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Arden's Day Blog

Arden's Day is a type I diabetes care giver blog written by author Scott Benner. Scott has been a stay-at-home dad since 2000, he is the author of the award winning parenting memoir, 'Life Is Short, Laundry Is Eternal'. Arden's Day is an honest and transparent look at life with diabetes - since 2007.

type I diabetes, parent of type I child, diabetes Blog, OmniPod, DexCom, insulin pump, CGM, continuous glucose monitor, Arden, Arden's Day, Scott Benner, JDRF, diabetes, juvenile diabetes, daddy blog, blog, stay at home parent, DOC, twitter, Facebook, @ardensday, 504 plan, Life Is Short, Laundry Is Eternal, Dexcom SHARE, 生命是短暂的,洗衣是永恒的, Shēngmìng shì duǎnzàn de, xǐyī shì yǒnghéng de

Filtering by Category: Type I News

Juicebox Podcast in Diabetes Forecast Magazine!

Scott Benner

Diabetes podcasts in the spotlight!

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A huge thanks to Diabetes Forecast Magazine for spending some ink on the podcasts dedicated to people living with type 1 diabetes. You can listen to my show below or follow the link to Diabetes Forecast to see the others highlighted.

Apple Podcasts - http://bit.ly/JBPAPod
Android - http://bit.ly/jbpandroid
Spotify - http://bit.ly/JBPspot
Google Play - http://bit.ly/JBPGoogplay
or JuiceboxPodcast.com

 

Check out the latest edition of Diabetes Forecast Magazine… on your newsstand now.


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Statement from FDA Commissioner on Insulin Pricing

Scott Benner

The FDA has issued a statement intended to spur competition and lower prices. I’ve pulled out and included a few passages that are about insulin. You can read the entire statement as written here.

from FDA.gov

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework.

There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.

We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible.

We’re also releasing today two critical guidance documents that describe how the agency plans to implement Congress’ direction that we transition certain biological products currently approved as drugs under the FD&C Act to be licensed as biologics under the PHSA.

Transitioning these drugs to the PHSA will let them to be treated as biologics under that law. And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic.

Starting in March 2020, the approved marketing applications for the small subset of “biological products” such as insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA. Sponsors have known about this transition for a decade. They’ve had time to prepare.

As a result, we’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive. These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.

Today, we’re laying out our policy on how these products will transition from the drug pathway to the biologics pathway, and in so doing, how we intend to use this new framework to promote competition. The two guidance documents we’re releasing today, one final and one draft, describe how the FDA intends to accomplish the transition of these products under the “Deemed to be a License” provision of the BPCI Act. The final guidance deals with “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009,” finalizes the FDA’s draft guidance from 2016.

We’ve shaped these policies to implement the intent of Congress, and to make sure a few things happen. First, that the anti-evergreening provisions under the biosimilars legislation – meant to prevent sponsors from being able to game the exclusivity provisions to forestall biosimilar entry – will apply to these newly deemed products, including insulin.


Omnipod + Fiasp is cleared in Europe

Scott Benner

press release

Omnipod® Insulin Management System Now Available for Use in Europe with Fiasp® Fast-Acting Insulin

LONDON--(BUSINESS WIRE)--Oct. 2, 2018-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that Novo Nordisk’s Fiasp® (Fast-Acting Insulin Aspart) has been tested and found safe for use in Insulet’s Omnipod System in Europe. Fiasp® is a new-generation, ultra fast-acting insulin developed by Novo Nordisk that enters the bloodstream two times faster, compared to NovoRapid®, so it more closely matches a healthy body’s insulin response to a meal, thereby improving glycemic control. Insulet will showcase its Omnipod System during the European Association for the Study of Diabetes (EASD) annual meeting at the Messe Berlin Exhibition Halls in Berlin, Germany taking place 1st October to 5thOctober 2018.

This is the first European conference presence for Insulet since the Company assumed direct operations of its Omnipod System product line in Europe. At its booth (#3.P05), the Company will highlight the history of its innovation, from the current Omnipod System to its Omnipod Horizon™ Automated Glucose Control System currently in development. Insulet will also feature the Pod Challenge – an opportunity for attendees to wear a sample Pod to experience the freedom it allows patients.

“Our European team is thrilled for this opportunity to engage with leading regional healthcare practitioners and advocacy groups to showcase the unique benefits of our Omnipod System,” said DJ Cass, General Manager, Insulet Europe. “The addition of Fiasp for use with the Omnipod System provides another option for both patients and prescribers to support their diabetes management needs. EASD is an important venue for direct contact with the diabetes community across Europe so they can see firsthand how our innovative product will help make diabetes a smaller part of their patients’ lives.”

“It is encouraging to see that Fiasp keeps expanding its reach, potentially benefiting more people in need of it via the Insulet Omnipod System,” said Stephen Gough, Global Chief Medical Officer of Novo Nordisk. “With its ultra-fast acting profile, Fiasp has brought a new option for adults living with diabetes who require insulin to manage their post-meal spikes, and I am confident that they will find in Fiasp and the Omnipod System good allies to best manage their diabetes.”

Learn more about Omnipod today


My Father-Son Relationship interview with the BBC

Scott Benner

I was contacted recently by BBC World Services and asked to be part of a report they were doing about the relationships between fathers and sons. I want to thank reporter Nastaran Tavakoli-Far for using some of what I shared in her piece. It was incredibly interesting to listen while not knowing how much, if any, of what I shared would be used. The report is about 25 minutes long and features a number of fathers from all walks of life. Enjoy!

You can subscribe to the show here or listen online here… they cover a mired of topics.


Molly Fichtner named Head Coach at the University of Louisiana

Scott Benner

Congratulations to former Alabama catcher (and former Juicebox Podcast guest) Molly Fichtner on being named the Head Coach of the softball program at the University of Louisiana!

from SunBeltSports.org

Molly has an incredible passion for the game and is a tremendous leader. I look forward to seeing her impact and elevate the ULM softball program and having her in Louisiana.
— Jennie Finch, Olympic Gold Medalist

Molly Fichtner, who has seen success at the highest levels of the game, has been named ULM's seventh head softball coach, as announced by interim athletics director Scott McDonald on Friday, Sept. 21. The Houston, Texas, native has spent the last year as an assistant coach at East Carolina University. The appointment is pending approval by the University of Louisiana system's Board of Supervisors.
 
"Molly is highly-respected within the coaching community and her academic achievements garnered as a student-athlete have transferred over into her coaching career, leading her to great heights, and thankfully ULM," ULM Interim Athletics Director Scott McDonald said. "She has an outstanding reputation for player development and proven success in promoting the importance of academics with student-athletes. We are elated to have Molly join us at ULM, and we are thrilled about the impact she's going to have on the softball program and the community."
 
Fichtner makes the transition to ULM from Greenville where she was an assistant coach for the ECU softball program. Before her time with the Pirates, Fichtner spent two seasons in the same role at Dartmouth College.
 
After her honor-filled collegiate career, Fichtner remained at Alabama as a volunteer coach while pursuing her master's degree. After finishing her master's degree in 2015, she played one season in the National Fastpitch (NPF) league with the Dallas Charge.

You can read the rest of the article here.

Watch Molly’s press conference and listen to her appearance on the Juicebox Podcast.