The Association of British HealthTech Industries (ABHI) is excited to unveil a diverse delegation of UK HealthTech innovators at MEDICA 2024, one of the world's largest and most influential medical trade fairs.

Ampacet has introduced ProVital+ Gamma-Protect, a medical-grade additive designed to preserve mechanical and optical properties of polypropylene-based medical and pharmaceutical articles during gamma and e-beam sterilisation processes.

In this episode of The MedTalk Podcast, we're bringing you something a little different. One of our sister publications, European Pharmaceutical Manufacturer, secured an interview with Thermo Fisher Scientific's Urmi Prasad Richardson.

A review of 47,282 tree species by the International Union for Conservation of Nature found that more than one third are at risk of extinction

Scientific American staff and sleep experts share advice on how to get better sleep in the stressful days leading up to the U.S. presidential election—and those that come after

No, but the direction of our hair whorls could teach us about human development

A strange supernova remnant first appeared as a “guest star” seen in 1181 by sky watchers in China and Japan

The 2024 presidential election will have enormous consequences for the climate, and the health and future of children

Humans and pigs could both serve as mixing vessels for a bird flu–seasonal flu hybrid, posing a risk of wider spread

Efficient machines, paper ballots and human checks make the U.S. voting system robust

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.

Thousands of homes in Navajo and other tribal lands don’t have access to electricity. A $200-million federal funding effort aims to fix that problem with solar power and other clean energy

Several downballot races in the 2024 presidential election will carry implications for climate policy far beyond state lines

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

President-elect Trump vowed to promote fossil fuels, weaken pollution regulations and reverse Biden administration climate efforts

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

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

The new Trump administration is likely to reduce subsidies for Affordable Care Act insurance plans and roll back Medicaid coverage. Public health authorities worry that antivaccine activist Robert F. Kennedy, Jr., will be empowered

Focusing on size in health care might be doing more harm than good.

A fee created to push oil and gas companies to plug methane leaks could be axed by the incoming Trump administration, hampering efforts to curb the potent greenhouse gas

Today’s cannabis plant is highly cultivated and incredibly potent. Treating it like a commodity, and not a testable, regulated medicine, is hurting people

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 »

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 »

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.

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The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:Read more »

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.

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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.
Read more »

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 »

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 »

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 »

Today’s guest post comes from Greg Skalicky, President, EVERSANA and Faruk Abdullah, President, Professional Services & Chief Business Officer, EVERSANA

Greg and Faruk walk through the marketplace pressures driving Direct-to-Patient commercialization models. They argue that a technology-enabled infrastructure,  combined with clinical and reimbursement support specialists, can improve  patients' access to new therapies, shorten the time to therapy, and enable better overall clinical outcomes.

Click here to learn more about EVERSANA’s Direct-to-Patient care model.

Read on for Greg and Faruk’s insights.
Read more »

ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard and Kristen Surdam to discuss ACRO’s new D&I Site Resource Grants Program.

The post Bonus Episode: Fast Facts on the ACRO D&I Grants Program first appeared on ACRO.

Bonus Episode: Fast Facts on the ACRO D&I Grants Program ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristen Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the […]

The post Bonus Episode: ACRO’s Good Clinical Podcast first appeared on ACRO.

Today, ACRO is thrilled to announce the Good Clinical Podcast, where we take a look at the current state of clinical research and what direction the industry must head in to continue improving trials for patients. Host Sophia McLeod is joined by industry leaders to discuss the latest industry trends, cutting-edge innovation, and reflect on […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 1 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research. […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 2 first appeared on ACRO.

On the latest episode of ACRO’s Good Clinical Podcast, Nicole Stansbury (SVP, Global Clinical Operations, Premier Research) and Madeleine Whitehead (RBQM Product & People Lead, Roche) join the podcast to discuss ACRO’s collaboration with TransCelerate BioPharma, Inc., the impact that ICH E6(R3) will have on Good Clinical Practice, and implications for innovation. They dive deeper […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 3 first appeared on ACRO.

RBQM: Moving Beyond a Belt & Suspenders Approach to Data Quality On the latest episode of ACRO’s Good Clinical Podcast, Danilo Branco (Director, Central Monitoring Operations, Fortrea), Cris McDavid (Director, Global Clinical Operations, RBQM, Parexel), and Valarie McGee (Senior Director, Clinical Systems Optimization, the PPD Clinical Research Business of Thermo Fisher Scientific) join the podcast […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 5 first appeared on ACRO.

The State of Clinical Trials in the UK: 2024 Update On the season 2 finale of ACRO’s Good Clinical Podcast, Steve Cutler (CEO, ICON plc) and Professor Lucy Chappell (CEO, NIHR) join the podcast to discuss the current clinical research landscape in the UK. They dive deeper into the competitive nature of bringing clinical research to a country, process-related challenges that need to […]

The post Listen Now: ACRO’s Good Clinical Podcast Episode 6 first appeared on ACRO.

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).

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).

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

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

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

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

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

FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions. Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity. Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

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 […]

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 […]

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 […]

No, CRISPR gene editing technology is not going to “cure” heart disease. But a New York Times story by Gina Kolata on an extremely early study in animals prominently plays up just this extremely unlikely claim. The Times story is based on a press release issued by Verve Therapeutics, a new biotechnology company founded by Sekar Kathiresan, an influential cardiologist and genomic...

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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...

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<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>