Satisfy AI’s Water Demands

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




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Consciousness Might Hide in Our Brain’s Electric Fields

A mysterious electromagnetic mechanism may be more important than the firing of neurons in our brain to explain our awareness




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Let African Communities Manage Their Climate Adaptation Plans

Outside groups often offer their solutions for climate adaptation in Africa. But the best people to manage the climate crisis are the people in those communities themselves. For climate adaptation to succeed in Africa, let communities and local leaders show the way




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The Lucy Fossil’s Extraordinary Journey to Becoming an Icon of Human Evolution

The 3.2-million-year-old human ancestor known as Lucy rose to fame through an incredible combination of circumstances




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Eko’s Newest CORE 500 Stethoscope: A Review

Arriving in two boxes reminiscent of Apple product packaging – one for the chest piece (the part that contacts the body), and another for the detachable earpiece (tubes + ear tips) – the CORE 500 is clearly an upgrade from the Eko DUO stethoscope. Similar to its predecessor, the CORE 500 can be used with […]




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Robotic Ankle Helps with Postural Control in Amputees

Researchers at North Carolina State University have developed a robotic prosthetic ankle that can provide stability for lower limb amputees. The ankle uses electromyographic sensors placed on the sites of muscles in the residual limb that then convey the intentions of the wearer with regard to movement. So far, the system has been shown to […]




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A Wearable to Manage Parkinson’s Motor Symptoms: Interview with Lucy Jung, CEO at Charco Neurotech

Charco Neurotech, a medtech company based in the United Kingdom, has developed CUE1, a non-invasive wearable that is intended to assist those with Parkinson’s disease to manage their motor symptoms. The device is typically affixed to the sternum, and provides vibratory action in a focused region of the body. The technology is based on the […]




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Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

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.
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.
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Informa Connnect's Pharma/Biotech GTN Summit

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

View the Complete Agenda

Book Your Place

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

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

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

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

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


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




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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.

Read more »
       




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Informa Connect's Copay, Reimbursement and Access Congress

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

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

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

Why attend the Copay, Reimbursement and Access Congress?

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

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

See you there!

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



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

       




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Hospitals Are Relying More on PBMs to Manage Manufacturers' 340B Contract Pharmacy Restrictions: DCI's 2024 Market Analysis (rerun)

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.

Click here to see the original post from June 2024.



The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:
  • About 33,000 pharmacy locations—more than half of the entire U.S. pharmacy industry—act as contract pharmacies for the hospitals and federal grantees that participate in the 340B program. 
  • Five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market.
  • Federal grantees are aligned primarily with the vertically intergated organizations' retail pharmacies, while hospitals rely on mail and specialty pharmacies.
Over the past four years, manufacturers’ restrictions on 340B contract pharmacies have led hospitals to deepen their relationships with the largest PBMs—even as those PBMs have simultaneously limited hospitals’ direct participation in specialty pharmacy networks.

For an updated look at what’s next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D., on June 21 for his latest live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook.
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Another IRA Surprise: Part B Coinsurance Inflation Adjustments Are Increasing Patient Costs (rerun)

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.

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. Last night, I posted an updated analysis showing that the volatility in seniors' coinsurance rates continues. For the fourther quarter of 2024, coinsurance rates for 51 drugs increased, while rates for only 19 drugs decreased. What's more, rates for 17 drugs returned to their original 20% level. Click here to see our original post from May 2024.



Contrary to what you may have heard, the Inflation Reduction Act’s (IRA) inflation rebates for Medicare Part B drugs do not always save money for seniors.

As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing, not declining. In many cases, the coinsurance rate declines only briefly before rebounding back to the standard 20% rate. What’s more, these fluctuations have triggered huge jumps in patients’ out-of-pocket obligations for some drugs—even when a drug’s costs were falling.

Chalk off these coinsurance surprises to yet another unintended consequence of the IRA. Seniors who are expecting to see costs drop may find they are instead being taken for a rollercoaster ride.
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Informa Connect’s PBM Contracting Summit

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

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

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

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

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

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


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




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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.
Read more »
       




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Informa Connect’s Trade and Channel Strategies

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

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

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

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

Why do trade and channel professionals choose this pivotal event?

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

WHAT CAN YOU EXPECT?

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

See you there!

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


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




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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.
Read more »
       




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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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What is FDA’s role in regulating drugs? (15 seconds)

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

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What is FDA’s role in regulating drugs? (30 seconds)

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

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? 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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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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FDA Post-Election: Continuity and Progress Likely to Mark 2013

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/.




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More Columns Coming; The Alliance for a Stronger FDA

FDA Matters appreciates your patience. New columns will be coming in June, with fresh insights into FDA and the FDA-regulated world.  Meantime, I write a weekly column in the Friday Update, published by the Alliance for a Stronger FDA. If you want to receive the Friday Update when it's published each week, you can sign […]




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

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FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships

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

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




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

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  • Courts/First Amendment

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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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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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Medicines for Europe 23rd Regulatory Affairs Conference 2025

<p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>




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Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>




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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.




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Pharmacy negotiators in talks over plans to distribute COVID-19 treatments in primary care

The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care.




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Prime minister vows to reimburse community pharmacy's COVID-19 costs 'as soon as possible'

Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal.




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Risk of mortality drops in COVID-19 patients given anticoagulation within a day of hospital admission, research finds

Starting COVID-19 patients on prophylactic anticoagulation within 24 hours of being admitted to hospital has been linked to a reduced risk of mortality.




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Everything you should know about the coronavirus pandemic

The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public.




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MHRA to consult on making two progestogen-only contraceptives available without a prescription

Consultations on the reclassification of two progestogen-only contraceptive pills from prescription-only to pharmacy medicines have been launched.